Evidence Report/Technology Assessment 

Number 122

Knowledge and Access to Information on 

Recruitment of Underrepresented 

Populations to Cancer Clinical Trials 

Prepared For: 

Agency for Healthcare Research and Quality 

U.S. Department of Health and Human Services 

540 Gaither Road 

Rockville, MD 20850 

www.ahrq.gov 

Contract No. 290-02-0018 

Prepared by: 

Johns Hopkins University Evidence-based Practice Center 

The Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD 

Investigators 

Jean G. Ford, M.D. 

Mollie W. Howerton, Ph.D., M.P.H. 

Shari Bolen, M.D., M.P.H. 

Tiffany L. Gary, Ph.D. 

Gabriel Y. Lai, M.H.S. 

Jon Tilburt, M.D. 

M. Chris Gibbons, M.D., M.P.H. 

Charles Baffi, Ph.D., M.P.H. 

Renee F. Wilson, M.S. 

Carolyn J. Feuerstein, B.A. 

Peter Tanpitukpongse, B.A. 

Neil R. Powe, M.D., M.P.H., M.B.A. 

Eric B. Bass, M.D., M.P.H. 

AHRQ Publication No. 05-E019-2 

June 2005
This report may be used, in whole or in part, as the basis for development of clinical practice 

guidelines and other quality enhancement tools, or a basis for reimbursement and coverage 

policies. AHRQ or U.S. Department of Health and Human Services endorsement of such 

derivative products may not be stated or implied. 

AHRQ is the lead Federal agency charged with supporting research designed to improve the 

quality of health care, reduce its cost, address patient safety and medical errors, and broaden access 

to essential services. AHRQ sponsors and conducts research that provides evidence-based 

information on health care outcomes; quality; and cost, use, and access. The information helps 

health care decisionmakers—patients and clinicians, health system leaders, and policymakers—

make more informed decisions and improve the quality of health care services. 
ii 

This document is in the public domain and may be used and reprinted without permission except 

those copyrighted materials noted for which further reproduction is prohibited without the 

specific permission of copyright holders. 

Suggested Citation: 

Ford JG, Howerton MW, Bolen S, Gary TL, Lai GY, Tilburt J, Gibbons MC, Baffi C, Wilson 

RF, Feuerstein CJ, Tanpitukpongse P, Powe NR, Bass EB. Knowledge and Access to 

Information on Recruitment of Underrepresented Populations to Cancer Clinical Trials. Evidence 

Report/Technology Assessment No. 122 (Prepared by the Johns Hopkins University Evidencebased Practice Center under Contract No. 290-02-0018.) AHRQ Publication No. 05-E019-2. 

Rockville, MD. Agency for Healthcare Research and Quality. June 2005. 
iii 

Preface 

 The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-Based 

Practice Centers (EPCs), sponsors the development of evidence reports and technology 

assessments to assist public- and private-sector organizations in their efforts to improve the 

quality of health care in the United States. The National Cancer Institute, National Institutes of 

Health, requested and provided funding for this report. The reports and assessments provide 

organizations with comprehensive, science-based information on common, costly medical 

conditions and new health care technologies. The EPCs systematically review the relevant 

scientific literature on topics assigned to them by AHRQ and conduct additional analyses when 

appropriate prior to developing their reports and assessments. 

 To bring the broadest range of experts into the development of evidence reports and health 

technology assessments, AHRQ encourages the EPCs to form partnerships and enter into 

collaborations with other medical and research organizations. The EPCs work with these partner 

organizations to ensure that the evidence reports and technology assessments they produce will 

become building blocks for health care quality improvement projects throughout the Nation. The 

reports undergo peer review prior to their release. 

 AHRQ expects that the EPC evidence reports and technology assessments will inform 

individual health plans, providers, and purchasers as well as the health care system as a whole by 

providing important information to help improve health care quality. 

 We welcome comments on this evidence report. They may be sent by mail to the Task Order 

Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, 

Rockville, MD 20850, or by e-mail to epc@ahrq.gov. 

Carolyn M. Clancy, M.D. 

Director 

Agency for Healthcare Research and Quality 

Andrew C. von Eschenbach, M.D. 

Director 

National Cancer Institute, NIH 

Jean Slutsky, P.A., M.S.P.H. 

Director, Center for Outcomes and Evidence 

Agency for Healthcare Research and Quality 

Kenneth S. Fink, M.D., M.G.A., M.P.H. 

Director, EPC Program 

Agency for Healthcare Research and Quality 

Ernestine W. Murray, B.S.N., R.N., M.A.S. 

EPC Program Task Order Officer 

Agency for Healthcare Research and Quality 

The authors of this report are responsible for its content. Statements in the report 

should not be construed as endorsement by the Agency for Healthcare Research and 

Quality or the U.S. Department of Health and Human Services of a particular drug, 

device, test, treatment, or other clinical service. 
iv 

Acknowledgments 

 The Evidence-based Practice Center thanks Karen Robinson for her guidance in designing 

the literature search, Christine Napolitano for her assistance with literature searching and 

database management, Dhwani Mankad for her assistance with data entry and cleaning, and 

Brenda Zacharko for her assistance with data entry and final preparations of the report. 
v 

Structured Abstract 

Context: Since the enactment of the National Institutes of Health (NIH) Revitalization Act in 

1993, cancer researchers have made significant efforts to develop evidence regarding barriers to 

participation in clinical trials, especially for ethnic minority populations. While some advances 

have been made in defining these barriers, significant gaps remain in the available evidence in 

regard to efficacious and/or effective interventions to improve enrollment to cancer clinical 

trials. It is essential to address these gaps in the evidence, in order to fulfill the intent of the NIH 

Revitalization Act. Only a small proportion of cancer patients are enrolled in clinical trials, and 

recent evidence indicates that racial and ethnic minorities, adolescents, the elderly, rural 

populations and individuals of low socioeconomic status in general, are underrepresented in 

cancer clinical trials funded by the National Cancer Institute (NCI). At the request and with the 

financial support of the NCI, the Agency for Healthcare Research and Quality commissioned a 

systematic review of the existing evidence on the recruitment of underrepresented populations 

into cancer clinical trials, to be performed by the Johns Hopkins University Evidence-based 

Practice Center (EPC). 

Objectives: We developed a conceptual framework to guide our analysis of barriers and 

promoters of participation of underrepresented populations in cancer clinical trials. Our approach 

takes account of the fact that in order to participate in a trial, an individual must be aware of the 

trial, have the opportunity to participate, and be willing to accept participation. The barriers and 

promoters span the continuum from awareness to acceptance, and they differ, depending on the 

population and whether recruitment is to a treatment trial or to a prevention trial. We performed 

a systematic review of evidence concerning the effectiveness of interventions designed to 

improve recruitment of these underrepresented populations into cancer therapeutic and 

prevention trials. Our report focused on questions in the following areas: 1) methods used to 

study recruitment strategies; 2) measures of recruitment success; 3) comparison of two or more 

recruitment interventions for cancer treatment trials; 4) comparison of two or more recruitment 

interventions for cancer prevention trials; 5) barriers and promoters of recruitment; and 6) 

physician attitudes and perceptions about recruitment. 

Data Sources: Our comprehensive search plan included electronic and hand searching. In March 

2004, we searched the following electronic databases: MEDLINE®, the Cochrane CENTRAL 

Register of Controlled Trials (Issue 1, 2003), the Cochrane Database of Methodology Reviews 

(CDMR), the Cumulative Index of Nursing and Allied Health Literature (CINAHL®), the 

Psychological Abstracts (PsycINFO), and The Campbell Collaboration’s Social, Psychological, 

Educational, and Criminological Trials Register (C2-SPECTR). For hand searching, we 

identified 34 journals that we thought were most likely to contain relevant studies. We scanned 

the table of contents of the issues of these journals for relevant citations from January 2003 

through July 2004. 

Study Selection: Articles included in this evidence synthesis were English-language reports 

containing original data that addressed one of the specific research questions. We excluded 

articles that did not address underrepresented populations, did not address cancer treatment or 

prevention, or did not discuss recruitment to a controlled trial. 
vi 

Data Extraction: Pairs of reviewers assessed the study quality and abstracted data for each 

eligible article. Data were entered into a relational database. 

Data Synthesis: Overall, we identified 67 eligible articles that focused on the following areas: 

methods used to study recruitment strategies (n=13) measures of success (n=23), comparison of 

two or more recruitment interventions (n=5), barriers to and promoters of recruitment (n=45), 

and physician attitudes and perceptions regarding recruitment (n=10). These studies were 

heterogeneous in that they targeted community members, patients and physicians in a variety of 

contexts. Reports on methods to study recruitment interventions lacked consistency in reporting 

of target population characteristics such as age, gender, residence (urban or rural areas), 

socioeconomic status, and recruitment dates. All but two of the studies eligible for review 

regarding measures of success defined successful recruitment in a post-hoc fashion as actual 

participation of the targeted group; the studies rarely set specific recruitment goals a priori. 

Only five studies compared two or more strategies to promote accrual to cancer clinical 

trials. Overall, the eligible studies identified 118 distinct barriers to accrual to cancer clinical 

trials, including 97 barriers to accrual to therapeutic trials, 18 barriers to accrual to prevention 

trials, and 32 barriers to accrual to both therapeutic and prevention trials. There were more 

reported barriers to opportunity (n = 80) than to awareness (n = 8) or acceptance (n = 40) of 

clinical trials. Of the 59 distinct promoters of enrollment, most (n = 28) were promoters of the 

opportunity to participate in a cancer trial. There is a lack of information regarding efficacious 

recruitment strategies for all of the underrepresented racial and ethnic minority populations. 

Additionally, the available evidence suggests that the lack of availability of trials is a barrier to 

enrollment for the adolescent population. Moreover, study exclusion criteria such as age, 

comorbid conditions, functional status, and sometimes unwarranted provider concerns regarding 

drug toxicity, limit opportunities for the elderly to participate in cancer clinical trials. 

Transportation is an important barrier, among others, for rural populations. 

 The evidence suggests that provider attitudes and perceptions have a critical influence on 

enrollment results for underrepresented populations. Providers have declined to enroll patients 

because of their age, comorbid conditions, and mistrust of researchers; and for studies that 

targeted minority populations, mistrust of researchers and lack of provider awareness about trials 

were leading provider barriersthat decreased patient enrollment in clinical trials. 

 The strengths of the available evidence are the identification of numerous barriers and 

promoters of accrual to cancer screening trials, and the consistency of these barriers across the 

available studies. The limitations in study design and reporting of some of the available studies 

represent an important weakness of this evidence. Many of the studies had important limitations 

in: 1) representativeness; 2) justification of study methods; 3) reliability and validity of the data 

collection methods; 4) potential for bias/confounding based on study design; and 5) failure to 

control for potential sources of bias in the data analysis. Nevertheless, the evidence provides the 

basis for certain conclusions regarding future directions for research to improve enrollment of 

underrepresented populations in cancer clinical trials. 

 

Conclusions: Clinical investigators need effective strategies to improve participation of 

underrepresented populations in cancer clinical trials. The available evidence is consistent 

regarding barriers that reduce awareness, the opportunity to participate, and acceptance of cancer 

clinical trials. However, the patterns of occurrence of these barriers differ among the 

underrepresented populations; and for this reason, research strategies must address the needs of 
vii 

each population with some specificity. Future studies should build upon the existing evidence to 

further elucidate the nature of barriers and promoters of participation in cancer clinical trials. 

Research intervention strategies should be tailored to the specific context of an underrepresented 

population, to reduce barriers to awareness, opportunity, and acceptance of trial participation, 

and to demonstrate tangible results in terms of trial accrual. There are many barriers to 

enrollment in a cancer clinical trial, and piecemeal strategies will not suffice to ensure the 

participation of underrepresented populations. Research is needed on cost-effective strategies 

that bridge the cancer research center and the community in a manner that can be integrated into 

the context of the healthcare system and the clinical research team. Such research requires 

community involvement through all of its phases.
ix 

Contents 

Evidence Report 

Chapter 1. Introduction ...................................................................................................................3 

 Clinical Research and the Medically Underserved....................................................................3 

 Recruitment of Underrepresented Populations to Cancer Clinical Trials..................................5 

 Rationale for Commissioning this Evidence Report..................................................................7 

 Objectives and Scope of Report.................................................................................................7 

Chapter 2. Methodology .................................................................................................................9 

 Recruitment of Technical Experts and Peer Reviewers.............................................................9 

 Key Questions............................................................................................................................9 

 Conceptual Framework............................................................................................................10 

 Literature Search Methods.......................................................................................................12 

 Sources...............................................................................................................................12 

 Search Terms and Strategies..............................................................................................13 

 Organization and Tracking of Literature Search ...............................................................13 

 Title Review.............................................................................................................................14 

 Abstract Review.......................................................................................................................14 

 Inclusion and Exclusion Criteria........................................................................................14 

 Abstract Review Process....................................................................................................15

 Article Review .........................................................................................................................15 

 Quality Assessment and Data Abstraction.........................................................................15 

 Article Review Process......................................................................................................17 

 Grading of the Total Body of Evidence...................................................................................17 

 Peer Review .............................................................................................................................17 

Chapter 3. Results .........................................................................................................................19 

 Results of Literature Search and Abstract Review ..................................................................19 

 Results of Article Review Process...........................................................................................19

 Key Question 1: What Methods Have Been Used to Study Strategies to Recruit 

Underrepresented Populations into Cancer Prevention and Treatment Trials? .................20 

 Identification of Relevant Articles.....................................................................................20 

 Study Characteristics .........................................................................................................20 

 Target Population Characteristics......................................................................................20 

 Recruitment Methods Findings..........................................................................................21 

 Key Question 2: What Measures of Success Have Been Used to Evaluate the Efficacy 

and/or Effectiveness of Strategies for Recruitment of Underrepresented Populations 

into Cancer Prevention and Treatment Trials? ..................................................................22 

 Identification of Relevant Articles.....................................................................................22 

 Study Characteristics .........................................................................................................22 

 Target Population Characteristics......................................................................................22 

 Recruitment Goals and Measures of Success ....................................................................23 
x 

 Key Questions 3: Which Recruitment Strategies Have Been Shown to be Efficacious 

and/or Effective in Increasing Participation of Underrepresented Populations into 

Cancer Treatment Trials?...................................................................................................24 

 Key Question 4: Which Recruitment Strategies Have Been Shown to be Efficacious 

and/or Effective in Increasing Participation of Underrepresented Populations into 

Cancer Prevention Trials?..................................................................................................24 

 Identification of Relevant Articles.....................................................................................24 

 Quality of Studies ..............................................................................................................25 

 Results of Studies...............................................................................................................25 

 Grading of the Total Body of Evidence.............................................................................28 

 Key Question 5: What are the Documented Barriers and Promoters of Participation of 

Underrepresented Populations in Cancer Prevention and Treatment Trials......................28 

 Study Characteristics .........................................................................................................28 

 Target Population Characteristics......................................................................................29 

 Quality of Studies ..............................................................................................................29 

 Overall of Barriers and Promoters of Participation in Cancer Therapeutic and 

Prevention Trials................................................................................................................30 

 Barriers and Promoters of Participation in Cancer Therapeutic and Prevention Trials 

for African Americans .......................................................................................................30 

 Barriers and Promoters of Accrual to Therapeutic Trials for in Other 

Underrepresented Populations ...........................................................................................31 

 Barriers and Promoters of Accrual to Prevention Trials in African-American 

Populations.........................................................................................................................33 

 Barriers and Promoters of Accrual to Prevention Trials Among Other 

Underrepresented Populations ...........................................................................................34 

 Grading of the Total Body of Evidence.............................................................................35 

 Key Question 5a: Effects of Demographic Factors .................................................................35 

 Key Question 5b: Effects of Cultural Factors..........................................................................35 

 Key Question 6: What Effects do the Attitudes and Perceptions of Healthcare Providers 

Have on the Efficacy/Effectiveness of Strategies for Recruitment of 

Underrepresented Populations into Cancer Prevention and Treatment Trials? .................36 

 Identification of Relevant Articles.....................................................................................36 

 Study Characteristics .........................................................................................................36 

 Target Population Characteristics......................................................................................36 

 Quality of Studies ..............................................................................................................36 

 Results of Studies...............................................................................................................37 

 Grading of the Total Body of Evidence.............................................................................38 

Chapter 4. Discussion ...................................................................................................................39 

 Questions 1 and 2. Methods to Study Recruitment Strategies.................................................39 

 Questions 3, 4, 5, and 6. Barriers and Promoters of Participation in Cancer Clinical 

Trials ........................................................................................................................................40 

 Limitations ...............................................................................................................................42 

 Conclusions..............................................................................................................................43 

 Recommendations and Research Opportunities ......................................................................44 
xi 

References and Included Articles ..................................................................................................47 

Excluded Articles...........................................................................................................................51 

Figures 

Figure 1. Conceptual Framework .................................................................................................61 

Figure 2. Summary of Literature Search and Review Process .....................................................62 

Tables 

Table 1. Summary of the Characteristics of Studies About Strategies to Recruit 

Underrepresented Populations to Cancer Prevention and Treatment Trials .................65 

Table 2. Studies About Measures of Success Used to Evaluate the Effectiveness of 

 Strategies for Recruitment of Underrepresented Populations into Cancer 

 Prevention and Treatment Trials...................................................................................68 

Table 3. Summary of Study and Target Population Characteristics on the Efficacy or 

 Effectiveness of Recruitment Strategies for Increasing Participation of 

 Underrepresented Populations in Cancer Prevention and Treatment Trials.................75 

Table 4. Summary of Outcome Point Estimates on the Efficacy or Effectiveness of 

 Recruitment Strategies for Increasing Participation of Underrepresented 

 Populations in Cancer Prevention and Treatment Trials ..............................................77 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation 

 of Underrepresented Populations in Cancer Treatment Trials .....................................78 

Table 6. Summary of Studies Investigating the Barriers and Promoters of Participation 

 of Underrepresented Populations in Cancer Prevention Trials ....................................94 

Table 7. Summary of Studies on the Effects of Attitudes and Perceptions of Healthcare 

 Providers on the Effectiveness of Strategies for Recruitment of 

 Underrepresented Populations into Cancer Prevention and Treatment Trials............100 

Table 8. Grading of the Quality of Evidence on the Efficacy or Effectiveness of 

 Strategies for Recruiting Underserved Populations into Cancer Prevention 

 and Treatment Trials...................................................................................................102 

Table 9. Grading of the Quality of Evidence on Barriers to and Promoters of 

 Participation of Underserved Populations in Cancer Prevention and Treatment 

 Trials ...........................................................................................................................103 

Table 10. Grading of the Quality of Evidence on the Effects of Attitudes and 

 Perceptions of Healthcare Providers on Recruitment of Underserved 

 Populations into Cancer Prevention and Treatment Trials ........................................104 

Appendixes 

Appendix A. EPC Recruitment: Technical Experts and Peer Reviewers 

Appendix B. EPC Recruitment: Journals Hand Searched 
xii 

Appendix C. EPC Recruitment: Search Strategies 

Appendix D. EPC Recruitment to Clinical Trials Abstract Review Form 

Appendix E. EPC Recruitment: Article General Abstraction Form 

Appendix F. Evidence Tables 

Appendixes and Evidence Tables are provided electronically at: 

http://www.ahrq.gov/clinic/tp/recruittp.htm 
Introduction

The burden of cancer falls disproportionately

upon the medically underserved, and research

studies are essential to improving health care in

general, including for medically underserved

populations. Clinical trials are used to evaluate

efficacious prevention and treatment

interventions; however, studies often fail to recruit

the planned number of participants.1 Trials often

do not include an adequately diverse population

to ensure broad generalizability of results.2 Recent

studies of patients enrolled in cancer treatment

trials sponsored by the National Cancer Institute

(NCI) have demonstrated that the following

populations are underrepresented in terms of their

participation in cancer treatment trials: the

elderly, those of low socio-economic status, those

living in rural areas and Latino/Hispanic, Asian

/Pacific Islander and American Indian/Alaska

native men and women, as well as AfricanAmerican men.3,4 Since the 1980s cancer

prevention trials have been conducted with

participants at highest risk for disease to reduce

the cancer burden, and as in treatment trials,

adequate representation of underserved

populations in prevention trials is desirable.

Questions remain regarding the appropriate level

of inclusion, i.e., whether it might depend on the

prevalence of the condition/disease studied in the

overall population. This issue has not been

addressed adequately in the literature. Moreover,

there is substantial uncertainty about what are

important barriers and promoters of recruitment

of underrepresented populations, and what

evidence-based interventions would address them.

At the request of and with the financial

support of NCI, AHRQ commissioned a

systematic review of the existing evidence on the

recruitment of underrepresented populations into

cancer clinical trials, to be performed by the Johns

Hopkins University EPC. Specifically, the EPC

investigators were asked to consider six key

questions:

• Key Question 1: What methods (e.g., survey

studies, focus groups) have been used to

study strategies to recruit underrepresented

populations into cancer prevention and

treatment trials? We defined

underrepresented populations as including

the elderly, adolescents, those of low

socioeconomic status, those living in rural

areas, African Americans, Hispanics/Latinos,

Asian Americans, and American Indians.

• Key Question 2: What measures of success

(e.g., proportional representation relative to

the U.S. population; proportional

representation relative to incidence in a

specified population) have been used to

evaluate the efficacy and/or effectiveness of

strategies for recruitment of

underrepresented populations into cancer

prevention and treatment trials? 

• Key Questions 3 and 4: Which recruitment

strategies (e.g., media appeals, incentives,

etc.) have been shown to be efficacious

and/or effective in increasing participation of

Evidence Report/Technology Assessment

Number 122

Knowledge and Access to Information on

Recruitment of Underrepresented Populations to

Cancer Clinical Trials

Summary

Authors: Ford JG, Howerton MW, Bolen S, Gary TL, Lai GY, Tilburt J, Gibbons MC, 

Baffi C, Wilson RF, Feuerstein CJ, Tanpitukpongse P, Powe NR, Bass EB

Agency for Healthcare Research and Quality

Advancing Excellence in Health Care • www.ahrq.gov

Agency for Healthcare Research and Quality Evidence-Based

Practice
2

underrepresented populations in cancer treatment and

prevention trials?

• Key Question 5: What are the documented barriers to

and promoters of participation of underrepresented

populations in cancer prevention and treatment trials?

Examples of potential barriers include access, knowledge,

attitudes, eligibility, fatalism, religiosity/spirituality and

exclusions by design. Examples of potential promoters

include attitudes, altruism, advanced disease, financial

incentives, and no-cost treatment.

• Key Question 5a: Do these barriers and promoters

differ by age, gender, socioeconomic status or

race/ethnicity?

• Key Question 5b: Are these barriers and promoters

modified by cultural factors?

• Key Question 6: What effects do the attitudes and

perceptions of health care providers have on the

efficacy/effectiveness of strategies for recruitment of

underrepresented populations into cancer prevention and

treatment trials? Health care providers were defined as

including any health professional or health care

organization that provides health services to patients.

Methods

We developed a conceptual framework to guide our analysis,

based on the factors leading to the acceptance or refusal of

participation in a cancer clinical trial. This framework was

derived from a conceptual model developed previously by two

members of the EPC team.4 The premise for the framework is

that in order to accept or refuse participation in a clinical trial,

one must first be aware of the availability of the trial, and have

an opportunity to participate in the trial. The opportunity to

participate in a clinical trial may present itself first, encouraging

patients to seek information about the trial. This, in turn, may

lead to the decision to accept or refuse participation in the trial.

There are multiple pathways to successful recruitment to a

clinical trial, including: (1) patients/clients receiving

information about clinical trials in general through health care

providers or their own social ties, and subsequently accepting a

specific opportunity to participate in a trial; and (2) in the

absence of prior awareness about clinical trials, patients/clients

may consider an opportunity to participate in a trial, with the

result of encouraging them to seek or receive information

regarding the trial, thereby increasing trial awareness. Key

questions 5 and 6 of this report address barriers and promoters

of awareness, opportunity, and acceptance/refusal. 

Literature Search Methods

Searching the literature included the steps of identifying

reference sources, formulating a search strategy for each source,

and executing and documenting each search.

Sources

Our comprehensive search plan included electronic and

hand searching. In March 2004, we searched the following

electronic databases: MEDLINE®, the Cochrane CENTRAL

Register of Controlled Trials (Issue 1, 2003), the Cochrane

Database of Methodology Reviews (CDMR), the Cumulative

Index of Nursing and Allied Health Literature (CINAHL®),

the Psychological Abstracts (PsycINFO), and The Campbell

Collaboration’s Social, Psychological, Educational, and

Criminological Trials Register (C2-SPECTR).

Hand searching for possibly relevant citations took several

forms. First, we identified 34 journals by asking our experts

what journals were most likely to contain relevant articles. We

scanned the table of contents of each issue of these journals for

relevant citations from January 2003 through July 2004.

For the second form of hand searching, we used ProCite®, a

reference management software, to create a database of

reference material identified through an electronic search for

relevant guidelines and reviews, through discussions with

experts, and through the article review process. The principal

investigators reviewed the articles identified as being possible

review articles during the abstract review process. The

references in these review articles were searched to identify any

additional article for consideration. We also used MEDLINE®

to search articles published by selected experts known to have

interests related to our questions. Finally, we examined the

reference lists of eligible articles to identify any potentially

relevant articles (this was completed by the second reviewer as

part of the article review process). 

Study Selection

Articles included in this evidence synthesis were Englishlanguage reports of original data from published studies that

addressed one of the key questions.

Data Extraction

Pairs of reviewers assessed the study quality and abstracted

data for each eligible article. Data were entered into a relational

database. 
Results

Of the 4,436 citations retrieved by the search methods,

1,089 were eligible for abstract review and 218 of those were

eligible for article review. Only 67 of the articles were eligible

after article review. Many articles were excluded because they

did not address underrepresented populations, did not address

cancer treatment or prevention, or did not discuss recruitment

to a controlled trial. Ultimately, the EPC investigators

identified 14 articles on key question 1, 23 articles on key

question 2, five articles on key questions 3 and 4, 45 articles on

key question 5, and 10 articles on key question 6.

Key Question 1: Methods to Study Recruitment Strategies

We analyzed 14 articles to identify methods (e.g., survey

studies, focus groups) that have been used to study strategies to

recruit underrepresented populations into cancer prevention

and treatment trials. 5-18

• All 14 studies were of U.S. origin, primarily based in

community settings, and targeting patients/participants.

• The reported study designs of the 14 studies varied,

including descriptive (n = 4), randomized controlled trials

(n = 3), quasi-experimental (n = 1), comparisons of two or

more interventions (n = 2), survey (n = 1), qualitative (n =

1), case study (n = 1), and other (n = 1).

• There was substantial variability across the studies in the

reporting of demographic variables such as age, gender,

income or education levels of participants; information

regarding the racial or ethnic distributions of the

participants was available for only eight of these studies. 

• The reporting of the studies limited our ability to

accurately categorize age groups (e.g., adolescents, elderly),

socioeconomic status, or residence (urban versus rural). 

Overall, the evidence indicated the need for greater

consistency in the reporting of target population characteristics,

so that key findings may be considered in relation to specific

populations. This would make it feasible, when the sample size

is adequate, to conduct subgroup analyses to assess whether

barriers to recruitment vary by sociodemographic and cultural

factors. 

Key Question 2: Measures of Success

We sought to identify what measures of success (e.g.,

proportional representation relative to the U.S. population, or

proportional representation relative to incidence in a specified

population) have been used to evaluate the efficacy and/or

effectiveness of strategies for recruitment of underrepresented

populations into cancer prevention and treatment trials.

• All studies (n = 23) were from the U.S. and 22 studies

targeted patients/participants for the recruitment

intervention; and over 50 percent of the studies were

based on multi-center cancer clinical trials conducted in

community settings (n = 9) or hospital centers (n = 7). 5-9,

11, 13, 16, 17, 19-32

• Most of the reports were based on retrospective review of

enrollment to a single or multiple cancer trials.

• Only two articles reported having a recruitment goal for

the underrepresented group prior to enrollment in the

study. The majority of studies either defined recruitment

success as equaling the proportion of underrepresented

selected by the researcher (n = 13) for various reasons or as

the disease-specific proportion of underrepresented (n =

9). The rest of the studies defined recruitment success as

equaling the geographic proportion of underrepresented

(n = 2), or the local research institution’s proportion of the

underrepresented (n = 1).

• Very few studies evaluated recruitment success in

underrepresented groups especially those with low

socioeconomic status, Asian/Pacific Islanders, adolescents,

and rural populations (less than three studies in each

group). No study reported recruitment success measures

for American Indians/Alaska Natives.

The evidence reviewed indicated that success in recruitment

of underrepresented populations is defined primarily by the

goal of each study. When reporting on cancer trials,

investigators should give careful thought to success measures for

recruitment of underrepresented populations, avoid setting

such measures arbitrarily, and report recruitment results based

on the recruitment strategies for individual cancer clinical trials. 

Key Questions 3 and 4: Methods to Study Recruitment

Strategies

We sought to identify recruitment strategies (e.g., media

appeals, incentives, etc.) that have been shown to be efficacious

and/or effective in increasing participation of underrepresented

populations in cancer treatment and prevention trials. We

found a total of five eligible articles. 6, 7, 9, 11, 17

The results of the interventions varied from no observed

improvement to an increase in recruitment into cancer clinical

trials. Two studies examined enrollment differences between

two different intervention methods. Two other studies

compared enrollment differences between interventions to a

3
4

control group. These control groups were either no

intervention (usual medical care from physicians) or a standard

recruitment “intervention” of mailed letters and telephone

contact. However, whether various interventions had a true

effect (null, positive, or negative) was somewhat unclear. Some

authors cautioned that their results could be due to factors such

as changes in recruitment strategy during the duration of the

intervention. To give a clearer picture, each of the five studies is

discussed in detail.

Linnan et al. investigated the differences between passive and

active recruitment into a home-based cancer prevention

randomized trial among employees.17 In the passive employee

contact arm, the research team contacted the employees from a

list of employee names and telephone numbers provided by the

company. In the active employee contact arm, employees

actively signed up to participate. While lower enrollment and

higher attrition were observed in the passive recruitment arm,

the passive method enrolled a more diverse group of

participants than did the active recruitment method. 

Brewster et al. examined differences in recruitment into

cancer prevention clinical trials between a clinic registry

method and a media campaign targeting Latina women.6 In the

media recruitment strategy, the study was advertised in flyers

placed in local community businesses, and advertised in

community and regional newspapers in English and Spanish.

The odds of presenting to the clinic and of recruitment were

nearly three times more successful via the media campaign than

via the clinic registry.

Paskett et al. examined the effect of an intervention program

aimed at physicians and the community to increase the number

of rural patients with breast cancer or colorectal cancer in

clinical trials.7 The intervention program consisted of the

installation of a rapid tumor-reporting system to improve data

quality and to expedite the receipt of information on cancer

patients from physicians, a nurse facilitator who would notify

physicians of clinical trials, a quarterly newsletter mailed to

physicians about cancer treatment and clinical trials, and a

health educator who trained lay health educators and provided

community-based information about cancer screening,

treatment, and clinical trials. Five counties in North Carolina

received an intervention program while five counties in South

Carolina served as controls where usual medical care was

practiced. The rates of enrollment into clinical treatment trials

did not improve significantly in the intervention communities.

Moinpour et al. reported the results of a randomized trial in

increasing participation of minorities.9 Minority recruitment

strategies were designed and implemented in five pilot sites:

African Americans in four sites and Hispanics in one site.

While each site had a minority recruiter who was given

requirements and a set of tasks, the specific details of the

minority recruitment interventions for each site were not given.

The overall impact was minimal, and it was unclear if, and at

which site the intervention was fully implemented.

Ford et al. examined recruitment differences among African

Americans randomized into either a control group or three

increasingly intensive intervention arms.7 The control group

used a standard method of recruitment such as a standard

recruitment letter, African-American or Caucasian interviewers

for eligibility screening, baseline information collection via

mailed packets, and reminder phone calls and mailings for

completion of the mailed packets (Arm D). The basic

intervention arm (Arm A) attempted to reduce potential

sociocultural and individual barriers through the use of an

enhanced recruitment letter and eligibility screening by AfricanAmerican interviewers. The second more intensive intervention

arm (Arm B) did not use mailed packets for baseline

information collection but telephone interviews to facilitate

ease of participation in addition to the enhanced recruitment

letter. The third, and most intensive, intervention arm (Arm C)

did not use a mailing packet or telephone interview but a

church-based project site to gather baseline information in

addition to the enhanced recruitment letter and eligibility

screening telephone calls by an African American. The authors

reported significantly higher enrollment yield (3.9 percent) in

the most intensive church-based, face-to-face recruitment

intervention arm (Arm C), compared to the other two

intervention arms (2.5 percent [Arm A] and 2.8 percent [Arm

B]) or the control group (2.9 percent [Arm D]) (p < 0.01).

There is only scant evidence in support of specific

interventions to improve recruitment to cancer clinical trials, as

indicated by the small number of studies comparing

interventions.

Key Question 5: Barriers and Promoters of Recruitment

We sought to identify the documented barriers and

promoters of participation for underrepresented populations in

cancer prevention and treatment trials. Our search yielded 45

eligible studies that were conducted in a variety of settings.3,5, 8, 13,

22, 23, 25, 26, 29, 33-63 Among the underrepresented populations, the

available studies targeted African Americans primarily (n = 27),

as well as Latinos/Hispanics (n = 7); American Indian/Alaska

Native (n = 4 ); the elderly (n = 14); adolescents (n = 3);rural

populations (n = 2); and Asian/Pacific Islanders (n = 2). While

a large proportion of the available studies included populations
with low socioeconomic status, only one did so by design.9 The

search strategy yielded 40 U.S.-based studies, and we included

evidence from 5 non-U.S.-based studies that featured relevant

evidence.22

Barriers and promoters of participation in cancer

prevention and treatment trials 

Types of barriers and promoters identified. Overall, the

eligible studies identified 118 distinct barriers to accrual to

cancer clinical trials, including 97 barriers to accrual to

therapeutic trials, 18 barriers to accrual to prevention trials, and

32 barriers to accrual to both therapeutic and prevention trials.

There were more reported barriers to opportunity (n = 80) than

to awareness (n = 7) or acceptance (n = 40) of clinical trials. Of

the 59 distinct promoters of enrollment, most (n = 29) were

promoters of the opportunity to participate in a cancer trial. 

Barriers and promoters of accrual of African Americans to

cancer treatment trials. Overall, there were 19 studies of accrual

of African Americans to cancer therapeutic trials, which

reported 85 barriers to accrual to therapeutic trials, including

barriers to opportunity (n = 56), barriers to acceptance (n =

28), and awareness (n = 6). Of the 28 barriers to acceptance,

the most frequently reported were perceived harms of clinical

trial participation (n = 8), mistrust of research, researchers, and

the medical system (n = 10), and fear (n = 5). Promoters were

predominantly of promoters of awareness (n = 6). Of the

reported 14 promoters of opportunity, the most frequently

reported were culturally relevant education about trials (n = 3),

and providing transportation (n = 2). Of the 14 promoters of

acceptance, the most frequently reported were altruism (n = 3),

perceived benefits of trial participation (n = 5), and incentives

(n = 5).

Barriers and promoters of accrual to therapeutic trials in

other underrepresented populations. Latinos/Hispanics. Four

studies reported evidence on barriers to accrual of

Latinos/Hispanics to cancer therapeutic trials. The reported

eight barriers to opportunity were dominated by transportation

(n = 2), age (n = 1), toxicity of treatment (n = 1), comorbid

conditions (n = 1), and disease stage (n = 1). Of the seven

barriers to acceptance, the most frequently reported was

mistrust of research and the medical system (n = 2). Only two

of the eligible studies for this question reported evidence on

promoters of enrollment of Latinos/Hispanics. Brewster and

colleagues found that a media-based strategy was superior to a

clinic based strategy in recruiting Latino-Hispanic women.6

Others have reported the lack of adequate health insurance,

incentives, culturally relevant education about trials and the

perceived benefits of trial participation as additional promoters

of accrual for Latinos/Hispanics.5, 55

American Indians/Alaska Natives. The amount of evidence

available for the American Indians/Alaska Natives population

with regard to accrual to clinical trials, in general, was very

limited. The aggregate number of American Indians/Alaska

Natives in all of the eligible studies for which data on

population subgroups was reported, was 19.35, 41, 43, 55

Asian and Pacific Islanders. We did not find any evidence

regarding barriers or promoters of participation in cancer

prevention or treatment trial for the Asian and Pacific Islander

population.

The elderly. In the 11 available studies, barriers and

promoters of opportunity were predominant in this population.

Of the 22 barriers to opportunity, the most frequently reported

were age (n = 2).

Adolescents. Only two of the available studies yielded

evidence, and reported the lack of available trials as a significant

barrier to enrollment of adolescents. Promoters of participation

for this population included the perceived benefits of trial

participation, including a chance for better treatment, and

altruistic motives.

Rural populations. Only two of the available studies focused

on recruitment of rural populations to cancer clinical trials,

including cross-sectional surveys of physicians,11 and focus

groups. The studies reported numerous barriers to awareness,

opportunity and acceptance of trial participation. They also

reported altruism and incentives (financial and otherwise) as

promoters.43

Barriers and promoters of accrual to prevention trials in

African-American populations. Overall, there were 13 studies

of barriers and promoters of accrual of African Americans to

cancer prevention trials. We did not include studies of accrual

to other types of primary prevention trials (e.g., diet and

exercise) in this systematic review. Among the 41 barriers to

accrual to prevention trials, barriers to opportunity (n = 24)

were predominant, and of the 13 barriers to acceptance,

mistrust of research and the medical system (n = 8), and the

perceived harms of clinical trial participation (n = 4) were the

most frequently reported. Promoters included provision of

transportation (n = 1) and incentives (n = 2).

Chemoprevention trials.9, 37, 56 On average, each of the

chemoprevention trials reported two barriers (range: 1 to 2).

There were no barriers to awareness, two barriers to

opportunity, and three barriers to acceptance with mistrust of

research reported in two studies. In one study, promoters

included preference for the study’s principal investigator to be

5
black, and the perception that it is better to be treated by

research doctors.

Smoking cessation trials.5,56,60 Out of the three smoking

cessation trials in African-American populations, only one trial

reported barriers to accrual, and not being ready to quit may

have been a confounding factor. The reported promoters were

incentives, support, encouragement, prayer, the certainty of

receiving actual medication, and the impact of diagnosis on risk

perception. 

Screening trials.

7 The results of this one study were discussed

in detail under key questions 3 and 4.

Barriers and promoters of accrual to prevention trials

among other underrepresented populations.

Latinos/Hispanics. Overall, there were four studies reporting

primarily barriers to opportunity (n = 7), especially

transportation (n = 2). Mistrust of research and the medical

system (n = 2) and family considerations or issues (n = 2) were

the most frequent barriers to acceptance. 

American Indians/Alaska Natives and Asian and Pacific

Islanders. As discussed in the section on accrual to therapeutic

trials, very little information is available on these two

populations.

The elderly. Overall, there were three studies of barriers and

promoters of enrollment to cancer prevention trials in the

elderly. These studies reported three distinct barriers, age being

the most frequently cited (n = 2). Among the three promoters

of accrual to prevention trials, there were no promoters of

awareness or acceptance. The three reported promoters of

accrual were the entry criteria, age and low-income status.

Rural populations. The available evidence on barriers and

promoters of accrual of rural populations to cancer prevention

and treatment trials is based on two studies that we discussed in

the section on barriers and promoters of accrual to therapeutic

trials.10,43

Key Question 5a: Effects of Demographic Factors

Overall, the available evidence for key question 5 suggested

that accrual to or intention to participate in a trial varied by the

following sociodemographic factors: age (n = 16); gender 

(n = 3); socioeconomic status (n = 4); and race/ethnicity 

(n = 4). These barriers and promoters related most frequently

to study design barriers, including exclusion by age (n = 6),

study duration and visit structure (n = 4), comorbid conditions

(n = 7), and functional status (n = 6). Few trials were available

for adolescents; and as expected, parental influence was

reported as a factor in decision-making only in this population.

However, the available evidence did not suggest age as a factor

that reduced awareness or acceptance of participation.

Key Question 5b: Effects of Cultural Factors

Three of the studies reported that barriers or promoters of

enrollment varied by cultural factors,39,55,60 however, it is not

entirely clear whether such “cultural factors” refer to cultural

norms, values or beliefs. For the elderly population, enrollment

barriers and promoters did not vary by culturally relevant

factors other than race or ethnicity. The heterogeneity of the

available evidence and the definitional overlap among several of

the underrepresented populations limited our ability to

synthesize the evidence regarding whether some barriers or

promoters vary by cultural factors. 

Key Question 6: Role of Provider Attitudes and

Perceptions 

Nine studies presented data on how provider

attitudes/perceptions were barriers to and promoters of accrual

to cancer clinical trials. Four studies found provider atttitudes

as a barrier to enrollment11,23,44,64 while one study found provider

attitudes to be a promoter of patient accrual.23 The studies also

reported that patient age,23,59,65 comorbidity,

23,59 disease stage,23

mistrust of researchers,23,31 and lack of physician awareness

about trials44,52 were factors that prevented providers from

enrolling their patients into clincial trials. Two studies64, 66 found

that provider communication or method of presentation were

barriers to patient enrollment, whereas one study found it to be

a promoter of trial enrollment.41

For studies that targeted minority populations,29,44,52 mistrust

of researchers and lack of provider awareness about trials were

leading provider barriers 44,52 that decreased patient enrollment

in clinical trials. Additionally, concerns about patient noncompliance and a lack of available protocols were reasons cited

for not talking to patients about clinical trials.29 For studies that

targeted the elderly, provider attitudes regarding clinical trials

prevented them from sharing information about trials with

their patients in one study,23 and increased their willingness to

enroll patients in clinical trials in another study.

41

Discussion

Research Quality

Since the enactment of the National Institutes of Health

(NIH) Revitalization Act in 1993,67 cancer researchers have put

increased emphasis on recruitment of underrepresented

populations to clinical trials. However, this aspect of the human

research enterprise has received attention primarily in the

secondary analysis of ongoing clinical trials, rather than as an

area of focused scholarship. This reality is clearly reflected in the

quality of studies available for this evidence report. One of the

6
positive aspects of the studies available for our review is that

they have described a number of barriers and promoters of

participation in clinical trials. However, most of the evidence is

not based on rigorous studies, and a large proportion of the

available studies were not driven by any clear hypotheses. A

major weakness of the available evidence is the limited number

of studies that compared two or more interventions, especially

randomized controlled trials. The quality of the evidence

summarized raises some questions about its adequacy to answer

our questions regarding barriers and promoters of participation

in cancer clinical trials. However, because of the consistency

and patterns of occurrence of the identified barriers and

promoters, it does provide important insights into future

research directions. 

Recommendations and Future Research

Key Questions 1 and 2 

• Much of the available body of evidence was developed as

“evidence by convenience” in the context of recruitment

difficulties, or in retrospective analyses of recruitment of

underrepresented populations across multiple clinical

trials. There is a need for well-designed, controlled studies

of strategies to improve accrual to cancer prevention and

treatment trials. These studies should be hypothesisdriven, and include defined measures of success. They

should also meet the usual standards of the NIH peer

review process. 

• Investigators should give careful thought to success

measures for recruitment of underrepresented populations,

and they should avoid setting such measures arbitrarily.

Additionally, researchers should evaluate and report

recruitment results for underrepresented groups more

consistently. 

• More attention should be focused on issues of trial design.

If studies are not designed to address problems that are

relevant to patients in underserved communities, then

even the best recruitment strategies will be ineffective.

Similarly, trials that exclude patients with chronic

conditions will preferentially exclude the elderly, members

of minority groups, and patients with lower

socioeconomic status, because they are more likely to have

chronic conditions. Hence, recruitment efforts must

proceed hand-in-hand with initiatives to design relevant

and pragmatic trials.68

Key Questions 3, 4, 5, and 6

• Because of many underrepresented populations’ mistrust

of researchers and of research institutions, research efforts

to improve participation of underserved populations in

cancer clinical trials should be developed within the

framework of community-based participatory research,

with community involvement through all phases of the

research. 

• The need remains for community-based studies to

understand barriers to accrual in the community,

including attitudes toward clinical trial participation.

Whenever possible, such studies should be linked to the

implementation of cancer clinical trials, and include actual

recruitment as a major outcome. For example, several

studies have suggested culturally relevant education as a

strategy for improving accrual to cancer clinical trials.

There is a need to further investigate the efficacy of

culturally relevant education as a strategy to improve

accrual to cancer prevention trials and cancer treatment

trials. 

• There is an urgent need to understand why participation

of the Asian American/Pacific Islander and American

Indian/Alaska Native populations in cancer clinical trials is

minimal to non-existent. Studies of barriers and promoters

of their participation should be linked to opportunities to

participate. New research initiatives in this area may

require several years before they are fruitful in terms of

trial enrollment results. 

• Similarly, there is a continuing need to better understand

and improve upon strategies for recruitment of AfricanAmerican males and Latinos/Hispanics into cancer clinical

trials. Ideally, such studies should include documentation

of existing barriers within a population as a basis for

tailored interventions across the spectrum of barriers and

promoters, including awareness, opportunity and

decision-making.

• There is a need for further investigation of effective

communication strategies, including investigations on the

best approach to deliver information about clinical trials,

both at the community level and at the point of

interaction with the potential participant.

• In communities lacking established efforts to promote

awareness about clinical trials, sufficient time should be

allowed for relationships to be built with community

members, including community-based providers, before

accrual can begin. The period for building such

7
relationships may take several years, but it would vary

depending on the community and the existing

relationships prior to an intervention. 

• Some interventions (e.g., media-based strategy for

Hispanic women) have been shown to be effective in

increasing accrual to clinical trials. Such interventions

should be replicated, and where appropriate, the results

should be disseminated widely.

• To advance the evidence regarding efficacious strategies for

improving enrollment to cancer clinical trials, intervention

studies will need to be linked to one or more clinical trials,

depending on sample size requirements. The studies

should include collection of baseline information

regarding prevalent risk factors in the study population.

Systematic data collection about barriers and promoters of

trial participation should be linked to concrete plans for

designing interventions to address such barriers. Moreover,

the next generation of studies of barriers and promoters of

accrual should be multidisciplinary, including the

involvement of community-based participatory

researchers, social and behavioral scientists, as well as

health economists. 

• There are many barriers to care, and it is unlikely that

piecemeal strategies to address these barriers will be

effective to promote participation in cancer clinical trials.

There is a need for a cost-effective strategy to address

barriers to care on multiple levels, and in a manner that

can be integrated into the context of the health care

system and of the research team. To facilitate the

integration of recruitment interventions into health care

systems, especially the research team, a study should

compare the efficacy of a recruitment intervention

specialist to that of usual, opportunistic recruitment

practices. The recruitment intervention specialist would be

a professional or paraprofessional staff member who is

appropriately trained to promote awareness about clinical

trials in the community and to help patients overcome

barriers to opportunity. Ideally, the recruitment

intervention specialist would be indigenous to, or at least

have extensive familiarity with, the community targeted by

the recruitment effort. Thus, this role would be analogous

to that of a patient navigator for clinical trials, and its

cost-effectiveness should be investigated. 

• Research to improve enrollment of underrepresented

populations in cancer clinical trials must interface with

other ongoing initiatives designed to address cancer health

disparities through discovery, development, and delivery.

Such efforts must overcome the critical disconnect

between discovery and development on the one hand, and

delivery of cancer care on the other.

• Substantial resources will need to be dedicated to research

efforts to build upon the existing evidence on strategies for

improving enrollment of underrepresented populations in

cancer clinical trials. Many of the initiatives that

contributed to the available evidence were probably not

funded. NCI should dedicate adequate funds for welldesigned studies of barriers and promoters of accrual to

cancer clinical trials.

Further investigation is needed on barriers to recruitment of

all of the underrepresented populations, as defined in this

report, into cancer-related clinical trials. The specific

populations are: African Americans (especially men), Hispanics,

American Indians/Alaska Natives, Asian and Pacific Islanders,

adolescents, the elderly, and rural populations. Future studies

should include the evaluation of culturally tailored strategies to

promote awareness about cancer clinical trials among

underrepresented populations. Different types of intervention

approaches should be considered to promote accrual to cancer

therapeutic trials and cancer prevention trials. Research and

evaluation of recruitment strategies may yield stronger evidence

about ways to improve participation of underrepresented

populations in cancer clinical trials. The principal need is for

hypothesis-driven research, and ultimately randomized

controlled trials, to evaluate the most promising strategies for

recruiting underrepresented populations into cancer treatment

and prevention trials. 

Availability of the Full Report

The full evidence report from which this summary was taken

was prepared for the Agency for Healthcare Research and

Quality (AHRQ) by the Johns Hopkins University Evidencebased Practice Center, under Contract No. 290-02-0018. It is

expected to be available in June 2005. At that time, printed

copies may be obtained free of charge from the AHRQ

Publications Clearinghouse by calling 800-358-9295.

Requesters should ask for Evidence Report/Technology

Assessment No. 122, Knowledge and Access to Information on

Recruitment of Underrepresented Populations to Cancer Clinical

Trials. In addition, Internet users will be able to access the

report and this summary online through AHRQ’s Web site at

www.ahrq.gov.

8
Suggested Citation

Ford JG, Howerton MW, Bolen S, Gary TL, Lai GY, Tilburt

J, Gibbons MC, Baffi C, Wilson RF, Feuerstein CJ,

Tanpitukpongse P, Powe NR, Bass EB. Knowledge and Access

to Information on Recruitment of Underrepresented

Populations to Cancer Clinical Trials. Summary, Evidence

Report/Technology Assessment No. 122. (Prepared by the

Johns Hopkins University Evidence-based Practice Center,

under Contract No. 290-02-0018.) AHRQ Publication No.

05-E019-1. Rockville, MD: Agency for Healthcare Research

and Quality. June 2005.

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clinical trials: a conference at Tuskegee, researchers and the

community. Ann Epidemiol 2000;10(8 Suppl):S35-40.

46. Brown DR, Fouad MN, Basen-Engquist K, et al. Recruitment and

retention of minority women in cancer screening, prevention, and

treatment trials. Ann Epidemiol 2000;10(8 Suppl):S13-21.

47. Fouad MN, Partridge E, Wynn T, et al. Statewide Tuskegee Alliance

for clinical trials. A community coalition to enhance minority

participation in medical research. Cancer 2001;91(1 Suppl):237-41.

48. Outlaw FH, Bourjolly JN, Barg FK. A study on recruitment of black

Americans into clinical trials through a cultural competence lens.

Cancer Nurs 2000;23(6):444-51, quiz 451-2.

49. Chen CI, Skingley P, Meyer RM. A comparison of elderly patients

with aggressive histology lymphoma who were entered or not entered

on to a randomized phase II trial. Leuk Lymphoma 2000;38(3-

4):327-34.

50. Ling J, Rees E, and Hardy J. What influences participation in clinical

trials in palliative care in a cancer centre? Eur J Cancer

2000;36(5):621-6.

51. Lee MM, Chamberlain RM, Catchatourian R, et al. Social factors

affecting interest in participating in a prostate cancer chemoprevention

trial. J Cancer Educ 1999;14(2):88-92.

52. McCaskill-Stevens W, Pinto H, Marcus AC, et al. Recruiting minority

cancer patients into cancer clinical trials: a pilot project involving the

Eastern Cooperative Oncology Group and the National Medical

Association. J Clin Oncol 1999;17(3):1029-39.

53. Twelves CJ, Thomson CS, Young J, et al. Entry into clinical trials in

breast cancer: the importance of specialist teams. Scottish Breast

Cancer Focus Group and Scottish Cancer Therapy Network. Eur J

Cancer 1998;34(7):1004-7.

54. Mouton CP, Harris S, Rovi S, et al. Barriers to black women’s

participation in cancer clinical trials. J Natl Med Assoc 1997

;89(11):721-7.

55. Roberson NL. Clinical trial participation. Viewpoints from

racial/ethnic groups. Cancer 1994;74(9 Suppl):2687-91.

56. Lerman C, Rimer BK, Daly M, et al. Recruiting high risk women into

a breast cancer health promotion trial. Cancer Epidemiol Biomarkers

Prev 1994;3(3):271-6.

57. Millon-Underwood S, Sanders E, Davis M. Determinants of

participation in state-of-the-art cancer prevention, early

detection/screening, and treatment trials among African-Americans.

Cancer Nurs 1993;16(1):25-33.

58. Kemp N, Skinner E, Toms J. Randomized clinical trials of cancer

treatment—a public opinion survey. Clin Oncol 1984;10(2):155-61.

59. Spaight SJ, Nash S, Finison LJ, et al. Medical oncologists’

participation in cancer clinical trials. Prog Clin Biol Res 1984;156:49-

61.

60. Woods MN, Harris KJ, Mayo MS, et al. Participation of African

Americans in a smoking cessation trial: A quantitative and qualitative

study. J Natl Med Assoc 2002;94(7):609-618.

61. Green BL, Partridge EE, Fouad MN, et al. African-American attitudes

regarding cancer clinical trials and research studies: results from focus

group methodology. Ethn Dis 2000;10(1):76-86.

62. Robinson SB, Ashley M, and Haynes MA. Attitude of AfricanAmericans regarding prostate cancer clinical trials. J Community

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changes associated with exercise participation among women with

breast cancer. Psychooncology 2003;12(2):118-26.

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2003;327(7410):320-1. 
www.ahrq.gov

AHRQ Pub. No. 05-E019-1

June 2005

ISSN 1530-440X
 

Evidence Report
3 

Chapter 1. Introduction 

Clinical Research and the Medically Underserved 

 Until recently, contemporary cancer prevention and control research approaches have failed 

to address the basis of persistent health disparities; and they have produced mixed results in 

regard to the adoption, replication and diffusion of successful interventions in underserved 

communities. Medically underserved populations, including low-income and racial/ethnic 

minority populations, face substantial barriers to state-of-the-art cancer care throughout the 

continuum of cancer care, from preventive services to detection, to treatment and survival. 

Health disparities, including those related to cancer, have multiple causes, including sociopolitical, economic, cultural, and geographic factors. Disparities in cancer mortality rates are 

mediated, in part, by socioeconomic factors,1-3 and low socioeconomic status is a predictor of the 

lack of preventive services.4-6 African Americans have among the highest age-adjusted cancer 

incidence and mortality rates, even when controlling for poverty rates.1,3,7-9 Disparities in cancer 

mortality may be due to disparities in incidence and/or in life expectancy following diagnosis.1,10 

 Differences in access to medical care, including cancer detection and treatment, may be 

major determinants of racial disparities in cancer mortality, as the disparities in cancer mortality 

rates are greater than those in incidence rates,8 and African Americans and other minority 

populations are more likely to be diagnosed with advanced stage cancer than are Whites4,8; 

however, when cancer patients receive comparable treatment at the same disease stage, they 

experience similar treatment outcomes.11-20 Once diagnosed, African Americans receive less 

intensive treatment,9,21 and survive for a shorter duration.22-26 The physicians who care for 

African Americans are less likely to be board-certified than those who care for Caucasian 

patients,27 suggesting that cancer health disparities may be due, to a large degree, to disparities in 

the quality of care delivered by available health care systems.18,19 Moreover, there is evidence 

that compared to the rest of the population, racial/ethnic minority populations are less likely to 

receive optimal treatment regimens following the diagnosis of cancer.21 Therefore, to reduce 

these disparities, it is essential to identify and address existing barriers to care. 

 The goal of clinical cancer research is to advance knowledge and improve decision-making 

in cancer care. Clinical trials focused on cancer prevention and treatment serve health 

professionals and the public by translating the insights of the biological and public health 

sciences into effective health interventions. The National Cancer Institute (NCI) provides support 

for the evaluation of cancer prevention and treatment strategies through clinical trials. National 

research standards have been formulated to ensure that benefits and burdens of clinical research 

are distributed equitably in society.1

 However, many studies fail to recruit their planned number 

of participants; and studies that recruit too few patients might miss clinically important effects 

and are thus inappropriate uses of participants and resources.28 Clinical trials are used to evaluate 

the efficacy and effectiveness of health promotion, prevention, and cancer care intervention 

strategies; however, questions often remain regarding the generalizability of trial results to a 

population broader than those enrolled in the clinical trials. 

 Medically underserved groups have been underrepresented in cancer clinical trials.29 Since 

1993, the National Institutes of Health (NIH) has required that all sponsored clinical trials, 
4 

including cancer trials, ensure that women and members of minorities and their subpopulations 

be included in all human subjects research.30, 31 In addition, results must be reported so that 

potential differences in treatment effect can be detected between study subgroups. The NIH has 

sponsored several efforts to recruit women and racial/ethnic minorities into cancer clinical trials 

and other types of studies (e.g., cross-sectional and observational studies).30, 31 However, more 

than a decade following the institution of this NIH requirement, enrollment of minority 

populations into cancer clinical trials remains woefully inadequate. In a review of accrual to 

NCI-funded clinical trials, Sateren found that certain populations were underrepresented, 

including racial and ethnic minorities, the elderly, adolescents, rural populations and individuals 

of low socioeconomic status, irrespective of race/ethnicity.32 Barriers to participation in cancer 

clinical trials would differentially exclude members of these groups from the potential benefits of 

new treatments and ancillary care services. 

 According to a recent Institute of Medicine (IOM) Report: 

“The inclusion of ethnic minority and medically underserved individuals in clinical 

trials and the dissemination of information to their community and health care providers 

are critical links connecting scientific innovation with improvements in health and health 

care delivery. Enhancement of these links is clearly within the purview of NCI and NIH. 

Although many factors pose challenges to such improvements (e.g., mistrust of the 

scientific establishment among many members of ethnic minority communities), without a 

concerted effort to enhance this process, ethnic minority and medically underserved 

communities will continue to lag behind the American majority in benefiting from the 

tremendous recent scientific achievements and medical breakthroughs in cancer 

prevention, treatment, and control.”19 

 Thus, the IOM underscored the urgent need to improve opportunities for culturally sensitive 

recruitment and accrual of underrepresented populations to cancer clinical trials, as a necessary 

step in addressing the public health impact of cancer health disparities. 

 Some investigators have systematically documented a range of factors important to 

participation in clinical trials in general 33 and to the recruitment of minorities to a broad range of 

clinical trial types.34 More recently, systematic research on the reporting of minorities in cancer 

clinical trial publications has emerged. The literature in recent years has produced occasional 

reports of efficacious and/or effective recruitment strategies directed at medically underserved 

populations in cancer treatment and prevention trials. While generalization and extrapolation 

from other populations and disease states may be necessary, those interested in applying the 

evidence from clinical trials benefit most from studies conducted in specific populations with 

specific cancer prevention or treatment protocols. 

 On the basis of a systematic review of cancer prevention and treatment trials, Swanson and 

Bailar observed that: 

 

● The majority of cancer clinical trial reports do not even describe the race or ethnicity 

of trial participants; 

● When women and minorities are included in clinical trials, their participation more 

often appears to be by chance than by plan; 
5 

● When subgroup analyses are reported, it is rarely clearly stated whether they are done 

to test hypotheses or to generate hypotheses; 

● When subgroups are reported, differences in treatment or prevention effect often are 

found; 

● Trial report recommendations rarely limit the scope of their recommendations on the 

basis of participant gender or participant race or ethnicity; and 

● Trials often do not include participant populations that are adequately diverse to 

ensure broad generalizability of results.”29 

The first five of these practices are clear and correctible shortcomings in clinical trials. 

The sixth practice limits the generalizibility of trial results.29 However, Swanson and Bailar 

did not address barriers to and strategies for successful recruitment to cancer clinical trials 

since the 1993 change in NIH policy regarding the reporting of clinical trial accrual results 

for women and minority populations. 

Little has been done to systematically synthesize published evidence regarding 

recruitment of underrepresented populations to cancer clinical trials. Such an assessment 

should serve to strengthen the evidence base for our knowledge about progress in increasing 

participation in cancer clinical research. By using the research literature to assess the state of 

knowledge about recruitment of underrepresented populations to cancer clinical trials, we 

should accomplish the following: 

● Document how the problem has been studied to date, 

● Ascertain proven ways to improve the recruitment, 

● Unify our knowledge regarding persistent barriers to recruitment. 

 If nothing else, a comprehensive appraisal should serve to summarize from an evidencebased perspective what we do know and, equally importantly, what we do not know about the 

recruitment of the medically underserved to cancer clinical trials. Of equal importance may be 

reports of failed attempts to recruit underserved groups. Knowing what strategies have been 

ineffective can be as helpful in the process of discovery as ascertaining effective strategies. 

Furthermore, systematically documenting the barriers of various recruitment interventions may 

be equally important in future study designs. 

Recruitment of Underrepresented Populations to Cancer 

Clinical Trials 

 To summarize evidence for recruitment of underrepresented populations to cancer clinical 

trials, one must first overcome several barriers, not the least of which is defining 

“underrepresented.” We adopted a definition of underrepresented similar to the “priority 
6 

populations” defined in authorizing legislation for the Agency for Healthcare Research and 

Quality (AHRQ) and incorporated into the National Healthcare Disparities Report.35,36 For the 

purposes of this report, the following groups constitute the “underrepresented populations:” 

adolescents, older adults, those of low socioeconomic status, those residing in rural areas, 

African Americans, Hispanics/Latinos, Asian Americans, and American Indians. Although 

individual investigators may define each component of this definition somewhat differently, it 

provides a rough framework while preserving enough breadth to encompass the vast majority of 

populations affected by disparities in the U.S. healthcare system and in recruitment into cancerrelated trials. The definition is intended to encompass populations such as the elderly, that may 

be underrepresented in clinical trials even if they are not always considered medically 

underserved otherwise. 

 We used a conceptual framework adapted from previous work done at Johns Hopkins 

University that includes various relevant factors for participation in clinical trials (see Figure 1). 

A multitude of factors may contribute to an individual’s participation in cancer clinical trials. 

Research characteristics (study design, interventions) interrelate with participants’ backgrounds 

(sociodemographic factors, knowledge, attitudes, beliefs, etc.), which in turn contribute to an 

individual’s awareness of a clinical trial. These in combination with opportunity comprise the 

key determinants of participation. Literature from the past decade suggests that medically 

underserved populations face significant barriers to participation in clinical trials along the 

continuum from awareness to acceptance, and the nature and extent of these barriers may vary 

across specific underrepresented populations. 

 Heterogeneous research tools have been used to study recruitment of the medically 

underrepresented populations to clinical trials in a variety of geographic and social contexts. 

These tools range from open-ended qualitative approaches in the community to structured 

experimental designs in the workplace. The historical, social, and ethical context for including 

the underserved in clinical trials is replete with examples of abuse. This history makes the study 

of barriers and the testing of strategies to improve participation of the underserved potentially 

suspect for those appropriately concerned about abuse. 

 Complicating matters further, the literature shows that neither investigators nor policy 

makers have reached a consensus on a uniform definition of “success” in recruitment. For 

instance, some have suggested that if underserved minorities enroll in trials at least as often as 

non-underserved, success has been achieved. Others have argued that the proportion of those 

enrolled in a given trial should have subgroup demographics that are proportionately 

representative of the more immediate geographic area or the U.S. population as a whole. 

Arguably, the appropriate level of inclusion might depend on the prevalence of the 

condition/disease studied in the overall population. Others might have serious concerns about 

any set numerical outcome standard, relying instead on assurance of an ethically and culturally 

appropriate process of recruitment. Few authors have adequately discussed this problem. 

 Despite these challenges literature has emerged in recent years to warrant a summary of the 

evidence. 
7 

Rationale for Commissioning This Evidence Report 

 The NCI requested this report to summarize the state of scientific knowledge regarding the 

recruitment of underrepresented populations to cancer clinical trials. As envisioned by NCI, this 

report would: 

● Summarize the ways the problem has been studied to date; 

● Describe the measures of success used in the literature to assess recruitment; 

● Summarize strategies that have been found to be efficacious and /or effective in the 

recruitment of underrepresented populations to both cancer prevention and treatment 

trials; and 

● Summarize the barriers to and promoters of participation in clinical trials for these 

populations. 

 This report is limited to recruitment to cancer clinical trials (not, for example, recruitment to 

observational studies) and to the underrepresented populations as defined above. This report will 

be used by the NCI to guide future funding opportunities, identify priority areas for researchers, 

and educate clinical and cancer control investigators about the effectiveness of different 

recruitment approaches. We expect this report to serve the overall goal of improving 

opportunities for underrepresented populations to participate in cancer clinical trials, thereby 

eventually leading to a reduction in cancer health disparities for those populations. 

 However, we recognize that even if members of underrepresented populations do participate 

in cancer clinical trials, and reporting and recruitment are adequate, the benefits of clinical trial 

knowledge may not translate into improved cancer outcomes for these populations due to other 

factors. If systemic inequities persist in the healthcare delivery system, including in access to 

quality care, the availability of research data may not benefit underrepresented populations so 

much as other populations. Therefore, recruitment efforts to cancer clinical trials must interface 

with other ongoing initiatives designed to address cancer health disparities through discovery, 

development, and delivery, and to overcome the critical disconnect between discovery and 

development on the one hand, and delivery of cancer care on the other.10,38

Objectives and Scope of Report 

 This report summarizes and synthesizes the available evidence used to answer the key 

questions provided to the Johns Hopkins University Evidence-based Practice Center (EPC) by 

the NCI covering the following: research literature and study design characteristics, and proven 

strategies and barriers to the recruitment of the medically underserved to cancer prevention and 

treatment trials (see key questions in the Methods section). The report is comprehensive and 

current for literature published as of July 2004. In answering the above questions, we have 

written this report for the purpose of ongoing planning and priority setting of national cancer 
8 

research policy. In addition, we hope it will contribute to the growing national dialogue 

addressing disparities in health outcomes for various U.S. populations. 
9 

Chapter 2. Methods 

 

 The NCI requested an evidence report to synthesize the available evidence on the effect of 

interventions to increase participation by underrepresented populations in clinical trials, with an 

overall goal of improving the opportunities for underrepresented populations to participate in 

cancer-related clinical trials. The EPC was awarded this contract in December 2003. We 

established a team and work plan to develop the evidence report. The project consisted of 

recruiting technical experts, formulating and refining the specific questions, performing a 

comprehensive literature search, summarizing the state of the literature, constructing evidence 

tables, and submitting the report for peer review. 

Recruitment of Technical Experts and Peer Reviewers 

 At the beginning of the project, we recruited a panel of internal and external technical experts 

to give us input on key steps including the selection and refinement of the questions to be 

examined. The panel included seven internal technical experts from the Johns Hopkins 

University who had expertise in various aspects of recruitment strategies for controlled clinical 

trials and 15 external experts who had special interests in underrepresented populations (see 

Appendix A*

). Many of our external experts also were a part of the NCI Special Populations 

Network (SPN).37 In addition to this panel of technical experts, we recruited a group of peer 

reviewers to examine a draft of the evidence report, as described further in the section on Peer 

Review. This group included representatives of organizations or agencies having different 

perspectives on the topic (See Appendix A). We also sought input throughout the project from 

representatives of the NCI. 

Key Questions 

 We refined the original questions provided by AHRQ after obtaining input from the technical 

experts and NCI representatives. Listed below are the Key Questions addressed in this report. 

1. What methods (e.g., survey studies, focus groups) have been used to study strategies to 

recruit underrepresented populations into cancer prevention and treatment trials? We 

defined underrepresented populations as including the elderly, adolescents, those of low 

socioeconomic status, those living in rural areas, African Americans, Hispanics/Latinos, 

Asian Americans, and American Indians. We included the elderly as underrepresented 

because of concerns that they are not recruited into trials as aggressively as younger 

 

*

 Note: Appendixes cited in this report are provided electronically at: http://www.ahrq.gov/clinic/tp/recruittp.htm 
10 

patients when diagnosed as having cancer. We included adolescents as underrepresented 

because of concerns that they may be more resistant to participating in cancer-related 

trials than adults. 

2. What measures of success (e.g., proportional representation relative to the U.S. 

population; proportional representation relative to incidence in a specified population) 

have been used to evaluate the efficacy and/or effectiveness of strategies for recruitment 

of underrepresented populations into cancer prevention and treatment trials? 

3. Which recruitment strategies (e.g., media appeals, incentives, etc.) have been shown to be 

efficacious and/or effective in increasing participation of underrepresented populations 

in cancer treatment trials? 

4. Which recruitment strategies have been shown to be efficacious and/or effective in 

increasing participation of underrepresented populations in cancer prevention trials? 

5. What are the documented barriers to and promoters of participation of underrepresented 

populations in cancer prevention and treatment trials? Examples of potential barriers 

include access, knowledge, attitudes, eligibility, fatalism, religiosity/spirituality, and 

exclusion by design. Examples of potential promoters include attitudes, altruism, 

advanced disease, financial incentive, and no-cost treatment. 

a. How do these barriers and promoters differ by age, gender, socioeconomic status, or 

race/ethnicity? 

 

 b. How are these barriers and promoters modified by cultural factors? 

6. What effects do the attitudes and perceptions of healthcare providers have on the 

efficacy/effectiveness of strategies for recruitment of underrepresented populations into 

cancer prevention and treatment trials? Healthcare providers are defined as including 

any health professional or healthcare organization that provides health services to 

patients. 

Conceptual Framework 

We constructed a conceptual framework for our questions based on the relationships among 

the factors leading to a patient’s decision to enroll in a cancer-related clinical trial (see Figure 1). 

This framework was derived from a conceptual model developed by two members of the EPC 

team.39 

 The premise for the framework is that in order to accept or refuse participation in a 

clinical trial, one must first be aware of the availability of the trial and have an opportunity to 

participate in the trial. The opportunity to participate in a trial may present itself first, 

encouraging patients to seek information about the trial. This, in turn, may lead to the decision to 
 11 

accept or refuse participation in the trial. There are multiple pathways to recruitment into a trial, 

including: 1) patients/clients receiving information about clinical trials in general through 

healthcare providers or their own social ties, and subsequently accepting a specific opportunity to 

participate in the trial; and 2) in the absence of prior awareness about clinical trials, 

patients/clients may consider an opportunity to participate in a trial, with the result of 

encouraging them to seek or receive information regarding the trial, thereby increasing trial 

awareness. Key Questions 5 and 6 of this report address barriers to and promoters of awareness, 

opportunity, and acceptance/refusal. 

 In the hypothesized conceptual framework, there are several factors that are promoters of or 

barriers to clinical trial awareness. First, a person must know about and believe in the value of 

participating in the clinical trial before one can agree to participate. Knowledge about a clinical 

trial involves knowing what the anticipated outcomes may be, the costs of participation in terms 

of money, time, and effort, as well as information about the disease. Second, a person’s attitudes 

and beliefs regarding cancer, the medical profession, and medical research may influence their 

willingness to receive and attend to information about clinical trials. Third, a person’s belief in 

his/her ability to participate in a clinical trial, or self-efficacy, may influence awareness of the 

clinical trial. If individuals do not believe that they can participate in the trial, then they may not 

be open to hearing information about the trial. Fourth, the organizational environment, which 

involves the physical and psychosocial environment in which the information is being 

disseminated as well as the trial is being conducted, may influence a person’s willingness to 

receive information about clinical trials. If the organizational environment makes patients/clients 

uncomfortable or defensive, then they will be less open to recruitment efforts. The final 

hypothesized barrier to or promoter of clinical trial awareness is health literacy. A lack of 

understanding of the medical system, cancer, and health information in general lead to poor 

health literacy, making patients less inherently aware about clinical trials as well as more 

difficult to educate them about trials. 

 As denoted in the conceptual framework, individuals must have an opportunity to 

participate in a clinical trial before they can accept or refuse participation. Some barriers and 

promoters of opportunity are access to the hospital or clinical trial site, trial eligibility, advanced 

disease, comorbidities, and medical insurance status. Additionally, providers can play a vital role 

in the successful recruitment of patients to clinical trials in that they are often the gatekeepers of 

information about clinical trials. They can decide which patients to refer for trial participation. 

Therefore, provider knowledge, attitudes, and beliefs about clinical trials and their patients’ 

abilities to enroll in the trials may influence their disseminating information about the trials (key 

question 6). 

 The third main component of the conceptual framework involves acceptance/refusal of trial 

participation. The decision to accept or refuse enrollment in a clinical trial is based on many 

factors, which often involves a decisional balance. For example, do the perceived benefits 

outweigh the perceived harms? If so, then people are more likely to agree to enroll in a trial. 

Also, trust in the sponsor, physician, or investigator may play a large role in whether people are 

willing to participate in a clinical trial. Other factors that are important to acceptance/refusal are 

self-efficacy, quality of life, advanced disease, no cost treatment, financial incentives, as well as 

personal experience with cancer, the medical system, and clinical trials. The timing of the trial 

may also influence the decision to participate. For an example, a person who has just been 

diagnosed with cancer may be more or less willing to participate than someone who is at the end-
 12 

stage of cancer. Finally, religious beliefs and altruism may play a role in the decision regarding 

participation. 

 Encompassing clinical trial awareness, opportunity, and acceptance/refusal are 

sociodemographic factors that serve as moderators/covariates of participation. These 

sociodemographic factors include race/ethnicity, age, gender, geography, language, income, 

social ties, education, and culture. In the hypothesized conceptual framework, each of these 

factors influences individual barriers to and promoters of awareness, opportunity, and 

willingness to participate in cancer clinical trials among underrepresented populations. 

 As part of this report, we evaluated interventions to increase accrual to cancer clinical trials 

(Key Questions 3 and 4). The types of interventions targeted were directed at individuals, 

physicians/providers, the medical system, and the community; and intervention strategies varied, 

including incentives, as well as media-based campaigns. Based on our conceptual framework, 

interventions are directed at decreasing barriers to and/or promoters of clinical trial awareness as 

well as opportunities for participation and willingness to participate or actual enrollment. In 

addition, we looked at the types of studies used to address the recruitment of underrepresented 

populations to clinical trials (Key Question 1). These were expected to be primarily surveys, 

focus groups, and concurrent controlled trials (CCT) (both randomized and non-randomized). 

Finally, as denoted in the bottom right of the conceptual framework, we attempted to assess 

whether investigators reported on measures of success (Key Question 2). For example, if a 

recruitment goal was stated a priori, was that goal achieved? We attempted to identify the 

different ways recruitment success was measured. Some examples of potential success measures 

are proportional representation relative to the U.S. population and proportional representation 

relative to cancer incidence. 

Literature Search Methods 

 Searching the literature included the steps of identifying reference sources, formulating a 

search strategy for each source, and executing and documenting each search. 

Sources 

 Our comprehensive search plan included electronic and hand searching. In March 2004, we 

searched the following electronic databases: MEDLINE®, the Cochrane CENTRAL Register of 

Controlled Trials (Issue 1, 2003), the Cochrane Database of Methodology Reviews (CDMR), the 

Cumulative Index of Nursing and Allied Health Literature (CINAHL®), the Psychological 

Abstracts (PsycINFO), and The Campbell Collaboration’s Social, Psychological, Educational, 

and Criminological Trials Register (C2-SPECTR). This electronic search strategy was not 

limited by year of publication, and the MEDLINE database goes back to 1966 

 Hand searching for possibly relevant citations took several forms. Our experts identified 34 

journals that were thought to be most likely to contain relevant studies (see Appendix B). We 

scanned the table of contents of each issue of these journals for relevant citations from January 

2003 through July 2004. 

 For the second form of hand searching, we used ProCite® (ISI ResearchSoft, Berkeley, CA), 

a reference management software package, to create a database of reference material identified 
 13 

through an electronic search for relevant guidelines and reviews, through discussions with 

experts, and through the article review process. The investigators reviewed the articles identified 

as being possible review articles during the abstract review process. The references in these 

review articles were searched to identify any additional articles for consideration. We also used 

MEDLINE to search for articles published by selected experts known to have interests related to 

our Key Questions. 

 Finally, we examined the reference lists of eligible articles to identify any potentially relevant 

ones. This task was completed by the second reviewer as part of the article review process (see 

description of article review process below). 

Search Terms and Strategies 

 Search strategies, specific to each database, were designed to maximize sensitivity. Initially, 

we developed a core strategy for MEDLINE, accessed via PubMed, based on an analysis of the 

Medical Subject Headings (MeSH) and text words of key articles identified a priori. The 

PubMed strategy formed the basis for the strategies developed for the other electronic databases 

(see Appendix C). 

General search terms 

MEDLINE general search terms: (neoplasm [mh] OR cancer [tw] OR carcino*[tiab] OR 

tumor [tiab] OR oncolog*[tiab]) AND (patient selection [mh] OR recruit*[ti] OR participat*[ti] 

OR enrol*[ti] OR enlist*[ti]) AND eng [la] NOT (animal [mh] NOT human [mh]). 

PsychINFO general search terms: (neoplasm or cancer or carcinogen or tumor or oncolog*) 

and (patient selection or TI recruit* or TI participat* or TI enrol* or TI enlist* or TI refer*) and 

(trial* or stud*) And LA english and human. 

CINAHL general search terms: (neoplasm or cancer or carcino* or tumor or oncolog*) and 

(MW patient selection or MW research subject recruitment or TI recruit* or TI participat* or TI 

enrol* or TI enlist* or TI refer*) and (trial* or stud*) and LA English and human.

Cochrane Database (CENTRAL and Methodology Review) general search terms: 

(neoplasm* or cancer or carcino* or tumor* or oncolog*) and (patient selection or recruit*:ti or 

particip*:ti or enrol*:ti or enlist*:ti or refer*:ti) and (trial* OR stud*) NOT (animal NOT 

human). 

C2-SPECTR: {neoplasm} or {cancer} or {carcino} or {tumor} or {oncolog} 

OR All Non-Indexed Fields: {neoplasm} or {cancer} or {carcino} or {tumor} or {oncolog} 

AND All Non-Indexed Fields {patient selection} or {recruit} or {participat} or {enrol} or 

{enlist} or {refer} AND All Non-Indexed Fields {trial} or {stud} NOT All Non-Indexed Fields 

{animal} NOT {human}. 

Organization and Tracking of Literature Search 

 Whenever possible, the results of the searches were downloaded and imported into ProCite. 

We used the duplication check in the bibliographic software ProCite to include in the 

Recruitment Citations Database only articles that were not previously retrieved. This database 

was used to store citations and to track the search results and sources. We also used this database 
 14 

to track the results of the title and abstract review processes and the retrieval of the full text 

copies of articles (see Figure 2). 

Title Review 

 After the electronic databases were searched and citations downloaded into ProCite, the 

study team scanned all of the titles. During the scan, team members deleted any titles that did not 

apply to the study topics. Title scans were conducted in a parallel fashion by two independent 

reviewers. If a title was selected as irrelevant by both reviewers, it was tagged in the ProCite 

database and deleted from further study. 

Abstract Review 

 Specific inclusion and exclusion criteria were applied at each of the levels of review, with 

criteria becoming more stringent as the process moved from searching, to the review of titles, to 

the review of abstracts, and to the review of articles. After identifying a title as potentially 

relevant, two team members independently reviewed the abstract of the citation, and articles 

were included or excluded from the article review on this basis. Disagreements between 

reviewers were adjudicated by consensus. 

Inclusion and Exclusion Criteria 

 During the abstract review process, emphasis was placed on identifying all articles that could 

have original data pertinent to the questions about recruitment of underrepresented populations 

into cancer prevention and treatment trials. As previously described, representatives from NCI 

were consulted during the development of inclusion and exclusion criteria. 

 In evaluating titles and abstracts, the following criteria were used to exclude articles from 

further consideration: 

● Not written in English. 

● Did not include human data. 

● No original data. 

● Meeting abstract only (no full article for review). 

● Did not address cancer treatment or prevention. 

● Did not report a controlled trial or discuss recruitment to a controlled trial. 

● Article did not apply to any of the study questions. 
 15 

 For citations relevant to Key Questions 3 and 4, we limited eligibility further to studies that 

compared at least two groups. This comparison group could include groups from randomized and 

non-randomized designs with concurrent or historical controls. Non-controlled designs (e.g., case 

series with no comparison groups) were excluded for Key Questions 3 and 4, but remained 

potentially eligible for Key Questions 1 and 2. 

 When the initial exclusion criteria were developed, “not a U.S.-based study” was an 

exclusion criterion. As the review process progressed, however, the EPC team determined that 

this exclusion criterion might delete some articles from the review that could provide important 

information. Abstract reviews were then conducted on articles initially excluded because they 

were not U.S.-based studies. A number of articles were then eligible for article review that would 

not have been eligible otherwise. We included studies that addressed underrepresented minority 

populations using whatever definitions of race/ethnicity were provided by the study authors.

Abstract Review Process 

 We reviewed abstracts by printing titles and abstracts of all articles retrieved by the literature 

search on a standardized form and distributing them to two reviewers (see Appendix D*). The 

reviewers independently screened the abstracts for eligibility and classified them by research 

question addressed. When reviewers agreed that a decision regarding eligibility could not be 

made because of insufficient information, the full article was retrieved for review. 

 The results of the abstract review process were entered into the Recruitment Citations 

Database. Deleted citations were tagged with the reason for exclusion. Citations were returned to 

the reviewers for adjudication if there was disagreement on eligibility. 

Article Review 

 The purpose of the article review was to confirm the relevance of each article to the research 

questions, to determine methodological characteristics pertaining to study quality, and to collect 

evidence that addressed the research questions. Articles eligible for full review could address 

more than one of the Key Questions. If reviewers felt this was the case multiple forms were used. 

Quality Assessment and Data Abstraction 

 Forms were developed to confirm eligibility for a full article review, to assess study 

characteristics, and to extract the relevant data to address the study questions (see Appendix E). 

The forms were developed through an iterative process that included the review of forms used 

for previous EPC projects, discussions among team members, and pilot testing. This process was 

complex because of the heterogeneity of the literature. We developed a general form and 

question-specific content review forms for the abstraction of data to address Key Questions 1 and 

2, 3 and 4, and 5 and 6. We used one form to assess the quality of articles eligible for Key 

Questions 3 and 4, and a separate form to assess the quality of articles eligible for Key Questions 

5 and 6. A quality assessment form was not used for articles eligible for Key Questions 1 and 2 

because the questions called for only a listing of methods that have been used. The forms were 

color coded to aid reviewers.
 16 

 

Assessment of the quality of individual studies 

● The study quality assessment form Key Questions 3 and 4 had six sections and was 

completed only for studies that met the criteria for these Key Questions. 

● The first section addressed the representativeness of the study populations, thus 

allowing the reviewers to assess each study’s descriptions of setting and population as 

well as the inclusion/exclusion criteria and the characteristics of participants/nonparticipants. 

● The second section was used to evaluate potential bias and confounding factors. 

● The third section assessed the description of the recruitment strategy by evaluation of 

the details of the flow of participants through the clinical trial and the details of the 

recruitment strategy. 

● The fourth section assessed the reporting of recruitment outcomes and follow-up. It 

included the description of the measures used to define barriers and promoters to 

recruitment and each study’s reporting of the reasons for withdrawal from the study. 

● The fifth section assessed the statistical quality and interpretation, and the sixth 

covered conflict of interest. The last item called for an overall rating of the quality of 

the study. 

● The study quality assessment form for Key Questions 5 and 6 had three sections. 

● The first section covered the representativeness of the study population in much the 

same manner as the quality assessment form for Key Questions 3 and 4. 

● The second section was designed to assess the quality of survey studies. 

● The third section was designed to assess the quality of qualitative studies. 

Data abstraction 

A separate general abstraction form was used for each question to abstract information such 

as study design, intervention, study location, objectives, target population characteristics, and 

timeline. Additional question-specific forms were used for Key Questions 1 and 2, Key 

Questions 3 and 4, and Key Questions 5 and 6. Each of these three forms addressed questions 

dealing specifically with the respective Key Questions. 

Article Review Process 

 We used a serial article review process. In this process, the quality assessment and data 

abstraction forms were completed by the primary reviewer. The second reviewer, after reading 
 17 

the article, performed an independent assessment of the study’s quality using a separate quality 

assessment form and then checked each item on the data abstraction form for completeness and 

accuracy. The reviewer pairs were formed to include personnel with both clinical and 

methodological expertise. A third reviewer re-reviewed all articles that were marked as 

“ineligible” by the first two reviewers to ensure consistency in the classification of the articles. 

Reviewers were not masked to the articles’ authors, institution, or journal. In most instances, data 

were directly abstracted from the article. If possible, relevant data were also abstracted from 

figures. 

 All information from the article review process was entered in a relational database 

(Recruitment Evidence Database). The database was used to maintain and clean the data, as well 

as to create detailed evidence tables (see Appendix F†

) and summary tables (see Tables 1 to 7). 

Grading of the Total Body of Evidence 

 After all articles were reviewed, we graded the total body of evidence supporting each 

question on the basis of its quantity, quality, and consistency. Our evidence-grading scheme 

followed the approach recommended by the International GRADE Working Group.40 In terms of 

quantity of evidence for each question, we determined the number of studies and the total 

number of patients studied. We assessed the quality and consistency of evidence on each key 

question based on the criteria recommended by the Grade Working Group that applied to the 

questions (see Tables 8 to10). Although the GRADE criterion were developed primarily for 

treatment effectiveness questions, they are based on fundamental principles that apply to a 

variety of study questions. As shown in Tables 8 to 10, we downgraded our grading of the 

evidence if any of the following criteria were met: 1) if the studies had serious limitations in 

quality; 2) if the studies had important inconsistency; 3) if there was uncertainty about the 

directness or extent to which the people, measures and/or outcomes are similar to those of 

interest; 4) if data were imprecise or sparse; and 5) if the studies had high probability of 

reporting bias. 

Peer Review 

 Throughout the project, feedback was sought from the technical experts through ad hoc and 

formal requests for guidance. A draft of the completed report was sent to the technical experts 

and peer reviewers, as well as to the representatives of the NCI and AHRQ. Substantive 

comments were entered into a database. Revisions were made to the evidence report as 

warranted, and a summary of the comments and their disposition was submitted to AHRQ with 

the final report. 

 

†

 Note: Appendixes cited in the report are provided electronically at: http://www.ahrq.gov/clinic/tp/recruittp.htm 
19 

Chapter 3. Results 

Results of Literature Search and Abstract Review Process

 Results from the search and the abstract review process were maintained in a database 

developed in ProCite. A summary of the results of the search and review process is provided in 

Figure 2. 

 Of the 4451 citations retrieved by the search methods, 341 were duplicates leaving 4110 for 

title review. Of these, 1089 were reviewed at the abstract level. Two hundred eighteen articles 

were identified as eligible for full article review through the abstract review process. 

 Because many articles had more than one reason to be excluded the abstract reviewers did 

not need to agree on the main reason for applied at the abstract level. The most frequent reason 

for exclusion was that the article did not report a controlled trial or discuss recruitment to a 

controlled trial (used by one or both reviewers to delete 460 abstracts). The next most frequent 

reason for exclusion was that the article contained no original data (used by one or both 

reviewers to delete 173 abstracts). 

Results of Article Review Process 

From the abstract review process, 218 citations were identified for inclusion in the article 

review phase. At the article review level 151articles (70 percent) were excluded. The most 

frequent reasons for exclusion were that the article did not address an underrepresented 

population (69 articles, 45 percent), the article did not report on a controlled trial (36 articles, 24 

percent), or there was no subgroup analysis (16 articles, 11 percent). A listing of excluded 

articles with the reasons for exclusion is included in this report. 

Of the 67 articles included in this report, Key Question 1 was addressed by 13 articles, and 

Key Question 2 was addressed by 23 articles. Both Key Questions 3 and 4 were addressed by 

small numbers of articles (one and four respectively). For this reason, and the similarity of 

questions, the results of these two questions were combined (five total). Key Question 5 was 

addressed by 45 articles with questions 5a and 5b addressed by 30 and three articles respectively. 

Key Question 6 was addressed by 10 articles. 
20 

Key Question 1: What Methods Have Been Used to Study 

Strategies to Recruit Underrepresented Populations into 

Cancer Prevention and Treatment Trials? 

Identification of Relevant Articles 

 As indicated in Figure 2, we found 13 studies that were relevant to this question. Details 

about these studies are shown in Table 1, and Evidence Tables 1-1, 1-2, and 1-3 in Appendix F.b

Study Characteristics 

 All 13 studies were of U.S. origin, and most were based in a community setting.41-49 Studies 

by Advani et al. and Mauer et al.50,51 were hospital-based, with Advani et al. involving 

outpatients and Mauer et al. involving inpatients. One study52 was set in the workplace or 

workers’ homes. The specific setting for one study was unclear.53 The reported target population 

for all of the studies was patients/participants except one study44 where the target population was 

patient /participants and physicians. Three studies45,46,49 targeted physicians only. The reported 

study designs in all studies varied. A randomized controlled trial was the reported study design 

for two studies. 43,52 One study was quasi-experimental,41 and two studies compared two or more 

interventions.42,46 Descriptive study designs were used in four studies.44,47-49 One study used a 

survey design,50 and another employed a qualitative design.53 One used a case study design.51

 These studies dealt with a range of cancers. A few investigated trials for a specific cancer; for 

example, breast cancer was specified in three studies,46,47,50 and lung cancer was specified in 

three.43,48,52 The balance of the studies dealt with multiple types of cancer. Two reported a 

general focus that included all cancers.53 One investigated trials for any cancer type where there 

was an active protocol.44

 Four studies did not report the dates on which recruitment into the study started or 

ended.49,50,52,53 The recruitment ending date for one of the studies was reported as ongoing.45 All 

of the studies investigated the effectiveness of methods or the delineation of barriers to 

recruitment of individuals into trials (Evidence Table 1-1, see Appendix F). 

Target Population Characteristics 

 Of the 13 eligible studies, six reported mean age,42,43,46,47,52,53 which ranged from 43 years to 

62 years (see Evidence Table 1-2 in Appendix F). Within each of these studies the actual age 

range of participants was quite wide. For example, Brewster et al. reported a within-study range 

of 17 to 78 years of age.42 Five studies reported an age range.42,43,48,49,53 The reported age range 

in four of these studies was narrower than it was for Brewster et al.42 

Only eight studies reported the gender of the participants.41-43,46,48,49,52,53 Four studies reported 

that the majority of participants were male.43,46,50,52 The studies did not report usable information 

about the income or education levels of participants. 

 

b

 Note: Appendices cited in this report are provided electronically at: http://www.ahrq.gov/clinic/epcindex.htm 
21 

Information regarding the racial or ethnic distributions of the participants was available for 

only a few of these studies. Four studies reported that 6 percent, 100 percent, one percent, and 

100 percent, respectively, of participants were African American.41,43, 47, 54 Sears et al. reported 

that 9 percent of participants were Asian/Pacific Islanders,47 and Advani et al. reported that 33 

percent of its participants were American Indian.50 Sears et al. reported that 85 percent of 

participants in their study were Caucasian.47 In other studies, Advani et al and Randall-David et 

al. reported 67 percent and one percent of participants as Caucasian.50,53 Brewster et al. and 

Berman et al. reported that one percent of their participants were Latino/Hispanic.41,42 None of 

the studies reported having any adolescent participants. Ford et al., Zhu et al., and Thornquist et 

al. reported that the proportions of their participants who were elderly were 100 percent, one 

percent, and 25 percent, respectively.43,49,48 Over one-third (38 percent) of the participants in the 

study by Ford et al. reported low socioeconomic status.43 Approximately 64 percent of the 

participants in the study by Advani et al. were from a rural area.50 Three other studies reported 

that one percent of their participants were from rural areas.46,51,53

Recruitment Methods Findings 

 All but two of the studies defined successful recruitment into cancer-related controlled 

trials as actual participation of the targeted group50, 53 (Evidence Table 1-3, see Appendix F), and 

none of the studies set a priori recruitment goals. Eight of the studies reported recruitment start 

and end dates, 41-44,46-48,51 with the average reported time spent on recruitment being 33 months. 

Advani et al. defined successful recruitment as participants’ willingness to participate in the 

study and not their actual participation.50 We defined “methods” broadly as methods used to a) 

study recruitment, b) design the studies, c) identify the target populations, and d) recruit 

individuals into the clinical trials. Seven studies did not report the method used to design their 

recruitment strategies.43,44,47,48,51,52The primary outcomes of the studies varied and could be 

organized into primary, secondary, or tertiary categories. Linnan et al. and Zhu et al. were 

primary prevention projects.49,52 One study was a survivorship/recurrence-prevention project,45 

and two were chemoprevention studies.44,48 Each of the 13 studies initially mailed letters to 

recruit participants as part of the overall recruitment strategy. In addition to these mailings, 

telephone calls and fliers or posters strategically placed around the worksite or community were 

used in an attempt to recruit participants into the studies. One study advertised in community and 

regional newspapers that served as an important source of information for the area’s Spanish 

speaking population.42 These advertisements were printed in both English and Spanish. This 

study also used the local Spanish language television station, faith-based organizations, mental 

health facilities, and free clinic facilities in an attempt to get people to participate. One study 

used third party insurers to enlist participants.48 Four studies also enlisted the assistance of 

physicians to recruit participants into their project. 44-46, 48 Incentives, both monetary and 

material, were used in Paskett et al.45 One study enlisted the aid of local businesspersons to help 

in the recruitment of participants.43 Finally, none of the studies reported having set a goal for 

recruiting a specific percentage of participants before the start of the study. 
22 

Key Question 2: What Measures of Success Have Been Used 

to Evaluate the Efficacy and/or Effectiveness of Strategies for 

Recruitment of Underrepresented Populations into Cancer 

Prevention and Treatment Trials? 

Identification of Relevant Articles 

 As indicated in Figure 2, we found 23 studies that were relevant to this question (see Table 

2). Details about these studies are shown in Evidence Tables 2-1, 2-2, and 2-3, Appendix F. 

Study Characteristics 

 All studies except one were from the United States. 54 Twelve of the studies were reviews of 

multiple cancer clinical trials and, therefore, had multiple study settings.44,55-65 Nine of the 

studies occurred in a community setting41-44,46,48,49,66,67 and seven involved a hospital 

center42,44,51,58-60,63. Twenty studies targeted patients/participants for the recruitment 

intervention41-44,48,51,52,54-61,63-67, two studies targeted physicians, and one study targeted 

patients/participants and researchers.62 Most of the study designs to evaluate recruitment success 

were descriptive48,54-61,63,65 presenting recruitment results of a retrospective review of multiple 

cancer trials (n=11), 48,54-61,63,65 descriptive studies of enrollment into a cancer clinical trial 

(n=4),44,62,64,67 or a description of enrollment into a cancer trial using a survey, qualitative, or 

quasi-experimental study design (n=2). The rest of the study designs were two controlled clinical 

trials,42,46 two randomized controlled trials,43,52 a case-control study,66 and a case series.46 

 Nine studies evaluated recruitment into any cancer trial44,54-61; the remaining studies 

evaluated recruitment success for trials on breast cancer (n=6),46,49,51,63-65 colorectal cancer 

(n=5),43,46,51,63,65 prostate cancer (n=5),43,51,62,63,65 lung cancer (n=5),48,51,52,63,65 or cervical cancer 

(n=2).42,67 Sixteen of the studies evaluated recruitment or reviewed active trial enrollment during 

the 1990s.41-44,46,51,54,55,56,59,61-65,67 Three studies reported that recruitment/enrollment began in the 

1980s,48,58,60 one in the 1950s57; three did not report when recruitment began.49,52,66 The studies 

evaluating recruitment success were cancer treatment trials alone (n=14),44,46,51,54,56-59,61-66 cancer 

prevention trials alone (n=7),41-43,48,49,52,67 or involved treatment and prevention trials (n=2)55,60

(see Evidence Table 2-1 in Appendix F). 

Target Population Characteristics 

 For the eligible studies reporting mean age, the majority of the participants were middle-aged 

adults with a mean age between 40 to 60 years old.42,46,52,57,64,66 The age range when documented 

was mostly between 40 and 80 years.42,43,48,49,62,63 Three studies evaluating cervical cancer, 

smoking cessation and adolescent participation in clinical trials had a lower mean age from 20 to 

40 years.41,60,67 The gender distribution varied across studies from 0 to 100 percent male. Four 

studies reported information on low socioeconomic status or low annual income (less than 

$30,000 per year)42,43,52,49 while four studies reported having greater than 45 percent of 

participants with a high school education or less.41,49,52,66
23 

 In these studies, we found that the percentage of study subjects who were in 

underrepresented groups varied widely: elderly (ranged from 15 to 100 percent with the majority 

ranging from 20 to 50 percent),43,48,49,54,56,57,61,63,65,66 African Americans (ranged from 4 to 100 

percent with the majority between 4 to 30 percent),41,43,49,56,63,64,67 Latinos/Hispanics (ranged 

from 3 to 85 percent with the majority ranging from 3 to 6 percent),41,42,52,56,58,63,67 Asian /Pacific 

Islanders (ranged from 2 to 3 percent),63,67 American Indians/Alaska Natives (0 to 2 percent),67

rural (100 percent in both articles evaluating rural populations),46,51 adolescents (ranged from 21 

to 33 percent),60 and low socioeconomic status/low annual income (27 to 91 percent with the 

majority between 27 to 39 percent)42,43,51,52 (see Evidence Table 2-2 in Appendix F). 

Recruitment Goals and Measures of Success 

 All studies defined recruitment as actual participation in a cancer trial. Only two articles 

reported having a specific recruitment goal for the underrepresented group prior to enrollment in 

the study. One was a goal for the rural population based on the recruitment results of a prior 

study, 51 and the other was a goal for African American men 55 years old or older based on 

geographic representation (i.e. percent African American elderly men in the U.S.).62 The study 

by Maurer et al on rural populations met this recruitment goal while the Moinpour et al. study on 

African Americans did not, recruiting 4 percent instead of 8 percent.51,62

 Recruitment success was defined differently depending on the study. To better evaluate the 

recruitment success measures, we grouped them into four different categories: 1) geographic 

proportion underrepresented (i.e., proportion of U.S. population in an underrepresented group); 

2) disease-specific proportion underrepresented (i.e., proportion underrepresented with cancer or 

a specific type of cancer in a geographic area such as the U.S.); 3) proportion underrepresented 

selected by the researcher for various reasons (e.g., statistical power, convenience, or data from 

prior studies); and 4) research institution’s proportion underrepresented (i.e., proportion of 

population in the institution that was in an underrepresented group). 

 Most of the studies defined recruitment success as equaling the proportion underrepresented 

that was selected by the researcher for various reasons such as convenience (n=13),42-

44,46,48,49,51,52,54-55,57,66,67 or as the disease-specific proportion underrepresented (n=9).54-56,58,60,61,63-

65 The rest of the studies defined recruitment success based on the geographic proportion 

underrepresented (n=2),41,62 or the institution’s proportion underrepresented at a research 

institution (n=1).59 

 When examining the 12 articles on cancer treatment trials, recruitment success was mainly 

defined as being equal to the proportion set by the researcher,44,46,51,54,57,59,66 or the U.S. diseasespecific proportion underrepresented.54,56,58,59,61,63 For the eight articles on cancer prevention 

trials alone, recruitment success was defined mainly as being equal to the proportion set by the 

researcher.42,43,48,49,52,67 For the 3 studies that evaluated both prevention and treatment trials, the 

disease-specific proportion underrepresented was the major success definition used.55,58,64 

 Christian and Trimble in an article that did not meet our strict eligibility criteria (it contained 

no original data), reviewed data from the cancer therapy evaluation program that reports the NCI 

cancer clinical trials by race (American Indian/Alaska Native, Asian/Pacific Islander, African 

American, and Latino/Hispanic). They used the data from the 2000 U.S. census as a comparison, 

thereby providing another example of geographic representation as a measure of success.73 

A priori recruitment goals were rarely specified for underrepresented groups when evaluating 

recruitment success of cancer clinical trials. Additionally, the trials had no standard measure of 
24 

recruitment success. The majority of recruitment success measures were defined either as the 

proportion set by the researcher, often arbitrarily, or the disease-specific proportion of 

underrepresented. This was true across all underrepresented groups and regardless of whether the 

study addressed cancer treatment, prevention, or both. Very few studies evaluated recruitment 

success in underrepresented groups especially those with low socioeconomic status, 

Asian/Pacific Islanders, adolescents, and rural populations (less than three studies in each group). 

No study reported recruitment success measures for American Indian/Alaska Natives (see 

Evidence Table 2-3 in Appendix F). 

. 

Key Question 3: Which Recruitment Strategies Have Been 

Shown to be Efficacious and/or Effective in Increasing 

Participation of Underrepresented Populations in Cancer 

Treatment Trials? 

Key Question 4: Which Recruitment Strategies Have Been 

Shown to be Efficacious and/or Effective in Increasing 

Participation of Underrepresented Populations in Cancer 

Prevention Trials? 

Identification of Relevant Articles 

 As indicated in Figure 2, we found 5 studies that were relevant to these questions.42,43,46,52,62

Details about these studies are shown in Tables 3 and 4, and Evidence Tables 3/4-1, 3/4-2, 3/4-2, 

3/4-4, and 3/4-5 in Appendix F. 

 In reviewing the current literature on effective and/or efficacious recruitment strategies in 

improving participation of underrepresented populations in cancer clinical trials, we found a total 

of five eligible articles. Four articles examined recruitment strategies of underrepresented 

populations into cancer prevention trials,42,43,52,62 and the fifth article examined strategies of 

recruiting underrepresented populations into cancer treatment trials.46 

 The settings of the studies ranged from participants’ homes and community 

environments42,43,46,52 to community-based clinics and research sites42,62 (Evidence Table 3/4-1 

see Appendix F). Three studies focused on recruitment of underrepresented populations at the 

participant level;42,43,52 one study evaluated the recruitment of underrepresented populations 

through participants and physicians62 and one evaluated recruitment of underrepresented 

population through physicians46 (Evidence Tables 3/4-1 and 3/4-2 in Appendix F). The 

underrepresented populations examined included blue-collar workers in manufacturing 

companies, African-American and Latino/Hispanic men, Latina/Hispanic women in southern 

California, and cancer patients in rural counties of North and South Carolina. All five studies 

used randomized or non-randomized controlled trials to evaluate the efficacy or effectiveness of 

interventions to promote recruitment to cancer clinical trials (Evidence Table 3/4-3, Appendix 

F). 
25 

Quality of Studies 

 The studies on Key Questions 3 and 4 varied in their limitations as summarized in Quality 

Evidence Table 3/4-4 in Appendix F. We specifically examined each article based on 

representativeness, bias and confounding, recruitment description, outcomes and follow-up, 

statistical quality and interpretation, and conflict of interest. 

 Linnan’s study reported a good amount of detail on the description of the study setting and 

participant characteristics, inclusion and exclusion criteria, and recruitment methods. However, 

the authors did not adequately discuss their statistical analyses, address methods to account for 

bias and confounding such as randomization or blinding, state any information about definition 

of successful recruitment or recruitment barriers and promoters, or report their source of 

funding.52 

 Brewster’s study overall was considered to be of fair quality. The authors described in great 

detail the setting and population, inclusion and exclusion criteria, key participant characteristics, 

information about non-participants, and statistical analyses. In addition, the researchers 

explained differences between the two recruited populations and the recruitment description. 

However, the authors did not provide adequate information about the definition of successful 

recruitment or recruitment barriers and promoters, or about their source of funding.42 

 While Paskett’s study provided some details about the setting and population, and reported 

their source of funding, it was also of fair quality, due to the lack of information in certain areas. 

The researchers did not provide adequate information on participant characteristics or their 

recruitment methods, address issues of randomization or blinding, explain their statistical 

analyses, define recruitment success, or report reasons for withdrawal.46 

 In a good quality study, Ford and colleagues described in great detail the study setting, 

inclusion and exclusion criteria, participant characteristics, recruitment description, outcomes 

and follow-up, statistical analyses, and the source of funding. However, the researchers did not 

explain their randomization methods or how they addressed blinding.43 

 Moinpour’s study was not graded due to the lack of information.62 

Results of Studies 

 The results of the interventions varied from no observed improvement46 to an increase in 

recruitment into cancer clinical trials42,43,52 (Tables 3 and 4, and Evidence Table 3/4-4 in 

Appendix F). Two studies examined enrollment differences between two or more intervention 

methods.42,52 Two other studies compared enrollment differences between interventions and a 

control group.43,46 These control groups featured either no intervention45 (usual medical care 

from physicians) or a standard recruitment “intervention” of mailed letters and telephone 

contact.43 However, whether various interventions had a true effect (null, positive, or negative) 

was somewhat unclear. Some authors cautioned that their results could be due to factors such as 

changes in recruitment strategy during the duration of the intervention. To get a clearer picture, 

we discuss the five studies in detail. 

 Linnan et al. investigated the differences between passive and active recruitment into a 

home-based cancer prevention randomized trial among employees.52 In the passive employee 

contact arm, the research team contacted the employees from a list of employee names and 

telephone numbers provided by the company. In the active employee contact arm, employees 

actively signed up to participate. The research team examined differences in enrollment, reach, 
26 

and attrition along with organizational factors and behavioral risk factors between the two 

recruitment arms. Compared to the active employee contact, the passive employee contact 

reached a higher proportion of employees (74.5 percent vs. 24.4 percent) and had a higher 

attrition rate (46 percent vs. 29.9 percent). However, the active employee contact arm enrolled a 

larger proportion (77.5 percent vs. 40.9 percent, P<0.0001). Besides having a higher proportion 

of smokers and higher consumption of high-fat diets in passive employee contact arm, no 

significant differences were observed in other behavioral or organizational factors. While lower 

enrollment and higher attrition were observed in the passive recruitment arm, the passive method 

enrolled a more diverse group of participants than did the active recruitment method. The authors 

concluded that with the differences observed, the results provided insight into the advantages and 

disadvantages that researchers may encounter when designing and implementing recruitment 

strategies. They also noted that these different recruitment methods might not necessarily apply 

to all types of work sites. 

 Brewster et al. examined differences in recruitment into cancer prevention clinical trials 

between a clinic registry method and a media campaign targeting Latina/Hispanic women.42 In 

the clinic registry method, all women who had visited clinics as patients or a guardian were 

identified from the clinic registries. In the media recruitment strategy, the study was advertised in 

flyers placed in local community businesses, and advertised in community and regional 

newspapers in English and Spanish. Women who called in response to these announcements 

were screened for eligibility and subsequently scheduled if eligible. Compared to the clinic 

registry method, the media recruitment method resulted in a significantly larger proportion of 

women screened as a result of the media-based strategy were eligible (81 percent vs. 75 percent, 

p < 0.001), and were more likely to give telephone consent to participate (83 percent vs. 65 

percent, p <0.001). The odds of presenting to the clinic were three times higher for women 

recruited by the media campaign than for those recruited via the clinic registry (odds ratio [OR] 

= 3.00; 95% confidence interval [CI] 2.38 to 3.78). In addition, of the women who were screened 

by telephone, recruitment was nearly three times more successful via the media campaign than 

via the clinic registry (OR = 2.97; 95% CI 2.52 to 3.51). The authors concluded that the media 

campaign method was more advantageous than the clinic registry in recruiting women. The 

media campaign also recruited a larger number of Latina and uninsured women into the study. 

 Paskett et al. examined the effect of an intervention program aimed at physicians and 

community to increase the number of rural patients with breast cancer or colorectal cancer in 

clinical trials.44 The intervention program consisted of the installation of a rapid tumor-reporting 

system to improve data quality and to expedite the receipt of information on cancer patients to 

physicians, a nurse facilitator who would notify physicians of clinical trials, a quarterly 

newsletter mailed to physicians about cancer treatment and clinical trials, and a health educator 

who trained lay health educators and provided community-based information about cancer 

screening, treatment, and clinical trials. 

 Five counties in North Carolina received an intervention program while five counties in 

South Carolina served as controls where usual medical care was practiced. Data collection on 

clinical trail enrollment was obtained from medical record data and to evaluate the enrollment 

differences between the North Carolina counties and South Carolina counties. As noted in 

Evidence Table 3/4-4, the percentage of breast and colorectal cancer patients from North and 

South Carolina recruited into cancer clinical trials changed in the five-year span between 1991 

and 1996. In North Carolina, 15 percent (n = 24) of breast cancer patients and 4 percent of 

colorectal cancer patients were enrolled in clinical trials in 1991 while 6 percent (n=14) of breast 
27 

cancer patients and 5 percent of colorectal cancer patients were enrolled in 1996. In South 

Carolina, 6 percent (n = 6) of breast cancer patients and 5 percent of colorectal cancer patients 

were enrolled in 1991 while 50 percent (n = 16) breast cancer patients and no colorectal cancer 

patients were enrolled in 1996. The authors ultimately concluded that the rates of enrollment into 

clinical treatment trails did not improve significantly in the intervention communities. 

 However, the available data remain open to interpretation despite the varied changes in 

percentage of enrolled patients from 1991 to 1996 in each region. The reported numbers and 

percentage of enrolled breast cancer patients in North and South Carolina were presented for 

both 1991 and 1996, but only the percentage of enrolled colorectal cancer patients was given for 

each area. The number of colorectal cancer patients in North and South Carolina were given as 

one aggregate number. Thus, without the definitive numbers distinguishing colorectal cancer 

patients in North Carolina from those in South Carolina, it is unknown whether the reported 

percentages of enrolled colorectal cancer patients in 1991 and 1996 in both regions indicate an 

increase or decrease in enrolled patients into cancer clinical trials. In addition, the authors noted 

incomplete data on breast cancer cases in South Carolina in 1996 were obtained thus dictating 

caution in making comparisons. 

 Moinpour et al. reported the results of a randomized trial in increasing participation of 

minorities.62 Minority recruitment strategies were designed and implemented in five pilot sites: 

African Americans in four sites and Hispanics in one site. While each site had a minority 

recruiter who was given requirements and a set of tasks, the specific details of the minority 

recruitment interventions for each site were not given. The overall impact was minimal, 

according to the percentage of people recruited among the five sites before and after the 

implementation of the recruitment strategies. Four of the sites reported a decrease in percent 

enrolled (-0.3 percent, -0.5 percent, -2.8 percent, -0.6 percent) while only one site reported an 

increase in percent enrolled (+0.5 percent). Statistical significance of these results was not 

reported. The authors indicated that evaluation of the effectiveness of these strategies was 

difficult because execution of these interventions occurred near the end of the recruitment period. 

 Ford et al. examined recruitment differences among African Americans into cancer screening 

trials who were randomized into either three increasingly intensive intervention arms or a control 

group.43 The control group utilized a standard method of recruitment such as a standard 

recruitment letter, African American or Caucasian interviewers for eligibility screening, baseline 

information collection via mailed packets, and reminder phone calls and mailings for completion 

of the mailed packets (Arm D). The basic intervention arm (Arm A) attempted to reduce 

potential sociocultural and individual barriers through the use of an enhanced recruitment letter 

and eligibility screening by African American-only interviewers. The second increasinglyintensive intervention arm (Arm B) did not use mailed packets for baseline information 

collection but telephone interviews to facilitate ease of participation in addition to the enhanced 

recruitment letter. The third, and most intensive, intervention arm (Arm C) did not use a mailing 

packet or telephone interview but a church-based project site to gather baseline information in 

addition to the enhanced recruitment letter and eligibility screening telephone call by an African 

American. The authors reported significantly higher enrollment yield (3.9 percent) in the most 

intensive church-based intervention arm (Arm C), compared to the other two intervention arms 

(2.5 percent [Arm A] and 2.8 percent [Arm B]) or the control group (2.9 percent [Arm D]) (p < 

0.01). 
28 

Grading of the Total Body of Evidence 

Overall, the mixed results of the interventions mentioned in these studies denote a 

continuing need for trials that evaluate additional interventions (Table 8). The studies were 

limited to specific populations in certain locations. Also, very few studies were available to 

answer our proposed questions. The available information necessitates cautious interpretation 

due to limitations in the quality of the studies as summarized in Evidence Table 3/4-4 (see 

Appendix F). 

Key Question 5: What are the Documented Barriers and 

Promoters of Participation of Underrepresented Populations 

in Cancer Prevention and Treatment Trials? 

 We sought to identify the documented barriers and promoters of participation for 

underrepresented populations in cancer prevention and treatment trials; to assess whether these 

barriers and promoters differ by age, gender, socio-economic status or race/ethnicity; and 

whether they vary by cultural factors. We abstracted data from each of the eligible studies, and 

according to our conceptual framework (see Figure 1), we organized the barriers and promoters 

of enrollment, based on their likely effect on awareness about clinical trials, the opportunity to 

participate in a trial, and decision-making about whether or not to participate in a trial. Some of 

the barriers and promoters (e.g., lack of cultural competence) had the potential to affect multiple 

domains of the framework, e.g., both awareness and the opportunity to participate. We 

subdivided the identified barriers into the patient-, provider- and healthcare system level barriers. 

In addition, to the extent feasible we analyzed the eligible studies based on the type of trial(s) to 

which accrual was studied, namely, therapeutic trials, mixed trials (therapeutic and prevention), 

and prevention trials. We subdivided prevention trials into chemoprevention trials, smoking 

cessation trials, and screening trials. Primary prevention trials other than smoking cessation were 

not included in this systematic review. 

Study Characteristics 

 Our search yielded 45 eligible studies that were conducted in a variety of settings32,41-44,46-

48,50,53,58,60-62,64,66,69-97 including in the community (n = 25),41-44,46-48,53,66,70,71,73,75,77,79,80,81,83,86,88-

90,92-94 hospital inpatient and outpatient settings (n = 22),42,44,50,58,60,62,64,69,70,72-

74,76,78,87,89,85,87,91,95,96,97 a study based on recruitment logs of clinical trials groups (n = 1),62 and 

databases consisting of all NCI-funded clinical trials (n = 2).32,61 Most of the studies used 

patients/research participants as the primary respondents,32,41-44,47,48,50,53,69-81,83,85-87,89,90,93,94,96,97

while a few included interviews of healthcare professionals, including physicians, clinical 

research associates and data managers.44,46,62,66,79,80,87,84,88,91,92,95 Among the underrepresented 

populations in cancer clinical trials, the available studies targeted African Americans primarily 

(n = 27)32,41,43,47,50,58,62,64,66,69-71,74,75,79-81,85,86,88-94,97 and some of these focused exclusively on 

women (n = 5)47,73,74,86,93 or men (n = 4).43,62,85,94 The available studies also targeted other underrepresented populations: Latinos / Hispanics (n = 7)32,41,42, 62,66,74,93; American Indian/Alaska 
29 

Natives (n = 2)32,53, ,93; the elderly (n = 14)32,43,48,61,66,75-78,83,84,87,95,96; adolescents (n = 3)60,72,73; 

rural populations (n = 2)52,53; and Asian/Pacific Islanders (n = 2).32,91 While a large proportion of 

the available studies included low socioeconomic status (SES) populations, only one did so by 

design43; and the studies generally reported low SES in association with minority status. The 

designs of the eligible accrual studies were predominantly descriptive and/or qualitative, but also 

included case-control studies (n = 2)50,66 as well as controlled trials (n = 6)42,43,46,47,62,78 (both 

randomized and non-randomized). The studies provided evidence on enrollment to therapeutic 

trials (n = 29),32,44,46,47,50,53,58,60,61,64,66,69,70,72,73,75-79,81-84, 91,93-96 prevention trials (n = 11),41-

43,48,62,71,74,85,86,87,90 both (n = 5).80,88,89,92,97 

 Participation in a therapeutic trial typically involves accrual to a pre-randomization (or runin) phase, followed by randomized allocation of eligible subjects to the treatment arms. While 

most of the eligible studies addressed barriers to enrollment, few examined barriers to 

randomization of those enrolled in clinical trials. This report focuses on barriers and promoters 

of enrollment (see Evidence Table 5-3 in Appendix F), and it does not address barriers to 

retention of underrepresented populations in cancer clinical trials. Moreover, most of the 

available studies did not provide evidence on barriers to participation in early phase versus phase 

III cancer clinical trials. Therefore, we did not make a distinction between these two types of 

trials in the review. 

Target Population Characteristics 

 Tables 5 and 6 present selected characteristics of participants in eligible studies. The search 

strategy yielded 40 U.S.-based studies. In addition, because of the modest number of U.S.-based 

studies, we also included 5 non-U.S.-based studies76,87,83,87,96 that featured evidence of interest to 

this systematic review, including a study about the perspective of clinical research associates.87

The sample size varied among the studies, from 23 to 59,300, and in two studies, it was not 

reported. The reporting of age was not consistent across the studies, and it included reports of the 

mean age (n = 8),41,46,47,64,66,74,79,81 an age range (n = 18),32,44,48,60,69,70,73,75-77,83,84,86,87,90,91,95,96 or 

both (n = 7),42,43,53,71,72,89,97 however some (n = 12)50,58,61,62,78,80,87,85,88,92-94 did not provide age 

information. Similarly, only some studies reported the income levels of the participants (n = 

5).42,50,75,89,90 The proportion of males ranged from 0 to 100 percent, depending on the type of 

cancer trial (e.g., cervical cancer vs. prostate cancer) to which recruitment efforts were directed. 

Few of the studies reported the participation of American Indian/Alaska Natives, Asian/Pacific 

Islanders, adolescents or rural dwellers. 52,53,60,72,73,84, 91,93 More studies addressed barriers to 

accrual of African Americans (n = 27) than of any other racial/ethnic group. Among African 

Americans, there were four studies of barriers to accrual in males, and five in females. 

Quality of Studies 

 The articles were rated in terms of quality in each of five areas or domains: 1) 

representativeness, 2) justification of study methods, 3) reliability and validity of data collection 

methods, 4) potential for bias/confounding, and 5) data analysis. Selected aspects of quality are 

summarized in Evidence Table 5-4 (see Appendix F). In terms of representativeness, ten of 45 

studies provided adequate descriptions of study participants.42,47,50,60,64,69,70,77,78,87 For justification 

of study methods, six studies provided excellent documentation for the basis for their 

studies,43,69,75,79,84,93 and 27 other studies provided good documentation.41,42,46-48,50,58,60,64,66,70,72-
30 

74,77,80,81,83,85-92,97 With the exception of two studies,50,53 the study instruments used in the surveys 

and data collection methods used in the qualitative studies did not show adequate reliability and 

validity. While 14 studies46,58,66,70,75,81,85,86-91,93 made notable efforts to protect against 

confounding or other types of bias, only four were rated as excellent in this regard.58,70,86,92 For 

studies that used surveys as part of data collection, potential sources of confounding included 

participant response rates and selection of subjects; for studies that used qualitative techniques to 

collect data, the selection of subjects was a potential source of confounding. In terms of the 

description of the data analysis, all but three studies43,48,90 were inadequate in their reporting. 

Overall Barriers and Promoters of Participation in Cancer Therapeutic 

and Prevention Trials 

 Tables 5 and 6 present a summary of information regarding barriers to participation in cancer 

prevention and treatment trials (see Evidence Table 5-3 in Appendix F for additional detail). 

Types of Barriers Identified. Overall, the eligible studies identified 118 distinct barriers to 

accrual to cancer clinical trials, including 97 barriers to accrual to therapeutic trials, 18 barriers 

to accrual to prevention trials, and 32 barriers to accrual to both therapeutic and prevention trials. 

Across all of the studies, these barriers include eight barriers to awareness of cancer clinical 

trials, 80 barriers to the opportunity to participate in a cancer trial, and 40 barriers to acceptance 

of enrollment. Among these, 63 barriers were relevant at the patient level, 31 at the provider 

level, 20 at the study design level and seven at the healthcare systems level (see Evidence Table 

5-3 in Appendix F for additional detail).

 Types of Promoters Identified. The eligible studies identified 59 distinct promoters of 

enrollment to cancer clinical trials, including 36 promoters of enrollment to therapeutic trials, 14 

promoters of enrollment to prevention trials, and 17 promoters of enrollment to both therapeutic 

and prevention trials. Overall, these promoters include six promoters of awareness of cancer 

clinical trials, 29 promoters of the opportunity to participate in a cancer trial, and 25 promoters of 

the decision to enroll. We identified promoters at the patient level (n = 40) (see Evidence Table 

5-3 in Appendix F for additional detail), at the provider level (n = 12), at the study design level 

(n = 6), and at the healthcare system level (n = 2) (see Evidence Table 5-3 in Appendix F for 

additional detail). 

Barriers and Promoters of Participation in Cancer Therapeutic and 

Prevention Trials for African Americans 

 Barriers to Accrual to Cancer Therapeutic Trials in African American Populations.

Overall, there were 19 studies of barriers to accrual of African Americans to cancer therapeutic 

trials, and on average, each reported eight barriers (range: 0 to 20). Among the 85 barriers to 

accrual to therapeutic trials, there were six barriers to awareness, and the most frequently 

reported among them were lack of education about trials (n = 5),50,79,80,92,93 lack of dissemination 

of study opportunities to patients/providers (n = 3),88,92,93 and lack of knowledge about origins of 

cancer (n = 2).76,94 Of the reported 56 barriers to opportunity, the most frequently reported were 

costs (n = 5),58,79,80,88,92 functional status (n = 2), 58,69 time commitment or additional time 

required (n = 5),47,79,81,93,97 lack of or inadequate health insurance (n = 3),32,64, 81 and provider 
31 

attitudes (n = 4).79,91,92,94 Of the 28 barriers to acceptance, the most frequently reported were 

perceived harms of clinical trial participation (n = 8),45,80,81,89,91,92,94,97 mistrust of research, 

researchers, and the medical system (n = 10),62,74,79-81,89-94,97 and fear (n = 5). 88, 91-94 

 Promoters of Accrual to Therapeutic Trials in African American Populations. Among 

the 19 studies of accrual of African Americans to cancer therapeutic trials, each reported, on 

average, two promoters (range: 0 to 8). Among the 34 promoters of accrual to therapeutic trials, 

there were six promoters of awareness, including education programs for community physicians 

(n = 1),79 adequate knowledge about study (n = 1),80 and workshop on trials (n = 1).80 Of the 

reported 14 promoters of opportunity, the most frequently reported were culturally relevant 

education about trials (n = 3), 92-94 and providing transportation (n = 2).80,97 Of the 14 promoters 

of acceptance, the most frequently reported were altruism (n = 3),50,81,89 perceived benefits of 

trial participation (n = 5),50,89,93,94,97 and incentives (n = 5).80,81,93,94,97 

Barriers and Promoters of Accrual to Therapeutic Trials in Other 

Underrepresented Populations 

Because of the limited evidence available regarding barriers and promoters of participation in 

cancer therapeutic trials in populations other than African Americans, we discuss these barriers 

and promoters together within each of the following paragraphs. 

 Barriers and Promoters in Other Racial and Ethnic Minority Populations. 

 

 Latinos/Hispanics. Overall, three studies reported evidence on barriers to accrual of 

Latinos/Hispanics to cancer therapeutic trials, and on average, each reported seven barriers 

(range: 0 to 9).32,66,93 For this population, there were two barriers to awareness, and three barriers 

to acceptance. The reported 13 barriers to opportunity included age (n = 1),66 toxicity of 

treatment (n = 1),66 comorbid conditions (n = 1),66 and disease stage (n = 1).66 Two studies 

reported evidence on promoters of enrollment of Latinos/Hispanics to cancer therapeutic 

trials.32,93 

 American Indian/Alaska Natives. The amount of evidence available for the American Indian 

and Alaska Native population with regard to accrual to clinical trials was very limited. The 

aggregate number of American Indian/ Alaska Native participants in all of the eligible studies for 

which data on population subgroups was reported was 15.53,72,73,93 Most of the evidence 

regarding this population comes from focus groups conducted by Roberson (n = 28), which 

included African American, Latino/Hispanic and American Indian/ Alaska Native (n = 10) 

respondents, and addressed behavioral intention to participate in both cancer treatment and 

prevention trials.93 When asked “Why do you think people of your race do not participate in 

experimental studies?”, the responses included “lack of information”, “do not get involved”, and 

“mistrust—do not like to be treated as guinea pigs.” All of the participating groups reported 

“mistrust of white people” as a barrier. In a publication that was technically ineligible for this 

review, some investigators found that it took several years to build trust and lay the foundation 

for the conduct of cancer clinical trials with an American Indian/Alaska Native population.103

Roberson reported that the American Indian/Alaska Native participants suggested that programs 

and studies be set up on reservations, and details, including benefits, be explained. They also 

suggested videos, fliers, free food and money as potential incentives for participation. 
32 

 Asian/Pacific Islanders. We did not find any evidence regarding barriers or promoters of 

participation in any type of cancer clinical trial for the Asian/Pacific Islander population. The 

only available evidence was that this population is under-represented in NCI-funded cancer 

clinical trials.32

 Barriers and Promoters in the Elderly. Overall, there were 11 studies of barriers and 

promoters of enrollment of the elderly to cancer therapeutic trials. On average, each of these 

studies reported four barriers (range: 0 to 9). Among the studies of accrual to therapeutic trials, 

there were no promoters of awareness, two studies of promoters of opportunity, and six studies 

of promoters of acceptance. Of the 25 barriers to opportunity, the most frequently reported were 

age (n = 5), 66, 77,78,95,96 comorbidity exclusions (n = 3),61,76,84 transportation (n = 2),84,95 lack of or 

inadequate health insurance (n = 1),84 and inability to understand the trial (n = 2).84,95 In this 

population, concern about drug toxicity among both providers and participants (n = 2)66,84 was an 

important barrier to participation, even though such concern may not be substantiated in the 

literature on the basis of elderly status alone.104 Interestingly, in a study of protocol exclusion 

criteria that reduced the participation of the elderly in cancer clinical trials, Lewis and colleagues 

found that trials that did not specify life expectancy as an exclusion criteria resulted in relatively 

greater participation of elderly subjects than those that included this exclusion criteria.61 

 Barriers and Promoters in Adolescents. Only two of the available studies yielded evidence 

for our review of barriers to accrual of adolescents to therapeutic trials. Krailo and colleagues 

documented the lack of available trials as a significant barrier to enrollment of adolescents.60 In 

addition, Broome and colleagues reported that adolescents who enrolled in a trial had traveled 

long distances and tended to be highly anxious; however, neither distance nor being anxious 

constituted a barrier to enrollment.72 Similarly, financial incentives were neither a barrier nor a 

promoter of participation. Promoters of participation for this population included the perceived 

benefits of trial participation, including a chance for better treatment, and altruistic motives. 

However, some of the study participants had a limited understanding of a randomized controlled 

trial. 

 Barriers and Promoters in Rural Populations. Only two of the available studies focused 

on barriers to accrual of rural populations to cancer clinical trials. Paskett conducted serial crosssectional surveys for an aggregate sample size of 360 physicians who serve a rural population.46

The respondents identified the lack of education about clinical trials, and the lack of physician 

awareness about trials, as barriers. Additionally, they reported a number of barriers that reduced 

their opportunity to participate in clinical trials, including the logistical burden of trial 

participation, transportation, and established referral patterns. Moreover, the barriers to 

acceptance of trial participation were cost to the patient, perceived treatment risk, mistrust of 

research and of the medical system, the need to see an unfamiliar physician, and the perceived 

harms of trial participation. Randall-David conducted focus groups in the community on barriers 

to participation in prevention and treatment trials.53 This study identified similar barriers and 

promoters to those reported by Paskett and colleagues, and included the lack of dissemination of 

study opportunities to providers and patients, the method of presentation of the trial to physicians 

and patients, and religious belief, as additional barriers. This study also included altruism and 

incentives (financial and otherwise) as promoters. 
33 

Barriers and Promoters of Accrual to Prevention Trials in AfricanAmerican Populations 

 Overall, there were 13 studies of barriers and promoters to accrual of African Americans to 

cancer prevention trials. These included three studies of accrual to a chemoprevention trial,62,71,90

baseline data from the African American Men’s (AAMEN) study,43 and three studies of accrual 

to smoking cessation trials.41,86,97 However, we did not include studies of accrual to other types 

of primary prevention trials (e.g., diet and exercise) in this systematic review. 

 Barriers to Accrual to Prevention Trials in African-American Populations. 

On average, each of these studies reported five barriers (range: 0 to 20). Among the 41 barriers 

to accrual to prevention trials, there were five barriers to awareness, and the most frequently 

reported among them were lack of education about clinical trials (n = 3)74,80,92 and lack of 

dissemination of study opportunities to patient/provider (n = 2).88,92 Of the reported 24 barriers to 

opportunity, the most frequently reported were costs (n = 3), 80,88,92 the study’s duration and visit 

structure (n = 2),88,92 the time commitment (n = 1), 97 and lack of transportation (n = 1).97 Of the 

13 barriers to acceptance, the most frequently reported were fear (n = 3),74,88,92 mistrust of 

research and medical system (n = 8),62,74,80,88-90,92,97 perceived harms of clinical trial participation 

(n = 4),80,89,92,97 and family considerations (n = 1).74 

Chemoprevention Trials. 62,71,90 On average, each of the chemoprevention trials reported two 

barriers (range: 1 to 2). There were no barriers to awareness, two barriers to opportunity,62,71 and 

three barriers to acceptance with mistrust of research reported in two studies.62,90 

Smoking Cessation Trials .41,86,97 Out of the three smoking cessation trials in African 

American populations, only one trial reported barriers to accrual.97 The barriers were: 

transportation problems, time and family considerations, communication / methods of 

presentation, mistrust of medical research, perceived harms of trial participation, reluctance to 

quit smoking, and job issues. 

Screening Trials. 43 The AAMEN study is a randomized trial comparing four different 

strategies for accrual of African American men into the Prostate, Lung, Colorectal, and Ovarian 

(PLCO) trial. According to the baseline data from this enrollment trial, having an unlisted phone 

number was a statistically significant barrier to enrollment. Because the enrollment procedures 

included telephone-based recruitment, having an unlisted phone number functioned as a barrier 

to awareness about the study. Those who had been screened by the prostate-specific antigenscreening test within the previous three years were excluded from participation in the study. 

Interestingly, having a lower income level was a promoter of participation, suggesting both the 

lack of access to screening services in the targeted low-income African-American population, 

and the screening study as an opportunity for low-income men to access these services. 

 Promoters of Accrual to Cancer Prevention in African-American Populations. Among 

the 13 studies of barriers and promoters to accrual of African Americans to cancer prevention 

trials, each reported, on average, three promoters (range: 0 to 8). Among the 29 promoters of 

accrual to prevention trials, there were four promoters of awareness, each reported in a single 

study: reminder phone call,97 adequate knowledge about the study,80 a workshop on clinical 

trials,80 and culturally relevant education about trials.88 Of the 14 reported promoters of 

opportunity the most frequently reported was provision of transportation (n = 2).80,97 Of the 12 

promoters of acceptance, the most frequently reported was the use of incentives (n = 2).80.97 
34 

Chemoprevention Trials. 62,71,90 Of the three chemoprevention trials that enrolled African 

Americans, only Mouton’s study90 reported promoters for a total of two promoters to acceptance: 

preference for the study’s principal investigator to be Black, and perception that it is better to be 

treated by research doctors. 

Smoking Cessation Trials. 41,86,97 On average, each of the three smoking cessation trials 

reported five promoters (range: 3 to 8). While no promoters of awareness were reported, 11 

promoters of opportunity were reported including provision of transportation,97

communication/method of presentation,41 and employment status.86 The five reported promoters 

of acceptance were incentives, support, encouragement, prayer, the certainty of receiving actual 

medication, the impact of diagnosis on risk perception, and perceived benefit of trial 

participation. 

Screening Trials .43 Because the AAMEN study targeted a low-income African-American 

population, having a lower income level was a promoter of participation. 

Barriers and Promoters of Accrual to Prevention Trials Among Other 

Underrepresented Populations 

 Because of the limited evidence available regarding barriers and promoters of participation in 

cancer prevention trials in populations other than African Americans, we discuss these barriers 

and promoters together within each of the following paragraphs. 

 Barriers and Promoters in Other Racial and Ethnic Minority Populations. 

 Latinos/Hispanics. Overall, there were four studies that reported evidence on barriers and 

promoters to accrual of Latino/Hispanics to cancer prevention trials,41,42,62,74 and on average, 

each reported four barriers (range: 0 to 8). For this population, there was only one reported 

barrier to awareness, the lack of education about clinical trials.74 Of the reported seven barriers to 

opportunity, the most frequently reported was transportation (n = 2).42,74 Of the seven barriers to 

acceptance, the most reported was mistrust of research and the medical system (n = 2).62,74 

 American Indian/Alaska Natives. The limited amount of evidence available for the 

American Indian/Alaska Native population with regard to accrual to clinical trials in general, was 

discussed in the section on barriers and promoters to accrual to therapeutic trials. 

 Asian/Pacific Islanders. We did not find any evidence regarding barriers or promoters of 

awareness, opportunity or acceptance of cancer clinical trials for this population. The only 

available evidence was that this population is underrepresented in NCI-funded cancer clinical 

trials.32

 

 Barriers and Promoters in the Elderly. Overall, there were three studies of barriers and 

promoters of enrollment to cancer prevention trials in the elderly. These studies reported three 

distinct barriers, age being the most frequently cited (n = 2).43,48 On average, each of these 

studies reported one barrier (range: 0 to 3). Among the three promoters of accrual to prevention 

trials, there were no promoters of awareness or acceptance. The three reported promoters of 

accrual were the entry criteria,87 age,48 and low-income status.43 

 Barriers and Promoters in Rural Populations. The available evidence on barriers and 

promoters of accrual of rural populations to cancer prevention and treatment trials is based on 
35 

two studies that we discussed in the section on barriers and promoters of accrual to therapeutic 

trials.46,53

Grading of the Total Body of Evidence 

 The overall evidence denotes a wide variety of barriers and promoters that have an influence 

on the participation of underrepresented populations into cancer clinical trials. However, the 

overall was considered to be very low due to the limitations in quality and precision as well as 

the lack of strong evidence within the studies (see Table 9). In addition, a high probability of 

reporting bias existed within the studies. The evidence is based on 45 studies, 34 of which 

addressed cancer treatment trials, 16 of which addressed cancer prevention trials, and five of 

which addressed trials for both cancer treatment and prevention. While the studies were 

heterogeneous and contained over 35,000 participants in total, the majority of the studies 

generally focused on an African American population and an elderly population. Other 

underrepresented populations such as Latinos/Hispanics, Native Americans/Alaska Natives, 

Asian/Pacific Islanders, adolescent or rural populations were scarcely evaluated. 

Key Question 5a: Effects of Demographic Factors 

Overall, the available evidence for Key Question 5 suggested that accrual to or intention to 

participate in a trial varied by the following socio-demographic factors: age (n = 

16)32,43,47,48,50,58,60,64,66,75,77,78,86,90,95,96; gender (n = 3)32,70,75; SES (n = 4)32,43,44,86; race/ethnicity (n 

= 4).32,41,47,75 These barriers and promoters related most frequently to study design barriers, 

including exclusion by age (n = 3),58,60,64 study duration and visit structure (n = 4),44,79,88,92

comorbid conditions (n = 7),44,58,61,69,76,84,92 and functional status (n = 4).58,60,68,75 Few trials were 

available for adolescents; and as expected, parental influence was reported as a factor in 

decision-making only in this population. However, the available evidence did not suggest age as 

a factor that reduced awareness or acceptance of participation. 

 Few of the eligible studies attempted to assess whether the identified barriers or promoters 

varied by SES. However, some included measures of SES, such as income, education, suburban 

residence, and having a functioning telephone, in association with recruitment outcomes. A 

relatively large proportion of eligible studies reported on barriers or promoters of accrual of 

African Americans (n = 27). However, in this population as well as other groups, it was difficult 

to separate race/ethnicity and SES, central defining characteristics of some of the underrepresented populations, from the barriers themselves. 

 

Key Question 5b: Effects of Cultural Factors 

 Three of the studies reported that barriers or promoters of enrollment varied by cultural 

factors, however, it is not entirely clear whether such cultural factors refer to cultural norms, 

values, or beliefs. For the elderly population, enrollment barriers and promoters did not vary by 

culturally relevant factors other than race or ethnicity. The heterogeneity of the available 

evidence, and the definitional overlap among several of the underrepresented populations limited 

our ability to synthesize the evidence regarding whether some barriers or promoters vary by 

cultural factors. 
36 

Key Question 6: What Effects do the Attitudes and 

Perceptions of Healthcare Providers Have on the 

Efficacy/Effectiveness of Strategies for Recruitment of 

Underrepresented Populations into Cancer Prevention and 

Treatment Trials? 

Identification of Relevant Articles 

 In reviewing the current literature on question 6, we found a total of 10 eligible 

articles.46,56,64,66,84,88,92,95,100,101 Details about these studies are given in Table 7, and Evidence 

Tables 6-1, 6-2, 6-3, and 6-4 in Appendix F. 

Study Characteristics 

 Of the 10 studies eligible for review, two were published before 1990,95,101 three were 

published between 1990 and 1999,55,88,100 and five were published after 200046,64,66,76,92(see 

Evidence Table 6-1 in Appendix F). The study designs used were concurrent controlled trial 

(n=1),46 case-control (n=1),66 or descriptive (n=8)56,64,84,88,92,95,100,101 with three of the studies also 

employing qualitative techniques to facilitate in-depth assessments of physician attitudes and 

perceptions. Nine were U.S.-based studies and one was a British-based study. All were recruiting 

into treatment trials; three of the studies were also recruiting into prevention trials. 

Target Population Characteristics 

 Seven studies46,56,84,88,95,100,101 targeted physicians, one targeted physicians/investigators92 and 

two studies64,66targeted patients/participants as the study group of interest. Specific methods and 

techniques employed in these studies included surveys (n=8) that were implemented either via 

mail,46,56,84,100,101 telephone,66 or other methods. Other methods employed to assess physician 

barriers to enrolling patients into clinical trials were focus groups,92 workshops,88 and face-toface interviews95 (Evidence Table 6-2 in Appendix F). 

 Two studies employed physician interventions to increase patient accrual to clinical 

trials46,88with only one measuring the outcomes of their interventions.46

 Six of the studies targeted at least one of the underrepresented populations as a primary goal 

of the study. Three studies targeted either racial or ethnic minorities88,92 two studies targeted the 

elderly,66,84 and one study targeted rural populations.46 Four studies did not target an 

underrepresented population as a primary endpoint; however, data were presented on advanced 

age92,95,100 and social class (non-U.S. study)106 to merit their inclusion in this report. 

Quality of Studies 

 We evaluated the quality of studies in each of five areas or domains: 1) representativeness, 2) 

justification of study methods, 3) reliability and validity of data collection methods, 4) potential 
37 

for bias/confounding, and 5) data analysis. Selected aspects of study quality are summarized in 

Evidence Table 6-3 (see Appendix F). 

 In terms of representativeness, the studies were fairly well described (four clearly described 

study participants). For justification of study methods, five studies adequately documented the 

rationale for their studies. With the exception of one study,100 the study instruments used in the 

surveys and the data collection methods used in the qualitative studies had serious limitations in 

reliability and validity. Five studies used adequate measures to protect against bias or 

confounding. For studies that used surveys as part of data collection, this was based on 

participant response rate and selection of subjects; for studies that used qualitative techniques to 

collect data, this was based on the selection of subjects. In terms of the description of the data 

analysis, all studies were inadequate in their reporting. 

Results of Studies 

Role of provider attitudes. Nine studies presented data on how provider 

attitudes/perceptions were barriers to and promoters of accrual to cancer clinical trials. Four 

studies found provider atttitudes as a barrier to enrollment46,66,92,101 while one study found 

provider attitudes to be a promoter of patient accrual.84 The studies also reported that patient 

age,66,95,101 comorbidity,66,95 disease stage,66 mistrust of researchers,88,92 and lack of physician 

awareness about trials88,92were factors that prevented providers from enrolling their patients into 

clincial trials. Two studies56,100 found that provider communication or method of presentation 

were barriers to patient enrollment, whereas one study found it to be a promoter of trial 

enrollment.84

 For studies that targeted minority populations,64,88,92 mistrust of researchers and lack of 

provider awareness about trials were leading provider barriers88,92that decreased patient 

enrollment in clinical trials. Additionally, concerns about patient non-compliance and a lack of 

available protocols were reasons cited for not talking to patients about clinical trials.64

 For studies that targeted the elderly, provider attitudes regarding clinical trials prevented 

them from sharing information about trials to their patients in one study,66 and increased their 

willingness to enroll patients in clinical trials in another study84 (Evidence Table 6-4 in Appendix 

F). 

Study design barriers. Eight studies evaluated the role a clinical trial’s study design plays in 

the ability to accrue underrepresented populations to cancer clinical trials. Four studies reported 

issues with the protocol itself with the length of the trial and visit structure being issues in two 

studies,88,92 the strictness of the protocol in one study,92 and the amount of travel, failure to use 

the most effective drug, and the number of required lab tests being issues in one study.94 We also 

found that accrual to cancer treatment trials was decreased by study design issues including 

comorbid conditions,84,92 age exclusion,84,92 eligibility criteria,56 issues with randomization,92

medication exclusion,64 treatment toxicity and side-effects,95 life expectancy,84 and disease 

stage/location100 (Evidence Table 6-4 in Appendix F). 

Health care system. Two studies88,92 reported that the healthcare system itself played a role 

in decreased patient accrual to cancer clinical trials. Both studies found that a lack of 

dissemination of study opportunities to providers made it difficult for them to match potentially 

eligible patients to cancer clinical trials. Additionally, Pinto et al.92 found that a lack of cultural 
38 

competence among providers and/or staff as well as a lack of patient access to institutions 

conducting the clinical trials made it difficult to accrue patients to these trials. McCaskill-Stevens 

et al.88 found that a lack of minority investigators and personnel impeded accrual (Evidence 

Table 6-4 in Appendix F). 

 Clearly the impact of the provider on accrural has not been completely elucidated. While our 

review highlights that the role of individual level provider factors, study design and system level 

factors may be important to the accrual process, it is still unclear how these factors relate to each 

other, which are most important, if temporal or spatial effects occur or if any of these factors are 

synergistic. 

Grading of the Total Body of Evidence 

 As summarized in Table 10, we assessed the quantity, quality, and consistency of evidence 

on Question 6 and concluded that the studies merited an overall “very low” evidence grade. This 

grade is based primarily on the fact that all ten studies scored below the 50th percentile in the 

quality rating, with two scoring below the 25th percentile, based on study representativeness, 

justification, bias, reliability/validity, and statistical analysis. Additionally, points were deducted 

for imprecision or sparcity of data as well as the high probability of reporting bias, based on the 

study designs. Thus, the evidence was insufficient to determine with any confidence how 

healthcare providers’ attitudes and perceptions influence the efficacy/effectiveness of strategies 

for recruitment of underrepresented populations into cancer treatment and prevention trials. This 

evidence is based on studies where approximately 1,178 providers were interviewed or surveyed. 

Furthermore, the studies were heterogeneous in what underrepresented population they targeted. 
 39 

Chapter 4. Discussion 

Since the enactment of the NIH Revitalization Act in 1993,31 cancer researchers have made 

significant efforts to discover evidence regarding barriers to participation in clinical trials, 

especially for ethnic minority populations. While some advances have been made in defining 

these barriers, significant gaps remain in the available evidence in regard to efficacious and/or 

effective interventions to improve enrollment to cancer clinical trials. It is essential to address 

these gaps in the evidence to fulfill the intent of the NIH Revitalization Act. Only a small 

proportion of cancer patients are enrolled in cancer clinical trials and recent evidence indicates 

that racial and ethnic minorities, adolescents, the elderly, rural populations and individuals of 

low socioeconomic status in general, are underrepresented in NCI-funded cancer clinical trials.68

We undertook a systematic review to: 1) assess existing evidence regarding barriers and 

promoters of participation in cancer clinical trials; 2) understand the influence of physicians' 

attitudes on the accrual process; and 3) gain insight into research strategies to further develop the 

evidence in support of interventions to improve accrual to cancer clinical trials. While African 

American women are not underrepresented in cancer clinical trials, we examined the evidence 

from that population, as it may be relevant to barriers and promoters of enrollment of African 

American men to cancer clinical trials. 

Questions 1 and 2. Methods to Study Recruitment Strategies 

The available evidence is limited by the methods that have been used to date to study barriers 

and promoters of accrual to cancer clinical trials. A large proportion of the eligible studies were 

developed by convenience, i.e., as a way to describe investigators’ experience with recruitment 

of underrepresented populations. The available literature included some well-designed 

qualitative as well as quantitative studies, including controlled clinical trials. However, the 

methodological limitations of the available studies leave serious gaps in knowledge and 

information about efficacious and effective strategies to improve participation of 

underrepresented populations in cancer clinical trials. These gaps must be addressed in the 

context of well-designed studies that are informed by the accumulated evidence. 

One component missing in the literature is an agreement on what constitutes a "success 

measure" in terms of enrollment. The lack of agreed upon measures of success may be a key 

determinant of the lack of representation of certain population subgroups in accrual to cancer 

clinical trials. Several of the available studies offer excellent examples of approaches to 

characterize accrual data in a meaningful way in relation to a specific population. One approach 

is to obtain proportional representation relative to the U.S. population.32, 61 Another is to include 

a study population that features enrollment of population subgroups in proportion to the relative 

cancer incidence in each of the subgroups. In certain instances, investigators may also oversample certain underrepresented populations in an effort to enable meaningful subgroup analyses 

of underrepresented groups (e.g., the proportion necessary for subgroup analysis). The planning, 

design, implementation, and evaluation of a recruitment strategy are integral to the successful 

conduct of a clinical trial. Therefore, investigators should give careful thought to success 
 40 

measures for recruitment of underrepresented populations, and avoid setting such measures 

arbitrarily. Additionally, researchers should evaluate and report recruitment results for 

underrepresented groups more frequently. Such reports should not be based on the aggregate 

experience from multiple trials, but they should be based on the recruitment strategies for 

individual cancer clinical trials. Using better measures of success will help investigators improve 

the generalizability of cancer trial results to many different populations. It will also help identify 

effective recruitment strategies for underrepresented populations. Moreover, success in 

recruitment of these populations may provide novel insights into risk factors and the natural 

history of disease through hypothesis-driven subgroup analyses. 

Questions 3, 4, 5, and 6. Barriers and Promoters of 

Participation in Cancer Clinical Trials 

We developed a conceptual framework to guide our analysis of barriers and promoters of 

participation of underrepresented populations in cancer clinical trials. Our approach takes 

account of the fact that in order to participate in a clinical trial, an individual must be aware of 

the trial, have the opportunity to participate, and be willing to accept participation. The barriers 

and promoters span the continuum from awareness to acceptance, and they differ depending on 

the population and whether recruitment is to a treatment trial or to a prevention trial. Moreover, 

within cancer treatment trials, the barriers may differ when comparing early-phase trials to phase 

III, controlled clinical trials; however, we did not address this question because very few of the 

eligible studies distinguished between trial phases. While a number of publications have 

contributed important evidence regarding key barriers and promoters of participation in cancer 

clinical trial, the evidence remains limited. Based on our systematic review, the most frequently 

reported barriers across multiple underrepresented populations are: 1) mistrust of researchers and 

the medical system44,46,53,62,74,79-82,88-94,97; 2) the perceived harms of participation in a cancer 

clinical trial46,50,53,79,81,82,89,91,92,94,97; 3) the availability of transportation42,44,46,53,74,82,84,95,97; 4) lack 

of education about clinical trials46,50,53,74,79,80,91-94; and 5) the time commitment required for 

participation in a trial.42,47,53,79,81,91,93,97 The most frequently reported promoters are: 1) patient80-

82,93,94,97 and provider incentives44,53,92; 2) altruism50,53,72,81,82,89; and 3) culturally relevant 

education about trials.88,92-94 Consistent with our conceptual framework, these documented 

barriers and promoters intervene at the level of awareness about clinical trials, the opportunity to 

participate, and decision-making about participation in a trial. 

Overall, the eligible studies identified 118 distinct barriers to accrual to cancer clinical trials, 

including 97 barriers to accrual to therapeutic trials, 18 barriers to accrual to prevention trials, 

and 32 barriers to accrual to both therapeutic and prevention trials. The studies reported included 

seven barriers to awareness of cancer clinical trials, 80 barriers to the opportunity to participate 

in a cancer trial, and 40 barriers to acceptance of enrollment. Among these, 63 barriers were 

relevant at the patient level, 31 at the provider level, 20 at the study design level and seven at the 

healthcare systems level. The available evidence suggests that barriers that reduce the 

opportunity to participate in a trial are the most frequent factors limiting enrollment to both 

cancer prevention and treatment trials, especially for the elderly and racial and ethnic minority 

populations. The barriers that limit accrual opportunities include study design barriers such as 

age, exclusion criteria (e.g., comorbidity and functional status), lack of transportation, and lack 
 41 

of adequate health insurance. The high frequency of opportunity barriers signals the need for 

interventions directed to this type of barrier. 

Despite an extensive list of documented promoters of participation, we were able to identify 

only five studies that compared two or more interventions to improve enrollment to cancer 

clinical trials. These included one well-designed randomized controlled trial comparing multiple 

intervention strategies for accrual to the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer 

screening trial.43 In that study, we learned that a face-to-face recruitment strategy is superior to 

other, less intensive recruitment strategies in the context of the screening trial. However, the 

available evidence on efficacious strategies to improve participation in cancer clinical trials 

remains woefully inadequate. 

The nature and extent of the barriers and promoters of accrual differ across the 

underrepresented populations. For example, while the elderly have access to Medicare, many 

clinical trials remain functionally inaccessible to this population, because of study design 

barriers, including age restrictions, as well as provider fears about drug toxicity, that in many 

instances may be unsubstantiated.104 For adolescents,60,72 the major barrier is the lack of 

accessible trials; and for rural populations, transportation is a major barrier.46,53 For AfricanAmerican32,41,43,47,50,58,62,64,66,69-71,74,75,79-81,85,86,88-94,97 and Latino/Hispanic populations32,41,42,62,66, 

74,93 there are identifiable barriers through the continuum from awareness to acceptance of 

participation. However, we found no available evidence on barriers and promoters of enrollment 

to cancer clinical trials for the Asian and Pacific Islander population, and only one for the 

American Indian and Alaska Native population.93 Strategies for acquiring evidence to improve 

participation of underrepresented populations in cancer clinical trials must be informed by this 

diversity of barriers and promoters, and gaps in available evidence. Moreover, because of the 

overlap across the identified underrepresented populations and the geographic dispersion and 

cultural heterogeneity within each of the underrepresented populations, interventions to improve 

accrual to cancer clinical trials will need to be tailored to the cultural background of the targeted 

population and grounded in the local reality. 

Overall, the mixed results of the interventions mentioned in these studies denote a continuing 

need for future evaluations of additional recruitment interventions, including clinical trials that 

compare the relative efficacy of promising interventions to improve accrual. This lack of 

consistency also reflects the limitation of available studies on specific populations in varying 

locations. 

So, given the extensive list of barriers and promoters and the heterogeneity of the 

underrepresented populations, where do we begin? Clearly, it would be difficult to address each 

of the types of identified barriers individually, considering that each individual targeted for 

enrollment is likely to present multiple barriers to participation. Since the available evidence 

indicates that certain barriers may be universal, strategic interventions directed at some of the 

most frequent barriers may indeed be efficacious, effective and cost-effective, to improve cancer 

clinical trial enrollment. However, investigators must approach this issue with caution, given the 

uncertainty regarding the available evidence. Future research studies should give consideration to 

system-level interventions to address multiple barriers and promoters, with tailoring based on 

known, culturally specific, as well as patient-identified barriers. Several of the eligible studies 

recommended the use of personnel who are known to the community, in efforts to improve 

accrual to cancer clinical trials. Such individuals can be trained to promote awareness about 

cancer clinical trials in the community and to identify and solve barriers for individual patients in 

collaboration with the research team. The efficacy and cost-effectiveness of this approach needs 
 42 

to be evaluated further as a comprehensive solution for barriers to accrual to cancer clinical 

trials. In addition, the research designs should emphasize interventions that have a high 

likelihood of institutionalization, through their integration into the routine conduct of cancer 

clinical trials in comprehensive cancer centers, cancer research centers, and in the wider 

community. Indeed, the evaluation of the relative cost-effectiveness of different intervention 

strategies to improve accrual to cancer clinical trials is a serious gap that will need to be 

addressed in future studies. 

For several of the eligible publications, the primary outcome variable in regard to trial 

accrual was behavioral intention, rather than actual participation in a cancer clinical trial.50,53,71-

75,77,79-85,88-95 Primary prevention, chemoprevention and screening trials target individuals who do 

not have disease, and studies of attitudes and behavioral intention toward participation in clinical 

trials have been used in preparation for both cancer prevention trial, and for the implementation 

of educational campaigns to improve accrual to clinical trials. The literature provides few 

examples of translation of the results of studies of behavioral intention to participate in clinical 

trials into studies of accrual to therapeutic trials. It remains unclear whether behavioral intention 

expressed by individuals at risk for cancer is a good predictor of actual participation in cancer 

treatment trials. This is particularly salient when viewed within the context of the change in 

perceived risks to cancer and the immediacy of the perceived risks and benefits of trial 

participation following the diagnosis of cancer. To develop the evidence needed to improve 

accrual strategies for cancer therapeutic trials, investigators will need to use studies of behavioral 

intention to prepare and refine recruitment intervention strategies that would eventually be 

applied to patients, and emphasize studies of accrual to actual trials. 

The evidence suggests that special attention needs to be given to the barriers to participation 

in cancer clinical trials at the physician level. Clinicians form relationships with patients before 

they are diagnosed with cancer and they play an influential role in advising patients regarding 

participation in a trial. However, they often have limited awareness about opportunities to 

participate in trials, the trials often do not make sense to them from a fiscal point of view, and for 

elderly patients, some providers have serious concerns about the risks of participation in cancer 

clinical trials. Like cancer patients and individuals at risk for cancer, healthcare providers base 

their decisions on the balance of risks and benefits of trial participation, as well as their 

individual and organizational interests. While several studies have suggested the use of provider 

incentives 44,53,92 as a strategy for improving trial accrual, this idea has not received the 

appropriate level of attention in the available evidence. Here again, given the heterogeneity of 

clinical practice contexts, intervention strategies must be adapted to this context and have a high 

likelihood of being sustainable. 

Limitations 

This systematic review addresses barriers and promoters of participation to cancer clinical 

trials among populations that have been underrepresented in NCI-funded cancer clinical trials, 

namely, the elderly, adolescents, African Americans, Latinos/Hispanics, American 

Indians/Alaska Natives, rural populations and populations of low socioeconomic status in 

general. There is extensive overlap across these populations, and the population descriptions in 
 43 

the available studies may not always have captured the extent of such overlap, in terms of 

race/ethnicity, residence, socioeconomic status, or even age. 

Our search strategy included strict eligibility criteria, and it is possible that some relevant 

evidence was not included in the review. We found several articles that did not meet our initial 

eligibility criteria, but that contained important information regarding barriers and promoters of 

accrual to cancer clinical trials.76,82,83,87,96 For this reason, although the eligible articles were 

initially limited to U.S.-based studies, we included some relevant evidence from non-US based 

studies. 

We found some excellent examples of well-designed studies of enrollment to cancer 

screening programs,102,103,104 but the systematic review was limited to studies about recruitment 

of patients into cancer clinical trials. Nevertheless, we believe that some of the strategies that 

have been used in those programs may be relevant, especially to enrollment strategies for cancer 

prevention and screening trials. 

Within cancer treatment trials, the barriers may differ when comparing early-phase trials to 

phase III, controlled clinical trials. However, we did not find enough evidence to specifically 

address this question. 

We have pointed out some of the limitations of the available evidence in regard to: 1) 

representativeness; 2) justification of study methods; 3) reliability and validity of data collection 

methods; 4) the potential for bias/confounding; and 5) data analysis. We used a standardized 

approach to generate the body of evidence that is presented in this review, and although 

individually some of the studies limit our ability to reach firm conclusions, the sum of the 

evidence and its consistency across multiple studies allow us to formulate some 

recommendations for future research. 

Conclusions 

The results of many of the studies that we reviewed necessitate cautious interpretation, due to 

limitations of the study designs and settings, and the limited quality of a large proportion of the 

available publications. However, the available studies have generated, and in a few instances 

tested, hypotheses about determinants of accrual to cancer clinical trials. In addition, they have 

provided evidence for a large number of barriers and promoters of participation, some barriers 

and promoters being consistent across multiple studies and across underrepresented populations. 

Our search yielded limited information on certain populations, most notably the 

Asian/Pacific Islander, American Indian/Alaska Native, Latino/Hispanic, rural, and adolescent 

populations. This limits the depth of possible recommendations for these populations. Similarly, 

there is a continuing need for evidence of interventions that work for African-American men. 

Moreover, the evidence base needs to address how sociodemographic and cultural norms, values, 

and beliefs modify the known barriers. This is strongly suggested by the available evidence, but 

it is not defined. 

We found very few studies comparing two or more strategies in regard to their efficacy to 

increase accrual of underserved populations to cancer clinical trials.41,43,45,52,62 This is an 

important gap in the evidence base that must be overcome. 

Overall, the grade of the evidence on barriers and promoters of accrual of underserved 

populations to cancer clinical trials is low. However, the consistency of some of the barriers and 
 44 

the sheer number of barriers suggest the need for evidence-based interventions to address 

multiple barriers to accrual to cancer clinical trials. 

We recognize that even if members of underrepresented populations do participate in cancer 

clinical trials, and reporting and recruitment are adequate, the benefits of clinical trial knowledge 

may not translate into improved cancer outcomes for these populations due to other factors. If 

systemic inequities in the healthcare delivery system persist, including in access to high quality 

care, the availability of perfect research data may not benefit underrepresented populations so 

much as other populations.5

 Therefore, recruitment efforts to cancer clinical trials must interface 

with other ongoing initiatives designed to address cancer health disparities through discovery, 

development, and delivery, and to overcome the critical disconnect between discovery and 

development on the one hand, and delivery of cancer care on the other. 

Recommendations and Research Opportunities 

• Much of the available body of evidence was developed as “evidence by convenience” in 

the context of recruitment difficulties, or in retrospective analyses of recruitment of 

underrepresented populations across multiple clinical trials. There is a need for welldesigned, controlled studies of strategies to improve accrual to cancer prevention and 

treatment trials. These studies should be hypothesis-driven, and include defined measures 

of success. They should also meet the usual standards of the NIH peer review process. 

• Investigators should give careful thought to success measures for recruitment of 

underrepresented populations, and they should avoid setting such measures arbitrarily. 

Additionally, researchers should evaluate and report recruitment results for 

underrepresented groups more consistently. 

• More attention should be focused on issues of trial design. If studies are not designed to 

address problems that are relevant to patients in underserved communities, then even the 

best recruitment strategies will be ineffective. Similarly, trials that exclude patients with 

chronic conditions will preferentially exclude the elderly, members of minority groups, 

and patients with lower socioeconomic status, because they are more likely to have 

chronic conditions. Hence, recruitment efforts must proceed hand-in-hand with initiatives 

to design relevant and pragmatic trials.

• Because of many underrepresented populations’ mistrust of researchers and of research 

institutions,research efforts to improve participation of underrepresented populations in 

cancer clinical trials should be developed within the framework of community-based 

participatory research,with community involvement through all phases of the research. 

• The need remains for community-based studies to understand barriers to accrual in the 

community, including attitudes toward clinical trial participation. Whenever possible, 

such studies should be linked to the implementation of cancer clinical trials, and include 

actual recruitment as a major outcome. For example, several studies have suggested 

culturally relevant education as a strategy for improving accrual to cancer clinical trials. 
 45 

There is a need to further investigate the efficacy of culturally relevant education as a 

strategy to improve accrual to cancer prevention trials, and treatment trials. 

• There is an urgent need to understand why participation of the Asian / Pacific Islander, 

and American Indian/Alaska Native populations in cancer clinical trials is minimal to 

non-existent. Studies of barriers and promoters of their participation should be linked to 

opportunities to participate. New research initiatives in this area may require several 

years before they are fruitful in terms of trial enrollment results. 

• Similarly, there is a continuing need to better understand and improve upon strategies for 

recruitment of African American males and Latinos/Hispanics into cancer clinical trials. 

Ideally, such studies should include documentation of existing barriers within a 

population as a basis for tailored interventions across the spectrum of barriers and 

promoters, including awareness, opportunity and decision-making. 

• There is a need for further investigation of effective communication strategies, including 

investigations on the best approach to deliver information about clinical trials, both at the 

community level and at the point of interaction with the potential participant. 

• In communities lacking established efforts to promote awareness about clinical trials, 

sufficient time should be allowed for relationships to be built with community members, 

including community-based providers, before accrual can begin. The period for building 

such relationships may take several years, but it would vary depending on the community 

and the existing relationships prior to an intervention. 

• Some interventions (e.g., media-based strategy for Latina/Hispanic women) have been 

shown to be effective in increasing accrual to clinical trials. Such interventions should be 

replicated, for use in recruitment to different types of cancer trials, and where 

appropriate, the results should be disseminated widely. 

• To advance the evidence regarding efficacious strategies for improving enrollment to 

cancer clinical trials,recruitment intervention studies will need to be linked to one or 

more clinical trials,depending on sample size requirements. The studies should include 

collection of baseline information regarding prevalent risk factors in the study population. 

Systematic data collection about barriers and promoters of trial participation should be 

linked to concrete plans for designing interventions to address such barriers. Moreover, 

the next generation of studies of barriers and promoters of accrual should be 

multidisciplinary, including the involvement of community-based participatory 

researchers, social and behavioral scientists, as well as health economists. 

• There are many barriers to care, and it is unlikely that piecemeal strategies to address 

these barriers will be effective to promote participation in cancer clinical trials. There is a 

need for a cost-effective strategy to address barriers to care on multiple levels, and in a 

manner that can be integrated into the context of the healthcare system and of the 

research team. To facilitate the integration of recruitment interventions into healthcare 

systems, especially the research team, a study should compare the efficacy of a 
 46 

recruitment intervention specialist to that of usual, opportunistic recruitment practices. 

The recruitment intervention specialist would be a professional or paraprofessional staff 

member who is appropriately trained to promote awareness about clinical trials in the 

community and to help patients overcome barriers to opportunity. Ideally, the recruitment 

intervention specialist would be indigenous to, or at least have extensive familiarity with, 

the community targeted by the recruitment effort. Thus, this role would be analogous to 

that of a patient navigator for clinical trials, and its cost-effectiveness should be 

investigated. 

• Research to improve enrollment of underrepresented populations in cancer clinical trials 

must interface with other ongoing initiatives designed to address cancer health disparities 

through discovery, development, and delivery, and to overcome the critical disconnect 

between discovery and development on the one hand, and delivery of cancer care on the 

other. 

• Substantial resources will need to be dedicated to research efforts to build upon the 

existing evidence on strategies for improving enrollment of underrepresented populations 

in cancer clinical trials. Many of the initiatives that contributed to the available evidence 

were probably not funded. NCI should dedicate adequate funds for well-designed studies 

of barriers and promoters of accrual to cancer clinical trials. 
47 

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Control Clin Trials 1984;5(2):129-40. 

other: does not address underserved populations

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intervention to improve ongoing participation in 

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other: does not address underserved populations 

Baum M. The ATAC (Arimidex, Tamoxifen, alone or in 

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patient recruitment. Eur J Cancer 2002;38(15):1984-6. 

other: does not address underserved populations 

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participate in a cancer rehabilitation program an indicator 

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descriptive study. BMJ 2003;327(7410):320-1. 

other: does not address underserved populations

Cottin V, Arpin D, Lasset C, et al. Small-cell lung cancer: 

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other: does not address underserved populations

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methodology. J Adv Nurs 1998;27(3):488-96. 

no original data

Cox K. Setting the context for research:exploring the 

philosophy and environment of a cancer clinical trials unit. 

J Adv Nurs 2000;32(5):1058-65. 

other: does not address underserved populations

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other: does not address underserved populations

Crighton MH, Goldberg AN, Kagan SH. Reciprocity for 

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2002;29(10):E127-31. 

other: does not address underserved populations

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other: no subgroup analysis of an underserved 

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Cancer 2003;97(9):2327-33. 

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knowledge and beliefs? Soc Sci Med 2004 ;58(1):193-205. 

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survey to recruit health maintenance organization members 

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Biomarkers Prev 1992;1(5):413-6. 

other: does not address underserved populations

Derose KP, Hawes-Dawson J, Fox SA, et al. Dealing with 

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other: screening program

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melanoma, II:characteristics of patients enrolled and not 

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Dietrich AJ, O'Connor G, Keller A, et al. Will community 

physicians participate in rigorous studies of cancer control? 

The methodology and recruitment of a randomized trial of 

physician practices. Prog Clin Biol Res 1990;339:373-81. 

other: does not address underserved populations

DiPalma AM, Barnes SE, DiPalma JA. Patient participation 

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1998;91(4):342-4. 

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(prostate testing for cancer and treatment) study. 

Commentary:presenting unbiased information to patients 

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other: does not address underserved populations

Donovan JL, Peters TJ, Noble S, et al. Who can best recruit 

to randomized trials? Randomized trial comparing surgeons 

and nurses recruiting patients to a trial of treatments for 

localized prostate cancer (the ProtecT study). J Clin 

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other: does not address underserved populations

Ellis PM, Butow PN, Tattersall MH. Informing breast 

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other: does not address underserved populations

Ellis PM, Butow PN, Simes RJ, et al. Barriers to 

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other: does not address underserved populations

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other: does not address underserved populations

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Englisbe BH, Jimpson GE, Harper GR, et al. Encouraging 

mammography use among underserved women through a 

celebration of breast health. Am J Public Health 

1995;85(10):1446-7. 

does not report a controlled trial or recruitment to a 

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patients' expectations of benefit with standard breast cancer 

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1990;8(9):1476-82. 

other: no barriers to an underserved group reported

Fisher WB, Cohen SJ, Hammond MK, et al. Clinical trials 

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community oncologists. Med Pediatr Oncol 

1991;19(3):165-8. 

other: does not address underserved populations

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other: does not address underserved populations

Foley JF, Moertel CG. Improving accrual into cancer 

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other: does not address underserved populations

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no original data

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other: commentary

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does not report a controlled trial or recruitment to a 

controlled trial

Gohagan JK, Prorok PC, Hayes RB, et al. The Prostate, 

Lung, Colorectal and Ovarian (PLCO) Cancer Screening 

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and status. Control Clin Trials 2000;21(6 Suppl):251S272S. 

other: does not address underserved populations

Goodman GE, Valanis B, Meyskens FL Jr, et al. Strategies 

for recruitment to a population-based lung cancer 

prevention trial: the CARET experience with heavy 

smokers. Beta-Carotene and Retinol Efficacy Trial. Cancer 

Epidemiol Biomarkers Prev 1998;7(5):405-12. 

other: does not address underserved populations

Goodman PJ, Tangen CM, Crowley JJ, et al. 

Implementation of the Prostate Cancer Prevention Trial 

(PCPT). Control Clin Trials 2004;25(2):203-22. 

does not report a controlled trial or recruitment to a 

controlled trial

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from enrollment in the BEST study--a multicenter, 

randomized trial of group psychosocial support in 

metastatic breast cancer. J Clin Epidemiol 2000;53(1):47-

55. 

other: does not address underserved populations

Gordon EJ, Daugherty CK. Referral and decision making 

among advanced cancer patients participating in Phase I 

trials at a single institution. J Clin Ethics 2001;12(1):31-8. 

other: does not address underserved populations

Gudmundsdottir T, Tryggvadottir L, Allende M, et al. 

Eligibility and willingness of young Icelandic women to 
54 

participate in a HPV vaccination trial. Acta Obstet Gynecol 

Scand 2003;82(4):345-50. 

other: does not address underserved populations

Gurwitz JH, Guadagnoli E, Landrum MB, et al. The 

treating physician as active gatekeeper in the recruitment of 

research subjects. Med Care 2001;39(12):1339-44. 

does not report a controlled trial or recruitment to a 

controlled trial

Harris Y, Gorelick PB, Samuels P, et al. Why African 

Americans may not be participating in clinical trials. J Natl 

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does not report a controlled trial or recruitment to a 

controlled trial

Holcombe RF, Jacobson J, Li A, et al. Inclusion of black 

Americans in oncology clinical trials: the Louisiana State 

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Does not report a controlled trial or recruitment to a 

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Hudmon KS, Love RR, and Chamberlain RM. Perceived 

benefits of and barriers to participation in a phase I/II colon 

cancer chemoprevention trial. J Cancer Educ 

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other: does not address underserved populations

Hudmon KS, Stoltzfus C, Chamberlain RM, et al. 

Participants' perceptions of a phase I colon cancer 

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508. 

other: does not address underserved populations

Hunt JM, Gless GL, Straton JA. Pap smear screening at an 

urban aboriginal health service: report of a practice audit 

and an evaluation of recruitment strategies. Aust N Z J 

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does not report a controlled trial or recruitment to a 

controlled trial 

Hutchison C, Campbell S. Evaluation of an information 

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clinical trials in cancer. Eur J Cancer Care (Engl) 

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other: does not address underserved populations

Jack WJ, Chetty U, Rodger A. Recruitment to a prospective 

breast conservation trial: why are so few patients 

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other: does not address underserved populations 

Jenkins V, Fallowfield L. Reasons for accepting or 

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other: does not address underserved populations

Joffe S, Weeks JC. Views of American oncologists about 

the purposes of clinical trials. J Natl Cancer Inst 

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other: does not address underserved populations

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does not address cancer treatment or prevention

Joseph RR. Viewpoints and concerns of a clinical trial 

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no original data

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does not apply to the key questions

Klabunde C, Kaluzny A, Ford L. Community Clinical 

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Epidemiol Biomarkers Prev 1995 ;4(7):783-9. 

other: no subgroup analysis of an underserved 

population

Koretz MM, Jackson PM, Torti FM, et al. A comparison of 

the quality of participation of community affiliates and that 

of universities in the Northern California Oncology Group. 

J Clin Oncol 1983;1(10):640-4. 

other: does not address underserved populations

Langley C, Gray S, Selley S, et al. Clinicians' attitudes to 

recruitment to randomised trials in cancer care: a 

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9. 

other: does not address underserved populations

Langley GR, Sutherland HJ, Wong S, et al. Why are (or are 

not) patients given the option to enter clinical trials? 

Control Clin Trials 1987;8(1):49-59. 

other: does not address underserved populations

Lara PN Jr, Higdon R, Lim N, et al. Prospective evaluation 

of cancer clinical trial accrual patterns: identifying potential 

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other: does not address underserved populations

Larkey LK, Staten LK, Ritenbaugh C. et al. Recruitment of 

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of Embajadoras in Arizona. Control Clin Trials 

2002;23(3):289-98. 

other: primary prevention trial

Lee JY, Marks JE, Simpson JR. Recruitment of patients to 

cooperative group clinical trials. Cancer Clin Trials 

1980;3(4):381-4. 

other: no subgroup analysis of an underserved 

population

Leslie NS, Deiriggi P, Gross S, et al. Knowledge, attitudes, 

and practices surrounding breast cancer screening in 

educated Appalachian women. Oncol Nurs Forum 

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does not apply to the key questions 
55 

Liaschenko J, Underwood SM. Children in research: 

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participation. Journal of Family Nursing 2001;7(1):71-91. 

other: does not address underserved populations

Lindholm E, Berglund B, Haglind E, et al. Factors 

associated with participation in screening for colorectal 

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other: does not address underserved populations 

Llewellyn-Thomas HA, McGreal MJ, Thiel EC, et al. 

Patients' willingness to enter clinical trials: measuring the 

association with perceived benefit and preference for 

decision participation. Soc Sci Med 1991;32(1):35-42. 

other: does not address underserved populations

Loescher LJ, Graham VE, Aickin M, et al. Development of 

a contingency recruitment plan for a phase III 

chemoprevention trial of cervical dysplasia. Prog Clin Biol 

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other: no subgroup analysis of an underserved 

population

Mannel RS, Walker JL, Gould N, et al. Impact of 

individual physicians on enrollment of patients into clinical 

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other: does not address underserved populations

Marcus AC, Ahnen D, Cutter G, et al. Promoting cancer 

screening among the first-degree relatives of breast and 

colorectal cancer patients:the design of two randomized 

trials. Prev Med 1999;28(3):229-42. 

other: no subgroup analysis of an underserved 

population

Martin RC 2nd, Polk HC Jr, Jaques DP. Does additional 

surgical training increase participation in randomized 

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other: no subgroup analysis of an underserved 

population

McCusker J, Wax A, Bennett JM. Cancer patient 

accessions into clinical trials: a pilot investigation into 

some patient and physician determinants of entry. Am J 

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does not apply to the key questions

McNeil C. Why patients enroll in clinical trials: physicians 

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no original data

Mettlin C, Cummings KM, Walsh D. Risk factor and 

behavioral correlates of willingness to participate in cancer 

prevention trials. Nutr Cancer 1985;7(4):189-98. 

Other: does not address underserved populations 

Mick R, Lane N, Daugherty C, et al. Physician-determined 

patient risk of toxic effects: impact on enrollment and 

decision making in phase I cancer trials. J Natl Cancer Inst 

1994;86(22):1685-93. 

other: does not address underserved populations

Miller HH, Bauman LJ, Friedman DR, et al. Psychosocial 

adjustment of familial polyposis patients and participation 

in a chemoprevention trial. Int J Psychiatry Med 

1986;16(3):211-230. 

other: no subgroup analysis of an underserved 

population

Moon TE, Levine N, Cartmel B, et al. Design and 

recruitment for retinoid Skin Cancer Prevention (SKICAP) 

trials. The Southwest Skin Cancer Prevention Study Group. 

Cancer Epidemiol Biomarkers Prev 1995;4(6):661-9. 

other: no subgroup analysis of an underserved 

population

Motzer SA, Moseley JR, Lewis FM. Recruitment and 

retention of families in clinical trials with longitudinal 

designs. West J Nurs Res 1997;19(3):314-33. 

other: does not address underserved populations

Naranjo LE, Dirksen SR. The recruitment and participation 

of Hispanic women in nursing research: a learning process. 

Public Health Nurs 1998;15(1):25-9. 

does not address cancer treatment or prevention

Omenn GS, Goodman G, Grizzle J, et al. Recruitment for 

the beta-carotene and retinol efficacy trial (CARET) to 

prevent lung cancer in smokers and asbestos-exposed 

workers. West J Med 1992;156(5):540-4. 

does not report a controlled trial or recruitment to a 

controlled trial

Owen JE, Klapow JC, Roth DL, et al. Improving the 

effectiveness of adjuvant psychological treatment for 

women with breast cancer:the feasibility of providing 

online support. Psychooncology 2004;13(4):281-92. 

other: does not address underserved populations

Pentz RD, Flamm AL, Sugarman J, et al. Study of the 

media's potential influence on prospective research 

participants' understanding of and motivations for 

participation in a high-profile phase I trial. J Clin Oncol 

2002;20(18):3785-91. 

other: no subgroup analysis of an underserved 

population

Prochaska JO, Velicer WF, Fava JL, et al. Evaluating a 

population-based recruitment approach and a stage-based 

expert system intervention for smoking cessation. Addict 

Behav 2001;26(4):583-602. 

other: does not address underserved populations

Psillidis L, Flach J, Padberg RM. Participants strengthen 

clinical trial research: the vital role of participant advisors 

in the Breast Cancer Prevention Trial. J Womens Health 

1997;6(2):227-32. 

no original data

Richardson MA, Post-White J, Singletary SE, et al. 

Recruitment for complementary/alternative medicine trials: 

who participates after breast cancer. Ann Behav Med 

1998;20(3):190-8. 

other: no subgroup analysis of an underserved 
56 

population

Rimer BK, Schildkraut JM, Lerman C, et al. Participation 

in a women's breast cancer risk counseling trial. Who 

participates? Who declines? High Risk Breast Cancer 

Consortium. Cancer 1996;77(11):2348-55. 

other: no subgroup analysis of an underserved 

population

Roberts F. Qualitative differences among cancer clinical 

trial explanations. Soc Sci Med 2002;55(11):1947-55. 

other: does not address underserved populations

Rogers AS. Adolescent under enrollment in national 

clinical research: it is time to ask why. J Adolesc Health 

1997;21(6):374-5. 

no original data

Ruffin MT 4th, Baron J. Recruiting subjects in cancer 

prevention and control studies. J Cell Biochem Suppl 

2000;34:80-3. 

no original data

Schaefer KM, Ladd E, Gergits MA, et al. Backing and 

forthing: the process of decision making by women 

considering participation in a breast cancer prevention trial. 

Oncol Nurs Forum 2001;28(4):703-9. 

other: does not address underserved populations

Schatzkin A, Lanza E, Freedman LS, et al. The polyp 

prevention trial I: rationale, design, recruitment, and 

baseline participant characteristics. Cancer Epidemiol 

Biomarkers Prev 1996;5(5):375-83. 

other: primary prevention trial

Schiffman M, Adrianza ME. ASCUS-LSIL Triage Study. 

Design, methods and characteristics of trial participants. 

Acta Cytol 2000;44(5):726-42. 

other: does not address underserved populations

Schutta KM, Burnett CB. Factors that influence a patient's 

decision to participate in a phase I cancer clinical trial. 

Oncol Nurs Forum 2000;27(9):1435-8. 

does not report a controlled trial or recruitment to a 

controlled trial

Scott DA, Valery PC, Boyle FM, et al. Does research into 

sensitive areas do harm? Experiences of research 

participation after a child's diagnosis with Ewing's sarcoma. 

Med J Aust 2002;177(9):507-10. 

does not report a controlled trial or recruitment to a 

controlled trial

Segnan N, Senore C, Giordano L, et al. Promoting 

participation in a population screening program for breast 

and cervical cancer:a randomized trial of different 

invitation strategies. Tumori 1998;84(3):348-53. 

does not report a controlled trial or recruitment to a 

controlled trial

Seroussi B, Bouaud J. Using OncoDoc as a computer-based 

eligibility screening system to improve accrual onto breast 

cancer clinical trials. Artif Intell Med 2003;29(1-2):153-67. 

other: does not address underserved populations

Shavers VL, Lynch CF, Burmeister LF. Racial differences 

in factors that influence the willingness to participate in 

medical research studies. Ann Epidemiol 2002;12(4):248-

56. 

does not report a controlled trial or recruitment to a 

controlled trial

Siminoff LA, Zhang A, Colabianchi N, et al. Factors that 

predict the referral of breast cancer patients onto clinical 

trials by their surgeons and medical oncologists. J Clin 

Oncol 2000;18(6):1203-11. 

other: no subgroup analysis of an underserved 

population

Simon C, Zyzanski SJ, Eder M, et al. Groups potentially at 

risk for making poorly informed decisions about entry into 

clinical trials for childhood cancer. J Clin Oncol 

2003;21(11):2173-8. 

does not report a controlled trial or recruitment to a 

controlled trial

Simon MS, Brown DR, Du W, et al. Accrual to breast 

cancer clinical trials at a university-affiliated hospital in 

metropolitan Detroit. Am J Clin Oncol 1999;22(1):42-6. 

other: no subgroup analysis of an underserved 

population

Slevin M, Mossman J, Bowling A, et al. Volunteers or 

victims: patients' views of randomised cancer clinical trials. 

Br J Cancer 1995;71(6):1270-4. 

other: does not address underserved populations

Sorensen JB, Rossel P, Holm S. Patient-physician 

communication concerning participation in cancer 

chemotherapy trials. Br J Cancer 2004;90(2):328-32. 

other: does not address underserved populations

Spiro SG, Gower NH, Evans MT, et al. Recruitment of 

patients with lung cancer into a randomised clinical trial: 

experience at two centres. On behalf of the Big Lung Trial 

Steering Committee. Thorax 2000;55(6):463-5. 

other: does not address underserved populations

Strauss B. Best hope or last hope: access to phase III 

clinical trials of HER-2/neu for advanced stage breast 

cancer patients. J Adv Nurs 2000;31(2):259-66. 

no original data

Sugarman J, Regan K, Parker B, et al. Ethical ramifications 

of alternative means of recruiting research participants 

from cancer registries. Cancer 1999;86(4):647-51. 

other: does not address underserved populations

Susman EJ, Dorn LD, Fletcher JC. Participation in 

biomedical research: the consent process as viewed by 

children, adolescents, young adults, and physicians. J 

Pediatr 1992;121(4):547-52. 

does not report a controlled trial or recruitment to a 

controlled trial
57 

Sutherland HJ, da Cunha R, Lockwood GA, et al. What 

attitudes and beliefs underlie patients' decisions about 

participating in chemotherapy trials? Med Decis Making 

1998;18(1):61-9. 

other: does not address underserved populations

Taylor KM, Kelner M. Interpreting physician participation 

in randomized clinical trials: the Physician Orientation 

Profile. J Health Soc Behav 1987;28(4):389-400. 

other: does not address underserved populations

Taylor KM, Margolese RG, Soskolne CL. Physicians' 

reasons for not entering eligible patients in a randomized 

clinical trial of surgery for breast cancer. N Engl J Med 

1984;310(21):1363-7. 

other: does not address underserved populations

Taylor KM. Physician participation in a randomized 

clinical trial for ocular melanoma. Ann Ophthalmol 

1992;24(9):337-44. 

other: no barriers to an underserved group reported

Trauth JM, Musa D, Siminoff L, et al. Public attitudes 

regarding willingness to participate in medical research 

studies. J Health Soc Policy 2000 ;12(2):23-43. 

other: does not address underserved populations

Tworoger SS, Yasui Y, Ulrich CM, et al. Mailing strategies 

and recruitment into an intervention trial of the exercise 

effect on breast cancer biomarkers. Cancer Epidemiol 

Biomarkers Prev 2002;11(1):73-7. 

other: primary prevention trial

Wang LD, Zheng S, Zheng ZY, et al. Primary 

adenocarcinomas of lower esophagus, esophagogastric 

junction and gastric cardia:in special reference to China. 

World J Gastroenterol 2003;9(6):1156-64. 

no original data

Weijer C, Freedman B, Shapiro S, et al. Assessing the 

interpretation of criteria for clinical trial eligibility: a 

survey of oncology investigators. Clin Invest Med 

1998;21(1):17-26. 

does not report a controlled trial or recruitment to a 

controlled trial 

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prostate cancer screening among low-income men. Psychol 

Health Med 2000;5(4):439-450. 

does not report a controlled trial or recruitment to a 

controlled trial

Weinrich SP, Greiner E, Reis-Starr C, et al. Predictors of 

participation in prostate cancer screening at worksites. J 

Community Health Nurs 1998;15(2):113-29. 

does not report a controlled trial or recruitment to a 

controlled trial

Weinrich SP, Weinrich M, Mettlin C, et al. Urinary 

symptoms as a predictor for participation in prostate cancer 

screening among African American men. Prostate 

1998;37(4):215-22. 

does not report a controlled trial or recruitment to a 

controlled trial

Winn RJ, Miransky J, Kerner JF, et al. An evaluation of 

physician determinants in the referral of patients for cancer 

clinical trials in the community setting. Prog Clin Biol Res 

1984;156:63-73. 

other: does not address underserved populations

Woods VD, Montgomery SB, Herring RP. Recruiting 

black/African American men for research on prostate 

cancer prevention. Cancer 2004;100(5):1017-25. 

does not report a controlled trial or recruitment to a 

controlled trial

Wright JR, Crooks D, Ellis PM, et al. Factors that influence 

the recruitment of patients to Phase III studies in oncology: 

the perspective of the clinical research associate. Cancer 

2002;95(7):1584-91. 

other: does not address underserved populations 

Yancey AK, Miles OL, McCarthy WJ, et al. Differential 

response to targeted recruitment strategies to fitness 

promotion research by African-American women of 

varying body mass index. Ethn Dis 2001;11(1):115-23. 

other: primary prevention trial

Yeomans-Kinney A, Vernon SW, Frankowski RF, et al. 

Factors related to enrollment in the breast cancer 

prevention trial at a comprehensive cancer center during the 

first year of recruitment. Cancer 1995;76(1):46-56. 

other: does not address underserved populations

 

Yoder LH, O'Rourke TJ, Etnyre A, et al. Expectations and 

experiences of patients with cancer participating in phase I 

clinical trials. Oncol Nurs Forum 1997;24(5):891-6. 

other: does not address underserved populations

Yu M, Seetoo AD, Hong OS, et al. Cancer screening 

promotion among medically underserved Asian American 

women:integration of research and practice. Res Theory 

Nurs Pract 2002;16(4):237-48. 

does not report a controlled trial or recruitment to a 

controlled trial

Zabora JR, Morrison C, Olsen SJ, et al. Recruitment of 

underserved women for breast cancer detection programs. 

Cancer Pract 1997;5(5):297-303. 

does not report a controlled trial or recruitment to a 

controlled trial
61 

Figure 1. Conceptual Framework. 

Awareness

Opportunity

Acceptance/

Refusal

Awareness

Barriers/Promoters

Knowledge

Attitudes/Beliefs

Self-Efficacy

Organizational Environment

Health Literacy

(Q5)

Interventions

Individual-directed

Physician/Provider-directed

Medical system-directed

Community-based

Media campaigns

Incentives

(Q3 & Q4)

Opportunity Barriers/

Promoters

Provider knowledge

Provider attitudes/beliefs

Eligibility / Exclusions by design

Access

Medical Insurance

Advanced Disease

Co-morbidity

Organizational Environment

(Q5 & Q6)

Moderators/

Sociodemographic

Factors

Race/Ethnicity

Age

Gender

Geography

Language

Income

Social Ties

Education

Culture

(Q5a & Q5b)

M-  -  

Acceptance/Refusal

Barriers/Promoters

Perceived harms/benefits

Trust in sponsor/investigator

Self-efficacy

Altruism

Religious beliefs

Personal experience

No cost treatment

Financial incentives

Timing

(Q5)

Study Design

Surveys

Focus Groups

CCTs / RCTs

(Q1)
62 

Electronic Databases1

MEDLINE® – 3462 

CENTRAL – 414 

Methodology Reviews – 1 

Methodology Protocols – 1 

CINAHL® – 284 

PsycINFO – 152 

C2-SPECTR – 15 

Hand Searching 

107 

Abstract Review 

1089 

Duplicates 

341

Article Review 

218 

Articles Eligible 

67 

KQ 1 = 13 

KQ 2 = 23 

KQs 3 and 4 = 5 

KQ 5 = 45 

KQ 6 = 10 

Excluded – 

871 

Excluded 

151

Retrieved 

4451 

1

 CENTRAL - the Cochrane CENTRAL Register of Controlled Trials; CINAHL® - Cumulative Index of Nursing and Alliance 

Health Literature; PsycINFO - ; C2-SPECTR – The Campbell Collaboration’s Social, Psychological, Educational, and 

Criminological Trials Registry; KQ, Key Question 

Excluded - 

3021 

Title Review 

4110 

Figure 2. Summary of literature search and review process (number of articles).
65 

Table 1. Summary of the Characteristics of Studies about Strategies to Recruit Underrepresented Populations to Cancer Preve

Trials (Key Question 1). 

Author, Year 

Study Setting 

Study Design 

Study Objective(s) Type of 

Cancer Studied 

Target Population 

Sample Size 

Mean Age, y 

% Male 

Advani, 

2003 

Hospital outpatient 

Case-control A. To determine if AA oncology 

patients are less willing to participate in clinical trials. 

B. To better delineate existing barriers to recruitment in AAs. C. To compare attitudes of oncology patients who were treated in rural areas compared to a major medical center. 

Solid or hematologic malignancy (excluding melanoma) 

Patients/ Participants 

218 NR NR 

Berman, 

1998 

Community Quasiexperimental To determine whether there are racial and ethnic differences in 

recruitment. 

Smoking cessation 

Patients/ Participants 

435 NR 0 

Brewster, 

2002 

Community; Hospital outpatient 

CCT To review and compare the 

recruitment strategies associated with recruiting Latinas into cancer prevention trials. 

Cervical Patients/ 

Participants 

2,583 43 0 

Ford, 2004 Community RCT A. To demonstrate that lowincome and moderate to high 

income older AA men can be recruited into a cancer trial. B. To identify a method for increased participation of older AA men in cancer screening trials. 

Prostate, lung, colorectal 

Patients/ Participants 

12,400 62 100 

Kaluzny, 

1993 

Community; Hospital outpatient; Group practice 

Qualitative To describe the early 

implementation of the MBCCOP and identify the challenges that have emerged in developing a network aimed at increasing the participation of minority populations in clinical trials. 

All Patients/ 

Participants; Physicians 

NR NR NR 
66 

Table 1. Summary of the Characteristics of Studies about Strategies to Recruit Underrepresented Populations to Cancer Preve

Trials (Key Question 1). (continued) 

Author, Year 

Study Setting 

Study Design 

Study Objective(s) Type of 

Cancer Studied 

Target Population 

Sample Size 

Mean Age, y 

% Male 

Linnan, 

2002 

Work site; Workers' homes 

CCT A. Describe organizational factors 

associated with each selected employee - recruitment method. B. Investigate differences in employee reaction to enrollment and attrition based on elected recruitment method. C. Compare self-reported health behaviors and motivational readiness to change among employees enrolled in homebased intervention study by recruitment method. 

Lung Patients/ 

Participants 

10,014 43 53 

Maurer, 

2001 

Hospital inpatient 

Case series To determine whether 

participation in clinical trials would lead to generalizeable changes in patterns of care from before to after implementation. 

Breast, colon, rectum, lung, prostate 

Patients/ Participants 

75 NR NR 

Paskett, 

1995 

Community Descriptive A. Evaluate a Rural Cancer Care 

Intervention. B. Assess rural-based primary care physician knowledge, attitudes, and beliefs about patient and physician barriers to cancer clinical trials and accrual to clinical treatment trials. 

Colorectal Physicians 2,079 NR NR 

Paskett, 

2002 

Community CCT To develop and test an 

intervention to involve community physicians in clinical trial research. 

Breast, colorectal 

Physicians 364 47 84 
67 

Table 1. Summary of the Characteristics of Studies about Strategies to Recruit Underrepresented Populations to Cancer Preve

Trials (Key Question 1). (continued) 

Author, Year 

Study Setting 

Study Design 

Study Objective(s) Type of 

Cancer Studied 

Target Population 

Sample Size 

Mean Age, y 

% Male 

RandallDavis, 2001 Unclear Qualitative To elicit perceptions of urban and rural adults regarding 

participation in cancer clinical trials. 

All Patients/ 

Participants 

37 55 0 

Sears, 2003 Community RCT; 

Retrospective 

To examine recruitment, retention, and predictors of participation. 

Breast Patients/ 

Participants 

2,242 57 NR 

Thornquist, 

1991 

Community Descriptive; 

Retrospective 

To describe any differences in accrual and adherence to trial by age group or by gender. 

Lung Patients/ 

Participants 

2284 NR 53 

Zhu, 2000 Community Descriptive; 

Qualitative 

Present the strategy and outcomes of recruitment strategies to recruit elderly AA women in prevention and control studies. 

Breast Physicians 367 NR 0 

AA = African American AIAN =American Indian/ Alaskan Native CCT = Concurrent controlled trial MBCCOP = Minority Based Community Clinical Oncology Programs NR = not reported PI = Pacific Islander RCT = Randomized clinical trial SES = socioeconomic status 
68 

Table 2. Studies about Measures of Success used to Evaluate the Effectiveness of Strategies for Recruitment of underreprese

Cancer Prevention and Treatment Trials (Key Question 2). 

Author, Year 

Country Mean 

Age, y (Range) 

% Male 

% Underrepresented group(s) 

Study Setting 

Target Population 

Study Design 

Type of Cancer Studied 

Was Recruitment Goal Stated a Priori (Y/N). If yes, what was goal (in %)? 

SM

Treatment Trials 

Benson, 

1991 

U.S. NR NR 10% AA; 6% 

Lat/Hisp; 51% elderly 

Clinical Trials Cooperative Group (1839 hospitals, 194 universities) 

Patients/ Participants 

Crosssectional; Retrospective 

All NA 

sp

Goodwin, 

1988 

U.S. 53 NR 15% elderly SWOG Patients/ 

Participants 

Crosssectional; Retrospective 

All NA 

sMStog

Hunter, 

1987 

U.S. NR 43 4% AA; 3% 

Lat/Hisp 

Hospital inpatient; Hospital outpatient; 

Patients/ Participants 

Crosssectional; Retrospective 

All NA 

spCCpSf

Kaluzny, 

1993 

U.S. NR NR Community; 

Hospital outpatient; Group practice 

Patients/ Participants; Physicians 

Descriptive All NA 

sobecapCpef
69 

Table 2. Studies about Measures of Success used to Evaluate the Effectiveness of Strategies for Recruitment of underreprese

Cancer Prevention and Treatment Trials (Key Question 2). (continued) 

Author, 

Year 

Country Mean 

Age, y 

(Range) 

% Male % Underrepresented 

group(s) 

Study Setting 

Target Population 

Study Design 

Type of Cancer Studied 

Was Recruitment Goal Stated a Priori (Y/N). If yes, what was goal (in %)? 

SM

Kemeny, 

2003 

U.S. 48 (young 

group), 

74 (older 

group) 

0 50% elderly Community Patients/ 

Participants 

Case-control Breast NA 

suoc

Kladbunde, 

1999 

U.S. NR 29 29% AA CCOP, 

Hospitial inpatient 

Patients/ Participants 

Retrospective All NA 

ip

Lewis, 

2003 

U.S. 32% elderly NCI 

cooperative groups 

Patients/ Participants 

Crosssectional; Retrospective 

All NA 

sp

Maurer, 

2001 

U.S. NR 100% rural Hospital 

inpatient 

Patients/ Participants 

Case series Breast, 

colon, rectum, lung, prostate 

No elderly goal, Yes-rural goal; 40% of incident cancer cases & 54% would be eligible 

subeafpupt

Murthy, 

2004 

U.S. NR 

(30-57) 

32 9% AA; 2% 

Asian/PI; 3% Lat/Hisp; 32% elderly 

Hospital inpatient; Hospital outpatient 

Patients/ Participants 

Crosssectional; Retrospective 

Breast, colorectal, lung, prostate 

NA 

sp

Paskett, 

2002 

U.S. 47 87 100% rural Community Physicians CCT Breast , 

colorectal 

No 

sueai
70 

Table 2. Studies about Measures of Success used to Evaluate the Effectiveness of Strategies for Recruitment of underreprese

Cancer Prevention and Treatment Trials (Key Question 2). (continued) 

Author, 

Year 

Country Mean 

Age, y 

(Range) 

% 

Male 

% Underrepresented group(s) 

Study Setting Target 

Population 

Study Design 

Type of Cancer Studied 

Was Recruitment Goal Stated a Priori (Y/N). If yes, what was goal (in %)? 

SM

Trimble 

1994 

U.S. NR NR 100% elderly All NCIsponsored 

trials in 1992 

Patients/ Participants 

Descriptive; Retrospective 

Lung, prostate, colorectal, pancreas, leukemia, ovarian, breast 

NA 

sp

Yee, 

2003 

Canada NR NR 22% elderly Canada NCIC 

CTG treatment trials & U.S. SWOG treatment trials 

Patients/ Participants 

Crosssectional; Retrospective 

All NA 

spCsucct

Prevention Trials 

Berman, 

1998 

U.S. NR 49 85% 

Lat/Hisp; 15% AA 

Community Patients/ 

Participants 

Quasiexperimental Smoking cessation No G

pugs

Brewster, 

2002 

U.S. 43 

(17-78) 

0 78% 

Lat/Hisp; 39% low annual income 

Community; Hospital outpatient 

Patients/ Participants 

CCT Cervical No 

sutps
71 

Table 2. Studies about Measures of Success used to Evaluate the Effectiveness of Strategies for Recruitment of underreprese

Cancer Prevention and Treatment Trials (Key Question 2). (continued) 

Author, 

Year 

Country Mean 

Age, y 

(Range) 

% 

Male 

% Underrepresented group(s) 

Study Setting 

Target Population 

Study Design 

Type of Cancer Studied 

Was Recruitment Goal Stated a Priori (Y/N). If yes, what was goal (in %)? 

RecruitmSuccess 

Ford, 

2004 

U.S. 63 

(55-74) 

100 100% AA; 

100% elderly; 38% low SES 

Community Patients/ 

Participants 

RCT Prostate, 

lung, colorectal 

No Researc

1)Proporenrolled to enrollmstandard recruitmeand 2)prenrolled geriatric 

Linnan, 

2002 

U.S. 43 53 6% Lat/Hisp; 

27% low annual income 

Work site; Workers homes 

Patients/ Participants 

RCT Lung NA Researc

Proportioundersereligible f

Moinpour, 

2000 

U.S. NR 

(51-91) 

100 4% AA; 3% 

Lat/Hisp 

Hospital outpatient; NCI Comprehensive Cancer Center 

Patients/ Participants; Researchers 

Descriptive Prostate Yes; 8% AA Geograp

represenU.S. Prounderser

Schiffman, 

2000 

U.S. 27 

 (18-81) 

 NR 31% AA; 2% 

AIAN; 3% Asian/PI; 5% Lat/Hisp 

Community; Group practice 

Patients/ Participants 

Descriptive Cervical No Researc

Proportiounderserenrolled 
72 

Table 2. Studies about Measures of Success used to Evaluate the Effectiveness of Strategies for Recruitment of underreprese

Cancer Prevention and Treatment Trials (Key Question 2). (continued) 

Author, 

Year 

Country Mean 

Age, y 

(Range) 

% 

Male 

% Underrepresented group(s) 

Study Setting 

Target Population 

Study Design 

Type of Cancer Studied 

Was Recruitment Goal Stated a Priori (Y/N). If yes, what was goal (in %)? 

RecruitmSuccess 

Thornquist, 

1991 

U.S. NR 

(45-74) 

53 23% elderly Community Patients/ 

Participants 

Descriptive; Retrospective 

Lung No Researc

Wanted elderly pto evaluastudy. Alequal pain 5-year groups. 

Zhu, 2000 U.S. NR 

(65-85+) 

0 100% AA; 

100% elderly; 91% low annual income 

Community Physicians Qualitative Breast No Researc

African-Aelderly wAuthors participawere higcomparestudy witparticipa20-48% 
73 

Table 2. Studies about Measures of Success used to Evaluate the Effectiveness of Strategies for Recruitment of underreprese

Cancer Prevention and Treatment Trials (Key Question 2). (continued) 

Author, Year 

Country Mean 

Age, y (Range) 

% Male 

% Underrepresented group(s) 

Study Setting 

Target Population 

Study Design Type of 

Cancer Studied 

Was Recruitment Goal Stated a Priori (Y/N). If yes, what was goal (in %)? 

RecruitmSuccess 

Both Prevention and Treatment Trials 

Alexander, 

2000 

U.S. NR 41 1.9% 

Asian/PI, 26% elderly 

All NCIsponsored trials from 1994 to 1998 

Patients/ Participants 

Crosssectional; Retrospective 

All NA Disease-

proportiofor AsianResearcelderly: pyounger in the NCsupportetreatmen

Krailo, 

1993 

U.S. NR 

(0-19) 

NR 33% 

adolescent 

Hospital inpatient; Hospital outpatient 

Patients/ Participants 

Crosssectional; Retrospective 

All NA Disease-

proportiocounty: pundersercancer in 

Simon, 

2004 

U.S. 55 0 32% AA NCI 

Comprehensive Cancer Center 

Patients/ Participants 

Descriptive Breast No Disease-

proportioproportiounderserwith cancfrom the databaseDetroit 
74 

Table 2. Studies about Measures of Success used to Evaluate the Effectiveness of Strategies for Recruitment of underrepresen

Cancer Prevention and Treatment Trials (Key Question 2). (continued) 

AA = African American CCOP = Community Cooperative Oncology Program CCT = Concurrent controlled trial CTG = Clinical Trials Group Lat/Hisp = Latino/Hispanic NA = not applicable NCI = National Cancer Institute NCIC = Cancer Institute of Canada NR = Not reported PI = Pacific Islander SEER = Surveillance, Epidemiology, and End Results Program SES = Socioeconomic status SWOG = Southwest Oncology Group
75 

Table 3. Summary of Study and Target Population Characteristics on the Efficacy or Effectiveness of Recruitment Strategies fo

Participation of Underrepresented Populations in Cancer Prevention and Treatment Trials (Key Questions 3 and 4). 

Author, Year 

Study Setting 

Study Design 

Cancer Studied 

Target Population 

Study Subgroup Sample 

Size 

Mean Age, y 

Mean Education, y 

 % male 

 

Clinic registry 405 44 < HS graduate 

(54.7%) 

Brewster, 0 

2002 

Community; Outpatient hospital 

CCT Cervical Participants 

Media campaign 535 42 < HS graduate 

(48.5%) 

0 

AA, Arm A 3,079 AA, Arm B 3,075 AA, Arm C 2,949 

Ford, 2004 Community; 

Faith-based organization 

RCT Prostate, 

Lung, Colorectal 

Participants 

AA, Arm D 3,297 

NR NR 100 

Passive employee contact 

891 41 < HS graduate 

(50.4%) 

Linnan, 53 

2002 

Community RCT Lung Participants 

Active employee contact 

1,015 44 < HS graduate 

(39.5%) 

53 

AA, Site A, 1995 AA, Site A, 1996 AA, Site B, 1995 AA, Site B, 1996 AA, Site C, 1995 AA, Site C, 1996 AA, Site D, 1995 AA, Site D, 1996 Lat/Hisp, Site E, 1995 

Moinpour, 

2000 

Outpatient hospital 

RCT Prostate Participants; 

Researchers 

Lat/Hisp, Site E, 1996 

NR NR NR 100 

South Carolina 1993 72 44 NR 92 North Carolina 1993 124 49 NR 84 South Carolina 1996 62 45 NR 85 

Paskett, 

2002 

Community CCT Breast, 

Colorectal 

Physicians 

North Carolina 1996 102 49 NR 87 
76 

Table 3. Summary of Study and Target Population Characteristics on the Efficacy or Effectiveness of Recruitment Strategies fo

Participation of Underrepresented Populations in Cancer Prevention and Treatment Trials (Key Questions 3 and 4). (continued) 

AA = African American Cauc = Caucasian CCT = Concurrent controlled trial HS = High School Lat/Hisp = Latino/Hispanic NR = Not reported RCT = Randomized controlled trial 
77 

Table 4. Summary of Outcome Point Estimates on the Efficacy or Effectiveness of Recruitment Strategies for Increasing Partic

Underrepresented Populations in Cancer Prevention and Treatment Trials (Key Questions 3 and 4). 

Author, Year 

Descriptor of Point Estimate %, OR, difference) Point 

Estimate (value) 

Measure of Spread / Significance ( 95% CI, P value) 

Author Conclusio

Brewster, OR of women presenting to clinic (media campaign vs. clinic registry) 3.0 2.38 - 3.78 

2002 OR of women screened by telephone (media campaign vs. clinic registry) 3.0 2.52 - 3.51 

Media campaign rerecruitment results recruitment strateg

Ford, 2004 Difference of enrollment between Arm C vs. Arm D (%) Arm C = 

intervention included enhanced mailing process and church-based sessions Arm D = control group which received standard recruitment procedures 

1.0 P = .02 Arm C, the most int

interventions, yieldecompared to the cointervention arms (A

Linnan, 

2002 

Difference of enrollment between passive employee contact and active employee contact (%) 

36.6 P < .0001 Active recruitment 

enrollment, and smrecruitment had widdiversity. No signifiorganizational factopassive recruitmen

Change in Site A enrollment from 1995 to 1996 (%) 0.3 NR Change in Site B enrollment from 1995 to 1996 (%) 0.5 NR Change in Site C enrollment from 1995 to 1996 (%) 2.8 NR Change in Site D enrollment from 1995 to 1996 (%) 0.6 NR 

Moinpour, 

2000 

Change in Site E enrollment from 1995 to 1996 (%) 0.5 NR 

It was difficult to evrecruitment strateg

used at the final pe

Change in enrollment of breast cancer patients from 1991 to 1996, North Carolina (%) 

9.0 NR 

Change in enrollment of colorectal cancer patients from 1991 to 1996, North Carolina (%) 

1.0 NR 

Change in enrollment of breast cancer patients from 1991 to 1996, South Carolina (%) 

44.0 NR 

Paskett, 

2002 

Change in enrollment of colorectal cancer patients from 1991 to 1996, South Carolina (%) 

5.0 NR 

No improvement in into cancer clinical intervention. 

CI = Confidence interval OR = Odds ratio
78 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). 

Barriers Associated with Decrease in 

Reported Enrollment 

Promoters Ass

Repo

Author, Year 

Pop. (N) 

Setting Type of 

Cancer 

Method 

Awareness Opportunities DecisionMaking Awareness Opp

AdamsCampbell, 

2004 

AA (235) 

Hospital inpatient; Hospital outpatient 

Breast, colorectal, head and neck, lung, prostate 

Tumor registry review 

Study Design Barriers: Comorbidity exclusion; Functional status; Diagnostic test result cut-off; Lack of available protocols

Advani, 

2003 

AA, Whites (218) 

Hospital outpatient Solid or 

hematologic malignancy (excluding melanoma) 

Casecontrol Patient Barriers: 

Lack of education about trials*

Patient Barriers: Distance to clinic* 

Patient Barriers: Perceived harms of trial participation*; Chance of side-effects* 

PatieProm

Youn

Barofsky, 

1979 

AA (76) 

Community Hospital inpatient 

Histologically confirmed soft-tissue or osteosarcoma 

Qualitative: Semistructured interviews 

PatiePromBein

Broome, 

2001 

Adol (34) 

Community;Hospital inpatient; Hospital outpatient 

Hematological malignancy or solid tumors 

Qualitative: interviews 

 

Broome, 

2003 

Adol (34) 

Hospital inpatient Ewing's 

sarcoma, or hematological malignancy 

Qualitative: Semistructured interviews 

 
79 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in 

Reported Enrollment 

Promoters As

Repo

Author, Year Pop. (N) Setting Type of Cancer Method 

Awareness Opportunities DecisionMaking Awareness O

Brown, 2003 AA, 

Whites (438) 

Community NR Crosssectional; 

Descriptive (telephone surveys) 

Patient Barriers: African American older age*; Lower income* 

PPM

Chen, 2000 Elderly 

(68) 

Hospital inpatient 

Aggressive Histology Lymphoma 

Hospital registry review; Retrospective 

 Study Design 

Barriers: Comorbidity exclusion; Functional status; Previous cancer

Patient Barriers: Patient refusal Provider Barriers: Physician choice 

Comis, 2003 Elderly 

(887) 

Community NR Crosssectional; 

Descriptive (Telephone interview) 

Patient Barriers: Age

Diener-West, 

2001 

Elderly (4,191) 

Hospital inpatient; Hospital outpatient; Group practice; Solo practice 

Eye RCT Patient 

Barriers: Age*; Living near treatment center* 

SPLs
80 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in 

Reported Enrollment 

Promoters A

Re

Author, Year Pop. (N) Setting Type of Cancer Method 

Awareness Opportunities DecisionMaking Awareness 

Fouad, 2000 AA (103) Community NR Qualitative: 

Focus groups / key informant interviews 

Patient Barriers: Lack of education about trials 

Patient Barriers: Time commitment; Indirect costs; Lack/ inadequate health insurance Provider Barriers: Provider attitudes Study Design Barriers:Length of study/visit structure; Complexity of forms 

Patient Barriers: Mistrust of research and medical system; Blood draw; Radiation involvement; Past experiences Provider Barriers: Skepticism about lowincome patients' ability to participate; Concern that their patients would be randomized

Provider Promoters: Education programs for community physicians; Involvement of providers in prevention trials

Fouad, 2001 AA Community NR Qualitative: 

Focus groups / Key Informant Interviews 

Patient Barriers:Lack of education about trials; Lack of knowledge about origins of cancer; Culturally relevant education about clinical trials

Patient Barriers: Job issues; Indirect costs

Patient Barriers:Mistrust of research and medical system; Cultural barriers; Perceived harms of trial participation

Patient Promoters:Adequate knowledge about the study; Workshops on trials
81 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in Reported Enrollment Promoters Ass

Repo

Author, Year 

Pop. (N) 

Setting Type of 

Cancer 

Method 

Awareness Opportunities Decision-Making Awareness Oppo

Green, 

2000 

AA (103) 

Community NR Qualitative: 

Focus groups 

Patient Barriers: Time commitment 

Patient Barriers: Mistrust of research and medical system; Family considerations; Perceived harms of trial participation; Radiation involved in treatment

 

Grunfeld, 

2002 

CRAs (29) 

Hospital inpatient 

NR Qualitative: 

Semistructured interviews 

 Patient Barriers: 

Transportation; Language barrier; Provider Barriers: Provider attitudes; Commun-ication / method of presentation Study Design Barriers: Excessive requirements of study

Patient Barriers: Mistrust of researcher and medical system; Perceived harms of clinical trial participation; Physician expertise; Physician discouragement Provider Barriers: Physician beliefs about patient preference

 
82 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in 

Reported Enrollment 

Promoters A

Rep

Author, Year Pop. (N) Setting Type of Cancer Method 

Awareness Opportunities DecisionMaking Awareness 

Hunter, 1987 AA, 

Whites (17,773) 

Group practice; Hospital inpatient 

Any Descriptive; 

Qualitative; Retrospective 

Patient Barriers: Treatment toxicity; Costs Study Design Barriers: Comorbidity exclusion; Age exclusion; Functional status/Poor performance 

Patient Barriers: Experimentation Provider Barriers:Physicians' preference for specific treatment or alternative therapy
83 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in Reported 

Enrollment 

Promoters A

Re

Author, Year Pop. (N) Setting Type of Cancer Method 

Awareness Opportunities DecisionMaking Awareness 

Kaluzny, 

1993 

NR Community

Hospital outpatient; Group practice 

NR Descriptive; 

Qualitative 

Patient 

Barriers: Limited education or low literacy

Patient Barriers: Transportation; Language barriers; Socioeconomic conditions Provider Barriers: Mistrust of researchers; Provider attitudes; time available per patient; Lack of interest in protocols; Lack of support staff Study Design Barriers:Comorbidity; Length of study/ visit structure; Late stage disease; Healthcare System Barriers: Lack of dissemination of study opportunities to provider/patient; Lack of language services; lack of support staff to facilitate protocol 

Patient Barriers: Mistrust of researchers; Fear; Family considerations; Job issues; Indirect costs
84 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in 

Reported Enrollment 

Promoters As

Repo

Author, Year 

Pop. (N) Setting Type of Cancer Method 

Awareness Opportunities DecisionMaking Awareness Op

Kemeny, 

2003 

Elderly women vs. Younger women (154) 

Community Breast Case-control Patient Barriers: 

Age*; Disease stage*; Number of comorbidities* Provider Barriers: Toxicity of treatment; Thought patient ineligible; Patient comorbidity; 

Kemp, 

1984 

Population in Great Britain - Elderly (1,022) 

Community Breast, bone Descriptive; 

Cross-sectional 

 

Kornblith, 

2002 

Elderly (156) 

Hospital inpatient 

Breast Cross-sectional; 

Descriptive (Questionnaire targeting physicians) 

Patient Barriers: Transportation; Lack/ inadequate health insurance; Toxicity of treatment; Comorbidity; Patient unable to understand trial Study Design Barriers: Comorbidity exclusion; Life expectancy

ProProProattiCotionpre
85 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in Reported 

Enrollment 

Promoters A

Rep

Author, Year 

Pop. (N) 

Setting Type 

of Cancer 

Method 

Awareness Opportunities DecisionMaking Awareness 

Krailo, 

1993 

Adol (2,788) 

Hospital inpatient; Hospital outpatient 

All Hospital registry 

review, Qualitative 

Study design Barriers: Age; Treatment policies; Lack of available protocols

Lewis, 

2003 

Elderly (59,300) 

NCI cooperative groups 

NR Cross-sectional; 

Descriptive; Retrospec-tive (Secondary analysis of national databases) 

Patient Barriers: 

Protocol exclusions Study Design Barriers: Comorbidity exclusion; Functional status; Diagnostic test cutoff

McCaskillStevens, 

1999 

AA (89) Community All Qualitative 

(Discussion, questionnaires of physician) 

Provider Barriers: Lack of physician awareness of trials Healthcare System Barriers: Lack of 

dissemination of study opportunities to provider/patient 

Patient Barriers: Poverty/cost to patient Provider Barriers:Insufficient resources Study Design Barriers: Length of study/visit structure Healthcare System Barriers: Lack of minority personnel/ investigators

Patient Barriers: Mistrust of research and medical system; Fear; 

Cultural barriers Provider Barriers: Mistrust of researchers ; Lack of proven therapy 

Patient Promoters: Culturally relevant education about clinical trials
86 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in Reported 

Enrollment 

Promoters A

Rep

Author, Year 

Pop. (N) 

Setting Type of Cancer Method 

Awareness Opportunities Decision-Making Awareness O

MillonUnderwood, 

1993 

AA (220) 

Community NR Descriptive; 

Crosssectional 

 Patient Barriers:

Mistrust of medical research; Perceived harms of trial participation 

 

Outlaw, 

2000 

AA (56) 

Hospital inpatient 

NR Qualitative: 

Surveys of physicians and data managers 

Patient Barriers: Language barriers; Lack of education about trials; Culturally relevant education about clinical trials; Lack of access to healthcare Provider Barriers: Provider attitudes; Lack of support staff; Time required; Concern in patient's age/frailty ; Lack of minority providers Study Design Barriers: Complexity of clinical trials; disease stage

Patient Barriers: Mistrust of medical research; Fear; Cultural barriers; Indirect costs; Religious/ spiritual beliefs; Perceived harms of trial participation; Lack of comfort with high technology care; Lack of family support; Perceived discrimination Provider Barriers: Mistrust of researchers; Discomfort 
87 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in Reported Enrollment Promoters A

Re

Author, Year 

Pop. (N) 

Setting Type of 

Cancer 

Method 

Awareness Opportunities Decision-Making Awareness 

Paskett, 

2002 

Rural (360) 

Community Breast, 

colorectal 

CCT Patient 

Barriers: Lack of education about trials

Patient Barriers: Transportation; Costs; Lack//inadequate health insurance Provider Barriers: Logistical burden, Cost to patient, Established referral patterns; Perceived treatment risk Study Design Barriers: Eligibility

Patient Barriers: Mistrust of research & medical system,; Perceived harms of trial participation; Unfamiliar physician; Discomfort 
88 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in 

Reported Enrollment 

Promoters A

Rep

Author, Year Pop. (N) Setting Type of Cancer Method 

Awareness Opportunities DecisionMaking Awareness 

Pinto, 2000 AA (73) Community NR Qualitative: 

Focus groups with physicians 

Patient Barriers: Lack of education about trials Provider Barriers: Lack of provider awareness about trial; Healthcare System Barriers: Lack of dissemination of study opportunities to provider/ patient; 

Patient Barriers: Physicians do not offer trials; Cost Provider Barriers: Lack of time; Provider attitudes Study Design Barriers: Comorbidity exclusion, Length of study/visit structure, Protocols too complex; Randomization Healthcare System Barriers: Lack of cultural competence among provider and/or staff; Lack of access to institution conducting trial 

Patient Barriers: Mistrust of medical research; Fear; Cultural barriers, Perceived harms of participation Provider Barriers: Mistrust of researchers; Cultural barriers; Racial bias
89 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in Reported 

Enrollment 

Promoters A

Rep

Author, Year 

Pop. (N) 

Setting Type of Cancer Method 

Awareness Opportunities Decision-Making Awareness O

RandallDavid, 

2001 

Rural (37) 

Community All Qualitative: 

Focus groups 

Patient Barriers: Lack of education about trials Healthcare System Barriers: Lack of 

dissemination of study opportunities to provider/patient

Patient Barriers: Transportation; Time commitment Provider Barriers: Communication/ method of presentation

Patient Barriers: Mistrust of medical research; Fear; Lack of knowledge about origins of cancer; Family considerations, Religious/spiritual beliefs; Perceived harms of trial participation Provider Barriers: Mistrust of researcher 

PPIn(m

Roberson, 

1994 

AA, AIAN, Lat/ Hisp (28) 

Community NR Qualitative: 

Surveys 

Patient Barriers: Lack of education about trials; Lack of information/ awareness

Patient Barriers: Time commitment; Language barriers; Cultural barriers; Access to information 

Patient Barriers: Mistrust of medical research; Fear; Do not like to get involved 

 P

PCrea
90 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in Reported 

Enrollment 

Promote

Author, Year Pop. (N) Setting Type of Cancer Method 

Awareness Opportunities DecisionMaking Awareness 

Robinson, 

1996 

AA men (46) 

Community Prostate Qualitative: 

Focus groups 

Patient Barriers: Lack of knowledge of origins of cancer Healthcare System Barriers: Lack of dissemination of study opportunities to provider/ patient 

Patient Barriers: Lack of education about clinical trials Provider Barriers: Provider attitudes; Communication/ method of presentation 

Patient Barriers: Mistrust of research and medical system, Fear, Perceived harms of trial participation; Concerns about randomization Provider Barriers: Mistrust of researchers 

Sateren, 

2002 

AA (24,332) 

All patients from NCIfunded trials between April 1998-April 1999 

All Crosssectional; 

Descriptive; Retrospective (Secondary analysis of national database) 

Patient Barriers:Lack/ inadequate health insurance*; Being Black male aged 30-59 years*; Asian / Latino/ Hispanic adults* 
91 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in 

Reported Enrollment 

Promoters As

Repo

Author, Year Pop. (N) Setting Type of Cancer Method 

Awareness Opportunities DecisionMaking Awareness O

Sears, 2003 AA, 

White women (558) 

Community Breast RCT Patient 

Barriers: Time commitment; Willingness to travel; Stress; >65 years old; minority; Not married Study Design Barriers: Medication exclusion; Metastatic disease

Simon, 2004 AA, 

White women (319) 

Hospital inpatient 

Breast Descriptive; 

Qualitative (Secondary analysis of NCI patient log data; Interviews from site visits) 

Patient Barriers: Lack/ inadequate health insurance Provider Barriers: Patient likely to be noncompliant; No protocol available for disease stageStudy Design Barriers: Age exclusion; Medication exclusion 

Patient Barriers: Leaving care of physician to participate in trial*
92 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in Reported 

Enrollment 

Promoters Ass

Repor

Author, Year 

Pop. (N) 

Setting Type of Cancer Method 

Awareness Opportunities DecisionMaking Awareness Oppo

Spaight, 

1984 

Elderly (23) 

Hospital inpatient 

NR Qualitative: 

Structured interviews of physicians 

 Patient Barriers: 

Age; Transportation; Inability to understand protocol; Cost Study Design Barriers: Participation requires too much travel; Failure to use most effective drug; Too many lab tests

Patient Barriers: Patient resistance or potential noncompliance

 

Twelves, 

1998 

Elderly women (4,688) 

Hospital inpatient; Hospital outpatien; Solo practice 

Breast Retrospective; 

Tumor registry review 

Patient Barriers: Age*

PatiePromPlace treatmProviPromSurgehigh cReferoncol
93 

Table 5. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in Reported 

Enrollment 

Promoters As

Rep

Author, Year Pop. (N) Setting Type of 

Cancer 

Method 

Awareness Opportunities DecisionMaking Awareness Op

Woods, 2002 AA (120) Hospital 

outpatient 

NR Qualitative: Focus 

groups, Interviews 

 Patient Barriers: 

Transportation problems; Time commitment; Family considerations; Provider Barriers: Training in communicating with patients; Communication/ method of presentation

Patient Barriers: Mistrust of medical research; Perceived harms of clinical trial participation; Not ready to quit smoking; Job issues 

 Study Design Promoters: Reminder phone call

PaPrTrasuStPrLestustr

AA = African American Adol = Adolescent AIAN = American Indian/Alaska Native CCT = Concurrent controlled trial CRA = Clinical research associates Lat/Hisp = Latino Hispanic NCI = National Cancer Institute NR = Not reported Pop. = Population RCT = Randomized controlled trial SES = Socioeconomic status 
94 

Table 6. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). 

Barriers Associated with Decrease in 

Reported Enrollment 

Promoters As

Repo

Author, Year 

Pop. (N) Setting Type of 

Cancer 

Method 

Awareness Opportunities 

DecisionMaking Awareness O

Chemoprevention 

Bieniasz, 

2003 

AA women (66) 

Community Cervical 

(dysplasia) 

Qualitative: Semistructured interviews 

Patient Barriers:Intervention characteristics*

Ling, 2000 Elderly 

 (1,206) 

Hospital inpatient; Hospital outpatient 

NR Qualitative: 

Surveys 

StPrEn

Moinpour, 

2000 

AA and Lat/Hisp men (NR) 

Hospital outpatient; NCI Comprehensive Cancer Center 

Prostate RCT Study Design 

Barriers: Lack of time to establish presence in communities

Patient Barriers: Mistrust of research

Mouton, 

1997 

AA, White women (80) 

Community Breast, 

colorectal 

Descriptive; Cross-sectional (telephone surveys) 

Patient Barriers: Mistrust of research and medical system*; Perception of researchers not caring about patient 

Thornquist, 

1991 

Elderly (1,284) 

Community Lung Cohort; 

Prospective 

Patient Barriers: Age (50-54; 65-69)*

PaPr(6
95 

Table 6. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in 

Reported Enrollment 

Promoters A

Rep

Author, Year 

Pop. (N) Setting Type of 

Cancer 

Method 

Awareness Opportunities 

DecisionMaking Awareness O

Smoking cessation 

Berman, 

1998 

Lat/Hisp, AAs (435) 

Community Smoking 

cessation 

Quasiexperimental. Pa

PrLainaheinsOstPrPrCotioof 

Lerman, 

1994 

AA women (271) 

Community Breast Descriptive; 

Cross-sectional (Structured telephone interview) 

PaPr> mun# re≤HemAg

Woods, 

2002 

AAs (12) Hospital 

outpatient 

NR Qualitative: 

Focus groups, Interviews 

 Patient 

Barriers: Transportation; Time; Family Provider Barriers: Training in communicating with patients; Communication/ method of presentation

Patient Barriers: Mistrust of research; Perceived harms of trial participation; Not ready to quit smoking; Job issues 

Study Design Promoters: Reminder

phone call

PaPrTrsuStPrLestst
96 

Table 6. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in Reported 

Enrollment 

Promoters A

Rep

Author, Year 

Pop. (N) Setting Type of 

Cancer 

Method 

Awareness Opportunities 

DecisionMaking Awareness O

Screening trial 

Ford, 

2003 

AA men (34,376) 

Community Prostate, lung, 

and colorectal 

RCT Patient 

Barriers: Unlisted telephone number* 

Patient Barriers: Age* 

l

Other 

Brewster, 

2002 

Lat/ Hisp women (545) 

Community; Hospital outpatient 

Cervical CCT Patient 

Barriers: Family considerations (childcare problems); Work conflict; No time; Transportation; Other insurance /physician/clinic 

Patient Barriers: Did not wish to participate in a "study"; Modesty/ embarrassment Uncomfortable with test 

Brown, 

2000 

AA, Lat/Hisp, and White women (434) 

Hospital outpatient 

Breast and cervical 

Descriptive (Surveys, Interviews) 

Patient Barriers:Lack of education about clinical trials

Patient Barriers: Transportation Lack of health insurance / inadequate health insurance

Patient Barriers: Fear; Family considerations; Taste of drug; Mistrust of research and medical system

Fouad, 

2001 

AAs (103) Community NR Qualitative: 

Focus groups / Key informant interviews 

Patient Barriers:Lack of education about trials; Lack of knowledge about origins of cancer; Culturally relevant education about clinical trials

Patient Barriers: Job issues; Indirect costs

Patient Barriers:Mistrust of research and medical system; Cultural barriers; Perceived harms of trial participation

Patient Promoters:Adequate knowledge about study; Workshops on trials

ts
97 

Table 6. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in Reported 

Enrollment 

Promoters As

Repo

Author, Year 

Pop. (N) Setting Type of 

Cancer 

Method 

Awareness Opportunities 

DecisionMaking Awareness O

Lee, 1999 AA men 

(165) 

Hospital inpatient 

Prostate Descriptive; 

Cross-sectional (Surveys) 

 

McCaskillStevens, 

1999 

AAs (89) Community All Qualitative: 

Discussions, Questionnaires 

Provider Barriers: Lack of physician awareness of trials Healthcare System Barriers: Lack of dissemination of study opportunities to provider/patient 

Patient Barriers: Poverty/cost to patient Provider Barriers: Insufficient resources Study Design Barrier: Length of study/visit structure Healthcare System Barriers: Lack of minority personnel; Lack of minority investigators

Patient Barriers: Mistrust of research and medical system; Fear; Cultural barriers Provider Barriers: Mistrust of researchers; Lack of proven therapy

Patient Promoter: Culturally relevant education about trials

MillonUnder 

wood, 

1993 

AAs (220) Community NR Descriptive; 

Cross-sectional (Surveys) 

 Patient 

Barriers:Mistrust of medical research; Perceived harms of clinical trial participation 

 
98 

Table 6. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) 

Barriers Associated with Decrease in Reported 

Enrollment 

Promoters As

Repo

Author, Year 

Pop. (N) Setting Type of 

Cancer 

Method 

Awareness Opportunities 

DecisionMaking Awareness O

Pinto, 

2000 

AAs (73) Community NR Qualitative: 

Focus groups 

Patient Barriers: Lack of education about trials Provider Barriers: Lack of provider awareness about trial Healthcare System Barriers: Lack of dissemination of study opportunities to provider/ patient 

Patient Barriers: Physicians do not offer trials; Cost Provider Barriers: Lack of time; Provider attitudes Study Design Barriers: Comorbidity exclusion, Length of study/visit structure, Protocols too complex; Randomization Healthcare System Barriers: Lack of cultural competence among providers and/or staff; Lack of access to institution conducting trial 

Patient Barriers: Mistrust of medical research; Fear; Cultural barriers, Perceived harms of participation Provider Barriers: Mistrust of researchers; Cultural barriers; Racial bias

PaPrCureedabtriPrPrIn(fiot
99 

Table 6. Summary of Studies Investigating the Barriers and Promoters of Participation of Underrepresented Populations in Can(Key Question 5). (continued) CCT = Concurrent controlled trial HS = High school NCI = National Cancer Institute NR = Not reported Pop. = Population PSA = Prostate specific antigen RCT = Randomized controlled trial AA = African American Lat/Hisp = Latino/Hispanic 
100 

Table 7. Summary of Studies on the Effects of Attitudes and Perceptions of Healthcare Providers on the Effectiveness of StrateUnderrepresented Populations into Cancer Prevention and Treatment Trials (Key Question 6).

Author, year 

Study Setting 

Target Population 

Targeted Underrepresented Population 

Sample Size 

Study Design How 

Measured 

Type of Cancer Studied 

Study Objective(s) 

Benson, 

1991 

Community Physicians NR 252 Descriptive Mailed survey NR Investigate the reason

do not place patients in 

Fallowfield, 

1997 

Community Physicians NR 357 Descriptive Mailed survey All Compare results of ph

orientation profile used ECOG study with that from surveying 357 Broncologists. 

Kemeny, 

2003 

Hospital inpatient 

Patients; Participants 

Elderly 154 Case-control Telephone 

survey; Interview 

Breast A. Test the extent to w

older breast cancer pathan 65 years) were oftrials compared to youB. Assess reasons whchoose not to offer a trolder patients and why chose to, or refused to 

Kornblith, 

2002 

Hospital inpatient 

Physicians Elderly 156 Descriptive Mailed survey Breast Test the magnitude of 

recruitment among eldcancer patients from pperspective. 

McCaskillStevens, 

1999 

Community Physicians Minorities 90 Qualitative Open-ended 

questionnaire 

Breast, Colorectal, Lung, Prostate 

Identify barriers and soAfrican American accrtrials. 

Paskett, 

2002 

Community Physicians Rural 196 (in 

1993) 

168 (in 

1996) 

CCT Mailed survey Breast, 

colorectal 

A. Evaluate a Rural CaIntervention. B. Assess rural based physician knowledge, abeliefs about patient abarriers to cancer cliniaccrual to clinical treat
101 

Table 7. Summary of Studies on the Effects of Attitudes and Perceptions of Healthcare Providers on the Effectiveness of StrateUnderrepresented Populations into Cancer Prevention and Treatment Trials (Key Question 6). (continued)

Author, year 

Study Setting 

Target Population 

Targeted Underrepresented Population 

Sample Size 

Study Design How 

Measured 

Type of Cancer Studied 

Study Objective(s) 

Pinto, 2000 Community Physicians; 

Investigators 

Minorities 73 Qualitative Focus groups All Identify barriers to acc

minority patients and dsolutions to these barrphysician's perspective

Richardson, 

1986 

Community Physicians NR 59 Descriptive Mailed survey NR Assess attitudes and p

medical oncologists recancer trial participatio

Simon, 

2004 

Hospital inpatient 

Patients; Participants 

AA 319 Descriptive Survey Breast Understand factors ass

accrual to breast cance

Spaight, 

1984 

Community Physicians NR 23 Descriptive/ 

Qualitative 

Face-to-face interview 

NR Assess factors influenc

trials participation from perspective of medical and hematologists. 

AA = African Americans CCT = Concurrent controlled trial ECOG = Eastern Cooperative Oncology Group NMA = National Medical Association NR = Not reported 
102 

Table 8. Grading of the Quality of Evidence on the Efficacy or Effectiveness of Strategies for Recruiting 

Underserved Populations Into Cancer Prevention and Treatment Trials (Key Questions 3 and 4). 

Quantity of Evidence:

Number of studies 4 

Total number of patients studied 2,846 

Quality and Consistency of Evidence:

Were study designs randomized trials (high quality), non-randomized 

controlled trials (medium quality), or observational studies (low 

quality)? 

Medium 

Did the studies have serious (-1) or very serious (-2) limitations in 

quality? (Enter 0 if none) 

Very serious (-2) 

Did the studies have important inconsistency? (-1) Inconsistent (-1) 

Was there some (-1) or major (-2) uncertainty about the directness or 

extent to which the people, interventions and outcomes are similar to 

those of interest? 

None (0) 

Were data imprecise or sparse? (-1) Sparse (-1) 

Did the studies have high probability of reporting bias? (-1) No (0) 

Did the studies show strong evidence of association between 

intervention and recruitment outcome? (“strong” if significant relative 

risk or odds ratio > 2 based on consistent evidence from 2 or more 

studies with no plausible confounders (+1); “very strong” if significant 

relative risk or odds ratio > 5 based on direct evidence with no major 

threats to validity (+2)) 

No (0) 

Did the studies have evidence of a dose-response gradient? (+1) No (0) 

Did the studies have unmeasured plausible confounders that most 

likely reduced the magnitude of the observed association? (+1) 

No (0) 

Overall grade of evidence (high, medium, low, very low) Very low* 

*According to the evidence grading system recommended by the international GRADE Working Group, the overall grade was 

based on the initial assessment of the study designs (medium quality) with lowering of the grade by one or two levels for each of 

the limitations identified. “Very Low” grade of evidence means that any estimate of effect is very uncertain. 
103 

Table 9. Grading of the Quality of Evidence on Barriers to and Promoters of Participation of Underserved 

Populations in Cancer Prevention and Treatment Trials (Key Question 5). 

For 

Treatment 

Trials 

For Prevention Trials For 

Treatment 

and/or 

Prevention 

Trials 

Quantity of Evidence:

Number of studies 32 13 3 

Total number of patients studied 28,689 7,948 (excluding AAMEN) 

24,119 (assumed with 

minimum of 16,171 who 

are the same throughout 

the three AAMEN studies) 

413 

Quality and Consistency of Evidence: 

Were study designs appropriate for determining effects 

of providers= attitudes and perceptions? (Yes = high 

quality; no = low quality) 

Yes Yes Yes 

Did the studies have serious (-1) or very serious (-

2) limitations in quality? (Enter 0 if none) 

-1 -1 -1 

Did the studies have important inconsistency? (-1) 0 0 0 

Was there some (-1) or major (-2) uncertainty 

about the directness or extent to which the people 

and measures are similar to those of interest? 

0 0 0 

Were data imprecise or sparse? (-1) -1 -1 -1 

Did the studies have high probability of reporting bias? (-1) -1 -1 -1 

Did the studies show strong evidence of 

association? (“strong” if significant relative risk or 

odds ratio > 2 based on consistent evidence from 

2 or more studies with no plausible confounders 

(+1); Avery strong@ if significant relative risk or odds 

ratio > 5 based on direct evidence with no major 

threats to validity (+2)) 

0 0 0 

Did the studies have unmeasured plausible 

confounders that most likely reduced the 

magnitude of the observed association? (+1) 

0 0 0 

Overall quality grade (high, medium, low, very low) Very Low Very Low Very Low 

*According to the evidence grading system recommended by the international GRADE Working Group, the overall grade was 

based on the initial assessment of the study designs (medium quality) with lowering of the grade by one or two levels for each of 

the limitations identified. “Very Low” grade of evidence means that any estimate of effect is very uncertain.
104 

Table 10. Grading of the Quality of Evidence on the Effects of Attitudes and Perceptions of HealthCare 

Providers on Recruitment of Underserved Populations Into Cancer Prevention and Treatment Trials (Key 

Question 6). 

Quantity of Evidence:

Number of studies 10 

Total number of patients studied 1,651 

Quality and Consistency of Evidence:

Were study designs appropriate for determining effects of providers= attitudes and 

perceptions? (Yes = high quality; no = low quality) 

Yes 

Did the studies have serious (-1) or very serious (-2) limitations in quality? (Enter 0 if 

none) 

-1 

Did the studies have important inconsistency? (-1) 0 

Was there some (-1) or major (-2) uncertainty about the directness or extent to which 

the people and measures are similar to those of interest? 

0 

Were data imprecise or sparse? (-1) -1 

Did the studies have high probability of reporting bias? (-1) -1 

Did the studies show strong evidence of association? (Astrong@ if significant relative 

risk or odds ratio > 2 based on consistent evidence from 2 or more studies with no 

plausible confounders (+1); Avery strong@ if significant relative risk or odds ratio > 5 

based on direct evidence with no major threats to validity (+2)) 

0 

Did the studies have unmeasured plausible confounders that most likely reduced the 

magnitude of the observed association? (+1) 

0 

Overall quality grade (high, medium, low, very low) Very Low* 

*According to the evidence grading system recommended by the international GRADE Working Group (REF), the overall grade 

was based on the initial assessment of the study designs (medium quality) with lowering of the grade by one or two levels for 

each of the limitations identified. “Very Low” grade of evidence means that any estimate of effect is very uncertain. 
Appendixes 

Appendix A. EPC Recruitment: Technical Experts and Peer Reviewers 

Appendix B. EPC Recruitment: Journals Hand Searched 

Appendix C. EPC Recruitment: Search Strategies 

Appendix D. EPC Recruitment to Clinical Trials Abstract Review Form 

Appendix E. EPC Recruitment: Article General Abstraction Form 

Appendix F. Evidence Tables 
Appendix A. EPC Recruitment: Technical Experts and Peer Reviewers 

A-1 

EPC Recruitment: Technical Experts and Peer Reviewers 

External Technical Experts and Peer Reviewers 

Luis Baez, M.D. 

Division of Hemetology and Oncology 

University of Puerto Rico 

San Juan, PR 

Michaele Christian 

National Cancer Institute 

U.S. National Institutes of Health 

Bethesda, MD 

Mona Fouad, M.D., M.P.H. 

The University of Alabama at Birmingham 

Birmingham, AL 

Cary Gross, M.D. 

Yale University 

New Haven, CT 

Melissa Hudson, M.D. 

Department of Hematology-Oncology 

Director, After Completion of Therapy 

Clinic 

St. Jude Children=s Research Hospital 

Chanita Hughes, Ph.D. 

Assistant Professor 

Department of Psychiatry 

University of Pennsylvania 

Philadelphia, PA 

Marjorie Kagawa-Singer, Ph.D., M.N., R.N. 

Associate Professor 

UCLA School of Public Health & Asian 

American Studies 

Los Angeles, CA 

*Judith Kaur, M.D. 

Medical Director for Native American 

 

* Member of the Special Populations Network (SPN) 

Programs 

Associate Professor of Oncology 

Mayo Clinic College of Medicine 

Rochester, MN 

Jon Kerner, Ph.D. 

Cancer Prevention & Control 

National Cancer Institute 

U.S. National Institutes of Health 

Bethesda, MD 

Worta McCaskill-Stevens, Ph.D. 

Treatment & Prevention Trials, Minority 

Physicians and Clinical Trial Accrual 

National Cancer Institute 

U.S. National Institutes of Health 

Bethesda, MD 

*Electra D. Paskett, Ph.D. 

Division of Epidemiology and Biometrics 

The Ohio State University 

Columbus, OH 

Eliseo Perez-Stable, M.D. 

Dept. General Internal Medicine 

University of California, San Francisco 

San Francisco, CA 

*Amelie Ramirez 

Associate Director for Community Research 

San Antonio Cancer Institute 

San Antonio, TX 

Vickie Shavers, Ph.D. 

Racial/ Ethnic Health Disparities 

National Cancer Institute 

U.S. National Institutes of Health 

Bethesda, MD 

 
Appendix A. EPC Recruitment: Technical Experts and Peer Reviewers (continued) 

A-2 

Cynthia Vinson 

Dissemination and Diffusion 

National Cancer Institute 

U.S. National Institutes of Health 

Bethesda, MD

Internal Technical Experts 

Martin Abeloff, M.D. 

Director and Professor 

Oncology Administration 

Johns Hopkins University School of 

Medicine 

Lawrence Appel, M.D., M.P.H. 

Professor 

Division of General Internal Medicine 

Johns Hopkins University School of 

Medicine 

Steve Goodman, M.D., Ph.D. 

Associate Professor Oncology-Clinical 

Trials and Biometrics 

Johns Hopkins University School of 

 

David Levine, M.D. 

Professor 

Division of General Internal Medicine 

Johns Hopkins University School of 

Medicine

Jonathan Samet, M.D. 

Professor and Chair 

Department of Epidemiology 

Johns Hopkins University Bloomberg 

School of Public Health

Medicine 
Appendix B. EPC Recruitment: Journals Hand Searched

B-1 

EPC Recruitment: Journals Hand Searched 

All journals searched January 2003 through June 2004. 

Journal Title 

American Journal of Epidemiology 

American Journal of Preventive Medicine 

American Journal of Public Health 

Annals of Epidemiology

Annals of Family Medicine 

Archives of Pediatric and Adolescent Medicine 

British Medical Journal 

CA - A Cancer Journal for Clinicians 

Cancer 

Cancer Causes and Control 

Cancer Epidemiology, Biomarkers and Prevention 

Clinical Trials 

Controlled Clinical Trials 

Ethnicity and Disease 

Ethnicity and Health 

Gerontologist 

Gerontology 

Health Services Research 

Journal of General Internal Medicine 

Journal of Clinical Epidemiology 

Journal of Clinical Oncology 

Journal of Community Health 

Journal of the American Medical Association (JAMA) 

Journal of Health Care for the Poor and Underserved 

Journal of the National Cancer Institute (JNCI) 

Journal of the National Medical Association

Annals of the New York Academy of Science 

Journal of School Health 

Lancet 

New England Journal of Medicine 

Pediatrics 

Preventive Medicine 

Psycho- Oncology 

Social Science and Medicine 
Appendix C. EPC Recruitment: Search Strategies 

C-1 

EPC Recruitment: Search Strategies 

MEDLINE Strategy 

(neoplasm[mh] OR cancer[tw] OR carcino*[tiab] OR tumor[tiab] OR 

oncolog*[tiab]) AND (patient selection[mh] OR recruit*[ti] OR 

participat*[ti] OR enrol*[ti] OR enlist*[ti]) AND eng[la] NOT 

(animal[mh] NOT human[mh]) 

3676 

ADD AOR refer*[ti]@

Most of these titles aren’t relevant

6844 

Try ((recruitment terms) AND (strategies/methods/etc))

ADD AAND strateg*[tiab] OR method*[tiab]@

Can’t use this phrase because the Donovan et al. study doesn’t mention 

strategy or method

1688 

PsychINFO Strategy 

neoplasm or cancer or carcinogen or tumor or oncolog* 17106

patient selection or TI recruit* or TI participat* or TI enrol* or TI enlist* 

or TI refer* 

18396

trial* or stud* 1186777

And LA english 

(neoplasm or cancer or carcinogen or tumor or oncolog*) and (patient 

selection or TI recruit* or TI participat* or TI enrol* or TI enlist* or TI 

refer*) and (trial* or stud*) And LA english and human 

152

CINAHL Strategy 

neoplasm or cancer or carcino* or tumor or oncolog* 67915

MW patient selection or MW research subject recruitment or TI recruit* 

or TI participat* or TI enrol* or TI enlist* or TI refer* 

12547

trial* or stud* 306204

And LA English and 

(neoplasm or cancer or carcino* or tumor or oncolog*) and (MW patient 

selection or MW research subject recruitment or TI recruit* or TI 

participat* or TI enrol* or TI enlist* or TI refer*) and (trial* or stud*) 

1070

(neoplasm or cancer or carcino* or tumor or oncolog*) and (MW patient 

selection or MW research subject recruitment or TI recruit* or TI 

participat* or TI enrol* or TI enlist* or TI refer*) and (trial* or stud*) 

and LA English and human 

284
Appendix C. EPC Recruitment: Search Strategies (continued) 

C-2 

Cochrane Database (CENTRAL and Methodology Review) Strategy

Neoplasm* 20087 

neoplasm* OR cancer OR carcino* OR tumor* or oncolog* 39642 

(neoplasm* or cancer or carcino* or tumor* or oncolog*) and (patient 

selection or recruit*:ti or particip*:ti or enrol*:ti or enlist*:ti or refer*:ti) 

436 

(neoplasm* or cancer or carcino* or tumor* or oncolog*) and (patient 

selection or recruit*:ti or particip*:ti or enrol*:ti or enlist*:ti or refer*:ti) 

and (trial* OR stud*) 

416 

(neoplasm* or cancer or carcino* or tumor* or oncolog*) and (patient 

selection or recruit*:ti or particip*:ti or enrol*:ti or enlist*:ti or refer*:ti) 

and (trial* OR stud*) NOT (animal NOT human) 

414 

C2-SPECTR Strategy 

All Indexed Fields: {neoplasm} or {cancer} or {carcino} or {tumor} or 

{oncolog} 

16 

All Indexed Fields: {neoplasm} or {cancer} or {carcino} or {tumor} or 

{oncolog} 

OR All Non-Indexed Fields: {neoplasm} or {cancer} or {carcino} or 

{tumor} or {oncolog} 

28 

All Indexed Fields: {neoplasm} or {cancer} or {carcino} or {tumor} or 

{oncolog} 

OR All Non-Indexed Fields: {neoplasm} or {cancer} or {carcino} or 

{tumor} or {oncolog} 

AND All Non-Indexed Fields {patient selection} or {recruit} or 

{participat} or {enrol} or {enlist} or {refer} 

18 

All Indexed Fields: {neoplasm} or {cancer} or {carcino} or {tumor} or 

{oncolog} 

OR All Non-Indexed Fields: {neoplasm} or {cancer} or {carcino} or 

{tumor} or {oncolog} 

AND All Non-Indexed Fields {patient selection} or {recruit} or 

{participat} or {enrol} or {enlist} or {refer} 

AND All Non-Indexed Fields {trial} or {stud} 

15 

All Indexed Fields: {neoplasm} or {cancer} or {carcino} or {tumor} or 

{oncolog} 

OR All Non-Indexed Fields: {neoplasm} or {cancer} or {carcino} or 

{tumor} or {oncolog} 

AND All Non-Indexed Fields {patient selection} or {recruit} or 

{participat} or {enrol} or {enlist} or {refer} 

AND All Non-Indexed Fields {trial} or {stud} 

NOT All Non-Indexed Fields {animal} NOT {human} 

15 
Appendix D. EPC Recruitment to Clinical Trials Abstract Review Form 

D-1 

EPC Recruitment to Clinical Trials

Abstract Review Form 

<print date> Reviewer: _________

 

<Record #> Data Entry: ________

 

<title> 

 

<abstract> 

Delete article because (check one):

9 not in English 

9 not U.S.-based study 

9 does not include human data 

9 no original data 

9 meeting abstract (no full article for review) 

9 does not address cancer treatment or prevention 

9 does not report a controlled trial or discuss recruitment to a 

controlled trial 

9 other: (specify) ________________________ 

9 Unclear: get article to decide

Do not go on if any item above is checked.

Article may address the following questions (check 

all that apply):

9 efficacious research methodologies (Q1) 

9 measures of success (Q2) 

9 participation in treatment trials (Q3) 

9 participation in prevention trials (Q4) 

9 documented barriers/promoters (Q5) 

9 barriers/promoters differ (Q5a) 

9 barriers/promoters modified (Q5b) 

9 attitudes and perceptions (Q6) 

9 This article does not apply to any of the questions 

9 Get article for reference regarding: 

_________________________________________ 
Appendix E. EPC Recruitment: Article General Abstraction Form 

E-1 

JOHNS HOPKINS EVIDENCE-BASED PRACTICE CENTER

RECRUITMENT OF MEDICALLY UNDERSERVED TO CANCER TRIALS

GENERAL ABSTRACTION FORM

Article ID: ___________________________ First Author:_________________________ 

Reviewer 1: __________________________ Reviewer 2: __________________________ 

Exclusion criteria: (Check one)

9 not in English 

9 not U.S.-based study 

9 does not include human data 

9 no original data 

9 meeting abstract (no full article for review) 

9 case report or case series (no denominator) 

9 letter 

9 does not address cancer treatment or prevention 

9 does not report a controlled trial or discuss recruitment to a controlled trial 

9 other: (specify)____________________________________________________________ 

***IF ANY OF THE ABOVE IS CHECKED, DO NOT CONTINUE***
Appendix E. EPC Recruitment: Article General Abstraction Form (continued) 

E-2 

1. Key Questions: (Check all that apply) 

9 1. What methods (survey studies, focus groups, etc.) have been used to study strategies to recruit 

medically underserved populations (the elderly, adolescents, those of low socioeconomic status, those 

living in rural areas, African Americans, Hispanics/Latinos, Asian-Americans, and American Indians, 

etc.) in cancer prevention and treatment trials? 

9 2. What measures of success (proportional representation relative to the U.S. population; 

proportional representation relative to incidence of a cancer in a specified population, etc.) have been 

used to evaluate the efficacy and/or effectiveness of strategies for recruitment of medically 

underserved populations in cancer prevention and treatment trials? 

NOTE: All studies eligible for Questions 3 & 4 have been determined to be eligible for Q 1 & 2. 

In addition:

Descriptive studies, such as studies that describe a recruitment strategy and results of that recruitment 

strategy, are eligible for Q 1 & 2 even if not for Q 3 & 4. 

9 3. Which recruitment strategies (media appeals, incentives, etc.) have been shown to be efficacious 

and/or effective in increasing participation of medically underserved populations in cancer treatment

trials? 

9 4. Which recruitment strategies have been shown to be efficacious and/or effective in increasing 

participation of medically underserved populations in cancer prevention trials? 

NOTE: Studies will be considered eligible for Questions 3 & 4 as long as two or more recruitment 

strategies are compared, and may include pre- and post-comparison or historical comparisons. 

9 5. What are the documented barriers to (access, knowledge, attitudes, eligibility, fatalism, 

religiosity/spirituality, exclusions by design, etc.) and promoters of (attitudes, role of altruism, 

advanced disease, financial incentives, no-cost treatment, etc.) participation of underserved populations 

in cancer prevention and treatment trials? 

9 5a. Do these barriers and promoters differ by age, gender, socioeconomic status, race/ethnicity? 

9 5b. Are these barriers and promoters modified by cultural factors? 

9 6. What effects do the attitudes and perceptions of health care providers have on the 

efficacy/effectiveness of strategies for recruitment of medically underserved populations to cancer 

prevention and treatment trials? 

NOTE: Questions 5 & 6 include studies that assess willingness to participate in cancer trials even if 

they only address hypothetical trials.

9 None of the above: IF THIS IS CHECKED, STOP HERE. 
Appendix E. EPC Recruitment: Article General Abstraction Form (continued) 

E-3 

STUDY CHARACTERISTICS 

2. What design was used to study the recruitment into this trial? (Check one) 

9 Randomized controlled trial 

9 Comparison of two or more non-randomized interventions (can include historical 

comparisons) 

9 Case series 

9 Survey 

9 Qualitative (focus group or in-depth interviews) 

9 Other (specify):________________________________________________________ 

9 Not applicable 

NOTE: Complete the article review forms for Q3 & Q4 only if the study has a comparison group 

3. What was the target population of the recruitment intervention? (Check all that apply)

9 Patients/participants 9 Researchers 

9 Physicians 9 Organizations 

9 Other (specify): ________________________________________________________ 

4. Where was the study conducted (study setting) OR where was the population recruited? 

(Check all that apply)

9 Community health facility (non-hospital) 9 Hospital inpatient 

9 Community (residents) 9 Hospital outpatient clinic 

9 School 9 Group practice 

9 Faith-based organization 9 Solo practice 

9 Work site 9 Other (specify): _____________________ 

9 Other community center (specify): _________________________________________ 

9 Unclear 

5. What were the main objectives of the study on recruitment strategies?

A. 

B. 

C. 
Appendix E. EPC Recruitment: Article General Abstraction Form (continued) 

E-4 

6. Enter the characteristics of the main target patient population (e.g., numbers AND/OR percentages). 

Use comment box if intervention is targeted at more than one population. Enter “NS” where the number (or 

percentage) is not specified and “NA” where not applicable. Enter age range only if mean and median not 

provided. 

Note: If the study does not define adolescent and elderly, then adolescent is defined as age between 12 

and 21 years and elderly is defined as age older than 65 years. 

9 Not applicable 

9 No information on targeted patient population 

N % 

Female 

Male 

African American 

American Indian/Alaskan Native 

Asian/Pacific Islander 

Caucasian 

Hispanic 

Adolescent: how defined __________________ 

______________________________________ 

Elderly: how defined _____________________ 

______________________________________ 

Low socioeconomic status: how defined _____ 

 ______________________________________ 

Rural 

Mean Median Range 

Age 

Years of education 

Income 

Other: 

______________________ 
Appendix E. EPC Recruitment: Article General Abstraction Form (continued) 

E-5 

Recruitment of Medically Underserved to Cancer Clinical Trials 

General Form - Addition

Comments:participant characteristics not captured in the previous tables: 

7. What type(s) of cancer was/were the focus of the clinical trial to which the recruitment efforts were 

directed?______________________________________________ 

8. What were the primary outcomes of the clinical trial to which the recruitment efforts were directed? 

(Check all that apply)

9 Cancer prevention 

 9 Primary 9 Chemoprevention 

 9 Secondary 

9 Cancer treatment 

 9 Therapeutic 9 Quality of life 

 9 Complementary & alternative medicine (CAM) 9 Recurrence prevention 

 9 Survival 9 Complications 

 9 Other _____________________________________________________________________ 

9 Survivorship 

 9 Chemoprevention 9 Quality of life 

 9 Complementary & alternative medicine(CAM) 9 Recurrence prevention 

 9 Survival 9 Complications 

 9 Other ____________________________________________________________________ 

9 Other: ______________________________________________________________________ 

9 Other: ______________________________________________________________________ 

9. Date recruitment started: _______________________ 

10. Date recruitment ended: ________________________ 

11. Other comments about the study not already reported:

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________ 
Appendix E. EPC Recruitment: Article General Abstraction Form (continued) 

E-6 

6. 

Mean Median Range 

Age (specify) 

Years of education 

(specify) 

Income (specify) 

Other (define): 

Other (define): 

Other (define): 
Appendix E. EPC Recruitment: Key Questions 1 and 2 Content Review Form (continued) 

E-7 

JOHNS HOPKINS EVIDENCE-BASED PRACTICE CENTER

RECRUITMENT OF THE MEDICALLY UNDERSERVED 

IN CANCER CLINICAL TRIALS 

QUESTION 1 AND 2 - CONTENT REVIEW FORM

Article ID: _______________________________ First Author: _____________________________ 

Reviewer 1: ______________________________ Reviewer 2: ______________________________ 

GENERAL QUESTIONS 

1. How was recruitment defined? 

□ Willingness to participate 

□ Actual participation 

□ Other (specify):___________________________________________________________ 

□ Not defined 

□ Not applicable 

RECRUITMENT METHODS 

2. What method was used to design the recruitment plan? (Check all that apply) 

□ Focus group 

□ Survey 

□ In-person interviews 

□ Literature review 

□ Other (specify): _________________________________________________________________ 

□ Not reported 

□ Not applicable 
Appendix E. EPC Recruitment: Key Questions 1 and 2 Content Review Form (continued) 

E-8 

3. Describe the recruitment intervention(s): 

A. ________________________________________________________________________________ 

__________________________________________________________________________________ 

B. ________________________________________________________________________________ 

__________________________________________________________________________________ 

C. ________________________________________________________________________________ 

__________________________________________________________________________________ 

D. ________________________________________________________________________________ 

__________________________________________________________________________________ 

E. ________________________________________________________________________________ 

__________________________________________________________________________________ 

□ F. Not applicable 

□ G. Not reported 

MEASURES OF SUCCESS OF RECRUITMENT 

4. Was a recruitment goal for the underserved group(s) stated a priori? 

□ Yes 

□ No 

□ Not applicable 

 If yes, what was the recruitment goal (percentage) for the underserved group(s)_____________ 

5. What recruitment success measure was used in this study? 

□ Geographic representation (e.g., % Asian in Baltimore compared to % Asian in study) 

□ U.S. proportion of underserved group (e.g., % African-American in U.S. compared to % AfricanAmerican in study) 

□ Disease-specific proportion of underserved (e.g., % Native American with lung cancer compared 

to % Native American in study) 

□ Research institution proportion of underserved (e.g., % underserved in that research institution 

compared to % in study) 

□ Measure of recruitment success set arbitrarily by researchers. 

Specify: _________________________________________________________________ 

□ Other (specify): ___________________________________________________________ 

□ Not reported 

□ Not applicable 
Appendix E. EPC Recruitment: Key Questions 1 and 2 Content Review Form (continued) 

E-9 

6. If a measure of success was used, for which underserved group(s) was that measure reported? 

(Check all that apply) 

□ African American 

□ Asian American/Pacific Islander 

□ Hispanic 

□ Pacific Islander 

□ Native American 

□ Elderly 

□ Adolescent 

□ Rural 

□ Low socioeconomic status 

□ Other (specify): ___________________________________________________________ 

□ Not applicable 

7. Other comments about the study not already reported: 

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________ 

_____________________________________________________________________________________ 
JOHNS HOPKINS EVIDENCE-BASED PRACTICE CENTER

RECRUITMENT OF THE MEDICALLY UNDERSERVED 

IN CANCER CLINICAL TRIALS 

QUESTION 3 AND 4 - CONTENT REVIEW FORM

Article ID: _______________________________ First Author: ___________________________

Reviewer 1: ______________________________ Reviewer 2: ____________________________

1. Sample size and number of individuals who participated in the study of the recruitment strategy, by target populgroup(s) that were the target of the intervention(s) for entire study (total for all groups). Enter “NS” where the number of parand “NA” where not applicable (e.g., if no participants in study). “#completed” refers to the number of participants included 

study. 

Patients Providers Researchers 

# 

enrolled 

# 

randomized 

# 

completed 

study 

# 

enrolled 

# 

randomized

# 

complete

d study 

# 

enrolled 

# 

randomized

# 

completed 

study 

# 

enrolled 

Comments: __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

E-10 
EPC Recruitment: Key Questions 3 and 4 Content Review Form 

2 
EPC Recruitment: Key Questions 3 and 4 Content Review Form 

3 

2. At what level was the assignment of the recruitment intervention(s) made (i.e., if the trial was 

randomized, what was/were the unit(s) of randomization)? (Check all that apply) 

Patients 

Providers 

Researchers 

Organizations 

Other (specify): __________________________________________________________ 

Not applicable 

3. How many recruitment intervention arms did the study involve? ___________________________ 

 Name each group that was compared including control and each intervention group. 

Group Name 

A 

B 

C 

D 

E 

Note: Each group listed above needs to have a Question 3 and 4 Supplemental Content Review 

form filled out. 

4. Outcomes of recruitment intervention assessed by (check one): 

Clinic 

Patients 

Providers 

Researchers 

Combination (specify): _____________________________________________________ 

Other (specify): ___________________________________________________________ 
Appendix E. EPC Recruitment: Key Questions 3 and 4 Content Review Form (continued) 

E-11 

5. Outcomes – Please provide details in boxes for ALL outcomes that are presented in the study. 

Point Estimate 

Outcome of Interest 

N 

(Outcome 

of Interest) Mean Median Risk Ratio Odds Ratio Difference Rate Ratio 

(

A. B. C. D. 

E-12 
6. Were the study recruitment goals met? 

Yes 

No 

Unclear 

7. Authors’ conclusion/summary (check one): 

Overall improvement in recruitment after intervention 

Partial improvement or mixed results 

No improvement after intervention 

Decrease in recruitment 

Unclear 

Other (specify): ___________________________ 

8. Briefly summarize the authors’ main conclusion(s): 

____________________________________________________________________________ 

____________________________________________________________________________ 

____________________________________________________________________________ 

9. Other comments about the study not already reported: 

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________ 
Appendix E. EPC Recruitment: Key Questions 3 and 4 Quality Review Form (continued) 

E-19 

JOHNS HOPKINS EVIDENCE-BASED PRACTICE CENTER

RECRUITMENT OF THE MEDICALLY UNDERSERVED 

IN CANCER CLINICAL TRIALS 

QUESTION 3 AND 4 – QUALITY REVIEW FORM

Article ID: _______________________________ First Author: _____________________________ 

Reviewer 1: ______________________________ Reviewer 2: ______________________________ 

REPRESENTATIVENESS OF STUDY POPULATIONS 

1. How would you characterize the authors’ description of the setting and population from which 

the study sample was drawn, and the dates of the study? 

a. Adequate (setting AND population described AND start and end date specified) 2 

b. Fair (one or more of these NOT reported OR poor description) 1 

c. Inadequate (not specified) 0 

2. The degree to which detailed inclusion/exclusion criteria were provided was: 

a. Adequate (detailed description of specific inclusion and exclusion criteria OR statement 

that all eligible patients enrolled) 2 

b. Fair (some description, but would be difficult to replicate with the information 

provided) 1 

c. Inadequate (minimal description or none at all) 0 

3. The degree to which information provided on excluded or non-participating patients was: 

a. Adequate (all reasons for exclusion AND number excluded OR no exclusions) 2 

b. Fair (only one of above criteria specified or information not sufficient to allow 

replication) 1 

c. Inadequate (none of the above criteria specified) 0 
Appendix E. EPC Recruitment: Key Questions 3 and 4 Quality Review Form (continued)

E-20 

4. How well does the study describe key participant characteristics at enrollment? 

Demographics: age, gender, race/ethnicity, education, income, occupation 

Medical characteristics: currently diagnosed with cancer (cancer survivor); never diagnosed with cancer; 

screened for cancer 

a. Good: Both categories described well (i.e., most items in the category described) 2 

b. Fair: One of the two categories described well 1 

c. Poor: No key patient characteristic categories described well 0 

BIAS AND CONFOUNDING 

5. The random assignment of participants to study group was: 

a. Adequate (investigators could not predict assignment) 2 

b. Partial (date of birth, admission date, hospital record number, or other non-random 

scheme for assignment OR did not state) 1 

c. Not randomized 0 

d. Unclear 0 

6. Did the participant groups have any important differences in terms of key characteristics? 

Demographics: age, gender, race/ethnicity, education, marital status, occupation, days from index MI to 

first day of therapy 

Medical characteristics: currently diagnosed with cancer (cancer survivor); never diagnosed with cancer; 

screened for cancer 

a. Groups equivalent in all factors examined 2 

b. Groups have minor difference in one or two factors 1.5 

c. Groups have an important difference in one or more factors OR a minor difference in 

more than two factors 1 

d. Analysis not done 0 
Appendix E. EPC Recruitment: Key Questions 3 and 4 Quality Review Form (continued)

E-21 

7. For the recruitment trial, the blinding of clinician, patient, and/or outcome assessors was: 

a. Excellent (all three blinded, including all treatment arms) 2 

b. Good (only two of the three blinded, OR some but not all of the arms) 1.5 

c. Fair (only one of the three blinded) 1 

d. Poor (no blinding OR not stated) 0 

e. Not applicable NA 

DESCRIPTION OF RECRUITMENT STRATEGY 

8. Did the study describe details of the flow of participants through each stage of the clinical trial? 

For each group, reporting of the number of participants assigned to intervention, received 

intended intervention, completed the study protocol, and analyzed for the primary outcome was: 

a. Adequate (all of the above described) 2 

b. Fair (one of the above NOT described) 1 

c. Inadequate (more than one of above NOT described) 0 

9. The study description of the details of the recruitment strategy (i.e., methods of accrual, 

recruitment goals, measures of success) was: 

a. Adequate (all of the above described) 2 

b. Fair (one of the above NOT described) 1 

c. Inadequate (more than one of above NOT described) 0 

OUTCOMES AND FOLLOW-UP 

10. How were the outcome measures of recruitment success defined? 

e.g., proportional representation relative to the U.S. population, proportional representation relative to 

incidence of a cancer in a specified population 

a. Adequate(clear definitions of each outcome AND exact techniques to assess the 

outcome) 2 

b. Fair (some description, but information not sufficient to allow replication) 1 

c. Inadequate (no information provided) 0 
Appendix E. EPC Recruitment: Key Questions 3 and 4 Quality Review Form (continued)

E-22 

11. The description of the measures used to define the recruitment barriers and promoters was: 

Barrier measures: awareness, knowledge, attitudes/beliefs, self-efficacy, organizational environment, 

health literacy, access, eligibility, provider knowledge, provider attitudes/beliefs, fatalism, 

religiosity/spirituality, exclusions by design, eligibility, advanced disease 

Promoter measures: attitudes, role of altruism, advanced disease, financial incentives, no-cost treatment, 

etc 

a. Adequate (clear definitions of each measure AND exact techniques to assess the 

measure) 2 

b. Fair (some description, but information not sufficient to allow replication) 1 

c. Inadequate (no information provided) 0 

12. Did the study report the numbers of and reasons for withdrawals from the study protocol or 

patients/participants otherwise lost to follow-up? 

a. Numbers and reasons reported (or no withdrawals) 2 

b. Only numbers OR reasons reported 1 

c. Neither given 0 

STATISTICAL QUALITY AND INTERPRETATION 

13. The statistical analyses used to determine recruitment success were: 

a. Adequate (identified for all analyses) 2 

b. Fair (identified for some of the analyses) 1 

c. Inadequate (not identified) 0 

14. Were withdrawals, crossovers, and loss to follow-up handled appropriately in the analysis? 

a. Loss to follow-up, withdrawals, or crossovers handled 2 

b. By intention to treat/screen 2 

c. Sensitivity analysis 1 

d. None of the above 0 
Appendix E. EPC Recruitment: Key Questions 3 and 4 Quality Review Form (continued)

E-23 

CONFLICTS OF INTEREST 

15. The description of study’s reporting or identification of the sources of funding was: 

a. Adequate (source AND type or degree of involvement OR no funding) 2 

b. Fair (source only) 1 

c. Inadequate (neither) 0 

16. Reflecting on this study as a whole, what is your overall impression of the quality of the study? 

(Check one) 

Excellent 

Very good 

Good 

Fair 

Poor
Appendix E. EPC Recruitment: Key Questions 3 and 4 Supplemental Content Review 

Form (continued) 

E-14 

JOHNS HOPKINS EVIDENCE-BASED PRACTICE CENTER

RECRUITMENT OF THE MEDICALLY UNDERSERVED 

IN CANCER CLINICAL TRIALS 

QUESTION 3 AND 4 – SUPPLEMENTAL CONTENT REVIEW FORM

Article ID: _______________________________ First Author: _____________________________ 

Reviewer 1: ______________________________ Reviewer 2: ______________________________ 

Group Name (From Item 3, p2, Recruitment Content Review Form for Q 3&4) 

_____________________ 

[If no patients in study, skip to Item 2S]

1S. Enter subject characteristics as given, (e.g., numbers OR percentages) Enter “NS” where the 

number of participants is not specified and “NA” where not applicable. Enter age range only if mean 

is not provided. 

 If the study does not define adolescent and elderly, then adolescent is defined as age between 12 and 

21 years and elderly is defined as age older than 65 years. 

 No patient information 

N % 

Female 

Asian/Pacific Islander 

African American 

Caucasian 

Hispanic 

American Indian/Alaskan Native 

Adolescent: how defined_______________________ 

Elderly: how defined__________________________ 

Low socioeconomic status: how defined___________ 

___________________________________________ 

Rural 
Appendix E. EPC Recruitment: Key Questions 3 and 4 Supplemental Content Review 

Form (continued) 

E-15 

Mean Median Range 

Age 

Years of education 

Income 

Other 

2S. Briefly describe the group intervention described on this form. Enter “NS” where number of 

participants is not specified and “NA” where not applicable. “# completed” refers to total # 

included in analysis for this group. 

Column 1 Column 2 

Patients

# recruited 

 

 # 

completed 

 

Providers

# recruited 

 

 # 

completed 

 

Clinics

# recruited 

 

 # 

completed 

Indicate group type and provide brief group 

description (e.g., providers given computer 

reminders; patients given written material) 

 No intervention/usual care 

 Provider intervention 

 Patient intervention 

 Researcher intervention 

 Other ____________________________ 

3S. Describe this trial group (intervention or control). 

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________ 
Appendix E. EPC Recruitment: Key Questions 3 and 4 Supplemental Content Review 

Form (continued) 

E-16 

4S. What recruitment methods were used in the intervention? (Check all that apply) 

Written material 

Book Poster 

Pamphlet Journal 

Flyer Article 

Audio-Visual (AV) material 

Audiotape DVD 

Videotape 

Case studies 

Computer-based material 

Website tutorial (w/URL) CD-ROM 

E-mail DVD 

Lecture/workshop 

Self-study 

Small group 

Simulated patients/participants 

Media 

Newspaper 

Radio 

□ Public service announcements (PSAs) 

□ Paid ads 

Television 

□ Public service announcements (PSAs) 

□ Paid ads 

Other: __________________________________________________________________ 

5S. Number of training sessions for recruitment intervention? 

______________sessions 

Not specified 

Not applicable 
Appendix E. EPC Recruitment: Key Questions 3 and 4 Supplemental Content Review 

Form (continued) 

E-17 

6S. What was the total duration for the most intensive training session for the recruitment 

intervention? 

< 1 hours 

1 – 2 hours 

3 – 4 hours 

5 – 6 hours 

Not specified 

Not applicable 

7S. What was the total amount of training for the recruitment intervention? 

< 2 hrs 

2 – 10 hrs 

11 – 20 hrs 

> 20 hrs 

Not specified 

Not applicable 

8S. How often were the training sessions held for the recruitment intervention? 

Once only 

Weekly 

Monthly 

Other: __________________________________________________________________ 

Not specified 

Not applicable 

9S. What was the total number of training sessions held for the recruitment intervention? 

0 

1 

2 

3 – 4 

5 or more 
Appendix E. EPC Recruitment: Key Questions 3 and 4 Supplemental Content Review 

Form (continued) 

E-18 

10S. How much time elapsed from the beginning to the end of the intervention? 

< 1 day 

1 – 29 days 

1 – 3 months 

4 – 6 months 

7 – 12 months 

> 1 year 

Not specified 

11S. Was recruitment of medically underserved populations a primary outcome of this study? 

Yes 

No 

12S. Comments about the intervention if not captured by the previous questions (i.e., brief 

description of the intervention, including duration and frequency). 

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________ 
Appendix E. EPC Recruitment: Key Questions 5 and 6 Content Review Form (continued) 

E-24 

JOHNS HOPKINS EVIDENCE-BASED PRACTICE CENTER

RECRUITMENT OF THE MEDICALLY UNDERSERVED 

IN CANCER CLINICAL TRIALS 

QUESTION 5 AND 6 - CONTENT REVIEW FORM

Article ID: _______________________________ First Author: _____________________________ 

Reviewer 1: ______________________________ Reviewer 2: ______________________________ 

1. What types of barriers or promoters for recruitment of the medically underserved to cancer 

prevention/treatment trials did this study address? (Check all that apply) 

Provider 

Patient 

Study design (e.g., restrictive inclusion and exclusion criteria) 

Healthcare system (e.g., lack of clinical trials opened at a particular institution) 

Other (specify): _____________________________________________________ 

Not Applicable 
2. What patient barriers/promoters were associated with decreased or increased enrollment into cancer treatment/p

(Check one box in each row) 

No 

Statistically 

Significant 

Decrease 

Statistically 

Significant 

Increase 

Reported 

Qualitatively 

Important 

Decrease* 

Reported 

Qualitatively 

Important 

Increase* 

U

Mistrust of research and medical system 

G G G G G 

Fear G G G G G Lack of knowledge about origins of cancer 

G G G G G 

Embarrassment G G G G G Transportation G G G G G Time commitment G G G G G Family considerations G G G G G Leaving care of physicians to participate in trial G G G G G Patient satisfaction with primary care doctor G G G G G Language barriers G G G G G Cultural barriers G G G G G Job issues G G G G G Indirect costs (e.g., income loss) G G G G G Lack of or inadequate health insurance G G G G G 

* As reported based on qualitative methods 

E-25
What patient barriers/promoters were associated with decreased or increased enrollment into cancer treatment /pre

(Check one box in each row) 

No 

Statistically 

Significant 

Decrease 

Statistically 

Significant 

Increase 

Reported 

Qualitatively 

Important 

Decrease* 

Reported 

Qualitatively 

Important 

Increase* 

U

Religious/spiritual beliefs 

G

G

G

G

G

Lack of education about clinical trials 

G

G

G

G

G

Incentives (financial or other) 

G

G

G

G

G

No-cost treatment 

G

G

G

G

G

Lodging 

G

G

G

G

G

Culturally relevant education about clinical trials 

G

G

G

G

G

Perceived benefits/harms of clinical trial participation 

G

G

G

G

G

Other (specify): _______________________________ 

G

G

G

G

G

Other (specify): _______________________________ 

G

G

G

G

G

* As reported based on qualitative methods

E-26
3. What provider barriers/promoters were associated with decreased or increased enrollment into cancer treatment 

(Check one box in each row) 

No 

Statistically 

Significant 

Decrease 

Statistically 

Significant 

Increase 

Reported 

Qualitatively 

Important 

Decrease* 

Reported 

Qualitatively 

Important 

Increase* 

U

Mistrust of researchers (e.g., loss of clientele) 

G

G

G

G

G

Cultural competence training 

G

G

G

G

G

Training in communicating with patients 

G

G

G

G

G

Provider race/ethnicity 

G

G

G

G

G

Medical staff race/ethnicity 

G

G

G

G

G

Provider attitudes 

G

G

G

G

G

Incentive (financial or other) 

G

G

G

G

G

Communication/ method of presentation 

G

G

G

G

G

Ability to speak patient’s language 

G

G

G

G

G

Other (specify): _______________________________ 

G

G

G

G

G

Other (specify): _______________________________ 

G

G

G

G

G

* As reported based on qualitative methods 

E-27
4. What study design barriers/promoters were associated with decreased or increased enrollment into cancer treatm

(Check one box in each row) 

No 

Statistically 

Significant 

Decrease 

Statistically 

Significant 

Increase 

Reported 

Qualitatively 

Important 

Decrease 

Reported 

Qualitatively 

Important 

Increase 

U

Comorbidity exclusion 

G

G

G

G

G

Age exclusion 

G

G

G

G

G

Medication exclusion 

G

G

G

G

G

Functional status 

G

G

G

G

G

Length of study/visit structure (e.g., interference with work hours) 

G

G

G

G

G

Diagnostic test result cut-off 

G

G

G

G

G

Other (specify): _______________________________ 

G

G

G

G

G

Other (specify): _______________________________ 

G

G

G

G

G

* As reported based on qualitative methods 

E-28 
5. What health care system barriers/promoters were associated with decreased or increased enrollment into cancer 

trials? (Check one box in each row) 

No 

Statistically 

Significant 

Decrease 

Statistically 

Significant 

Increase 

Reported 

Qualitatively 

Important 

Decrease* 

Reported 

Qualitatively 

Important 

Increase* 

U

Lack of minority doctors 

G

G

G

G

G

Lack of other minority personnel 

G

G

G

G

G

Lack of cultural competence among providers and/or staff 

G

G

G

G

G

Lack of dissemination of study opportunities to provider/patient 

G

G

G

G

G

Lack of language services 

G

G

G

G

G

Other (specify): _______________________________ 

G

G

G

G

G

Other (specify): _______________________________ 

G

G

G

G

G

* As reported based on qualitative methods 6. Did this study report any information about how barriers and promoters are modified by cultural factors? 

Yes, describe briefly: __________________________________________________________________________No 

7. Other comments about the study not already reported: ______________________________________________________________________________________________________________________________________________________________________________________________________

E-29 
Appendix E. EPC Recruitment: Key Questions 5 and 6 Quality Review Form (continued) 

E-30 

JOHNS HOPKINS EVIDENCE-BASED PRACTICE CENTER

RECRUITMENT OF THE MEDICALLY UNDERSERVED 

IN CANCER CLINICAL TRIALS 

QUESTION 5 AND 6 – QUALITY REVIEW FORM

Article ID: _______________________________ First Author: _____________________________ 

Reviewer 1: ______________________________ Reviewer 2: ______________________________ 

REPRESENTATIVENESS OF STUDY POPULATIONS 

1. How would you characterize the authors’ description of the setting and population from which 

the study sample was drawn, and the dates of the study? 

a. Adequate (setting AND population described AND start and end date specified) 2 

b. Fair (one or more of these NOT reported OR poor description) 1 

c. Inadequate (not specified) 0 

2. The degree to which detailed inclusion/exclusion criteria were provided was: 

a. Adequate (detailed description of specific inclusion and exclusion criteria OR statement 

that all eligible patients enrolled) 2 

b. Fair (some description, but would be difficult to replicate with the information 

provided) 1 

c. Inadequate (minimal description or none at all) 0 

3. The degree to which information provided on excluded or non-participating patients was: 

a. Adequate (all reasons for exclusion AND number excluded OR no exclusions) 2 

b. Fair (only one of above criteria specified or information not sufficient to allow 

replication) 1 

c. Inadequate (none of the above criteria specified) 0 
Appendix E. EPC Recruitment: Key Questions 5 and 6 Quality Review Form (continued) 

E-31 

4. How well does the study describe key participant characteristics at enrollment? 

Demographics: age, gender, race/ethnicity, education, income, occupation 

Medical characteristics: currently diagnosed with cancer (cancer survivor); never diagnosed with cancer; 

screened for cancer; cancer survivor 

a. Good: both categories described well (i.e., most items in the category described) 2 

b. Fair: one of two categories described well 1 

c. Poor: neither category described well 0 

5. Was the design of the study based on a conceptual model of the reported research? 

a. Yes 2 

b. No 0 

c. Unclear 0 

QUALITY REVIEW OF SURVEYS 

[IF THIS IS NOT A SURVEY SKIP TO Q16] 

6. What data collection methods were used in the study? (Check all that apply) 

Self-administered questionnaire 

By mail 

Group-administered setting 

Face-to-face interviews 

Telephone interviews 

Computer or computer assisted device (CAD) 

Other _____________________________________________________________________ 
Appendix E. EPC Recruitment: Key Questions 5 and 6 Quality Review Form (continued) 

E-32 

7. What was the response rate or the proportion of eligible people that actually completed the 

questionnaire? 

a. 80 – 100 % 2 

b. 60 – 79 % 1.5 

c. 40 – 59 % 1 

d. 20 – 39 % 0.5 

e. < 20 % 0 

f. Unclear 0 

8. What was the intra-rater reliability of the survey instrument? 

a. 80 – 100 % 2 

b. 60 – 79 % 1.5 

c. 40 – 59 % 1 

d. 20 – 39 % 0.5 

e. < 20 % 0 

f. Unclear/Not reported 0 

g. Not applicable N/A 

9. What was the inter-rater reliability of the survey instrument? 

a. 80 – 100 % 2 

b. 60 – 79 % 1.5 

c. 40 – 59 % 1 

d. 20 – 39 % 0.5 

e. < 20 % 0 

f. Unclear/Not reported 0 

g. Not applicable N/A 
Appendix E. EPC Recruitment: Key Questions 5 and 6 Quality Review Form (continued) 

E-33 

10. Was the survey instrument validated in terms of face, construct, and/or criteria validity? 

Face validity: The extent to which the instrument appears to be measuring what it is supposed to 

measure. 

Construct validity: The extent to which the measure of concern correlates with other measures in 

predicted ways, but for which no true criterion exists. 

Criterion validity: The extent to which an instrument correlates with another more accurate (and usually 

more expensive) instrument (criterion). 

a. Adequate: two or three of above types of validity 2 

b. Fair: One of the above types of validity 1 

c. Inadequate: None of the above type of validity 0 

11. Was the study planned to have adequate power to detect differences between groups? 

a. Yes 2 

b. No 1 

c. Unclear 0 

d. Not applicable N/A 

12. Was the study planned to have adequate power to detect changes within groups? 

a. Yes 2 

b. No 1 

c. Unclear 0 

d. Not applicable N/A 

13. How well was the research question and objective(s) stated? 

a. Adequate (research questions clear and objectives presented in specific terms) 2 

b. Fair (research question and objectives presented but not in specific terms) 1 

c. Inadequate (research question unclear AND/OR objectives not presented) 0 
Appendix E. EPC Recruitment: Key Questions 5 and 6 Quality Review Form (continued) 

E-34 

14. How were the study participants selected? 

a. Consecutive selection 2 

b. Random sampling 2 

c. Other purposive sampling 1 

d. Convenience sample 0 

e. Unclear 0 

15. Did the authors adequately justify the target population(s)? 

a. Yes 2 

b. Not specified 0 

c. Unclear 0 

QUALITY REVIEW OF QUALITATIVE STUDIES 

16. How were the data generated? (Check all that apply) 

□ Field observation/participant observation

□ In-depth interviews

□ Focus groups

□ Document analysis

□ Other ___________________________________________________________________

□ Not specified

17. Did the study use multiple methods of data collection? 

a. Adequate (three or more methods were used) 2 

b. Fair (two methods were used) 1 

c. Inadequate (one method OR unclear) 0 

18. Did the authors justify the method(s) of data generation? 

a. Yes 2 

b. No 0 

c. Unclear 0 
Appendix E. EPC Recruitment: Key Questions 5 and 6 Quality Review Form (continued) 

E-35 

19. How were the study participants selected?

a. Random sampling 2 

b. Other systematic sampling (e.g., consecutive selection) 2 

c. Convenience sampling 1 

d. Other 0 

e. Unclear 0 

20. How many times were study participants interviewed? 

[If the study used an in-depth interview method, circle “not applicable”] 

a. Two or more times (adequate) 2 

b. Once (fair) 1 

c. Never OR unclear (inadequate) 0 

d. Not applicable N/A 

21. How were the data captured? 

a. Adequate ( both recorded AND transcribed) 2 

b. Fair (recorded but not transcribed OR note taking only) 1 

c. Inadequate (not recorded OR unclear) 0 

d. Not applicable N/A 

22. How would you rate the overall quality of this study? 

[Answer Q 22 for ALL studies] 

Excellent (excellent depth and breadth of study participant selection and data collection/analysis)

Good

Fair 

Poor
Appendix F. Evidence Tables 

Evidence Table 1-1. Characteristics of Studies About Methods Used to Study Strategies to Recruit Underrepresented PopulatioPrevention and Treatment Trials (Key Question 1). 

Author, Year 

U.S. or nonU.S. 

Study Setting 

Target Population 

Study Design 

Type of Cancer Studied 

Recruitment Dates 

Study Objective(s) 

Advani, 2003 

U.S. Hospital 

outpatient 

Patients/ Participants 

Case-control Solid or 

hematologic malignancy (excluding melanoma) 

NR A. Determine if African-Amer

less willing to participate in clB. Better delineate existing bAfrican Americans. C. Compare attitudes of oncotreated in rural areas comparcenter. 

Berman, 1998 

U.S. Community, 

school district 

Patients/ Participants 

Quasiexperimental Smoking cessation 1990-1992 Determine whether there are 

in recruitment. 

Brewster, 2002 

U.S. Community; 

Hospital outpatient 

Patients/ Participants 

CCT Cervical 1999-2000 Review and compare the rec

associated with recruiting Latprevention trials. 

Ford, 2004 U.S. Community Patients/ 

Participants 

RCT Prostate, lung, 

and colorectal 

1996-2001 Evaluate the outcomes of a r

to recruit African American mPLOC screening trial. 

Kaluzny, 1993 

U.S. Community; 

Hospital outpatient; Group practice 

Patients/ Participants; Physicians 

Descriptive; Qualitative 

All 1990-1992 Describe the early implement

identify the challenges that haa network aimed at increasinminority populations in clinica

Linnan, 2002 

U.S. Work site; 

Workers homes 

Patients/ Participants 

RCT Lung NR A. Describe organizational fa

employee recruitment methodB. Investigate differences in eattrition based on elected recC. Compare self-reported heamotivational readiness to chaenrolled in home-based intervrecruitment method. 

F-1
Appendix F. Evidence Tables (continued) 

Evidence Table 1-1. Characteristics of Studies About Methods Used to Study Strategies to Recruit Underrepresented PopulatioPrevention and Treatment Trials (Key Question 1). (Continued) 

Author, Year 

U.S. or nonU.S. 

Study Setting 

Target Population 

Study Design 

Type of Cancer Studied 

Recruitment Dates 

Study Objective(s) 

Maurer, 2001 

U.S. Hospital 

inpatient 

Patients/ Participants 

Case series Breast, colon, 

rectum, lung, prostate 

1993-1997 Determine whether participat

lead to generalizable changebefore to after implementatio

Paskett, 1995 

U.S. Community Physicians Community 

physicians 

Colorectal Cancer 

1991-present 

Get community physicians inresearch. 

Paskett, 2002 

U.S. Community Physicians CCT Breast and 

colorectal 

1993-1996 A. Evaluate a rural cancer ca

B. Assess rural-based primarC. Assess physician knowledabout patient and physician btrials and accrual to clinical tr

RandallDavid, 2001 

U.S. Unclear Patients/ 

Participants 

Qualitative All NR Use focus groups to elicit per

adults regarding participation 

Sears, 2003 

U.S. Community Patients/ 

Participants 

Descriptive; Retrospective 

Breast 1999-2000 Examine recruitment, retentio

participation. 

Thornquist, 1991 

U.S. Community Patients/ 

Participants 

Descriptive; Retrospective 

Lung cancer prevention 

1985-1988 Describe any differences in a

trial by age group--relevant to 

calculation 

Zhu, 2000 U.S. Community Physicians Descriptive; 

Qualitative 

Breast Cancer NR Present the strategy and outc

elderly African American womand control studies. 

CARET = Beta-carotene and Retinol Efficacy Trial CCT = Concurrent controlled trial MBCCOP = Minority-based Community Clinical Oncology Program NR = Not Reported PLOC =Prostate, Lung, Ovarian and Colorectal Cancer RCT = Randomized controlled trial 

F-2 
Appendix F. Evidence Tables (continued) 

Evidence Table 1-2. Target Population Characteristics of Studies About Methods Used to Evaluate Strategies to Recruit Underinto Cancer Prevention and Treatment Trials (Key Question 1). 

Author, Year 

U.S. or non-U.S. 

Mean Age, y 

Age, Range 

% Male 

% Underrepresented 

Study Setting 

Target Population 

Study Design 

Type oStudie

Advani, 

2003 

U.S. NR NR NR 33% AIAN; 64% 

rural 

Hospital outpatient 

Patients/ Participants 

Case-control Solid o

hematomalign(excludmelano

Berman, 

1998 

U.S. NR NR 0 15% AA; 85% 

Latino/Hispanic 

Community Patients/ 

Participants 

Quasi experimental 

Smokincessat

Brewster, 

2002 

U.S. 43 17-78 0 78% 

Latino/Hispanic; 39% with <$10,000/y income 

Community; Hospital outpatient 

Patients/ Participants 

CCT Cervica

Ford et al, 

2004 

U.S. 62 55-74 100 100% AA; 100% 

elderly; 35% low SES 

Community Patients/ 

Participants 

RCT Prosta

and co

Kaluzny, 

1993 

U.S. NR NR NR NR Community; 

Hospital outpatient; Group practice 

Patients/ Participants; Physicians 

Descriptive; Qualitative 

All 

Linnan, 

2002 

U.S. 43 NR 53 6% 

Latino/Hispanic; 27% with <29,999/ yr income 

Work site; Workers' homes 

Patients/ Participants 

RCT Lung 

Maurer, 

2001 

U.S. NR NR NR 100% rural Hospital 

inpatient 

Patients/ Participants 

Case series Breast

rectumprostat

Paskett, 

1995 

U.S. NR NR NR NR Community Physicians Community 

physicians 

Colore

F-3 
Appendix F. Evidence Tables (continued) 

Evidence Table 1-2. Target Population Characteristics of Studies About Methods Used to Evaluate Strategies to Recruit Underrin Cancer Prevention and Treatment Trials (Key Question 1). (continued)

Author, Year 

U.S. or non-U.S. 

Mean Age, y 

Age, Range 

% Male 

% Underrepresented 

Study Setting 

Target Population 

Study Design 

Type oStudie

Paskett, 

2002 

U.S. 47 NR 84 100% rural Community Physicians CCT Breast

RandallDavi2, 

2001 

U.S. 55 18-72 0 100% rural Unclear Patients/ 

Participants 

Qualitative All 

Sears, 

2003 

U.S. 56 NR NR 6% AA; 9% 

Asian/PI 

Community Patients/ 

Participants 

RCT; Retrospective 

Breast 

Thornquist 

et al, 1991 

U.S. NR 45-74 53 23% elderly Community Patients/ 

Participants 

Descriptive; Retrospective 

Lung 

Zhu, 2000 U.S. NR 65-85 0 100% AA; 100% 

elderly; 91% with <$15,000/ y income 

Community Physicians Descriptive; 

Qualitative 

Breast 

AA = African American AIAN =American Indian/ Alaskan Native CCT = Concurrent controlled trial NR = Not reported PI = Pacific Islander RCT = Randomized controlled trial SES = Socioeconomic status 

F-4
Appendix F. Evidence Tables (continued) 

Evidence Table 1-3. Methods That Have Been Used to Study Strategies to Recruit Underrepresented Populations into Cancer PTrials (Key Question 1).

Author, Year Recruitment 

definition 

Method(s) to design recruitment 

Primary Outcomes 

Recruitment Intervention(s) 

Advani, 2003 Willingness to 

participate 

Survey Therapeutic 

treatment; Willingness to participate 

NR 

Berman, 

1998 

Actual participation 

NR Primary 

prevention 

A. Individuals interested in participating in a smoking-cessation prtelephone to participate. B. Tailored. C. Opportunistic. D. General publicity presentations, media, distribution of flyers. 

Brewster, 

2002 

Actual participation 

Literature Review; Assumed based on introduction but not reported specifically by author 

Secondary prevention 

A. First 6 months, bilingual letters of introduction mailed with retur

research personnel made 3 attempts to contact patients (only indparticular clinic). B. Second 6 months, media recruitment (study advertised weekly newspapers in English or Spanish). Fliers placed in local businesorganizations, churches, mental health and free clinics, and 2 Spastations. 

Ford, 2004 Actual 

Participation 

Addressed barriers to recruitment of minority group members 

Primary Prevention 

A & B. Eligibility screening telephone call conducted; baseline info

mailed packet; telephone and mailed reminder to return baseline C. Eligibility screening telephone call conducted; church-based prcollection of baseline information took place at church, transportachurches D. Standard recruitment letter and mailing process, eligibility screCaucasians or African Americans, telephone and mailed remindeinformation. 

Kaluzny, 

1993 

Actual participation 

NR Treatment A. Modification and translation of protocol consent forms and edu

low literacy and non-English speakers. B. Promotional and educational materials to increase awareness 

practicing in minority communities. C. Design of interdisciplinary teams to aid with protocol recruitmefollow-up. D. Targeting younger physicians (interns, residents, fellows) and eneeds of minority populations to them. E. Development of data management systems to track and evalua

services in large minority populations 

Linnan, 2002 Actual 

participation 

NR Primary 

prevention 

A. Letter from CEO to workers. B. Recruitment events at work wgiveaways. C. Flyers, posters, and notices at work. D. Passive 

F-5 
Appendix F. Evidence Tables (continued) 

Evidence Table 1-3. Methods That Have Been Used to Study Strategies to Recruit Underrepresented Populations into Cancer PTrials (Key Question 1). (continued)

Author, Year Recruitment 

definition 

Method(s) to design recruitment 

Primary Outcomes 

Recruitment Intervention(s) 

Maurer, 2001 Actual 

participation 

NR Treatment NR 

Paskett, 1995 Actual 

participation 

Lead oncologist model 

Survivorship; Recurrence prevention 

A. Medical oncologists as community leaders carry out activities iclinics. B. Lead oncologist meets with community physicians. Cmeet at yearly meetings. 

Paskett, 2002 Actual 

participation 

NR Treatment A. Tumor reporting - for state cancer registry. 

B. Nurse facilitator to inform physicians on available trails. C. Quarterly newsletter to physicians about cancer treatment and D. Health educator for community about cancer screening and tre

RandallDavid, 2001 Not defined Focus group used to assess 

beliefs which subsequently were used to establish an awareness campaign 

No particular trial, no recruitment attempted. 

NA 

Sears, 2003 Actual 

participation 

NR Therapeutic 

CAM 

A. Provide contact information on all eligible patients within 5 weeB. Mail introductory letter to patient 1 to 5 weeks after surgery. 

C. Called patient 2 to 6 weeks after surgery; 3 calls without respo

Thornquist, 

1991 

Actual participation 

NR Chemoprevention A. Mailings to all insurers of Seattle-based King County Medical B

Zhu, 2000 Actual 

participation 

In-person interview 

Primary prevention 

A. Use of in-person communications by door-to-door canvassing. B. Use of local spokesperson to establish trust and increase credC. Representation of African-Americans among research staff and 

women in direct contact with potential subjects. D. Provisions of monetary and/or material incentives. 

CAM = complimentary alternative medicine CEO = Chief Executive Officer MBCCOP = Minority-based Community Clinical Oncology Program NCI = National Cancer Institutes NR = Not reported NA = Not applicable 

F-6 
Appendix F. Evidence Tables (continued) 

Evidence Table 2-1. Characteristics of Studies about Measures of Success Used to Evaluate the Efficacy or Effectiveness of Stof Underrepresented Populations into Cancer Prevention and Treatment Trials (Key Question 2). 

Author, Year 

Country Study Setting Target Population Study Design Type of 

Studied 

Alexander, 

2000 

U.S. All NCI-sponsored trials from 1994 

to 1998 

Patients/Participants Cross-sectional; 

Descriptive; Retrospective 

All 

Benson, 

1991 

U.S. Clinical Trials Cooperative Group 

(1839 hospitals, 194 universities) 

Patients/Participants Cross-sectional; 

Descriptive; Retrospective 

All 

Berman, 

1998 

U.S. Community Patients/Participants Quasi-experimental Smoking 

cessatio

Brewster, 

2002 

U.S. Community; Hospital outpatient Patients/Participants CCT Cervica

Ford, 2004 U.S. Community Patients/Participants RCT Prostate

colorect

Goodwin, 

1988 

U.S. SWOG Patients/Participants Cross-sectional; 

Descriptive; Retrospective 

All 

Hunter, 

1987 

U.S. Hospital inpatient; Hospital 

outpatient; 

Patients/Participants Cross-sectional; 

Descriptive; Retrospective 

All 

Kaluzny, 

1993 

U.S. Community; Hospital outpatient; 

Group practice 

Patients/Participants; Physicians 

Descriptive All 

Kemeny, 

2003 

U.S. Community Patients/Participants Case-control Breast 

Kladbunde, 

1999 

U.S. CCOP, Hospitial inpatient Patients/Participants Retrospective All 

Krailo, 

1993 

U.S. Hospital inpatient; Hospital 

outpatient 

Patients/Participants Cross-sectional; 

Descriptive; Retrospective 

All 

Lewis, 

2003 

U.S. NCI cooperative groups Patients/Participants Cross-sectional; 

Descriptive; Retrospective 

All 

Linnan, 

2002 

U.S. Work site; Workers homes Patients/Participants RCT Lung 

Maurer, 

2001 

U.S. Hospital inpatient Patients/Participants Case series Breast, 

rectum, prostate 

Moinpour, 

2000 

U.S. Hospital outpatient; NCI 

Comprehensive Cancer Center 

Patients/Participants; Researchers 

Descriptive Prostate 

F-7 
Appendix F. Evidence Tables (continued) 

Evidence Table 2-1. Characteristics of Studies about Measures of Success Used to Evaluate the Efficacy or Effectiveness of Stof Underrepresented Populations into Cancer Prevention and Treatment Trials (Key Question 2). (continued) 

Author, Year 

Country Study Setting Target Population Study Design Type of 

Studied 

Murthy, 

2004 

U.S. Hospital inpatient; Hospital 

outpatient 

Patients/Participants Cross-sectional; 

Descriptive; Retrospective 

Breast, lung, pro

Paskett, 

2002 

U.S. Community Physicians CCT Breast, 

Schiffman, 

2000 

U.S. Community; Group practice Patients/Participants Descriptive Cervica

Simon, 

2004 

U.S. NCI Comprehensive Cancer Center Patients/Participants Descriptive Breast 

Thornquist, 

1991 

U.S. Community Patients/Participants Descriptive; 

Retrospective 

Lung 

Trimble, 

1994 

U.S. All NCI trials in 1992 Patients/participants Retrospective review of 

NCI trials in 1992 

All 

Yee, 2003 Canada Canada NCIC CTG treatment trials 

& U.S. SWOG treatment trials 

Patients/Participants Cross-sectional; 

Descriptive; Retrospective 

All 

Zhu, 2000 U.S. Community Physicians Descriptive; Qualitative Breast 

CCOP = Community clinical oncology program CCT = Concurrent controlled trial CTEP = Cancer Therapy Evaluation Program NCI = National Cancer Institute NCI = National Cancer Institutes NCIC CTG = National Cancer Institute of Canada Clinical Trials Group NR = Not reported RCT = Randomized controlled trial SWOG = Southwest Oncology group 

F-8
Appendix F. Evidence Tables (continued) 

Evidence Table 2-2. Characteristics of Studies about Measures of Success Used to Evaluate the Efficacy or Effectiveness of Stof Underrepresented Populations into Cancer Prevention and Treatment Trials (Key Question 2).

Author/ year 

Country Mean 

Age, y 

Age Range, y 

% High School or Less 

% Male 

% White 

% Underrepresented Study Setting Target Population Study Design 

Alexander, 

2000 

U.S. NR NR NR 41 NR NR NCI-sponsored 

trials from 1994 to 1998 

Patients/ Participants 

Crosssectional; Descriptive; Retrospectiv

Benson, 

1991 

U.S. NR NR NR 85 10% AA; 6% 

LH; 51% elderly 

Clinical Trials Cooperative Group (1,839 hospitals, 194 universities) 

Patients/ Participants 

Crosssectional; Descriptive; Retrospectiv

Berman, 

1998 

U.S. NR NR 84 49 85% 

Hispanic; 15% AA 

Community Patients/ 

Participants 

Quasiexperimenta

Brewster, 

2002 

U.S. 43 17-78 NR 0 22 78% LH; 

39% low annual income 

Community; Hospital outpatient 

Patients/ Participants 

CCT 

Ford, 2004 U.S. 63 (55-74) NR 100 0 100% AA; 

100% elderly; 38% low SES 

Community Patients/ 

Participants 

RCT 

Goodwin, 

1988 

U.S. 53 NR NR NR NR 15% elderly SWOG Patients/ 

Participants 

Crosssectional; Descriptive; Retrospectiv

Hunter, 

1987 

U.S. NR NR NR 43 93 4% AA; 3% 

LH 

Hospital inpatient; Hospital outpatient; 

Patients/ Participants 

Crosssectional; Descriptive; Retrospectiv

Kaluzny, 

1993 

U.S. NR NR NR NR NR NR Community; 

Hospital outpatient; Group practice 

Patients/ Participants; Physicians 

Descriptive 

F-9
Appendix F. Evidence Tables (continued) 

Evidence Table 2-2. Characteristics of Studies about Measures of Success Used to Evaluate the Efficacy or Effectiveness of Stof Underrepresented Populations into Cancer Prevention and Treatment Trials (Key Question 2). (continued)

Author/ year 

Country Mean 

Age, y 

Age Range, y 

% High School or Less 

% Male 

% White 

% Underrepresented Study Setting Target Population Study Design 

Kemeny, 

2003 

U.S. 48 

(young 

group), 

74 

(older 

group) 

NR 45 0 NR 50% elderly Community Patients/ 

Participants 

Case-contro

Kladbunde, 

1999 

U.S. NR NR NR 0 30 NR CCOP, 

Hospital inpatient 

Patients/ Participants 

Retrospectiv

Krailo, 

1993 

U.S. NR 0-19 NR NR NR NR Hospital 

inpatient; Hospital outpatient 

Patients/ Participants 

Crosssectional; Descriptive; Retrospectiv

Lewis, 

2003 

U.S. NR NR NR NR NR 32% elderly NCI 

cooperative groups 

Patients/ Participants 

Crosssectional; Descriptive; Retrospectiv

Linnan, 

2002 

U.S. 43 NR 50 53 91 6% LH; 27% 

low income 

Work site; Workers homes 

Patients/ Participants 

RCT 

Maurer, 

2001 

U.S. NR NR NR NR NR 100% rural Hospital 

inpatient 

Patients/ Participants 

Case series 

Moinpour, 

2000 

U.S. NR 51-91 25 100 91 NR Hospital 

outpatient; NCI Comprehensive Cancer Center 

Patients/ Participants; Researchers 

Descriptive 

Murthy, 

2004 

U.S. NR 30-75 NR 32 86 9% AA; 2% 

Asian/PI; 3% LH; 32% elderly 

Hospital inpatient; Hospital outpatient 

Patients/ Participants 

Crosssectional; Descriptive; Retrospectiv

Paskett, 

2002 

U.S. 47 NR NR 87 NR 100% rural Community Physicians CCT 

F-10 
Appendix F. Evidence Tables (continued) 

Evidence Table 2-2. Characteristics of Studies about Measures of Success Used to Evaluate the Efficacy or Effectiveness of Stof Underrepresented Populations into Cancer Prevention and Treatment Trials (Key Question 2). (continued)

Author/ year 

Country Mean 

Age, y 

Age Range, y 

% High School or Less 

% Male 

% White 

% Underrepresented Study Setting Target Population Study Design 

Schiffman, 

2000 

U.S. 27 18-81 31 NR 64 31% AA; 2% 

AIAN; 3% Asian/PI; 5% LH 

Community; Group practice 

Patients/ Participants 

Descriptive 

Simon, 

2004 

U.S. 55 NR NR 0 57 32% AA NCI 

Comprehensive Cancer Center 

Patients/ Participants 

Descriptive 

Thornquist, 

1991 

U.S. NR 45-74 53 23% elderly Community Patients/ 

Participants 

Descriptive; Retrospectiv

Trimble, 

1994 

U.S. NR NR NR NR NR 100% 

elderly 

NCI cancer trials 

Patients/ Participants 

Descriptive; retrospective 

Yee, 2003 Can NR NR NR NR NR 22% elderly Canada NCIC 

CTG treatment trials & U.S. SWOG treatment trials 

Patients/ Participants 

Crosssectional; Descriptive; Retrospectiv

Zhu, 2000 U.S. NR 65-85+ 88 0 100% AA; 

100% elderly; 91% low income 

Community Physicians Descriptive; 

Qualitative 

F-11 
Appendix F. Evidence Tables (continued) 

Evidence Table 2-2. Characteristics of Studies about Measures of Success Used to Evaluate the Efficacy or Effectiveness of Stof Underrepresented Populations into Cancer Prevention and Treatment Trials (Key Question 2). (continued)AA = African American AIAN = American Indian/Alaska Native Can = Canada CCOP = Community Cooperative Oncology Program CCT = Concurrent controlled trial CTG = Clinical trials group LH = Latino/Hispanic NCIC =National Cancer Institute of Canada NR = Not reported PI = Pacific Islander RCT = randomized controlled trial SES = Socioeconomic status SWOG = Southwest Oncology Group 

F-12 
Appendix F. Evidence Tables (continued) 

Evidence Table 2-3. Studies about Measures of Success Used to Evaluate the Efficacy or Effectiveness of Strategies for RecruiUnderrepresented Populations into Cancer Prevention and Treatment Trials (Key Question 2).

Author, Year 

Recruitment Definition 

Primary Outcomes of Trial 

Was Recruitment Goal Stated a priori (Y/N). If yes, what was goal (in %)? 

Recruitment Success Measure For W

GrouSucc

Alexander, 

2000 

Actual participation 

Primary and secondary prevention; Treatment for NCI supported trials 

NA Disease-specific proportion in U.S. for 

Asian/PI; Researcher set for elderly: proportion younger Asian/PIs in the NCIsupported treatment trials 

Asian

Benson, 

1991 

Actual participation 

Treatment NA Disease-specific proportion in U.S. Africa

Latin

Berman, 

1998 

Actual participation 

Primary prevention 

No Geographic representation: proportion 

underserved group in school district. 

LatinAme

Brewster, 

2002 

Actual participation 

Secondary prevention 

No Researcher set: Proportion underserved 

that agreed to participate in study 

Latin

Ford, 2004 Actual 

participation 

Primary prevention 

No Measurement of enrollment of increasingly 

intensive intervention strategies compared to the control arm 

Africa

Goodwin, 

1988 

Actual participation 

Treatment NA Researcher set: New Mexico non-SWOG 

cancer trials proportion of underserved groups 

Elde

Hunter, 

1987 

Actual participation 

Treatment; Phase I, II, III trials 

NA Disease-specific proportion in U.S.: 

Compared CCOP participation to SEER data from 1973-1977 

Africa

Kaluzny, 

1993 

Actual participation 

Treatment NA Researcher set: Proportion of minoritybased CCOP eligible patients compared to 

annual proportion of CCOP eligible patients who entered trials from 1985-89 

AfricaLatin

Kemeny, 

2003 

Actual participation 

Treatment NA Researcher set: Proportion underserved 

offered a cancer trial 

Elde

Kladbunde, 

1999 

Actual participation 

Treatment NA Research Institution proportion Africa

Krailo, 

1993 

Actual participation 

Prevention and treatment 

NA Disease-specific proportion in county: 

proportion underserved with cancer in county 

Adole

Lewis, 

2003 

Actual participation 

Treatment NA Disease-specific proportion in U.S. Elde

Linnan, 

2002 

Actual participation 

Primary prevention 

NA Researcher set: Proportion underserved 

eligible for trial 

Low scho

F-13 
Appendix F. Evidence Tables (continued) 

Evidence Table 2-3. Studies about Measures of Success Used to Evaluate the Efficacy or Effectiveness of Strategies for RecruiUnderrepresented Populations into Cancer Prevention and Treatment Trials (Key Question 2). (continued)

Author, Year 

Recruitment Definition 

Primary Outcomes of Trial 

Was Recruitment Goal Stated a priori (Y/N). If yes, what was goal (in %)? 

Recruitment Success Measure For W

GrouSucc

Maurer, 

2001 

Actual participation 

Treatment No elderly goal, Yes-rural 

goal; 40% of incident cancer cases & 54% would be eligible 

Researcher set: proportion underserved based upon elements from another study for rural and proportion underserved participated in trial for elderly 

Elde

Moinpour, 

2000 

Actual participation 

Treatment Yes; 8% African American Geographic representation: U.S. proportion 

underserved 

Africa

Murthy, 

2004 

Actual participation 

Treatment NA Disease-specific proportion in U.S. Africa

Latin

Paskett, 

2002 

Actual participation 

Treatment No Researcher set: Proportion underserved 

enrolled pre and post intervention 

Rura

Schiffman, 

2000 

Actual participation 

Secondary prevention 

No Researcher set: Proportion underserved 

enrolled in the trial 

 Afric

Simon, 

2004 

Actual participation 

All treatment trials except one diet intervention 

No Disease-specific proportion: proportion 

underserved group with cancer(taken from the SEER database) in Detroit 

Africa

Thornquist, 

1991 

Actual participation 

Primary prevention/ Chemoprevention 

No Researcher set: Wanted enough elderly 

participants to evaluate them in study. Also wanted equal participation in 5-year age groups. 

Elde

Trimble, 

1994 

Actual participation 

Cancer treatment; phase II and III trials 

NA Disease-specific proportion in the U.S. Elde

Yee, 2003 Actual 

participation 

Treatment NA 1) Disease-specific proportion in Canada. 

2) Researcher set: proportion underserved compared to U.S SWOG cancer treatment trial rates. 

Elde

Zhu, 2000 Actual 

participation 

Primary prevention 

No Researcher set for African-American elderly 

women: Authors noted participation rates were high, compared to other study with participation rate ranging from 20-48% 

Africa

F-14 
Appendix F. Evidence Tables (continued) 

Evidence Table 2-3. Studies about Measures of Success Used to Evaluate the Efficacy or Effectiveness of Strategies for RecruiUnderrepresented Populations into Cancer Prevention and Treatment Trials (Key Question 2). (continued)CCOP = Community Cooperative Oncology Program NA = Not applicable NCI = National Cancer Institute PI = Pacific Islander SEER = Surveillance, Epidemiology, and End Results Program SES = Socioeconomic status SWOG = Southwest Oncology Group 

F-15 
Appendix F. Evidence Tables (continued) 

Evidence Table 3/4-1. Characteristics of Studies on the Efficacy or Effectiveness of Recruitment Strategies for Increasing Partic

Underrepresented Populations in Cancer Prevention and Treatment Trials (Key Questions 3 and 4).

Author, Year 

Study setting 

Target population 

Study Design 

Type of Cancer studied 

Recruitment Dates 

Study Objective(s) 

Brewster, 

2002 

Community; Outpatient hospital 

Participants CCT Cervical 1999-2000 Review and compare the recruitment strategies as

recruiting Latinas into cancer prevention trials 

Ford, 

2004 

Community; Faith-based organization 

Participants RCT Prostate, 

Lung, Colorectal 

1996-2001 Test effectiveness of three increasingly intensive re

strategies in recruiting African-American men to the Screening Trial 

Linnan, 

2002 

Community Participants RCT Lung NR 1) Describe organizational factors associated with 

employee recruitment method. 

2) Investigate differences in employee reaction, enattrition based on selected recruitment methods. 3) Compare self-reported health behaviors and moreadiness to change among employees enrolled in intervention study by recruitment method. 

Moinpour, 

2000 

Outpatient hospital 

Participants; Researchers 

RCT Prostate 1993-1997 Summarize the challenges of enrolling and random

Americans and other minorities in the prostate can(PCPT). 

Paskett, 

2002 

Community Physicians CCT Breast, 

Colorectal 

1992-1996 1) Evaluate a rural cancer care intervention. 

2) Assess rural-based primary care physician knowattitudes/beliefs about patient and physician barrie3) To study cancer clinical trials and accrual to clintrials. 

CCT = Concurrent controlled trial PLCO = Prostate, Lung, Cervical, Ovarian RCT = Randomized controlled trial 

F-16 
Appendix F. Evidence Tables (continued) 

Evidence Table 3/4-2. Target Population Characteristics of Studies on the Efficacy or Effectiveness of Recruitment Strategies f

Participation of Underrepresented Populations in Cancer Prevention and Treatment Trials (Key Questions 3 and 4).

Author, Year 

Target Population 

Study Subgroup Sample 

size 

Mean Age, y 

Mean Education 

Mean Income (per year) 

 % Male 

 % AA 

% Cauc 

Clinic registry 405 44 < HS graduate 

(55%) 

< $10,000 

(41%) > 

$10,000 (59%) 

Brewster, 0 0 2002 

Participants 

Media campaign 535 42 < HS graduate 

(49%) 

< $10,000 

(38%) > 

$10,000 (62%) 

0 0 

AA, Arm A 3,079 AA, Arm B 3,075 

AA, Arm C 2,949 

Ford, 2004 

Participants 

AA, Arm D 3,297 

NR NR NR 100 100 

Passive employee 

contact 

891 41 < HS graduate 

(50.4%) 

< $29,999 

(24%) 

Linnan, 53 NR 2002 

Participants 

Active employee 

contact 

1,015 44 < HS graduate 

(39.5%) 

< $29,999 

(14%) 

53 NR 

AA, Site A, 1995 AA, Site A, 1996 AA, Site B, 1995 AA, Site B, 1996 

AA, Site C, 1995 AA, Site C, 1996 AA, Site D, 1995 AA, Site D, 1996 

Lat/Hisp, Site E, 1995 

Moinpour, 2000 

Participants; Researchers 

Lat/Hisp, Site E, 1996 

NR NR NR NR 100 NR 

South Carolina 1993 72 44 NR NR 92 NR 

North Carolina 1993 124 49 NR NR 84 NR 

South Carolina 1996 62 45 NR NR 85 NR 

Paskett, 2002 

Providers 

(physicians) 

North Carolina 1996 102 49 NR NR 87 NR 

AA = African American Cauc. = Caucasian HS = High School Lat/Hisp = Latino/Hispanic NR = not reported 

F-17 
Appendix F. Evidence Tables (continued) 

Evidence Table 3/4-3. Interventions Used in Studies on the Efficacy or Effectiveneses of Strategies for Increasing Participation Populations in Cancer Prevention and Treatment Trials (Key Questions 3 and 4). 

Author, Year 

Target Population Intervention Group Elapsed 

Duration of Interventions 

UnderrepreRecruitmenOutcome 

Clinic registry Women were identified from clinic registry and contacted to 

participate. 

Brewster, 1 year 

2002 

Media campaign The study advertised using several media strategies (flyers, 

newspapers). Women responded to these advertisements. 

Yes: objectivreview recrustrategies asrecruiting Laprevention tr

AA, Arm A Enhanced mailing process; eligibility screening conducted by 

AA interviewers; baseline information gathered via mailed packet. 

NR 

AA, Arm B Enhanced mailing process; eligibility screening conducted by 

AA interviewers; baseline information gathered via telephone interviews. 

NR 

AA, Arm C Enhanced mailing process; eligibility screening and church 

project sessions conducted by AA; baseline information gathered at church sessions; letters and telephone call reminders for church session 

NR 

Ford, 

2004 

AA, Arm D Control group: standard PLCO trial recruitment procedures; 

eligibility screening conducted by AA or Caucasian interviewers; baseline information gathered via mailed packets 

NR 

Yes: enrollmto cancer sc

Passive employee contact 

Companies provided list of employee names and home telephone numbers to research team and employees (target population) were contacted by research team to participate in study. 

Linnan, NA 

2002 

Active employee contact 

Companies did not provide employee list to research team. Instead, employees (target population) actively contacted research team to partcipate in the study. 

NA 

No, target poworksite emppopulation inpersons with school educarelatively low

AA, Site A, 1995 AA, Site A, 1996 AA, Site B, 1995 AA, Site B, 1996 AA, Site C, 1995 AA, Site C, 1996 AA, Site D, 1995 AA, Site D, 1996 Lat/Hisp, Site E, 1995 

Moinpour, 

2000 

Lat/Hisp, Site E, 1996 

No specific details of intervention for each of the five sites were given. 

3.5 years No, but the s

failures in incminority partcancer prevewere presen

F-18 
Appendix F. Evidence Tables (continued) 

Evidence Table 3/4-3. Interventions Used in Studies on the Efficacy or Effectiveneses of Strategies for Increasing Participation Populations in Cancer Prevention and Treatment Trials (Key Questions 3 and 4). (continued) 

Author, Year 

Target Population Intervention Group Elapsed 

Duration of Interventions 

UnderrepreRecruitmenOutcome 

Physicians in North Carolina, 1993 Physicians in North Carolina, 1996 

Interventions included tumor-reporting system to expedite receipt of data on cancer patients to physicians, nurse facilitator and quarterly newspapers to inform physicians of cancer treatment and clinical trials, and health educators to provide community-based cancer education about cancer screening, treatment, and clinical trials. 

4 years 

Physicians in South Carolina, 1993 

Paskett, 

2002 

Physicians in South Carolina, 1996 

Control group (usual medical care in South Carolina counties) NA 

Yes: enrollmpatients to c

AA = African American CCT = Concurrent controlled trial Lat/Hisp = Latino/Hispanic NA = Not applicable NR = Not reported PLCO = Prostate, Lung, Cervical, Ovarian RCT = Randomized controlled trial 

F-19 
Appendix F. Evidence Tables (continued) 

F-20 

Evidence Table 3/4-4. Quality of Studies on the Efficacy or Effectiveness of Strategies for Increasing Participation of 

Underrepresented Populations in Cancer Prevention and Treatment Trials (Key Questions 3 and 4). 

Author/ 

Year 

Representativenessa Bias and 

confoundingb Recruitment 

Descriptionc

Outcomes 

and FollowUpd 

Statistical 

Quality and 

Interpretatione

Conflict of 

Interest Meanf

 Linnan, 

2002 

 

Brewster, 

2002 

Paskett, 

2002 

Moinpour, 

2000 NA NA NA NA NA NA 

Ford, 

2004 

 

Excellent: > 75% quality score 

Good: 50-74% quality score 

Fair: 25-49% quality score 

Poor: <25% quality score 

NA Not applicable 

a

 Representativeness: Score was based on a total maximum score of 8 points. This included the authors' description of setting and 

population (2 points), detail on provided inclusion and exclusion criteria (2 points), information provided on non-participants (2 

points), and description of key participant characteristics (2 points). b

 Bias and Confounding: Score was based on a total maximum score of 6 points. This included random assignment of participants 

to a study group (2 points), differenced of participants between groups (2 points), and details on the recruitment trial, blinding of 

the clinician, patient and/or outcome assors (2 points). c

 Recruitment description: Score was based on a total maximum score of 4 points. This included details on the flow of 

participants through each stage of the clinical trial (2 points), and description of the details of the recruitment strategy (2 points). d

 Outcomes and Follow-up: Percentage score was based on a total maximum score of 6 points. This included how the recruitment 

success outcomes were defined (2 points), description of the measures used to define the recruitment barriers and promoters (2 

points), and whether the study reported the numbers and reasons for withdrawals from the study protocol (2 points). e Statistical Quality and Interpretation: Percentage score was based on a total maximum score of 4 points. This included the 

statistical analyses used to determine recruitment success (2 points), and whether withdrawals, crossovers, and loss to follow-up 

were handled appropriately (2 points). 

f Conflict of Interest: Percentage score was based on a total maximum score of 2 points. Did the study report it's source of funding 

(2 points) 
Appendix F. Evidence Tables (continued) 

Evidence Table 3/4-5. Outcome Point Estimates on the Efficacy or Effectiveness of Recruitment Strategies for Increasing ParticUnderrepresented Populations in Cancer Prevention and Treatment Trials (Key Questions 3 and 4). 

Author, Year 

Descriptor of Point Estimate (%, OR, difference) Point 

Estimate (value) 

Measure of Spread / Significance (CI, P value) 

Author Conclusion 

OR of women presenting to clinic (media campaign vs. clinic registry) 

Brewster, 3.0 2.38 - 3.78 

2002 

OR of women screened by telephone (media campaign vs. clinic registry) 

3.0 2.52 - 3.51 

Media campaign recruitment yielresults compared to the clinic reg

Ford, 

2004 

Difference of enrollment between Arm C vs. Arm D Arm C = intervention included enhanced mailing process and church-based sessions Arm D = control group which received standard recruitment procedures 

1.0 P = .02 Arm C, the most intensive of the 

higher enrollment compared to thother intervention arms (Arms A 

Linnan, 

2002 

Difference of enrollment between passive employee contact and active employee contact (%) 

36.6 P < .0001 Active recruitment had lesser rea

smaller attrition rate. Passive recand financial diversity. No significorganizational factors comparing recruitment. 

Change in Site A enrollment from 1995 to 1996 (%) 0.3 NR Change in Site B enrollment from 1995 to 1996 (%) 0.5 NR Change in Site C enrollment from 1995 to 1996 (%) 2.8 NR Change in Site D enrollment from 1995 to 1996 (%) 0.6 NR 

Moinpour, 

2000 

Change in Site E enrollment from 1995 to 1996 (%) 0.5 NR 

It was difficult to evaluate effectivrecruitment strategies since the s

final period of accrual. 

Change in enrollment of breast cancer patients from 1991 to 1996, North Carolina (%) 

9 NR 

Change in enrollment of colorectal cancer patients from 1991 to 1996, North Carolina (%) 

1 NR 

Change in enrollment of breast cancer patients from 1991 to 1996, South Carolina (%) 

44 NR 

Paskett, 

2002 

Change in enrollment of colorectal cancer patients from 1991 to 1996, South Carolina (%) 

5 NR 

No improvement in enrollment of cancer clinical trials was observe

CI = Confidence interval OR = Odds ratio 

F-21 
Appendix F. Evidence Tables (continued) 

F-22 

Evidence Table 5-1. Characteristics of Studies Investigating the Barriers and Promoters of Participation of Underrepresented P

Prevention and Treatment Trials (Key Question 5).

Author, Year 

Study Setting Target 

Population 

Targeted Underrepresented Population 

Study Design How 

Measured 

Type of Cancer Studied 

Study Objectiv

AdamsCampbell, 

2004 

Hospital inpatient; Hospital outpatient 

Patients/ Participants; Physicians 

AA Tumor 

registry review 

Enrollment NR Breast, 

colorectal, head and neck, lung, prostate 

Determine AA bto enrollment in 

Advani, 

2003 

Hospital outpatient 

Patients/ Participants 

AA Case-control Surveys, 

phone interview 

Solid or hematologic malignancy (excluding melanoma) 

A. Determine if Aoncology patienless willing to pain trials. B. Betdelineate existinbarriers to recruAAs. C. Compaattitudes of oncopatients who wetreated in rural acompared to a mmedical center. 

Barofsky, 

1979 

Community; Hospital inpatient 

Patients/ Participants 

AA Qualitative Semistructured 

Interview 

Histologically confirmed softtissue or osteosarcoma 

Determine the eand nature of panonparticipation soft tissue and osteosarcoma pat NCI. 

Berman, 

1998 

Community Patients/ 

Participants 

Lat/Hisp, AA 

Quasi experimental. 

Survey; Enrollment 

Smoking cessation 

Determine whetthere are race & differences in recruitment. 
Appendix F. Evidence Tables (continued) 

F-23 

Evidence Table 5-1. Characteristics of Studies Investigating the Barriers and Promoters of Participation of Underrepresented P

Prevention and Treatment Trials (Key Question 5). (continued)

Author, Year 

Study Setting Target 

Population 

Targeted Underrepresented Population 

Study Design How 

Measured 

Type of Cancer Studied 

Study Objectiv

Bieniasz, 

2003 

Community Patients/ 

Participants 

AA women Qualitative Semistructured 

interview 

Cervical (dysplasia) 

A. Explore womintention to parta chemopreventfor cervical dyspB. Identify womeattitudes to certaoutcomes from participation in C. Determine wwomen would coregarding partic

Brewster, 

2002 

Community; Hospital outpatient 

Patients/ Participants 

Latino / Hispanic women 

CCT Enrollment Cervical Review and com

the recruitment strategies assocwith recruiting Linto cancer prevtrials. 

Broome, 

2003 

Hospital inpatient; 

Patients/ Participants 

Children; Adolescents 

Qualitative Semistructured 

interview 

Ewing's sarcoma, acute lymphatic leukemia or hematological malignancy 

How childrens' relationships witparents and clininfluence particithe study. 

Broome, 

2001 

Community; Hospital inpatient; Hospital outpatient 

Patients/ Participants 

Children; Adolescents 

Qualitative Interview Hematological 

malignancy or solid tumors 

Assess childrenadolescents' understanding aresearch and thinvolvement in tdecision to partitrials. 
Appendix F. Evidence Tables (continued) 

F-24 

Evidence Table 5-1. Characteristics of Studies Investigating the Barriers and Promoters of Participation of Underrepresented P

Prevention and Treatment Trials (Key Question 5). (continued)

Author, Year 

Study Setting Target 

Population 

Targeted Underrepresented Population 

Study Design How 

Measured 

Type of Cancer Studied 

Study Objectiv

Brown, 

2000 

Hospital outpatient 

Patients/ Participants 

AA and Hispanic women 

Descriptive Survey; 

Interview; Enrollment 

Breast, cervical A. Determine fa

related to intentparticipate in a cprevention trial fcervical neoplasAddress differenAA and Caucasfactors affecting trial accessibility participation. 

Brown, 

2003 

Community Patients/ 

Participants 

AA Crosssectional; 

Descriptive 

Telephone surveys 

NR Analysis on fact

affecting willingnolder AAs and wparticipate in clitreatment study

Chen, 

2000 

Hospital inpatient 

Patients/ Participants 

Elderly Hospital 

registry review; Retrospective 

Enrollment NR Aggressive 

histology lymphoma 

Compare baselipatient charactetreatments, and outcomes of eldpatients who weentered or not einto a randomizephase I trial. 

Comis, 

2003 

Community Patients/ 

Participants 

Elderly (by sub-group analysis) 

Crosssectional; Descriptive 

Telephone interview 

NR Examine attitude

regarding particin cancer trials. 

DienerWest, 

2001. 

Hospital inpatient; Hospital outpatient; Group practice; Solo practice 

Patients/ Participants 

Elderly (by sub-group analysis) 

RCT Enrollment; 

Face-to-face interview 

Eye Study and comp

predictors of patparticipation in 2 multicenter trials conducted concin the U.S. and 
Appendix F. Evidence Tables (continued) 

F-25 

Evidence Table 5-1. Characteristics of Studies Investigating the Barriers and Promoters of Participation of Underrepresented P

Prevention and Treatment Trials (Key Question 5). (continued)

Author, Year 

Study Setting Target 

Population 

Targeted Underrepresented Population 

Study Design How 

Measured 

Type of Cancer Studied 

Study Objectiv

Ford, 2003 Community Patients/ 

Participants 

AA men RCT Enrollment NR Prostate, lung, 

colorectal 

A. Demonstrate low-income and moderate to higincome older AA can be recruited cancer trial. B. Identify a meincreased particof older AA men cancer screenin

Fouad, 

2000 

Community Patients/ 

Participants; Physicians 

AA Qualitative Focus groups 

/ key informant interview 

NR A. Determine th

perceptions of Aresidents regardparticipation in research. B. Determine hecare providers perceptions of bto participation otrials. 

Fouad, 

2001 

Community Patients/ 

Participants; Physicians 

AA Qualitative Focus groups 

/ key informant interview 

NR Ascertain the 

community's perspective of participating in t

Green, 

2000 

Community Patients/ 

Participants 

AA Qualitative Focus group NR Identify importan

regarding AAs' perceptions/ attitoward trials anplan a conferen

Grunfeld, 

2002 

Hospital inpatient 

Researchers Clinical 

research associates 

Qualitative Semistructured 

interview 

NR Get the views of 

research associbarriers and facto accrual. 
Appendix F. Evidence Tables (continued) 

F-26 

Evidence Table 5-1. Characteristics of Studies Investigating the Barriers and Promoters of Participation of Underrepresented P

Prevention and Treatment Trials (Key Question 5). (continued)

Author, Year 

Study Setting Target 

Population 

Targeted Underrepresented Population 

Study Design How 

Measured 

Type of Cancer Studied 

Study Objectiv

Hunter, 

1987 

Group practice; Hospital inpatient 

Patients/ Participants 

AA Descriptive; 

Qualitative; Retrospective 

Secondary analysis of program data 

All A. Provide 

characteristics ocancer patient population from patients entered are derived. B. Describe the by which patientrecruited and sefrom trials as determined from CCOP physicianpatient log. 

Kaluzny, 

1993 

Community; Hospital outpatient; Group practice 

Patients/ Participants; Physicians 

NR Descriptive; 

Qualitative 

Secondary analysis of NCI patient log data; Interviews from site visits 

NR Describe the ea

implementation MBCCOP and idthe challenges temerged in devea network aimed increasing the participation of mpopulations in tr

Kemeny, 

2003 

Community Patients/ 

Participants; Physicians 

Elderly Case-control Patient 

interviews; Selfadministered written questionnaires for physicians 

Breast A. Were patients 

than 65 years oftrial more often younger patients B. Assess reasooncologists chooto offer a trial to older patients anpatients chose trefused to partic
Appendix F. Evidence Tables (continued) 

F-27 

Evidence Table 5-1. Characteristics of Studies Investigating the Barriers and Promoters of Participation of Underrepresented P

Prevention and Treatment Trials (Key Question 5). (continued)

Author, Year 

Study Setting Target 

Population 

Targeted Underrepresented Population 

Study Design How 

Measured 

Type of Cancer Studied 

Study Objectiv

Kemp, 

1984 

Community Patients/ 

Participants 

Elderly (by sub-group analysis) 

Descriptive; Crosssectional 

Face-to-face interview; Survey 

Breast, bone A. Assess wheth

people were preparticipate in randomized triawhether they wachoose their owtreatment. B. Assess whethnot people wantdoctor to provide information abotreatment and thsystem of alloca

Kornblith, 

2002 

Hospital inpatient 

Physicians Elderly Crosssectional; 

Descriptive 

Questionnaire Breast Test the magnit

barriers to recruamong elderly bcancer patients physician persp

Krailo, 

1993 

Hospital inpatient; Hospital outpatient 

Patients/ Participants 

Children; Adolescents 

Hospital registry review, Qualitative 

Enrollment NR All Assess the prop

children diagnoscancer who are in cancer studie

Lee, 1999 Hospital 

inpatient 

Patients/ Participants 

AA men Descriptive; 

Crosssectional 

Survey Prostate Assess factors a

interest in particin a prostate canchemopreventio
Appendix F. Evidence Tables (continued) 

F-28 

Evidence Table 5-1. Characteristics of Studies Investigating the Barriers and Promoters of Participation of Underrepresented P

Prevention and Treatment Trials (Key Question 5). (continued)

Author, Year 

Study Setting Target 

Population 

Targeted Underrepresented Population 

Study Design How 

Measured 

Type of Cancer Studied 

Study Objectiv

Lerman, 

1994 

Community Patients/ 

Participants 

AA women Descriptive; 

Crosssectional 

Structured telephone interview 

Breast Identify factors, 

especially sociodemographpsychological, hand risk factors breast cancer paassociated with decision to partia randomized tr

Lewis, 

2003 

NCI cooperative groups 

Patients/ Participants 

Elderly Crosssectional; 

Descriptive; Retrospective 

Secondary analysis of national database (NCI, CTEP, PDQ, SEER) 

NR Determine the 

proportion of eldparticipants in Nsponsored canctreatment trials f1997-2000. 

Ling, 2000 Hospital 

inpatient; Hospital outpatient 

Patients/ Participants 

Elderly (by sub-group analysis) 

Qualitative Survey NR Describe recruit

experiences into of a Palliative CCenter. 

McCaskillStevens, 

1999 

Community Physicians AA Qualitative Workshops 

with discussions and questionnaires 

All Identify barriers 

solutions to AA to cancer trials. 
Appendix F. Evidence Tables (continued) 

F-29 

Evidence Table 5-1. Characteristics of Studies Investigating the Barriers and Promoters of Participation of Underrepresented P

Prevention and Treatment Trials (Key Question 5). (continued)

Author, Year 

Study Setting Target 

Population 

Targeted Underrepresented Population 

Study Design How 

Measured 

Type of Cancer Studied 

Study Objectiv

MillonUnderwood, 

1993 

Community Patients/ 

Participants 

AA Descriptive; 

Crosssectional 

Survey NR A. Assess 

perceptions/attitand beliefs of AAregarding particin cancer studieB. Evaluate effeperception/attitubelief on willingnC. Evaluate role perceived risk, pexperience, perefficacy, economstatus on willingparticipate. 

Moinpour, 

2000 

Hospital outpatient; NCI Comprehensive Cancer Center 

Patients/ Participants; Researchers 

AA and Hispanic men 

RCT Enrollment NR Prostate Summarize cha

of enrolling and randomizing AAminorities in the 

Mouton,, 

1997 

Community Patients/ 

Participants 

AA women Descriptive; 

Crosssectional 

Telephone survey 

Breast,colorectal A. Compare atti

toward participacancer trials and attitudes toward screening and prevention for bwhite subjects. B. Discover why women decide tparticipate in catrials. C. Assess whetblacks are more participate in resthat is conducteblack researche
Appendix F. Evidence Tables (continued) 

F-30 

Evidence Table 5-1. Characteristics of Studies Investigating the Barriers and Promoters of Participation of Underrepresented P

Prevention and Treatment Trials (Key Question 5). (continued)

Author, Year 

Study Setting Target 

Population 

Targeted Underrepresented Population 

Study Design How 

Measured 

Type of Cancer Studied 

Study Objectiv

Outlaw, 

2000 

Hospital inpatient 

Physicians; Data managers 

AA Qualitative Survey NR Identify factors r

to AAs participatrials. 

Paskett, 

2002 

Community Physicians Rural CCT Survey, 

Enrollment NR 

Breast, colorectal 

A. Evaluate a RCancer Care Intervention. B. Assess rural-primary care phknowledge, attitand beliefs aboupatient and physbarriers to cancand accrual to ctreatment trials. 

Pinto, 2000 Community Physicians AA Qualitative Focus groups NR Identify barriers 

accrual of minorpatients and devsolutions to thesbarriers from phperspective 

RandallDavis, 

2001 

Community Patients/ 

Participants 

Rural Qualitative Focus groups All To elicit percept

urban and rural regarding particin cancer trial. 

Roberson, 

1994 

Community Patients/ 

Participants 

AA, American Indian or Alaskan Native, Lat/Hisp 

Qualitative Telephone 

survey 

NR Discuss racial/e

minority groups and opinions abclinical trial part

Robinson, 

1996 

Community Patients/ 

Participants 

AA men Qualitative Focus groups Prostate Identify attitudes 

AAs associated participation in pcancer trials. 
Appendix F. Evidence Tables (continued) 

F-31 

Evidence Table 5-1. Characteristics of Studies Investigating the Barriers and Promoters of Participation of Underrepresented P

Prevention and Treatment Trials (Key Question 5). (continued)

Author, Year 

Study Setting Target 

Population 

Targeted Underrepresented Population 

Study Design How 

Measured 

Type of Cancer Studied 

Study Objectiv

Sateren, 

2002 

All patients from NCIfunded trials between April 1998-April 1999 

Patients/ Participants 

AA Crosssectional; 

Descriptive; Retrospective 

Secondary analysis of national database (US Census, SEER) 

All Examine the im

socioeconomic fon accrual to to sponsored canctreatment trials 

Sears, 

2003 

Community Patients/ 

Participants 

AA women RCT; 

Retrospective 

Enrollment NR Breast Examine recruit

retention, and pof participation. 

Simon, 

2004 

Hospital inpatient 

Patients/ Participants 

AA Descriptive Survey Breast Better understan

factors associataccrual to breastrials. 

Spaight, 

1984 

Hospital inpatient 

Physicians Elderly Qualitative Structured 

interview 

NR Assess factors 

influencing trials participation from perspective of moncologists and hematologists 

Thornquist, 

1991 

Community Patients/ 

Participants 

Elderly (by sub-group analysis) 

Cohort; Prospective 

Enrollment NR Lung Describe any 

differences in acand adherence by age group or gender. 

Twelves, 

1998 

Hospital inpatient; Hospital outpatient; Solo practice 

Patients/ Participants 

Elderly women (by sub-group analysis) 

Retrospective; Tumor registry review 

Enrollment NR Breast Identify factors 

influencing enrointo invasive brecancer trials. 
Appendix F. Evidence Tables (continued) 

F-32 

Evidence Table 5-1. Characteristics of Studies Investigating the Barriers and Promoters of Participation of Underrepresented P

Prevention and Treatment Trials (Key Question 5). (continued)

Author, Year 

Study Setting Target 

Population 

Targeted Underrepresented Population 

Study Design How 

Measured 

Type of Cancer Studied 

Study Objectiv

Woods, 

2002 

Hospital outpatient 

Patients/ Participants 

AA Qualitative Focus groups 

/ interview 

NR A. Identify 

characteristics owho chose not tparticipate in a To understand wsome eligible participants did return for enrollmC. To see what strategies might participation mo

AA = African American CCOP = Community Clinical Oncology Program CCT = Concurrent controlled trials CTEP = Cancer Therapy Evaluation Program ECOG = Eastern Cooperative Oncology Group Lat/Hisp = Latino/Hispanic MBCCOP = Minority-based Community Clinical Oncology Program NCI = National Cancer Institute PCPT = Prostate Cancer Prevention Trial PDQ = Physician Data Query PLCO = Prostate, Lung, Colorectal, and Ovarian Cancer Trial RCT = Randomized controlled trial SEER = Surveilance, Epidemiology, and End Results Program SES = Socioeconomic status 
Appendix F. Evidence Tables (continued) 

F-33 

Evidence Table 5-2. Target Population Characteristics of Studies Investigating the Documented Barriers and Promoters of PartUnderserved Populations in Cancer Prevention and Treatment Trials (Key Question 5).

Author, Year U.S.or 

NonU.S. 

Sample Size 

Mean Age, y 

Age Range, y 

Mean Income ($) 

Income range ($) 

% Male 

% AA 

% AIAN 

% Asian /PI 

% White 

% Lat/ Hisp 

% Ado

AdamsCampbell, 

2004 

U.S. 235 NR 22-97 NR NR 30 100 0 0 0 0 NR 

Advani, 2003 U.S. 218 NR NR NR <15,000-

>35,000 

NR 33 NR NR 67 NR NR 

Barofsky, 

1979 

U.S. 103 NR ≤19-

≥50 

NR NR 65 16 0 0 84 0 NR 

Berman, 1998 U.S. 435 37 NR NR NR 49 15 0 0 0 85 NR 

Bieniasz, 

2003 

U.S. 66 37 18-81 28,045 NR 0 64 NR NR 27 NR NR 

Brewster, 

2002 

U.S. 545 43 17-78 NR <10,000-

≥10,000 

0 0 0 0 22 78 NR 

Broome,2003 U.S. 34 14 8-22 NR NR NR 9 3 3 73 12 10

Broome, 2001 U.S. 34 NR 8-22 NR NR NR 9 3 3 74 11 10

Brown, 2000 U.S. 434 Study 

1 = 32; Study 2 = NR 

NR NR NR 0 29 NR NR 54 17 NR 

Brown, 2003 U.S. 438 NR 50->75 NR <25,000-

>40,000 

33 49 0 0 51 0 NR 

Chen, 2000 NonU.S. 68 NR 65-89 NR NR 50 NR NR NR NR NR NR 
Appendix F. Evidence Tables (continued) 

F-34 

Evidence Table 5-2. Target Population Characteristics of Studies Investigating the Documented Barriers and Promoters of PartUnderserved Populations in Cancer Prevention and Treatment Trials (Key Question 5). (continued)

Author, Year U.S.or 

NonU.S. 

Sample Size 

Mean Age, y 

Age Range, y 

Mean Income ($) 

Income range ($) 

% Male 

% AA 

% AIAN 

% Asian /PI 

% White 

% Lat/ Hisp 

% Ado

Comis, 2003 U.S. 887 NR 18->65 NR NR 51 NR NR NR NR NR NR 

Diener-West, 

2001 

U.S. 4,191 NR NR NR NR NR NR NR NR NR NR NR 

Ford, 2003 U.S. 34,376 63 55-74 NR NR 100 100 0 0 0 0 

Fouad, 2000 U.S. 103 51 NR NR NR 31 100 NR NR NR NR NR Fouad, 2001 U.S. 103 NR NR NR NR 31 100 NR NR NR NR NR 

Green, 2000 U.S. 103 50.8 NR NR NR 30 100 NR NR NR NR NR 

Grunfeld, 

2002 

NonU.S. 29 NR NR NR NR NR NR NR NR NR NR NR 

Hunter, 1987 U.S. 17,773 NR NR NR NR 43 4 NR NR 93 NR NR 

Kaluzny, 

1993 

U.S. NR NR 51->71 NR NR NR NR NR NR NR NR NR 

Kemeny, 

2003 

U.S. 154 61 NR NR NR 0 NR* 0 0 77 NR* NR 

Kemp, 1984 NonU.S. 1,022 NR 16-70 NR NR 49 NR NR NR NR NR NR 

Kornblith, 

2002 

U.S. 156 NR 29-74 NR NR 69 3 3 NR 87 NR NR 

Krailo, 1993 U.S. 2,788 NR 0-19 NR NR NR NR NR NR NR NR 3

Lee, 1999 U.S. 165 NR NR NR NR 59 67 NR NR 33 NR NR 

Lerman, 1994 U.S. 271 NR 35->50 NR NR 0 NR NR NR 100 NR NR 

Lewis, 2003 U.S. 59,300 NR NR NR NR NR NR NR NR NR NR NR 

Ling, 2000 NonU.S. 1,206 NR 18-95 NR NR 35 NR NR NR NR NR NR 
Appendix F. Evidence Tables (continued) 

F-35 

Evidence Table 5-2. Target Population Characteristics of Studies Investigating the Documented Barriers and Promoters of PartUnderserved Populations in Cancer Prevention and Treatment Trials (Key Question 5). (continued)

Author, Year U.S.or 

NonU.S. 

Sample Size 

Mean Age, y 

Age Range, y 

Mean Income ($) 

Income range ($) 

% Male 

% AA 

% AIAN 

% Asian /PI 

% White 

% Lat/ Hisp 

% Ado

McCaskillStevens, 

1999 

U.S. 89 NR NR NR NR NR 56 0 0 0 0 NR 

MillonUnderwood, 

1993 

U.S. 220 27 18-47 30,626 13,915-

46,138 

56 100 NR NR NR NR NR 

Moinpour, 

2000 

U.S. NR NR NR NR NR 100 NR NR NR NR NR NR 

Mouton, 1997 U.S. 80 NR <56-

>72 

NR <25,000-

≥25,000 

0 36 0 0 64 0 NR 

Outlaw, 2000 U.S. 52 NR <40-

>61 

NR NR NR 2 0 2 96 0 NR 

Paskett, 2002 U.S. 360 47 NR NR NR 84 NR NR NR NR NR NR 

Pinto, 2000 U.S. 73 NR NR NR NR NR NR NR NR NR NR NR 

RandallDavid, 2001 U.S. 37 55 18-72 NR NR 8 31 6 NR 58 3 NR 

Roberson, 

1994 

U.S. 28 NR NR NR NR 12 29 36 0 0 36 NR 

Robinson, 

1996 

U.S. 46 NR NR NR NR 100 100 NR NR NR NR NR 

Sateren, 2002 U.S. 24,332 NR 0->80 NR NR 44 NR NR NR NR NR NR 

Sears, 2003 U.S. 558 57 NR NR NR 0 6 NR NR 85 NR NR 

Simon, 2004 U.S. 319 55 NR NR NR 0 32 NR NR 57 NR NR 

Spaight, 1984 U.S. 23 NR 33-65 NR NR 87 NR NR NR NR NR NR 

Thornquist, 

1991 

U.S. 1,284 NR 45-74 NR NR 52 NR NR NR NR NR NR 
Appendix F. Evidence Tables (continued) 

F-36 

Evidence Table 5-2. Target Population Characteristics of Studies Investigating the Documented Barriers and Promoters of PartUnderserved Populations in Cancer Prevention and Treatment Trials (Key Question 5). (continued)

Author, Year U.S.or 

NonU.S. 

Sample Size 

Mean Age, y 

Age Range, y 

Mean Income ($) 

Income range ($) 

% Male 

% AA 

% AIAN 

% Asian /PI 

% White 

% Lat/ Hisp 

% Ado

Twelves, 

1998 

NonU.S. 4,688 NR <50- ≥80 NR NR 0 NR NR NR NR NR NR 

Woods, 2002 U.S. 120 41 NR NR NR 27 100 NR NR NR NR NR 

*Kemeny, 2003 reports that 23% were Latino/Hispanic or African American. AA = African American Adol = Adolescent AIAN = American Indian/Alaska Native Lat/Hisp = Latino/Hispanic NR = Not reported PI = Pacific Islander SES = Socioeconomic status 
Appendix F. Evidence Tables (continued) 

F-37 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

AdamsCampbell, 

2004 

Study design 

NR NR NR NR Comorbidity 

exclusion; Functional status; Diagnostic test result cut-off; Lack of available protocols 

NR NR 

Advani, 

2003 

Patient Lack of 

education about clinical trials*; Perceived harms of clinical trial participation*; Chance of side effects*; Distance to clinic* 

Younger age*; Altruism*; Perceived benefits of clinical trial participation 

NR NR NR NR NR 

Barofsky, 

1979 

Patient NR Being male* NR NR NR NR NR 
Appendix F. Evidence Tables (continued) 

F-38 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Berman, 

1998 

Patient; Provider 

NR Lack/ 

inadequate health insurance for Latinos; Opportunistic strategies for Latinos 

NR Communication/ Method of 

presentation for Latinos and AAs 

NR NR NR 

Bieniasz, 

2003 

Patient Intervention 

characterristics* 

NR NR NR NR NR NR 

Brewster, 

2002 

Patient Did not wish 

to participate in study; Family considerations (childcare problems); Work conflict; No time; Modesty / embarrassment; Uncomfortable with test; Transportation; Other insurance / physician / clinic 

NR NR NR NR NR NR 
Appendix F. Evidence Tables (continued) 

F-39 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Broome, 

2001 

Patient NR Chance for 

better treatment; altruism 

NR NR NR NR NR 

Broome, 

2003 

Patient NR Family 

considerations; Trust, communication, and love of parents 

NR NR NR NR NR 

Brown, 

2000 

Patient Fear; 

Transportation; Family considerations; Taste of Drug; Mistrust of research and medical system; Lack of health insurance / inadequate health insurance; Lack of education about clinical trials 

NR NR NR NR NR NR 
Appendix F. Evidence Tables (continued) 

F-40 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Brown, 

2003 

Patient AA older 

age*; Lower income* 

Male gender* NR NR NR NR NR 

Chen, 

2000 

Patient; Provider; Study design 

Patient refusal 

NR Physician 

choice 

NR Comorbidity 

exclusion; Functional status; Previous cancer 

NR NR 

Comis, 

2003 

Patient Age NR NR NR NR NR NR 

DienerWest Patient; Study 

design 

Age*; Living near treatment center* 

NR NR NR NR Large tumor 

size* 

NR 

Ford, 

2004 

Patient; Study design 

Unlisted telephone number*; Age* 

Low income level* 

NR NR NR NR NR 
Appendix F. Evidence Tables (continued) 

F-41 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Fouad, 

2000 

Patient; Provider; Study design 

Mistrust of research and medical system; Time commitment; Indirect costs; Lack/inadequate health insurance; Lack of education about trials; Blood draw; Radiation involvement; Past experiences 

Benefit to family; Benefit to church 

Provider attitudes; Skepticism about lowincome patients' ability to participate; Concern that their patients would be randomized 

Education programs for community physicians; Involvement of providers in prevention trials 

Length of study/visit structure; Complexity of forms 

Easy to read consent forms; Using recruiters who are known to community 

NR 
Appendix F. Evidence Tables (continued) 

F-42 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Fouad, 

2001 

Patient Mistrust of 

research and medical system; Cultural barriers; Job issues; Indirect costs; Lack of education about trials; Lack of knowledge about origins of cancer; Culturally relevant education about clinical trials; Perceived harms of trial participation 

Provide transportation; Flexible scheduling; Provide childcare; Incentives (free meals); Adequate knowledge about the study; Workshops on trials; Trust 

NR NR NR NR NR 
Appendix F. Evidence Tables (continued) 

F-43 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Green, 

2000 

Patient Mistrust of 

research and medical system; Time commitment; Family considerations; Perceived harms of trial participation; Radiation involved in treatment 

Altruism*; Incentives*; No cost treatment* 

NR NR NR NR NR 

Grunfeld, 

2002 

Patient; Provider; Study Design 

Mistrust of researcher and medical system; Transportation; Language barrier; Perceived harms of clinical trial participation; Physician expertise; Physician discouragement 

Incentives (financial or other); Trial beneficial to them; Hope for care; Receive extra care; Benefit future generations 

Provider attitudes; Communication / method of presentation; Physician beliefs about patient preference 

NR Excessive 

requirements of study 

NR NR 
Appendix F. Evidence Tables (continued) 

F-44 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Hunter, 

1987 

Patient; Provider; Study Design 

Experimentation; Treatment toxicity; Costs 

NR Physician's 

preference for a specific treatment or alternative therapy 

NR Comorbidity 

exclusion; Age exclusion; Functional status /Poor performance 

NR NR 

Kaluzny, 

1993 

Patient; Provider; Study design; Healthcare system 

Mistrust of research and medical system; Fear; Transportation; Family considerations; Language barrier; Job issues; Indirect costs; Limited education or low literacy; Socioeconomic conditions of inner-city communities 

NR Mistrust of 

researchers; Provider attitudes; Little time available per patient; Lack of interest in protocol studies (unless money); Lack of support staff 

Incentive Comorbidity 

exclusion; Length of study/visit structure; Late stage disease 

NR Lack of 

disseminatioof study opportunities to provider/ patient; Lack of language services; lacof support staff to facilitate protocol activity 
Appendix F. Evidence Tables (continued) 

F-45 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Kemeny, 

2003 

Patient; Provider 

Age*; Disease stage*; Number of comorbidities* 

NR Toxicity of 

treatment; Thought patient ineligible; Patient comorbid conditions 

NR NR NR NR 

Kemp, 

1984 

Patient NR Less control 

over health decisions 

NR NR NR NR NR 

Kornblith, 

2002 

Patient; Provider; Study design 

Transportation; Lack/ inadequate health insurance; Toxicity of treatment; Comorbidity; Patient unable to understand trial 

NR NR Provider 

attitudes; Communication/ method of presentation 

Comorbidity exclusion; Life expectancy 

NR NR 

Krailo, 

1993 

Study design 

NR NR NR NR Age exclusion; 

Treatment policies; Lack of available protocols 

NR NR 
Appendix F. Evidence Tables (continued) 

F-46 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Lee, 1999 Patient NR Willingness 

to take pills 

NR NR NR NR NR 

Lerman, 

1994 

Patient NR Impact of 

diagnosis on risk perception*; >HS education; if > HS education: marriage, unemployment, # of affected relatives; ≤HS education: age, employment; Age* 

NR NR NR NR NR 

Lewis, 

2003 

Patient Protocol 

exclusions 

NR NR NR Comorbidity 

exclusion; Functional status; Diagnostic test cut-off 

Life expectancy 

NR 

Ling, 2000 Study 

design 

NR NR NR NR Entry criteria NR NR 
Appendix F. Evidence Tables (continued) 

F-47 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

McCaskillStevens, 

1999 

Patient; Provider; Study design; Healthcare system 

Mistrust of research and medical system; Fear; Cultural barriers; Poverty / cost to patient 

Culturally relevant education about clinical trials 

Mistrust of researchers; Lack of physician awareness of trials; Insufficient resources; Lack of proven therapy 

NR Length of 

study/visit structure 

NR Lack of 

minority personnel; Lack of minority investigatorsLack of disseminatioof study opportunities to provider/ patient 

MillonUnderwood, 

1993 

Patient Mistrust of 

medical research; Perceived harms of clinical trial participation 

Hope; Altruism; Perceived efficacy 

NR NR NR NR NR 

Moinpour, 

2000 

Patient; Study design 

Mistrust of research 

NR NR NR Lack of time to 

establish presence in communities 

NR NR 
Appendix F. Evidence Tables (continued) 

F-48 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Mouton, 

1997 

Patient Mistrust of 

research and medical system*; Perception of researchers not caring about patient 

Preference for study's Principal Investigator to be Black; Perception that it is better to be treated by research doctors 

NR NR NR NR NR 
Appendix F. Evidence Tables (continued) 

F-49 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Outlaw, 

2000 

Patient; Provider; Study design 

Mistrust of medical research; Fear; Language barriers; cultural barriers; Indirect costs; Religious/ spiritual beliefs; Lack of education (culturally relevant) about clinical trials; Perceived harms of trial participation; Lack of comfort with technology care; Lack of family support; Perceived discrimination; Lack of access to health care 

NR Mistrust of 

researchers; Provider attitudes; Lack of minority providers; Lack of support staff; Additional time required; concern in patient age frailty; Discomfort 

NR Complexity of 

clinical trials; Late stage disease 

NR NR 
Appendix F. Evidence Tables (continued) 

F-50 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Paskett, 

2002 

Patient; Provider; Study design 

Mistrust of research & medical system; Discomfort; Transportation; Unfamiliar physician; Costs; Lack /inadequate health insurance; Lack of education about trials; Perceived harms of participation 

NR Logistical 

burden; Cost to patient; Perceived treatment risk; Established referral patterns 

NR Eligibility NR NR 

Pinto, 

2000 

Patient; Provider; Study design; Healthcare system 

Mistrust of medical research; Fear;Cultural barriers; Lack of education about trials; Perceived harms of participation; Physicians do not offer trials; Cost 

Culturally relevant education about clinical trials 

Provider attitudes; Mistrust of researchers; Cultural barriers; Lack of provider awareness about trial; Lack of time; Racial bias 

Incentive (financial or other) 

Comorbidity exclusion; Length of study/visit structure; Protocols too complex; Randomization 

NR Lack of 

cultural competence among provider/stafLack of disseminatioof study opportunities to provider/ patient; Lack of access to institution 
Appendix F. Evidence Tables (continued) 

F-51 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

RandallDavid, 

2001 

Patient; Provider; Healthcare system 

Mistrust of medical research; Fear; Lack of knowledge about origins of cancer; Transportation; Time commitment; Family considerations; Religious/ spiritual beliefs; Lack of education about trials; Perceived harms of trial participation 

Altruism; Incentives (reimbursement); Perceived benefit of trial participation 

Mistrust of researcher; Communication / method of presentation 

NR NR NR Lack of 

disseminatioof study opportunities to provider/ patient 
Appendix F. Evidence Tables (continued) 

F-52 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Roberson, 

1994 

Patient Mistrust of 

medical research; Fear; Access to information; Time commitment; Language barriers; Cultural barriers; Lack of education about trials; Do not like to get involved; Lack of information / awareness 

Incentives; Culturally relevant education about trials; Perceived benefits of trial participation 

NR NR NR NR NR 
Appendix F. Evidence Tables (continued) 

F-53 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Robinson, 

1996 

Patient; Provider; Healthcare system 

Mistrust of research/ medical system; Fear; Lack of knowledge about origins of cancer; Lack of education about trials; Perceived harms of trial participation; Concerns about randomization 

Incentives; Culturally relevant education about trials; Perceived benefits of trial participation 

Mistrust of researchers; Provider attitudes; Communication/ method of presentation 

Competent/ experienced physician/ researcher; Compassionate provider 

NR NR Lack of 

disseminatioof study opportunities to provider/ patient 

Sateren, 

2002 

Patient; Provider; Healthcare system 

Lack/inadequate health insurance*; Being Black male aged 30-59 years*; Asian adults / Latino / Hispanic adults* 

Living in suburban area; Higher SES 

NR Higher number 

of oncology specialists 

NR NR NR 
Appendix F. Evidence Tables (continued) 

F-54 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Sears, 

2003 

Patient; Study design 

Time commitment; Willingness to travel, Stress; > 65 

years old; minority; Not married 

NR NR NR Medication 

exclusion; Metastatic disease 

NR NR 

Simon, 

2004 

Patient; Provider; Study design 

Leaving care of physician to participate in trial; Lack/ inadequate health insurance* 

NR Patient likely 

to be noncompliant; No protocol available for disease stage 

NR Age exclusion; 

Medication exclusion 

NR NR 

Spaight, 

1984 

Patient; Provider; Study design 

Age; Transportation; Inability to understand protocol; Patient resistance or potential noncompliance; Cost 

NR NR Advancement 

of cancer field 

Participation requires too much travel; Failure to use most effective drug; Too many lab tests 

NR NR 

Thornquist

, 1991 

Patient Age (50-54; 

65-69)* 

Age (60-64; 55-59)* 

NR NR NR NR NR 
Appendix F. Evidence Tables (continued) 

F-55 

Evidence Table 5-3: Results of Studies Investigating the Documented Barriers and Promoters of Participation of Underrepresented Prevention and Treatment Trials (Key Question 5). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Patient Barrier Associated with Decrease in Reported Enrollment 

Patient Promoter Associated with Increase in Reported Enrollment 

Provider Barrier Associated with Decrease in Reported Enrollment 

Provider Promoter Associated with Increase in Reported Enrollment 

Study Design Barrier Associated with Decrease in Reported Enrollment 

Study Design Promoter Associated with Increase in Reported Enrollment 

Healthcare System Barrier Associated with Decreasin Reported Enrollment 

Twelves, 

1998 

Patient; Provider 

Age* Place of 

initial treatment* 

NR Surgeons with 

high case load*; Referral to an oncologist* 

NR NR NR 

Woods, 

2002 

Patient; Provider; Study design 

Mistrust of medical research; Job issues; Transportation problems; Time commitment; Family considerations; Perceived harms of trial participation; Not ready to quit smoking 

Transportation support; Incentives; Perceived benefit of trial participation; Support/ encouragements/ prayer; Certainty of receiving actual medication 

Training in communicating with patients; Communication/ method of presentation 

NR NR Length of 

study/visit structure; Reminder phone calls 

NR 

* Statistically significant HS = High school NR = Not reported PSA = Prostate specific antigen test SES = Socioeconomic status 
Appendix F. Evidence Tables (continued) 

F-56 

Evidence Table 5-4. Quality of Studies Investigating the Documented Barriers and Promoters of Participation 

of Underrepresented Populations in Cancer Prevention and Treatment Trials (Key Question 5). 

Author, 

Year 

Representativenessa Justificationb Biasc Reliability & 

Validityd Analysise

 AdamsCampbell, 

2004 

 z { NA 

Advani, 

2003 z { z { 

Barofsky, 

1979 z z 

 

Berman, 

1998 

 

{ { { 

Bieniasz, 

2003 { 

 

NA 

Brewster, 

2002 z { 

Broome, 

2001 

 

NA 

Broome,2

003 

 

NA 

Brown, 

2000 

 

{ 

Brown, 

2003 z { { 

Chen, 

2000 z { NA NA NA 

Comis, 

2003 z { { 

DienerWest z { NA NA NA 

Ford, 

1998 { NA NA NA 

Ford, 

2003 z { z z 

Fouad, 

2000 z 

 

NA 
Appendix F. Evidence Tables (continued) 

F-57 

Evidence Table 5-4. Quality of Studies Investigating the Documented Barriers and Promoters of Participation 

of Underrepresented Populations in Cancer Prevention and Treatment Trials (Key Question 5). (continued) 

Author, 

Year 

Representativenessa Justificationb Biasc Reliability & 

Validityd Analysise

Fouad, 

2001 

 

NA 

Green, 

2000 

 

NA 

Grunfeld, 

2002 { { 

 

NA 

Hunter, 

1987 

 

 z NA 

Kaluzny, 

1993 { NA NA NA 

Kemeny, 

2003 

 

{ { 

Kemp, 

1984 

 

{ { 

Kornblith, 

2002 z { { { 

Krailo, 

1993 z NA NA NA 

Lee, 1999 

 

{ { 

Lerman, 

1994 z z { { 

Lewis, 

2003 { NA NA NA 

Ling, 

2000 { z { { 

McCaskillStevens, 

1999 

 

{ NA 

MillonUnderwood, 

1993 

 

{ 

Moinpour, 

2000 { { NA NA NA 
Appendix F. Evidence Tables (continued) 

F-58 

Evidence Table 5-4. Quality of Studies Investigating the Documented Barriers and Promoters of Participation 

of Underrepresented Populations in Cancer Prevention and Treatment Trials (Key Question 5). (continued) 

Author, 

Year 

Representativenessa Justificationb Biasc Reliability & 

Validityd Analysise

Mouton, 

1997 

 

{ z 

Outlaw, 

2000 

 

{ { 

Paskett, 

2002 

 

{ 

Pinto, 

2000 { 

 

NA 

RandallDavid, 

2001 

{ { z NA 

Roberson, 

1994 z { 

Robinson, 

1996 { { { { NA 

Sateren, 

2002 { NA NA NA 

Sears, 

2003 z 

 

NA 

Simon, 

2004 z { { { 

Spaight, 

1984 { NA { NA 

Thornquist, 

1991 

 

{ z 

Twelves, 

1998 { NA NA NA 

Woods, 

2002 

 

NA 
Appendix F. Evidence Tables (continued) 

F-59 

Evidence Table 5-4. Quality of Studies Investigating the Documented Barriers and Promoters of Participation 

of Underrepresented Populations in Cancer Prevention and Treatment Trials (Key Question 5). (continued) 

 z Excellent: > 75% quality score 

Good: 50-74% quality score 

Fair: 25-49% quality score

 { Poor: <25% quality score 

NA = Not applicable 

a

 Representativeness: Score was based on a total maximum score of 8 points. This included assessment of how well the study 

described the study setting and population (2 points), inclusion/exclusion criteria (2 points), non-participating patients (2 points), and 

patient characteristics at enrollment (2 patients). 

b

 Justification : Percentage score was based on a total maximum score of 6 points. This included whether the study design was 

based on a conceptual model (2 points), whether the research question and objectives were stated (2 points), and whether the 

target population was adequately justified (2 points). 

c

 Bias: Percentage score was based on a total maximum score of 4 points. This included the response rate or proportion of eligible 

people that actually completed the questionnaire (2 points), and the description of how study participants were selected (2 points). d

 Reliability and Validity: Percentage score was based on a total maximum score of 6 points. This included intra-rater reliability (2 

points), inter-rater reliability (2 points), and validation of the survey instrument (2 points) e

 Analysis: Percentage score was based on a total maximum score of 4 points. This included assessment of whether the study was 

planned to have adequate power to detect differences within groups (2 points), and whether the study was planned to have 

adequate power to detect changes within groups. 
Appendix F. Evidence Tables (continued) 

F-60 

Evidence Table 6-1. Characteristics of Studies on the Effects of Attitudes and Perceptions of Healthcare Providers on the Effica

Strategies for Recruitment of Underrepresented Populations into Cancer Prevention and Treatment Trials (Key Question 6). 

Author, Year 

Sample Size 

Study Setting 

Target Population of Study 

Targeted Underrepresented Population 

Study Design 

How Measured 

Type of Cancer Studied 

Study Objective(s) 

Benson, 

1991 

252 Community Physicians NR Descriptive Mailed 

survey 

NR Investigate the reaso

physicians do not plpatients in clinical tr

Fallowfield, 

1997 

357 Community Physicians NR Descriptive Mailed 

survey 

All Compare results of 

orientation profile usECOG study with thobtained from surveBritish oncologists. 

Kemeny, 

2003 

154 Hospital 

inpatient 

Patients; Participants 

Elderly Case-control Telephone 

survey; Interview 

Breast A. Test the extent to 

eligible breast canceolder than 65 years offered trials compayounger patients. B. Assess reasons woncologists chose na trial to their older pand why patients chrefused to participat

Kornblith, 

2002 

156 Hospital 

inpatient 

Physicians Elderly Descriptive Mailed 

survey 

Breast Test the magnitude 

to recruitment amonbreast cancer patienphysician perspectiv

McCaskillStevens, 

1999 

90 Community Physicians Minorities Descriptive/ 

Qualitative 

Openended questionnaire 

Breast, Colorectal, Lung, Prostate 

Identify barriers and to African American cancer trials. 

Paskett, 

2002 

196 (in 1993); 168 (in 1996) 

Community Physicians Rural CCT Mailed 

survey 

Breast, colorectal 

A. Evaluate a Rural Care Intervention. B. Assess rural-basecare physician knowattitudes, and beliefs patient and physiciato accrual to cancer trials. 
Appendix F. Evidence Tables (continued) 

F-61 

Evidence Table 6-1. Characteristics of Studies on the Effects of Attitudes and Perceptions of Healthcare Providers on the Effica

Strategies for Recruitment of Underrepresented Populations into Cancer Prevention and Treatment Trials (Key Question 6). (co

Author, Year 

Sample Size 

Study Setting 

Target Population of Study 

Targeted Underrepresented Population 

Study Design 

How Measured 

Type of Cancer Studied 

Study Objective(s) 

Pinto, 2000 73 Community Physicians; 

Investigators 

Minorities Descriptive/ 

Qualitative 

Focus groups 

All Identify barriers to a

minority patients & dsolutions to these bafrom physician's per

Richardson, 

1986 

59 Community Physicians NR Descriptive Mailed 

survey 

NR Assess attitudes and 

perceptions of mediconcologists regardintrial participation. 

Simon, 

2004 

319 Hospital 

inpatient 

Patients; Participants 

African Americans 

Descriptive Survey Breast Understand factors a

with accrual to breasclinical trials. 

Spaight, 

1984 

23 Community Physicians NR Descriptive/ 

Qualitative 

Face-toface interview 

NR Assess factors influe

clinical trials participthe perspective of moncologists and hematologists. 

CCT = Concurrent controlled trial ECOG = Eastern Cooperative Oncology Group NR = Not reported 
Appendix F. Evidence Tables (continued) 

F-62 

Evidence Table 6-2. Target Population Characteristics of Healthcare Providers Discussed in Studies on the 

Efficacy or Effectiveness of Strategies for Recruitment of Underrepresented Populations into Cancer 

Prevention and Treatment Trials (Key Question 6).

Author, Year U.S.or 

NonU.S. 

Study 

Mean 

Age, y 

Age 

Range, y 

 

% Male % AA % 

AIAN 

% Cauc % 

Elderly 

Benson, 1991 U.S. NR NR NR NR NR NR NR 

Brown, 2003 U.S. NR NR 33 49 NR 51 100 

Fallowfield, 1997 U.S. NR NR NR NR NR NR NR 

Kemeny et al, 2003 U.S. NR 48 to 74 NR NR NR NR 50 

Kornblith, 2002 U.S. NR NR 69 3 3 87 7 

McCaskill-Stevens, 1999 U.S. NR NR NR 1 0 0 NR 

Paskett, 2002 U.S. 49 NR 84 NR NR NR NR 

Pinto, 2000 U.S. NR NR NR NR NR NR NR 

Richardson, 1986 U.S. NR NR 1 NR NR NR NR 

Simon, 2004 U.S. 55 NR NR 32 NR 57 NR 

Spaight, 1984 U.S. NR 33 to 65 1 NR NR NR NR 

AA = African American 

AIAN = American Indian/Alaska Native 

Cauc = Caucasian 

NR = Not reported 
Appendix F. Evidence Tables (continued) 

F-63 

Evidence Table 6-3. Quality of Studies on the Effects of Attitudes and Perceptions of Healthcare Providers on 

the Effectiveness of Strategies for Recruitment of Underrepresented Populations into Cancer Prevention and 

Treatment Trials (Key Question 6). 

Author, 

Year Representativenessa

 Justificationb Biasc Reliability & Validityd Analysise

Benson, 

1991 

 

{ { 

Fallowfield, 

1997 

z { { 

Kemeny, 

2003 

z 

 

{ { 

Kornblith, 

2002 

z { { { 

McCaskillStevens et 

al., 1999 

 

{ N/A 

Paskett, 

2002 

 

{ 

Pinto, 

2000 

{ 

 

N/A 

Richardson 

1986 

{ { { { 

Simon, 

2004 

z { { { 

Spaight, 

1984 

{ { N/A 

N/A= Not Applicable 

z Excellent: 75-100% quality score 

 Good: 50-74% quality score

 

 Fair: 25-49% quality score 

{ Poor: <25% quality score 
Appendix F. Evidence Tables (continued) 

F-64

Evidence Table 6-3. Quality of Studies on the Effects of Attitudes and Perceptions of Healthcare Providers on 

the Effectiveness of Strategies for Recruitment of Underrepresented Populations into Cancer Prevention and 

Treatment Trials (Key Question 6). (continued) 

a - Representativeness: Score was based on a total maximum score of 8 points. This included assessment of how well the study 

described the study setting and population (2 points), inclusion/exclusion criteria (2 points), non-participating patients (2 points) 

and patient characteristics at enrollment (2 patients). 

b - Justification : Percentage score was based on a total maximum score of 6 points. This included whether the study design was

based on a conceptual model (2 points), whether the research question and objectives were stated (2 points), and whether the 

target population was adequately justified (2 points). 

c - Bias: Percentage score was based on a total maximum score of 4 points. This included the response rate or proportion of 

eligible 

people that actually completed the questionnaire (2 points), and the description of how study participants were selected (2 points). 

d -Reliability and Validity: Percentage score was based on a total maximum score of 6 points. This included intra-rater reliability 

(2 points), inter-rater reliability (2 points), and validation of the survey instrument (2 points) 

e - Analysis: Percentage score was based on a total maximum score of 4 points. This included assessment of whether the study 

was planned to have adequate power to detect differences within groups (2 points), and whether the study was planned to have 

adequate power to detect changes within groups. 

 
Appendix F. Evidence Tables (continued) 

F-65 

Evidence Table 6-4. Provider Barriers/Promoters on the Efficacy or Effectiveness of Strategies for Recruitment of UnderrepreseCancer Prevention and Treatment Trials (Key Question 6). 

Author, Year 

Type of Barrier/ Promoter 

Provider Barrier/ Promoter Associated with Decrease in Enrollment 

Provider Barrier/ Promoter Associated with Increase in Enrollment 

Study Design Barrier/ Promoter Associated with Decrease in Enrollment 

HealthPromoDecre

Benson, 

1991 

Provider Communication/ method of 

presentation; Need to obtain informed consent; Follow-up time; Insufficient resources 

 Age exclusion; Strict 

protocols 

Fallowfield, 

1997 

Provider Provider attitudes; 

Communicating/ method of presentation; Perceived patient intelligence as low 

Social class (i.e., working class easier to approach) 

Disease stage or location 

Kemeny, 

2003 

Provider; Patient 

Patient age*; Disease stage (Stage II)*; Comorbidity*; Provider attitudes; Toxicity of treatment; Ineligibility 

Kornblith, 

2002 

Provider; Patient; Study design 

 Provider attitudes; 

Communication/ method of presentation 

Comorbidity exclusion; Life expectancy 

McCaskillStevens, 

1999 

Provider; Patient; Study design; Healthcare system 

Mistrust of researchers; Lack of provider awareness of trials; Insufficient resources; Lack of proven therapy 

 Length of study/visit 

structure 

Lack oLack oLack oopport

Paskett, 

2002 

Provider; Patient 

Provider attitudes; Logistics; Cost; Referral patterns; Treatment risk; 

 Eligibility 

Pinto, 2000 Provider; 

Patient; Study design; Healthcare system 

Provider attitudes; Mistrust of researchers; Cultural barriers; Lack of provider awareness about trial; Lack of time; Racial bias 

Incentive (financial or other) Comorbidity exclusion; 

Length of study/visit structure; Protocols too complex; Randomization 

Lack oamong Lack oopportLack ocondu

Richardson, 

1986 

Provider Patient age Patients with regionalized 

disease*; Physician training*; Institutional affiliation* 
Appendix F. Evidence Tables (continued) 

F-66 

Evidence Table 6-4. Provider Barriers/Promoters on the Efficacy or Effectiveness of Strategies for Recruitment of UnderrepreseCancer Prevention and Treatment Trials (Key Question 6). (continued) 

Author, Year 

Type of Barrier/ Promoter 

Provider Barrier/ Promoter Associated with Decrease in Enrollment 

Provider Barrier/ Promoter Associated with Increase in Enrollment 

Study Design Barrier/ Promoter Associated with Decrease in Enrollment 

HealthPromoDecre

Simon, 

2004 

Provider; Patient 

Potential patient noncompliance; No protocol available for disease stage 

 Age exclusion*; Medication 

exclusion* 

Spaight, 

1984 

Provider; Patient; Study design 

Patient age; Cost; Potential patient non-compliance; Lack of patient understanding about trial; Comorbidity 

Advancement of cancer medicine 

Toxicity and side effects; Protocol (i.e., requires too much travel; failure to use most effective drug; too many lab tests) 

*Statistically significant