A Pilot Investigation to Examine the Effect of a Multi-Media, Computer Based Tool (Talking Touchscreen) on Enrollment in Adult Oncology-Specific Clinical Trials at an Academic Medical Center
Conditions: Lung Cancer, Gastric Cancer, Pancreatic Cancer
Sponsor: University of Chicago

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PPrroottooccooll  
 
Study Title: 
 A pilot investigation to examine the effect of a multi-media, computer based tool 
(Talking Touchscreen) on enrollment in adult oncology-specific clinical trials at an 
academic medical center 
Institution Name 
The University of Chicago 
 
Principal 
Investigator 
Contact 
Information: 
- Full address  
- Phone No. 
- Fax  No. 
- e-mail address 
Blase N. Polite, MD, MPP, Section of Hematology/Oncology 
Assistant Professor of Medicine 
Center for Gastrointestinal Oncology 
Center for Interdisciplinary Health Disparities Research 
The University of Chicago 
5841 S. Maryland Avenue, MC 2115, Suite G109 Chicago, IL 60637 (773) 702-2069 
(vm) 
(773) 834-3834 (Fax) 
bpolite@medicine.bsd.uchicago.edu 
 
Co-Investigator 
Toni M. Cipriano-Steffens, MA, Communications and Research Manager, Section 
of Hematology/Oncology,  
The University of Chicago 
Center for Interdisciplinary Health Disparities Research 
The University of Chicago 
5841 S. Maryland Avenue, MC 2115, Suite G109 Chicago, IL 60637  
(773) 702-3902 (vm) 
(773) 834-3834 (Fax) 
Co- Investigator 
Elizabeth A. Hahn, Associate Professor 
Department of Medical Social Sciences 
Feinberg School of Medicine 
Northwestern University 
633 N. St. Clair St., Suite 1900 
Chicago, IL 60611 
e-hahn@northwestern.edu 
(312) 503-9804 
 

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Section #2- Core Protocol 
 
2.1 Objectives & 
Hypotheses  
 
 
 
 
i. Objectives/Specific Aims 
Clinical trials lead to effective treatments for cancer patients. 
Hindering the success of these treatments are several factors, of which 
patients’ attitudes play an important role. Low rates of participation have 
and will continue to inhibit medicine’s progress in developing these 
lifesaving therapies. 1-3  
 
Enrollment in therapeutic cancer trials (CT) is low for minority 
populations4-7. Evidence shows African Americans (AA) are 30% less 
likely than whites (W) to enroll in clinical trials; a disparity that is 
worsening over time. Rather than conceptualizing race or ethnicity as a 
global factor influencing health behavior outcomes, as has been the 
norm,8,9 we chose to treat it as a descriptive-level variable through which 
other psychosocial variables coalesce to produce the perceived race-
outcome effect.10,11 Specifically, our intervention will evaluate changes in 
patient knowledge  and  beliefs about clinical trials within the context of 
the Behavioral Model for Vulnerable Populations 12.  
 
There is an urgent need for hypothesis-driven, quantitative studies 
with enrollment to trial as the primary outcome variable. 13 Although 
many interventions have been tested to overcome barriers to improve 
cancer health outcomes and disparities, they have been met with mixed 
success14,15. Overcoming barriers to positive health outcomes is a priority 
as established by the Agency for Healthcare Research and Quality 
(AHRQ), which released an Evidence Report on cancer clinical trials16. to 
the report recommends funding of research that documents and 
demonstrates promising practices in cancer clinical trial recruitment and 
retention efforts, and in particular, efforts to involve members of 
underserved minority, non-English speaking, poor and elderly 
communities. Specifically, the report’s conclusions are that there is 1) 
substantial uncertainty about effective approaches for cancer clinical 
trials recruitment, especially among minority populations; and 2) a need 
for further investigation of effective communication and trust-building 
strategies, including research on the best approaches for disseminating 
information about clinical trials, both at community levels and at points of 
interaction with potential participants. The report also identified increased 
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. 
 
To that end, our focus will be on the use of a proven and effective 
communication strategy aimed at improving patient knowledge of 

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available clinical trials leading to change in behavior to increased 
enrollment in clinical trials. Electronic health interventions17,18, including 
tablet computer-based interventions19 have shown promise in a variety of 
settings addressing barriers in health literacy20,21 and patient-provider 
communication22, among others. The Talking Touchscreen (TT) is a 
multimedia program using text, graphics and audio, that is installed on a 
tablet computer. It was developed and pilot tested among 410 English- 
and 414 Spanish-speaking patients, where its acceptability to self-
administer health measures was established.23,24 
 
We propose the following four specific aims for a TT pilot intervention: 
 
Specific Aim 1: To determine whether TT delivery of educational clinical 
trial information can improve clinical trial knowledge overall and within 
low literacy populations, in particular. 
Specific Aim 2: To determine the feasibility and acceptability of TT 
technology in a busy urban academic medical center oncology clinic. 
Specific Aim 3: To evaluate the proportion of patients who sign consent 
to enroll in a cancer-specific treatment clinical trial when one is offered, 
compared to historical data. 
Specific Aim 4: To evaluate the associations between socio-
demographics, health literacy, patient-reported outcomes (anxiety, 
depression, social support) and clinical trial enrollment, using the 
Behavioral Model for Vulnerable Populations.25  
 
We hypothesize that the TT educational tool will increase patient 
awareness and knowledge of clinical trials through the use of 
patient friendly technology in the immediate pre-visit period and will 
thereby increase clinical trial enrollment both by making patients 
more receptive to a clinical trial when discussed by their provider 
and increasing the likelihood that they will raise the issue of clinical 
trials with their provider. The effect will be most robust among 
those with low health literacy. 
 
2.2 Background & 
Rationale, 
Significance of 
Selected Topic & 
Preliminary Data  
 
ii. Significance and Background 
 
Clinical Trial Participation-General 
Cancer is the second leading cause of death in the United States 
[US]. Over the past 15 years, the overall incidence of new malignancies 
has remained relatively stable; however the mortality rates over that time 
period have declined markedly.26 Although the reasons for this success 
are manifold a significant portion of the credit belongs to the development 

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of novel therapeutic agents, which are brought to the market through 
patient participation in clinical trials. Clinical cancer research continues to 
be robust: a recent search of clinicaltrials.gov showed 127,886 registered 
clinical trials, of which 34,689 were related to cancer care [27.1%]. 
However, the pace of new drug development has continued to be slow. 
The US Food and Drug Administration approved four anti-cancer agents 
in 2010 and seven in 2011. 
 
As can be inferred from the high number of clinical trials to approved 
drug ratio, there are many logistical problems related to clinical trial 
administration that are becoming more prominent. Over the past 50 
years, the length of time that it takes to bring a new drug to the market 
has lengthened from 8 years to nearly 15.27 This is partially due to 
increased regulations and safety monitoring, although death due to 
toxicity has not decreased during this time period.27 The cost of bringing 
a new drug to the market has increased dramatically over the past few 
decades and now tops one billion US dollars, leading to increased 
market prices and healthcare costs.28 Phase III trials can often take a 
decade to complete and a significant portion of National Cancer Institute 
[NCI] sponsored adult oncology Phase III trials are unable to meet their 
accrual goals.29  
 
Improving the efficiency of clinical trial design and boosting enrollment 
in therapeutic adult oncology trials is a major initiative of the NCI. To this 
effect in recent years they have introduced the Community Clinical 
Oncology Program, the NCI Community Cancer Centers Program and 
the Minority-Based Community Clinical Oncology Program in an attempt 
to broaden the reach of clinical trials. However, despite the estimation 
that 20% of adult cancer patients are eligible to participate in a clinical 
trial, only 3-5% of patients nationwide are enrolled in a trial.30 Lessons 
can certainly be learned from colleagues in pediatric oncology, where 
data from the national pediatric cancer clinical trials groups in the US 
show that more than half of children with cancer in the US are enrolled in 
a clinical trial and the cure rate for children with cancer in the US now 
exceeds 80%.31 
  
Clinical Trial Participation-Race/Ethnicity 
Enrollment in therapeutic clinical trials is low, particularly so for 
minorities4-7. In a cross-sectional population-based study of over 37,000 
patients participating in NCI-sponsored clinical trials in multiple cancer-
sites over a 2 year period, only 1.3% of African-Americans enrolled in a 
clinical trial. Overall, African-Americans (AA) were 30% less likely than 
whites (W) to enroll (OR 0.71; 95%CI:0.68-0.74).7 Additional 
retrospective chart-based work in lung cancer suggests that even among 
those deemed eligible for a clinical trial, AA patients are 50% less likely 
to enroll in clinical trials32, a worsening trend for which the reasons are 
not clear. 

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Previous physician survey-based research in breast cancer suggests 
that African-Americans are over 60% less likely to be offered a clinical 
trial.33 This is mainly due to physician determined ineligibility based on 
patients’ comorbidities and overall performance status. When patients 
were offered clinical trials, there were no differences in enrollment by 
race; however, only 33% of all patients offered a trial agreed to 
participate with patient refusal listed as the main reason33. A similar 
analysis at Howard University Medical center also suggested that patient 
comorbidities rendered a large portion of their African-American cancer 
population ineligible for clinical trials34. Additional retrospective chart-
based work in lung cancer suggests that even among those deemed 
eligible for a clinical trial, African-American patients are 50% less likely to 
enroll in clinical trials32. When racial and ethnic minority populations do 
enroll in clinical trials, disparities in cancer outcome disappear. 35-39 
 
Barriers to Clinical Trial Enrollment: 
A survey of African-American physician members of the Cook County 
Physicians Association found that they perceive the major barriers to 
clinical trial enrollment among African-American patients to be: (1) Lack 
of patient awareness of trials, (2) patient mistrust, (3) patient burden from 
clinical trial enrollment, and (4) blind drug assignment.40 A recent 
systematic review found several barriers related to participating in clinical 
trials including feeling uninformed or inadequately informed, loss of 
decision-making control, and general feelings of uncertainty about trials. 
41 Interesting too are the findings from a frequently cited study 
investigating factors influencing enrollment in clinical trials with 40% of 
new cancer patients with access to a CT declining participation, which 
according to these authors, points to the need for continued efforts to 
educate both physicians and the public as to the value of clinical trials. 42 
Lending support to this need for increased knowledge about and 
awareness of clinical trials, our preliminary work showed the number one 
reason that patients did not consent to a trial if offered was that they felt 
overwhelmed by the information (56%).43  
 
Clinical Trial Accrual Interventions 
 
A systematic review published in 2006, which focused on 
recruitment of patients into randomized controlled cancer trials, found no 
studies that showed an improvement in clinical trial participation.44 These 
studies included easy to read versus standard consent form documents, 
and a study by Paskett and colleagues utilizing a multi-component, 
system level intervention which included lay and professional health 
educators providing community-based interventions. 45A more recent UK 
trial compared DVD-based information versus standard written 
information. There was a significant increase in clinical trial knowledge 
(p=0.007) and decrease in anxiety (p=0.011) in the intervention arm, but 
no difference in clinical trial participation which was quite high in both 

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arms (72% versus 76%). 46 In a recent randomized trial by Jacobsen and 
colleagues, intervention patients received a DVD which provided 
standard clinical trial information and also addressed common 
misperceptions and concerns about trials. The control group received the 
16-page NCI booklet l. Those in the DVD group showed a more positive 
attitude to clinical trials (p=0.016) and greater willingness to participate 
(p=0.011). 3 In this trial, 9% of the patients were non-white and 66% were 
college educated.  
 
Less is known about interventions directed at underrepresented 
populations. A systematic review of published studies, which focused on 
effectiveness of different strategies for recruitment of underrepresented 
populations into cancer trials, identified only 5 such studies (including the 
one by Paskett above). 47Only three found that interventions such as 
media campaigns and church-based project sessions improved accrual 
to cancer trials. One of the studies, which looked at the rate of enrollment 
of African-American men to the prostate, lung, colorectal and ovarian 
(PLCO) cancer screening trial, showed the greatest increase (3.9%) in 
participation in the most intensive, church-based intervention arm, which 
had the highest rate of face-to-face contact . The commonly shared 
characteristic between these studies was that they increased interaction 
time with participants through targeted messaging. The problem remains 
that few studies have investigated the effectiveness of strategies to 
recruit minority and ethnic populations to clinical trials. 
 
 
In light of the above, we agree completely with the following 
conclusions from the Agency for Healthcare Research and Quality 
technology report on Recruitment of Underrepresented Populations to 
Cancer Clinical Trials: 1) There is substantial uncertainty about effective 
approaches for cancer clinical trials recruitment, especially among 
minority populations. 2) There is a need for well-designed, 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. 3) 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.16  
 
An estimated 35% of new patients who seek care in medical 
oncology clinics at the University of Chicago are African-American. This 
statistic, along with one of the robust cancer clinical trial programs in the 
country, make us uniquely suited to meet the challenge put forth by the 
AHRQ and does so in a way that if successful, is exportable to other 
cancer centers around the country treating underrepresented 
populations. . 
 

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Low Health Literacy and Its Effect on Participation 
An estimated 90 million Americans have literacy rates below the high 
school level, implications of which are far reaching, and key to 
understanding poorer health outcomes in those populations most 
affected. Low health literacy too, is a potential explanation for poor 
clinical trial participation, which is linked to patients’ health knowledge 
and outcomes.21 Health literacy is “the degree to which individuals have 
the capacity to obtain, process, and understand basic health information 
and services needed to make appropriate health decisions.” This 
involves using a range of skills (e.g., reading, listening, speaking, writing) 
to perform health-related tasks.  According to the National Adult Literacy 
Survey, 21% of Americans have low literacy skills and another 27% have 
marginal literacy skills.52 Low health literacy has been correlated with 
lower rates of adherence with breast,53 colon,54 and cervical55 cancer 
screening and women with low health literacy were less likely to follow 
through on abnormal mammography results.55 In men with prostate 
cancer, low health literacy has also been correlated with diagnosis at a 
later stage56 and may limit understanding of complex information and 
patient participation in the shared decision making process.57  
 
Low health literacy affects physician-patient communication as 
doctors are often unable to communicate effectively with this population, 
due to a mismatch in the way physicians provide information and the way 
patients process information.22 Patients who are deficient in literacy skills 
may receive insufficient information for treatment decision-making and 
are often excluded from outcome evaluation in a clinical practice setting 
where patient-reported data are collected on forms.58-60 Several national 
organizations have recognized that low literacy creates barriers to 
healthcare,59,61 yet literacy skills are rarely assessed by healthcare 
providers and low literate patients are often uncomfortable disclosing 
their reading deficiencies.  
 
 
Although investigations of the effects of low literacy rates on 
participation in clinical trials is sparse 62, studies do suggest that the risk 
of poor health outcomes increased as low health literacy is often 
exacerbated by the inadequate and poorly communicated information 
about clinical trials 63-66 including a doctor’s reluctance to broach the 
subject of clinical trials with the patient. 67,68 Doctors also fail to recognize 
low literacy in patients as it is not usually apparent during casual visits to 
the doctor 69, and so when complications caused by cancer arise, low 
health literacy makes effective communication ever more tenuous. 
 
Using Proven Communication Strategies to Improve Low Health 
Literacy 
 
Work in the Health Communication field has identified the complexity 
of the exchange of messages within the medical field as a primary barrier 
to achieving positive patient health outcomes 66 as the physician-patient 

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encounter creates meaning subject to the perceptions and interpretation 
of each participant - patient and doctor.70 Understanding that information 
is power and that when some have access to facts others do not, 
inequality exists. The result: ineffective communication between patients 
and physicians leading to poorer health outcomes. Studies  have 
demonstrated that patients recall and comprehend as little as 50% of 
what was said by their physician.60 This puts patients with low health 
literacy at an increased risk of misunderstanding.  
 
 
One area effective in improving issues related to cancer care in 
patients across literacy levels, including increasing adherence to 
screening guidelines and understanding of the informed consent process, 
are multimedia interventions. 20,71Patients frequently seek information 
about their disease and treatment; 72-76 about 85% of patients identify 
information needs as important.74 Although use of the Internet is 
increasing, printed materials remain the most common source of 
information.77-80 Despite the importance of cancer information, research 
has consistently shown that patients and family members are dissatisfied 
with cancer education.75  
 
Improved quality of communication between patients and healthcare 
providers can have a positive effect on patient outcomes, including 
improved information recall,81 satisfaction,82-85 biological status,86 overall 
health-related quality of life (HRQL)87,88 and adherence to doctors’ 
recommendations.85 In breast cancer patients, satisfaction with 
communication increases when patients take a structured approach to 
preparing for the interaction with their doctor.89 A previous study showed 
that when oncologists addressed issues on a “question prompt sheet,” it 
promoted patient confidence to ask about prognosis, alleviated patient 
anxiety and reduced visit length.90 In addition, implementations of 
personal health records have shown that patients feel more empowered 
when they have access to this information.91 Interventions are needed to 
target important issues regarding patients’ willingness to engage in 
information seeking, such as cultural factors, knowledge about illness 
and disease, ability to prepare questions in advance and the ability to ask 
questions spontaneously.92  
 
Interactive health communication has the potential to reduce disease 
risk, improve HRQL, influence health services use and improve 
adherence.93 Computer-based education programs are acceptable to 
people of different ages, education levels, SES and ethnicity, and 
outcomes studies have demonstrated improvements in knowledge, 
HRQL, reduced hospitalizations, improved functional status, reduced 
pain, confidence in asking questions and self-efficacy.93 Visual and 
graphic presentations of cancer information have been shown to increase 
patient knowledge and satisfaction in a randomized clinical trial.94 
Multimedia interventions have proven effective in improving issues 

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related to cancer care in patients with low literacy including adhering to 
screening guidelines and the informed consent process.20 Computer-
assisted patient education is increasingly being implemented in clinical 
settings. In a small pilot study at an urban community health center, the 
handheld multimedia computer was well-received by patients, and was 
rated as more helpful than their previous education. 95 
 
Multimedia platforms appear promising for patient educational 
activities by offering better consistency and quality control of the 
message, and at the same time overcoming literacy and language 
barriers.96-98 A recent review identified 30 studies to compare multimedia 
and print health materials, with 56 outcomes evaluated.97 Multimedia led 
to better outcomes vs. print in 21 (38%) comparisons, with the remainder 
showing no differences (54%) or an advantage for print (9%). The 
authors of this review also noted that the types of multimedia varied 
widely and that there is a need for studies to compare “message-
equivalent” tools (same content, different format). Our proposed study 
will provide important information about the use of the TT for clinical trial 
education in clinical settings. The results will inform a future study to 
compare equivalent tools (paper vs. TT).  
 
The use of new information technologies has been recommended as 
a strategy for improving access to health information and for enhancing 
the quality of communication in healthcare delivery.99 The proposed 
study plans to use an interactive health communication tool as an 
intervention to target improvement in clinical trial enrollment in adult 
cancer patients and to study its use among patients with low health 
literacy through increasing patient knowledge of and changing beliefs 
about clinical trials within the context of the Behavioral Model for 
Vulnerable Populations.25 
 
 Theoretical Framework: The Behavioral Model for Vulnerable 
Populations 
The Behavioral Model was developed to understand why people use 
health services, and to assist in developing policies to promote equitable 
access to healthcare.10, 11 The model is illustrated in Appendix 1, and 
the specific domains to be measured in this proposed project are listed 
below the figure. Use of health services is a function of a predisposition 
to use health services, factors that enable or impede use, and the need 
for care. Health outcomes were added to the model in recognition that 
improved patient outcomes are explicit goals of effective health services 
delivery. Feedback loops were also added to emphasize the model’s 
dynamic and recursive nature. The model was recently revised to include 
domains (such as literacy) that are relevant to understanding health and 
health-seeking behavior of vulnerable populations.25  
 
The adapted model for vulnerable populations has been successfully 

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used to evaluate utilization and patient outcomes among homeless 
adults,12 to evaluate patients’ perceptions of their relationships with 
primary care practitioners,86 and to examine adherence to cervical 
cancer screening among publicly housed African American and Latino 
women.87 The model is consistent with approaches to enhance 
patient-centered care and improve patient outcomes through the 
use of interactive health communication strategies.62 Please see the 
Behavioral Model for Vulnerable Populations in Appendix 1. 
 
iii. Rationale 
a. Cancer Relevance 
More than ever before, we are entering an era of “personalized 
medicine”. New oncology drugs are targeting patients whose tumors 
have specific mutations or other molecular abnormalities, often with 
highly effective results. Patients with breast or gastric cancer whose 
tumors over-express Her-2/neu receive trastuzumab. Patients with lung 
cancer who have a specific mutation in the gene for the epidermal growth 
factor receptor (EGFR) receive erlotinib, and those with a rearrangement 
of the anaplastic lymphoma kinase (ALK) gene receive crizotinib. These 
are but a few of the recent additions to the cancer therapeutic 
armamentarium that have generated such enthusiasm about the 
possibility of personalized therapeutics. However, unless we include a 
diverse patient population in our trials, we will likely miss important 
signatures that lead to important future therapies that reflect our diverse 
patient population. By specifically targeting more vulnerable patient 
populations, this proposal, if successful, can lead to increased cancer 
therapeutic clinical trial enrollment and be used as a model for other 
researchers around the country including those in charge of the NCI 
Cancer Cooperative Groups. 
 
b. National Funding 
If successful, this project has tremendous opportunity for RO1 level or 
Program Level National Funding. As we point out in the text, the specific 
areas we are targeting were the very ones identified by AHRQ in their 
2005 report “Knowledge and Access to Information on Recruitment of 
Underrepresented Populations to Cancer Clinical Trials.” In addition, we 
have purposely designed this trial to utilize standardized resources (the 
NCI pamphlet, the PROMIS measures) so that it is readily exportable to 
other cancer centers across the country. In our opinion, the use of “home 
grown” messaging and measurements while methodologically appealing, 
limits the ability to export the intervention to other settings quickly. Finally 
the PI and Co-PI of this study are well situated to move the findings from 
this study to a more National level. Dr. Polite serves as Chair of the 
ASCO Health Disparities Advisory group and is a cadre member of the 
Alliance cooperative group (formerly CALGB, NCTTG, and ACOSOG) 
health disparities committee. Dr. Hahn has served in a leadership role on 
numerous AHRQ-, NIH- and foundation-funded projects and has 

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received funding from multiple National bodies including ACS, AHRQ, 
NCI, and NHLBI. This funding includes the use of the Talking 
Touchscreen technology which indicates that it has already been well 
received by National Funders. 
 
IV. Preliminary Studies 
 
A. University of Chicago Clinical Trial Study 
 
General Findings: Clinical Trial Participation at the University of 
Chicago 
Funding from an ACS-IRG (Polite BN) and an ASCO Young 
Investigator Award (Ray M) allowed us to perform a paired survey of 
physicians and 375 new patients (57% white and 34% African American) 
seen in the cancer clinics at the University of Chicago Medical Center 
from September 2008-May 2010 to determine oncologist and patient 
attitudes toward enrollment in therapeutic cancer clinical trials. 43Of the 
375 patients approached, 338 (90%) agreed to participate and returned 
their survey forms. 
 
 In terms of health literacy (using one question health literacy 
screener100 with those “quite” and “extremely confident” filling out medical 
forms classified as having high health literacy) 63% of the sample had 
high health literacy and 37% low health literacy. Whites were more likely 
than AA to have high health literacy (79% vs. 57%; p<0.0001) 
 
Knowledge of clinical trials in general, differed significantly by both 
race and health literacy status. 
 
 High vs. Low HL: 77% vs. 48% (p<0.0001) 
 White vs. AA: 83% vs. 56% (p<0.0001) 
 
Clinical Trial Participation 
As shown in Table 1 below, overall 10% of our patients signed 
consent for a therapeutic clinical trial with African American patients more 
likely to sign consent. When a trial is available and offered, 41% of all 
patients and 63% of our African American patients sign consent. Those 
with higher health literacy are more likely to sign consent and to sign 
when offered. 
 
 
 
 
 
 
 
 

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Table 1: Clinical Trial Participation 
 
All 
W 
AA 
p-value 
HHL 
LHL 
p-
value 
Signed 
Consent 
10% 
10% 18% 
0.07 
12% 
7% 
0.2 
Clinical 
Trial 
Available 
57% 
61% 46% 
0.06 
58% 
54% 
0.69 
Offered 
if 
Available 
35% 
36% 31% 
0.7 
37% 
30% 
0.47 
Signed if 
Offered 
41% 
37% 63% 
0.2 
42% 
33% 
0.6 
W-White; AA-African American; HHH-High Health Literacy; LHL-Low Health Literacy 
 
To better understand the findings regarding African American race 
and health literacy, we ran a multivariable logistic regression model that 
controlled for both variables. As displayed in Table 2, when controlling 
for health literacy, AA are 2 times more likely than whites to enroll in a 
clinical trial. Similarly, those with high health literacy are 2.5 times as 
likely to enroll as those with low health literacy, controlling for race.  
 
Table 2-Signed Consent: Logistic Regression Models 
 
OR 
(bivariate) 
95% CI 
OR 
(multivariable
) 
95% CI 
AA:White 
1.9 
0.9-3.7 
2.1 
0.8-5.2 
HHL:LHL 
1.8 
0.6-4.9 
2.5 
0.8-7.8 
 
These data are consistent with our hypothesis that low health literacy 
is a potential barrier to trial participation. These results also suggest that 
the impact may be particularly helpful for our African American patients 
since low health literacy is an intervenable factor which may be 
dampening what appears to otherwise be enthusiastic support for trial 
participation in our patient population. 
 
Barriers to Participation 
The number one reason that patients did not consent to a trial if 
offered was that they felt overwhelmed by the information (56%). 
Measured barriers which correlated with not signing consent if offered 
were lack of social support (p=0.05), lack of emotional support (p=0.01), 
high levels of anxiety (OR 0.51; 95% CI 0.13-1.87) and high levels of 
depression (OR 0.45;95% CI 0.09-2.08). Despite our a priori hypothesis 
that physician trust would play an important role, no measure of 
physician/institution trust predicted clinical trial enrollment at the 
University of Chicago.  
 

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B. General Findings: Talking Touchscreen Technology in 
Vulnerable Populations  
The Talking Touchscreen [TT] is a multimedia program using text, 
graphics and audio that is installed on a tablet computer. It was 
developed and pilot tested among 410 English- and 414 Spanish-
speaking cancer patients, where its acceptability to self-administer health 
measures was established.23,24  Its utility for self-administration of a  
health literacy measure was then tested among 610 patients in four 
separate primary care clinics in the Chicago area.101 The internal 
consistency reliability coefficients for each of the six health literacy item 
subsets were all high [range 0.83-0.91]. The tool was well accepted by 
the participants; 92.5% of participants reported no difficulty using the TT; 
96.7% of participants required no help or a little help from study 
personnel to use the TT; >95% of participants rated the design elements 
of the TT as good, very good or excellent; >95% of the participants rated 
their experience as the same or better than expected and would 
recommend participation to other people.102 The TT is well accepted 
among individuals who are computer naïve and have low literacy.102 It 
can be adapted to provide complex information about diseases and 
treatments in simple and easy to understand terms using text, pictures, 
and audio, and has broad research potential in clinical cancer care. 
Below is a list of completed and ongoing studies from our group utilizing 
this technology. 
 
Multimedia Health Information Technology (HIT) Programs for 
Vulnerable Patients (R01-HS010333, ACS #TURSG-02-069: Hahn, PI). 
In response to national initiatives, we received funding to improve 
outcomes measurement in low literacy patients and to validate an 
innovative HIT (to be used in this proposal). We developed the “Talking 
Touchscreen” (TT), a bilingual multimedia program that allows patients 
with varying literacy, language and computer skills to self-administer 
questionnaires.58,103 Patients reported that the TT was easy to use, and 
commented on the usefulness of the multimedia approach. 23,103 Over 
60% of both low and high literacy patients preferred the TT over other 
alternatives (interviewer or no preference) 23. The majority (87%) said 
they would be willing to complete TT surveys when they visit the doctor in 
the future. This multimedia program maximizes opportunities to 
assess patient-reported outcomes. 
 
CancerHelp® Patient Education Software (Muench and Miller, PIs). 
The CancerHelp Institute’s (www.cancerhelp.org/) mission is to provide 
patient education information, especially to minorities and those with low 
literacy skills, with its user-friendly, interactive touchscreen software. The 
Institute collaborates with the NCI through a license agreement to 
distribute NCI material. Users rated the software very highly in ease of 
use and quality of information. Among 57 cancer patients in an ongoing 
study (R18-HS017300; see below), all reported that they were able to 

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find the information they wanted in the software, and that it helped them 
better understand their disease and treatment “somewhat” (47%) or “a 
lot” (51%) (manuscript in preparation). It has been used by more than 
230 hospitals, clinics and oncology practices in 40 states.  
 
Implementing a low-literacy, multimedia IT system to enhance patient-
centered cancer care (R18-HS017300: Hahn, PI). The objective of this 
randomized trial is to test whether a low literacy, multimedia information 
and assessment system used in daily clinical practice enhances patient-
centered care and improves patient outcomes. CancerHelp-Talking 
Touchscreen (TT) delivers user-friendly patient education information 
and enables low literacy patients to self-administer questionnaires. A 
similar approach will be used in the proposed study. 
 
Literacy Assessment Benefits and Patient Preferences (Coleman 
Foundation: Hahn, PI). This study evaluated patient attitudes and 
preferences regarding literacy screening. We enrolled 97 cancer patients 
(67% African American); 42 were reading at or below the 7th grade level. 
Most (96%) agreed that “It is important for doctors and nurses to know 
about their patients’ reading abilities,” and 84% would be willing to have 
their literacy level provided to their doctors and nurses 104. This 
suggests that literacy assessment is acceptable to patients, and 
they consider it important for clinicians to be aware of their 
patients’ reading abilities.  
 
   
C. Current Trials in University of Chicago Lung Cancer Clinic 
The Thoracic oncology clinic at the University of Chicago currently 
has over 20 active therapeutic cancer clinical trials for patients with Small 
Cell and Non- Small Cell Lung cancer. These trials cover every stage 
and line of therapy including phase I trials for multi-treated patients. They 
also include trials for patients with poor performance status. This 
situation is unparalleled by almost any other cancer center in the United 
States and makes the University of Chicago the ideal place to perform 
the study laid out in this grant. A list of current and pending clinical trials 
is included in Appendix 5. 
 
Additional Cancer Site Added to Study: 
The Gastric Cancer clinic is part of the University of Chicago GI 
Oncology clinic.  It is staffed primarily by Dr. Dan Catenacci.  We would 
like to add this clinic to our study. This expands our tumor types from 
those seen in the thoracic clinic allowing for more generalizability of our 
study while at the same time speeding accrual to the trial.  We have 
selected this clinic because like the thoracic oncology program, the 
gastric cancer program has trials available to patients with all stages of 
gastric cancer including multiple trials for patients with metastatic 
disease. His program also overlaps with the Thoracic oncology program 
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in the treatment of esophageal cancer. 
 
 
2.3 Study Design 
 
V. Study Design and Methodology 
Study Type and Sample Size 
This will be a pilot study performed at an urban academic center in south-
side Chicago to collect preliminary data in hopes of conducting a larger, 
randomized intervention. Based on the last two years in our Thoracic 
oncology clinic at the University of Chicago, we estimate that 600 new 
patients will be seen over the 2-year period of this study, an amount that 
will easily provide the number of patients necessary to fulfill the 
requirement of this pilot study.  
For this study, over 2 years, we will contact 150 new lung cancer patients 
of which 80% (120) will agree to participate in our study. Based on the 
current clinical trial portfolio in the Thoracic oncology clinic (see 
Appendix 5), which has grown substantially since our last study, it is 
estimated that trials are now technically available for about 80% of the 
new patient population (for our pilot of 120 patients that leaves about 
100). Of our 100, we estimate, based on our previous work,  that a 
clinical trial will actually be offered to 40% of these patients (40).  
Patient Population/Recruitment 
All new cancer patients presenting to the University of Chicago 
outpatient oncology clinics are currently pre-screened for cancer type 
and set up for appointments by our new patient intake coordinators. New 
patients with Non-Small Cell Lung cancer and Small Cell carcinoma will 
be contacted by our study coordinator who will call them 2-3 days prior to 
their appointment to ascertain their interest in participating in the 
research study. Those interested will be asked to arrive at their new visit 
60-90 minutes prior to the appointment time.  
 
Study Procedure 
 
Patients will use the Talking Touchscreen (TT) to complete a pre-
intervention survey which will ascertain clinical trial knowledge (detailed 
in SA#1, surveys in Appendix 4) and the following information using the 
instruments detailed in SA#4: socio-demographics, health literacy, 
anxiety, depression, and social support. They will then use the TT to view 
the NCI’s educational module on “Taking Part in Cancer Treatment 
Research Studies”. (see Appendix 3 for a sample screen shot). The NCI 
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booklet will be adapted as an interactive multimedia learning program. 
This interactive program and the pre/post survey assessments will run on 
the same tablet PCs. The “Listen and Learn Modules” allow persons with 
diverse literacy and computer skills to learn and go at their  
own pace. Once the session is complete, patients will complete a post-
intervention survey to measure any change in clinical trial knowledge and 
a feasibility (evaluation) survey (detailed in SA#2, survey in Appendix 4) 
to discern patient attitudes toward their using technology as a means of 
information collection and dissemination during their doctor’s visit. The 
researcher will also complete a simple questionnaire addressing the 
effect, if any, of introducing technology into the patient visit. 
  
 
Talking Touchscreen Design and Implementation 
The integration and programming of the measurement tools and the 
NCI’s “Taking Part in Cancer Treatment Research Studies” pamphlet 
(Appendix 1) into the TT will be handled by the Informatics team at 
Northwestern University’s Assessment Center (Assessment CenterSM; 
http://www.assessmentcenter.net/) and educational software developers 
at the CancerHelp Institute( www.cancerhelp.org) under the supervision 
of Co-PI Elizabeth Hahn, a medical sociologist and biostatistician, and a 
team including a Senior Developer, an IT Project Manger, and a user 
support specialist who will be available for logistic troubleshooting 
relating to hardware and software malfunctions which may occur. As 
detailed in the preliminary study section above, this group has significant 
expertise in the scope of work being performed in this study and in 
particular adapting interactive health messaging to low literacy health 
populations. Audio recordings for the TT will be done by Wordly Voices 
(http://www.worldlyvoices.com/) a company whose sole focus is on 
recording custom voice prompts. 
 
2.4 Study Flowchart 
 
 

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2.5 Study 
Procedures 
Specific Aims in Detail 
We have listed each specific aim with corresponding procedures and 
data analysis plan: 
 
Specific Aim 1: To determine whether TT delivery of educational clinical 
trial information can improve  clinical trial knowledge overall and in within 
low literacy populations in particular. 
Hypothesis 1a: The interactive multimedia TT educational tool will 
results in significant gains in patients’ pre-post assessments for each of 
the domains listed below. 
 
Knowledge 
Patients will self-administer pre- and post-tests on the TT. The Clinical 
Trial questionnaire was developed by Jacobsen and colleagues 3 and 
contains the following items (see Appendix 4): 
 
Attitudes toward clinical trials- 20 item likert measure of Positive 
attitudes toward clinical trials (eg, “being in a clinical trial benefits other 
patients”) and negative attitudes (eg, “being in a clinical trial is likely to 
cause a patient harm. After reverse coding the negative items, responses 
to all items are combined into an average score (possible range, 1 to 5). 
Knowledge about clinical trials-13 items have response options  true, 
false, or don’t know. The total score represents the number of items 

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answered correctly (possible range, 0 to 13). 
Perceived ability (self-efficacy)- 9 item likert scale to measure ability to 
carry out actions involved in making an informed decision about clinical 
trial participation (eg, “I think I could get the information I need to decide 
whether to be in a clinical trial”). After reverse coding the negative items, 
responses to all items are combined into an average score (possible 
range, 1 to 5). 
Willingness to participate in clinical trials will be measured using one 
likert scaled item: “If a cancer clinical trial were offered to you, would you 
agree to take part in it?” (“definitely yes” to “definitely no”). 
 
Specific Aim 2: To determine the feasibility and acceptability of TT in a 
busy urban academic medical center oncology clinic. 
Feasibility 
The use of new information technologies has been recommended as a 
strategy for improving access to health information and for enhancing the 
quality of communication in healthcare delivery.99 Our preliminary data 
show the number one reason that patients did not consent to a trial if 
offered was that they felt overwhelmed by the information (56%).  
 
Hypothesis 2a: By providing the patient important information as to the 
options they may have in terms of their cancer treatment, directly prior to 
their talking with their physician and through use of an easy interactive 
tool, such as the proven TT in low-literacy populations, we will not 
interrupt or decrease the patient experience but enhance the physician-
patient interaction, leading to increased participation in clinical trials. 
This pilot study will provide to us the opportunity to understand the 
feasibility of using technology as a way to educate a cancer population 
about clinical trials within the healthcare environment of a busy, urban 
hospital setting. We will use this as an opportunity to understand how to 
integrate technology into clinic flow so that it is not disruptive but rather 
increases the efficacy of the physician-patient visit by educating patients 
as to clinical trials before seeing the physician. We estimate that the 
survey items will take 20-30 minutes to complete and that patients will 
spend 15-30 minutes with the TT. Our experience is that 60 minutes is 
not an unreasonable burden, given the waiting time and other factors 
associated with a new visit. We will administer a simple evaluation 
questionnaire following the completion of the patient encounter with the 
TT, to measure their experience, including degree of difficulty.  
 
Hypothesis 2b: The use of the TT will not effect clinic flow nor pose an 
additional burden to patient, physician or staff. 
The researcher will also complete a simple questionnaire addressing the 
effect, if any, of introducing technology into the patient visit. 
 
Data Analysis 

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We will administer a simple evaluation questionnaire to understand the 
patient’s experience with the TT. We will adapt other questionnaires used 
in a previous TT study and will calculate descriptive summaries of the 
responses. 
Specific Aim 3: To evaluate the proportion of patients who sign consent 
to enroll in a cancer-specific treatment clinical trial when one is offered, 
compared to historical data. 
At the completion of the physician visit for that day, physicians will fill out 
a previously validated form asking the following questions: 
 
 Is there a clinical trial here for this cancer and stage, regardless of 
the patient’s other characteristics? 
 Did you discuss a clinical trial with this patient? 
 Did the patient specifically ask you about a clinical trial before you 
brought it up? 
 Was the patient offered participation in a treatment-related clinical 
trial? 
 If offered, did the patient sign consent? 
 
Actual enrollment in a clinical trial (signed consent) will be confirmed 
using linkage to our clinical trial database, e-VELOS, which we used 
successfully in our previous study. 
 
In our previous trial, 40% of patients offered a clinical trial enrolled in 
a trial.  For our low literacy population, 30% enrolled when offered.  We 
expect to be able to improve on these baseline values both by increasing 
patient understanding of the trial process and by improving their 
communication with their physician.   
 
Specific Aim 4: To evaluate the associations between socio-
demographics, health literacy, patient-reported outcomes (anxiety, 
depression, social support) and clinical trial enrollment, using the 
Behavioral Model for Vulnerable Populations.25  
Instruments 
Tables 3 and 4 contain the instruments we will use: 
 
TABLE 3: PROMIS INSTRUMENTS (www.nihpromis.org) 
Construct 
Social 
Support 
Measure 
Tools 
Scoring for all 
PROMIS 
Psychometrics 
Background 
Information/Psychometrics 
PROMIS 
Companionship 
Scale 
PROMIS V 2.0 
short form-4 
items. . 
Reliability: The 
degree to which a 
measure is free of 
error. It can be 
estimated by the 
PROMIS developed several 
instruments to measure the quality 
of social support, which refers to 
functional aspects of supportive 
relationships, i.e., interpersonal 

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internal 
consistency of the 
responses to the 
measure, or by 
correlating total 
scores on the 
measure from two 
time points when 
there has been no 
true change in 
what is being 
measured (for z- 
scores, reliability = 
1 - SE2). 
Standard Error 
(SE): The possible 
range of the actual 
final score based 
upon the scaled T-
score. With a T-
score of 52 and a 
SE of 2, the 95% 
confidence 
interval around the 
actual final score 
ranges from 48.1 
to 55.9 (T-score + 
(1.96*SE) = 52+ 
3.9 = 48.1 to 
55.9).Alpha=0.96 
Minimum number 
of items (4) must 
be answered in 
order to receive a 
score for 
emotional support 
CAT.  
As additional 
items are 
administered, the 
potential for error 
is reduced and 
confidence in the 
respondent’s 
score increases. 
CAT will continue 
until either the 
standard error 
drops below a 
specified level, or 
the participant has 
answered the 
maximum number 
of questions (12), 
whichever occurs 
first. 
relationships that serve particular 
functions. This includes the 
interactive process by which 
emotional, instrumental or 
informational support is obtained 
from one's social network. It also 
includes companionship, feeling 
cared for and valued as a person, 
communication with others, and 
feelings of belonging and trust. 
Measures of social support generally 
seek information about a person’s 
perception of the availability or 
adequacy of resources provided by 
others. The social support measures 
do not use a time frame (e.g. over 
the past seven days). 
---------------------------------------------- 
Assesses perceived availability of 
someone with whom to share 
enjoyable social activities such as 
visiting, talking, celebrations, etc. 
 
 
PROMIS 
Emotional 
Support Scale 
 
PROMIS v2.0 
short form-8 
items 
Alpha=0.98 
Assesses perceived feelings of 
being cared for and valued as a 
person; having confidant 
relationships.  
PROMIS 
PROMIS v2.0-
Alpha=0.95 
Assesses perceived availability of 

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Informational 
Scale 
8 item short 
form 
helpful information or advice.  
PROMIS 
Instrumental 
Support Scale 
PROMIS v2.0-
8 item short 
form 
Alpha=0.96 
Assesses perceived availability of 
assistance with material, cognitive or 
task performance.  
PROMIS 
Anxiety Scale 
8-item 
PROMIS 
Short Form V 
1.0-Anxiety 
8A 
 
Measures self-reported fear 
(fearfulness, panic), anxious 
misery (worry, dread), 
hyperarousal (tension, 
nervousness, restlessness), and 
somatic symptoms related to 
arousal (racing heart, dizziness). 
Anxiety is best differentiated by 
symptoms that reflect autonomic 
arousal and experience of threat. 
Only one behavioral avoidance 
item is included in the item bank; 
therefore, behavioral fear 
avoidance is not fully evaluated. 
The anxiety short form is generic 
rather than disease-specific. It 
assesses anxiety over the past 
seven days. 
PROMIS 
Depression 
Scale 
8-item 
PROMIS 
short form 
Assesses self-reported negative 
mood (sadness, guilt), views of 
self (self-criticism, 
worthlessness), and social 
cognition (loneliness, 
interpersonal alienation), as well 
as decreased positive affect and 
engagement (loss of interest, 
meaning, and purpose). Somatic 
symptoms (changes in appetite, 
sleeping patterns) are not 
included, which eliminates 
consideration of these items’ 
confounding effects when 
assessing patients with 
comorbid physical conditions. 
The depression short form is 
generic rather than disease-
specific. It assesses depression 
over the past seven days. 
 
TABLE 4: ADDITIONAL INSTRUMENTS 
Construct 
Measure 
Reference 
Background Information/Psychometric
Demographics 
Standard 
questionnaires 
used in our 
clinic. 
 
Collecting employment, income, 
education, country of origin (including 
parents’), race, height, weight, marital 
status (i.e. married or cohabitating), 
length of marriage/relationship, specific 
cancer diagnosis and length of disease. 
Medical Forms 
1. Health 
Literacy single-
item screener 
 
2. Health 
Wallace 
2006100 
 
 
Hahn et al., 
1. a single item previously validated 
by Wallace and colleagues in an 
urban university primary care clinic.  
 When compared to the Rapid 
Estimate of Adult Literacy in Medicine 

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Literacy 
Assessment 
Using Talking 
Touchscreen 
Technology 
(Health LiTT). 
 
 
2011101  
(REALM) instrument, the question, 
“How confident are you filling out 
medical forms by yourself?” had an 
Area Under the Receiver-Operator 
Curve (AUROC) of 0.82 (95% 
CI:0.77-0.86) for limited health 
literacy and 0.79 (95% CI:0.74-0.83) 
for limited or marginal health literacy.  
 Health LiTT is a novel, self-
administered multimedia test that 
meets psychometric standards 
(reliability of 0.90 or higher) for 
measurement of individual 
respondents, especially in the low to 
middle range of health literacy. 
 
Health literacy has been previously 
shown to correlate with disparities in 
health outcome. 
Comorbidities 
Self-
Administered 
Comorbidity 
Questionnaire 
(SCQ) 
Katz et al., 
2003 
 Contains 12 medical conditions 
developed based on their frequency 
in general practice and their inclusion 
in published and commonly used 
comorbidity instruments.  
 Patients are asked if they have the 
condition, if they receive treatment for 
it and if the condition limits their 
activity. The highest possible score is 
36, but in our survey will be 33 since 
we will eliminate the cancer 
comorbidity in that all patients have 
this in our cohort.  
 This survey has been shown to have 
excellent test-retest reliability (ICC of 
0.81) and moderate to high 
concordance with the Charlson Index 
(kappa>= 0.46 for all conditions 
except lung disease).  
 In terms of predictive validity the 
instrument also has modest 
associations with health status one 
year after assessment of 
comorbidities as measured by 
correlations with the Physical 
Component Summary of the SF-36 
(R2 0.22 of which 69% was explained 
by SCQ comorbidity score) and was 
superior to the Charlson Index in that 
regard.  
Clinical Trial 
Knowledge 
Survey 
Pre/Post Test 
Survey 
measuring 
change in 
knowledge, 
attitudes and 
beliefs and 
effect on 
behavior  
Jacobsen et 
al., 20123 
Instrument measuring at baseline and 
follow-up: Attitudes towards clinical 
trials, knowledge about clinical trials, 
self-efficacy for clinical trial decision, 
receptivity to clinical trial information, 
willingness to participate in clinical 
trials. 
 
Health Literacy- As in SA#2 above. 

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Psychosocial Measures-Participants will use the TT to complete short 
forms for anxiety, depression,  and social support developed in the 
Patient-Reported Outcomes Measurement Information System 
(PROMIS) initiative (www.nihpromis.org). All PROMIS measures are 
based on T-scores, with a mean of 50 and a standard deviation of 10 in 
the reference population. Raw scores for this study will be calculated and 
then transformed to T-scores using PROMIS look-up tables (see 
http://www.assessmentcenter.net/Manuals.aspx).  
 
In addition, the following tumor specific factors will be obtained-cancer 
type (NSCLC, SCLC), stage, and line of therapy for current stage as 
ascertained by physician survey but broken down as follows: 
 
 Never treated with chemo 
 Received first line treatment only 
 Received second-line treatment 
 Received three or greater lines of treatment. 
 
Data Analysis 
Categorical variables will be summarized as frequency counts and 
percentages and continuous variables will be summarized as medians 
and ranges. A logistic regression model will be set up with health literacy 
(as defined above) as the primary independent variable and enrollment in 
a clinical trial if one is offered as the primary dependent variable. The 
second model will control for race, income, cancer stage, line of 
treatment and co morbidity score. 
 
2.6 Study Duration 
Study duration will be 2 years. 
2.7 Statistical 
Analysis and 
Sample Size 
Justification  
The principal investigator is supported by a Biostatistics Core Facility 
offered through the University Chicago’s Comprehensive Cancer Center, 
which provides collaborative statistical support to investigators for the 
design, conduct, and analysis of clinical trials, observational and 
population-based studies, and basic science research projects. 
Variables/Time Points of Interest 
These are described in detail under each specific aim listed in the Study 
Procedures section, above. 
 
Statistical Methods 
These are described in detail under each specific aim listed in the Study 
Procedures section, above. 
 
Sample Size: (Power described above under each Specific Aim.) 
For Specific Aims 1 and 2: 
Data Analysis 

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Three subscales on the pre- and post-questionnaire will assess attitudes 
towards clinical trials, knowledge about clinical trials and perceived 
ability.  Change scores will be calculated and evaluated using a paired t-
test. A sample size of 120 will have 80% power to detect an effect size as 
small as 0.258 using a paired t-test with a 0.050 two-sided significance 
level.   
 
Based on our previous study, we estimate that 60% of these patients will 
have high health literacy (72) and the remaining 40% (48) will have low 
health literacy.  We will evaluate  differences in pre- and post-test 
changes by health literacy group. We will also estimate the correlation 
between change scores and the continuous measure of health literacy. 
  
For Specific Aims 3 and 4: 
Based on the current clinical trial portfolio in the Thoracic oncology clinic 
(see Appendix 4), it is estimated that trials are available for 80% of the 
new patient population (including patient eligibility) (100 patients over 2 
years) and of these, 40% will be offered participation (40). Our previous 
data suggested that when offered, 40% of these patients will sign 
consent. We hypothesize that our TT intervention will increase both the 
percentage of patients offered a trial (because of active participation from 
the patient in inquiring about trials) and in the percentage of patients who 
sign when offered. These impacts will be most profound in the low 
literacy group. 
 
An effect size of 0.20 (H0: 0.4, HA:0.6) is a reasonable estimate for 
this pilot to be able to produce a clinically significant improvement in 
cancer clinical trial enrollment. A sample size of 40 (those offered 
enrollment) should give us 80% power to detect a 20% difference in trial 
enrollment from our baseline hypothesized value of 40%  at a one-sided 
alpha level of 0.05. 
 
2.8 Specific Drug 
Supply 
Requirements  
NA 
 
2.9 Adverse 
Experience 
Reporting 
NA  
2.10 Itemized Study 
Budget  
A preliminary study budget must be provided with the initial proposal submitted to give 
guidance to the MISP Review Committee as to the expected study costs.   A refined 
itemized budget detailing the costs associated with the study should be provided with 
the final protocol or included in the study agreement as Exhibit B.   

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2.11 References 
References 
 
 
1. 
Comis RL, Miller JD, Aldige CR, et al: Public attitudes toward 
participation in cancer clinical trials. J Clin Oncol 21:830-5, 2003 
 
2. 
Evans KR, Lewis MJ, Hudson SV: The role of health literacy on 
african american and hispanic/latino perspectives on cancer clinical trials. J 
Cancer Educ 27:299-305, 2012 
 
3. 
Jacobsen PB, Wells KJ, Meade CD, et al: Effects of a Brief 
Multimedia Psychoeducational Intervention on the Attitudes and Interest of 
Patients With Cancer Regarding Clinical Trial Participation: A Multicenter 
Randomized Controlled Trial. Journal of Clinical Oncology, 2012 
 
4. 
Giuliano AR, Mokuau N, Hughes C, et al: Participation of 
minorities in cancer research: the influence of structural, cultural, and linguistic 
factors. Ann Epidemiol 10:S22-34, 2000 
 
5. 
Swanson GM, Ward AJ: Recruiting minorities into clinical trials: 
toward a participant-friendly system. J Natl Cancer Inst 87:1747-59, 1995 
 
6. 
Sateren WB, Trimble EL, Abrams J, et al: How 
sociodemographics, presence of oncology specialists, and hospital cancer 
programs affect accrual to cancer treatment trials. J Clin Oncol 20:2109-17, 
2002 
 
7. 
Murthy VH, Krumholz HM, Gross CP: Participation in cancer 
clinical trials: race-, sex-, and age-based disparities. Jama 291:2720-6, 2004 
 
8. 
Magai C CN, Adjei BA, Hershman D, Neugut A.: Psychosocial 
influences on suboptimal adjuvant breast cancer treatment adherence among 
African American women: implications for education and intervention. Health 
Educ Behav Dec;35:835-54, 2008 
 
9. 
Cameron L LE, Leventhal H: Seeking medical care in response to 
symptoms and life stress. Psychosom Med. 57:37-47, 1995 Jan-Feb 
 
10. 
Consedine NSM, Carol; Bonanno, George A.  : Moderators of the 
emotion inhibition-health relationship: A review and research agenda. Review of 
General Psychology 6:204-228, Jun 2002 
 
11. 
Consedine NS MC, Krivoshekova YS, Ryzewicz L, Neugut AI.: 
Fear, anxiety, worry, and breast cancer screening behavior: a critical review. 
Cancer Epidemiol Biomarkers Prev. 13:501-10, 2004 Apr 
 
12. 
Gelberg L, Andersen, R.M., Leake, B.D.: The Behavioral Model 
for Vulnerable Populations: application to medical care use and outcomes for 
homeless people. Health Serv Research 34:1273-1302, 2000 
 
13. 
Ford JG, Howerton MW, Lai GY, et al: Barriers to recruiting 
underrepresented populations to cancer clinical trials: a systematic review. 
Cancer 112:228-42, 2008 
 
14. 
Masi CM, Blackman DJ, Peek ME: Interventions to enhance 
breast cancer screening, diagnosis, and treatment among racial and ethnic 
minority women. Med Care Res Rev 64:195S-242S, 2007 
 
15. 
Peek ME, Han JH: Disparities in screening mammography. 
Current status, interventions and implications. J Gen Intern Med 19:184-94, 
2004 
 
16. 
Ford JG, Howerton M. W., Bolen S., et al: Knowledge and 

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Access to Information on Recruitment of Underrepresented Populations to 
Cancer Clinical Trials. Rockville (MD): Agency for Healthcare Research and 
Quality (US); 2005 Jun. (Evidence Reports/Technology Assessments, No. 122.) 
Preface. Available from: http://www.ncbi.nlm.nih.gov/books/NBK37796/.  
 
17. 
Baker TB, Hawkins R, Pingree S, et al: Optimizing eHealth 
breast cancer interventions: which types of eHealth services are effective? Transl 
Behav Med 1:134-145, 2011 
 
18. 
Gustafson DH, Hawkins R, McTavish F, et al: Internet-Based 
Interactive Support for Cancer Patients: Are Integrated Systems Better? J 
Commun 58:238-257, 2008 
 
19. 
Abernethy AP, Ahmad A, Zafar SY, et al: Electronic patient-
reported data capture as a foundation of rapid learning cancer care. Med Care 
48:S32-8, 2010 
 
20. 
Makoul G, Cameron KA, Baker DW, et al: A multimedia patient 
education program on colorectal cancer screening increases knowledge and 
willingness to consider screening among Hispanic/Latino patients. Patient Educ 
Couns 76:220-6, 2009 
 
21. 
Davis TC, Williams MV, Marin E, et al: Health literacy and 
cancer communication. CA Cancer J Clin 52:134-49, 2002 
 
22. 
Doak CC, Doak LG, Friedell GH, et al: Improving 
comprehension for cancer patients with low literacy skills: strategies for 
clinicians. CA Cancer J Clin 48:151-62, 1998 
 
23. 
Hahn EA, Cella D, Dobrez DG, et al: The impact of literacy on 
health-related quality of life measurement and outcomes in cancer outpatients. 
Qual Life Res 16:495-507, 2007 
 
24. 
Hahn EA, Du H, Garcia SF, et al: Literacy-fair measurement of 
health-related quality of life will facilitate comparative effectiveness research in 
Spanish-speaking cancer outpatients. Med Care 48:S75-82, 2010 
 
25. 
Gelberg L, Andersen RM, Leake BD: The Behavioral Model for 
Vulnerable Populations: application to medical care use and outcomes for 
homeless people. Health Serv Res 34:1273-302, 2000 
 
26. 
Jemal A, Siegel R, Xu J, et al: Cancer statistics, 2010. CA Cancer 
J Clin 60:277-300, 2010 
 
27. 
DiMasi JA, Hansen RW, Grabowski HG: The price of 
innovation: new estimates of drug development costs. J Health Econ 22:151-85, 
2003 
 
28. 
Adams CP, Brantner VV: Estimating the cost of new drug 
development: is it really 802 million dollars? Health Aff (Millwood) 25:420-8, 
2006 
 
29. 
Cheng SK, Dietrich MS, Dilts DM: Predicting accrual 
achievement: monitoring accrual milestones of NCI-CTEP-sponsored clinical 
trials. Clin Cancer Res 17:1947-55, 2011 
 
30. 
Lara PN, Jr., Paterniti DA, Chiechi C, et al: Evaluation of factors 
affecting awareness of and willingness to participate in cancer clinical trials. J 
Clin Oncol 23:9282-9, 2005 
 
31. 
Bleyer WA: The U.S. pediatric cancer clinical trials programmes: 
international implications and the way forward. Eur J Cancer 33:1439-47, 1997 

      MISP Template: Protocol 
27 
Final Version: 11/15/201310 28 2014 
 
32. 
Du W, Gadgeel SM, Simon MS: Predictors of enrollment in lung 
cancer clinical trials. Cancer 106:420-5, 2006 
 
33. 
Simon MS, Du W, Flaherty L, et al: Factors associated with 
breast cancer clinical trials participation and enrollment at a large academic 
medical center. J Clin Oncol 22:2046-52, 2004 
 
34. 
Adams-Campbell LL, Ahaghotu C, Gaskins M, et al: Enrollment 
of African Americans onto clinical treatment trials: study design barriers. J Clin 
Oncol 22:730-4, 2004 
 
35. 
Albain KS, Unger JM, Crowley JJ, et al: Racial Disparities in 
Cancer Survival Among Randomized Clinical Trials Patients of the Southwest 
Oncology Group. Journal of the National Cancer Institute 101:984-992, 2009 
 
36. 
Dignam JJ: Efficacy of systemic adjuvant therapy for breast 
cancer in African-American and Caucasian women. J Natl Cancer Inst 
Monogr:36-43, 2001 
 
37. 
Dignam JJ, Colangelo L, Tian W, et al: Outcomes among 
African-Americans and Caucasians in colon cancer adjuvant therapy trials: 
findings from the National Surgical Adjuvant Breast and Bowel Project. J Natl 
Cancer Inst 91:1933-40, 1999 
 
38. 
Dignam JJ, Ye Y, Colangelo L, et al: Prognosis after rectal cancer 
in blacks and whites participating in adjuvant therapy randomized trials. J Clin 
Oncol 21:413-20, 2003 
 
39. 
Yothers G, Sargent DJ, Wolmark N, et al: Outcomes Among 
Black Patients With Stage II and III Colon Cancer Receiving Chemotherapy: An 
Analysis of ACCENT Adjuvant Trials. Journal of the National Cancer Institute 
103:1498-1506, 2011 
 
40. 
Lynch GF, Gorelick PB, Raman R, et al: A pilot survey of 
African-American physician perceptions about clinical trials. J Natl Med Assoc 
93:8S-13S, 2001 
 
41. 
Mills EJ, Seely D, Rachlis B, et al: Barriers to participation in 
clinical trials of cancer: a meta-analysis and systematic review of patient-
reported factors. Lancet Oncol 7:141-8, 2006 
 
42. 
Klabunde CN SB, Butler B, Atkins J Factors influencing 
enrollment in clinical trials for cancer treatment. Southern Medical Journal  
92:1189-1193, 1999 
 
43. 
Ray M, Smith DM, Olopade OI, et al: A prospective paired 
survey of oncologist and patient attitudes towards therapeutic cancer clinical 
trial (CT) enrollment in a diverse academic health center patient population. . 
Journal of Clinical Oncology, 2010 ASCO Annual Meeting Proceedings 28 
(suppl; abstr 6120) 2010 
 
44. 
Mc Daid C , Hodges Z , Fayter D, et al: Increasing participation 
of cancer patients in randomised controlled 
trials: a systematic review. Trials 7:16, 2006 
 
45. 
Paskett ED, Cooper MR, Stark N, et al: Clinical trial enrollment 
of rural patients with cancer. Cancer Pract 10:28-35, 2002 
 
46. 
Hutchison C, Cowan C, McMahon T, et al: A randomised 
controlled study of an audiovisual patient information intervention on informed 
consent and recruitment to cancer clinical trials. Br J Cancer 97:705-11, 2007 

      MISP Template: Protocol 
28 
Final Version: 11/15/201310 28 2014 
 
47. 
Lai GY, Gary TL, Tilburt J, et al: Effectiveness of strategies to 
recruit underrepresented populations into cancer clinical trials. Clin Trials 3:133-
41, 2006 
 
48. 
Education Network to Advance Cancer Clinical Trials 
(ENACCT) and 
Community-Campus Partnerships for Health (CCPH). (2008). Communities as 
Partners in Cancer Clinical Trials: Changing Research, Practice and Policy. 
Silver Spring, MD.  
 
49. 
Health Literacy: A Prescription to End Confusion. in Committee 
on Health Literacy, Board on Neuroscience and Behavioral Health (The National 
Academics Press, Washington, D.C., 2004).  
 
50. 
U.S. Department of Health and Human Services. Healthy People 
2010: Understanding and Improving Health. Washington, D.C.: U.S. 
Government Printing Office;2000. 2nd ed.  
 
51. 
Committee on Health Literacy, Board on Neuroscience and 
Behavioral Health. Health Literacy: A Prescription to End Confusion. 
Washington,D.C.: The National Academics Press; 2004.  
 
52. 
Kirsch IS, Jungeblut A, Jenkins L, et al: Adult Literacy in 
America: A First Look at the Results of the National Adult Literacy Survey., in 
Education UDo (ed). Washington, D.C., National Center for Education 
Statistics, 1993, pp 178 
 
53. 
Pagan JA, Brown CJ, Asch DA, et al: Health Literacy and Breast 
Cancer Screening among Mexican American Women in South Texas. J Cancer 
Educ, 2011 
 
54. 
Shelton RC, Jandorf L, Ellison J, et al: The influence of 
sociocultural factors on colonoscopy and FOBT screening adherence among 
low-income Hispanics. J Health Care Poor Underserved 22:925-44, 2011 
 
55. 
Garbers S, Schmitt K, Rappa AM, et al: Functional health literacy 
in Spanish-speaking Latinas seeking breast cancer screening through the 
National Breast and Cervical Cancer Screening Program. Int J Womens Health 
1:21-9, 2010 
 
56. 
Bennett CL, Ferreira MR, Davis TC, et al: Relation between 
literacy, race, and stage of presentation among low-income patients with prostate 
cancer. J Clin Oncol 16:3101-4, 1998 
 
57. 
Kim SP, Knight SJ, Tomori C, et al: Health literacy and shared 
decision making for prostate cancer patients with low socioeconomic status. 
Cancer Invest 19:684-91, 2001 
 
58. 
Hahn EA, Cella D: Health outcomes assessment in vulnerable 
populations: measurement challenges and recommendations. Arch Phys Med 
Rehabil 84:S35-42, 2003 
 
59. 
Health literacy: report of the Council on Scientific Affairs. Ad 
Hoc Committee on Health Literacy for the Council on Scientific Affairs, 
American Medical Association. JAMA 281:552-7, 1999 
 
60. 
Schillinger D, Piette J, Grumbach K, et al: Closing the loop: 
physician communication with diabetic patients who have low health literacy. 
Arch Intern Med 163:83-90, 2003 
 
61. 
Health Literacy: A Prescription to End Confusion, Committee on 

      MISP Template: Protocol 
29 
Final Version: 11/15/201310 28 2014 
Health Literacy, Board on Neuroscience and Behavioral Health. Washington, 
D.C., The National Academics Press, 2004 
 
62. 
Krieger JL, Parrott RL, Nussbaum JF: Metaphor use and health 
literacy: a pilot study of strategies to explain randomization in cancer clinical 
trials. J Health Commun 16:3-16, 2011 
 
63. 
Cassileth BR, Zupkis RV, Sutton-Smith K, et al: Informed 
consent -- why are its goals imperfectly realized? N Engl J Med 302:896-900, 
1980 
 
64. 
Penman DT, Holland JC, Bahna GF, et al: Informed consent for 
investigational chemotherapy: patients' and physicians' perceptions. J Clin Oncol 
2:849-55, 1984 
 
65. 
Sutherland HJ, Lockwood GA, Till JE: Are we getting informed 
consent from patients with cancer? J R Soc Med 83:439-43, 1990 
 
66. 
Williams CJ, Zwitter M: Informed consent in European 
multicentre randomised clinical trials--are patients really informed? Eur J Cancer 
30A:907-10, 1994 
 
67. 
Fallowfield L, Lipkin M, Hall A: Teaching senior oncologists 
communication skills: results from phase I of a comprehensive longitudinal 
program in the United Kingdom. J Clin Oncol 16:1961-8, 1998 
 
68. 
Tannock IF: The recruitment of patients into clinical trials. Br J 
Cancer 71:1134-5, 1995 
 
69. 
Lindau ST, Tomori C, Lyons T, et al: The association of health 
literacy with cervical cancer prevention knowledge and health behaviors in a 
multiethnic cohort of women. American Journal of Obstetrics and Gynecology 
186:938-943, 2002 
 
70. 
Barlund DC: The mystification of meaning: doctor-patient 
encounters. J Med Educ.  51:716-25, 1976 
 
71. 
Murphy PW CA, Walker L, Arnold CL, Chesson LM Comparing 
the effectiveness of video and written material for improving knowledge among 
sleep disorders clinic patients with limited literacy skills. Southern Medical 
Journal 93:297-304, 2000 
 
72. 
Manfredi C, Czaja R, Price J, et al: Cancer patients' search for 
information. J Natl Cancer Inst Monogr:93-104, 1993 
 
73. 
Manfredi C, Czaja R, Buis M, et al: Patient use of treatment-
related information received from the Cancer Information Service. Cancer 
71:1326-37, 1993 
 
74. 
Whelan TJ, Mohide EA, Willan AR, et al: The supportive care 
needs of newly diagnosed cancer patients attending a regional cancer center. 
Cancer 80:1518-24, 1997 
 
75. 
Chapman K, Rush K: [Patient and family satisfaction with cancer 
information: pamphlet evaluation]. Can Oncol Nurs J 13:164-75, 2003 
 
76. 
Coulter A: Patient information and shared decision-making in 
cancer care. Br J Cancer 89 Suppl 1:S15-6, 2003 
 
77. 
Monnier J, Laken M, Carter CL: Patient and caregiver interest in 
internet-based cancer services. Cancer Pract 10:305-10, 2002 
 
78. 
Eysenbach G: The impact of the Internet on cancer outcomes. CA 
Cancer J Clin 53:356-71, 2003 

      MISP Template: Protocol 
30 
Final Version: 11/15/201310 28 2014 
 
79. 
Peterson KA, Radosevich DM, O'Connor PJ, et al: Improving 
Diabetes Care in Practice: findings from the TRANSLATE trial. Diabetes Care 
31:2238-43, 2008 
 
80. 
Basch EM, Thaler HT, Shi W, et al: Use of information resources 
by patients with cancer and their companions. Cancer 100:2476-83, 2004 
 
81. 
Roter DL, Hall JA, Katz NR: Relations between physicians' 
behaviors and analogue patients' satisfaction, recall, and impressions. Med Care 
25:437-51, 1987 
 
82. 
Bertakis KD, Roter D, Putnam SM: The relationship of physician 
medical interview style to patient satisfaction. J Fam Pract 32:175-81, 1991 
 
83. 
Liang W, Burnett CB, Rowland JH, et al: Communication 
between physicians and older women with localized breast cancer: implications 
for treatment and patient satisfaction. J Clin Oncol 20:1008-16, 2002 
 
84. 
Ong LM, Visser MR, Lammes FB, et al: Doctor-patient 
communication and cancer patients' quality of life and satisfaction. Patient Educ 
Couns 41:145-56, 2000 
 
85. 
Ashton CM, Haidet P, Paterniti DA, et al: Racial and ethnic 
disparities in the use of health services: bias, preferences, or poor 
communication? J Gen Intern Med 18:146-52, 2003 
 
86. 
Kaplan SH, Greenfield S, Ware JE, Jr.: Assessing the effects of 
physician-patient interactions on the outcomes of chronic disease. Med Care 
27:S110-27, 1989 
 
87. 
Kerr J, Engel J, Schlesinger-Raab A, et al: Communication, 
quality of life and age: results of a 5-year prospective study in breast cancer 
patients. Ann Oncol 14:421-7, 2003 
 
88. 
Velikova G, Booth L, Smith AB, et al: Measuring quality of life 
in routine oncology practice improves communication and patient well-being: a 
randomized controlled trial. J Clin Oncol 22:714-24, 2004 
 
89. 
Sepucha KR, Belkora JK, Mutchnick S, et al: Consultation 
planning to help breast cancer patients prepare for medical consultations: effect 
on communication and satisfaction for patients and physicians. J Clin Oncol 
20:2695-700, 2002 
 
90. 
Brown RF, Butow PN, Dunn SM, et al: Promoting patient 
participation and shortening cancer consultations: a randomised trial. Br J 
Cancer 85:1273-9, 2001 
 
91. 
Connecting Americans to their Healthcare, Working Group on 
Policies for Electronic Information Sharing Between Doctors and Patients, 
Markle Foundation, 2004 
 
92. 
Cegala DJ, Broz, S.L. : Provider and patient communication skills 
training, in Thompson TL, Dorsey, A., Miller, K. (ed): Handbook of Health 
Communication. Mahwah, NJ, Lawrence Erlbaum Associates, Inc., 2003, pp 95-
119 
 
93. 
Wired for Health and Well-Being: The Emergence of Interactive 
Health Communication, in Services DoHaH (ed). Science Panel on Interactive 
Communication and Health. Washington, D.C., 1999 
 
94. 
Greimel ER, Gappmayer-Locker E, Girardi FL, et al: Increasing 
women's knowledge and satisfaction with cervical cancer screening. J 

      MISP Template: Protocol 
31 
Final Version: 11/15/201310 28 2014 
Psychosom Obstet Gynaecol 18:273-9, 1997 
 
95. 
Denizard-Thompson NR, Singh S, Stevens SR, et al: iPod 
technology for teaching patients about anticoagulation: a pilot study of mobile 
computer-assisted patient education. Prim Health Care Res Dev 13:42-7, 2012 
 
96. 
Krishna S, Balas EA, Spencer DC, et al: Clinical trials of 
interactive computerized patient education: implications for family practice. J 
Fam Pract 45:25-33, 1997 
 
97. 
Wilson EA, Makoul G, Bojarski EA, et al: Comparative analysis 
of print and multimedia health materials: A review of the literature. Patient Educ 
Couns 89:7-14, 2012 
 
98. 
Wofford JL, Smith ED, Miller DP: The multimedia computer for 
office-based patient education: a systematic review. Patient Educ Couns 59:148-
57, 2005 
 
99. 
Kreps GL, Arora NK, Nelson DE: Consumer/provider 
communication research: directions for development. Patient Educ Couns 50:3-
4, 2003 
 
100. 
Wallace LS, Rogers ES, Roskos SE, et al: Brief report: screening 
items to identify patients with limited health literacy skills. J Gen Intern Med 
21:874-7, 2006 
 
101. 
Hahn EA, Choi SW, Griffith JW, et al: Health literacy assessment 
using talking touchscreen technology (Health LiTT): a new item response 
theory-based measure of health literacy. J Health Commun 16 Suppl 3:150-62, 
2011 
 
102. 
Yost KJ, Webster K, Baker DW, et al: Acceptability of the 
talking touchscreen for health literacy assessment. J Health Commun 15 Suppl 
2:80-92, 2010 
 
103. 
Hahn EA, Cella D, Dobrez D, et al: The talking touchscreen: a 
new approach to outcomes assessment in low literacy. Psychooncology 13:86-
95, 2004 
 
104. 
Hahn EA, Garcia SF, Cella D: Patient attitudes and preferences 
regarding literacy screening in ambulatory cancer care clinics. Patient Related 
Outcome Measures 1:19-27, 2010 
 
 
 
2.12 Publication 
Plan 
Generally, a publication plan is discussed between the investigator and Merck /MSD 
during time when the protocol is under development.  Details of the publication and the 
obligations to Merck/MSD are outlined in the study agreement.   
 
The following should be considered for the publication plan: 
 What are your publication plans? How many manuscripts do you anticipate? 
 Include projected target date for manuscript submission and name of the journal 
 Do you anticipate abstracts?  How many? 
 What scientific meetings would you consider presenting the study results? 
 
2.13 Curriculum 
Vitae 
 
Investigator should provide curriculum vitae in English and a listing of references to Merck/MSD. 

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2.13 Protocol 
Submission for 
Investigator-
Initiated Studies  
U.S. protocols should be submitted by US investigators directly or through the Global Research 
Specialist at  www.merckiisp.com   
 
Non U.S. protocols should be submitted to the MSD office by the investigators.