Comparative Effectiveness of Interventions to Improve Screening Among Rural Women
Phase: NA
Conditions: Breast, Cervical or Colorectal Cancer Screening Needed
Sponsor: Ohio State University Comprehensive Cancer Center

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The Ohio State University Comprehensive Cancer Center 
Comparative Effectiveness of Interventions to Improve Screening among Rural Women: 
Rural Interventions for Screening Effectiveness (RISE) 
NCT02795104 
Principal Investigators  
Electra Paskett, PhD  
Victoria Champion, RHD,RN,FAAN 
1590 North High Street, Suite 525  
600 Barnhill Drive NU 340G 
Columbus, OH 43201  
Indianapolis, IN  46202 
Phone: (614) 293-3917  
Phone: (317) 274-4187 
Fax: (614) 293-5611  
Fax: (317) 278-2021 
Email: electra.paskett@osumc.edu  
Email: vchampio@iu.edu 
Co-Investigators 
Mira Katz, PhD, MPH  
Susan Rawl, PhD, RN, FAAN 
1590 North High Street, Suite 525  
600 Barnhill Drive, NU 345E 
Columbus, OH 43201  
Indianapolis, IN  46202 
Phone: (614) 293-6603  
Phone: (317) 278-2217 
Fax: (614) 293-5611 
Fax: (317) 278-2021 
Email: mira.katz@osumc.edu 
Email: srawl@iu.edu  
Eric Seiber, PhD 
Yi (Wendy) Xu, PhD 
1841 Neil Avenue 
1841 Neil Avenue 
210 Cunz Hall 
208 Cunz Hall 
Columbus, OH 43201 
Columbus, OH 43201 
Phone: (614) 247-4471  
Phone: (614) 292-0662  
Fax: (614) 247-1955 
Email: yu.1636@osu.edu 
Email: seiber.7@osu.edu 
 
Gail Grever, MD 
Tamika Dawson, MD 
2050 Kenny Road 
1 American Sq, Ste 185 
Morehouse Pavillion 
One America Tower 
Columbus, OH 43201 
Indianapolis, IN 46282 
Phone: (614) 293-8054 
Phone: (317) 948-6161 
Fax: (614) 293-6890 
Fax: (317) 638-0678 
Email: gail.grever@osumc.edu 
Email: tdawson1@IUHealth.org 
Biostatisticians 
Greg Young, MS 
Patrick Monahan, PhD 
320 Lincoln Tower 
Indiana University 
1800 Cannon Dr 
410 W. Tenth St., Suite 3000 
Columbus, OH 43210  
Indianapolis, IN 46202-3002 
Phone: (614) 293-6491  
Phone: (317) 278-8086  
Fax: (614) 688-6600 
Fax: (317) 274-2678 
Email: gregory.young@osumc.edu 
Email: pmonahan@iu.edu 
Project Staff 
Ryan Baltic, MPH 
 
1590 North High Street, Suite 525 
 
Columbus, OH 43201 
 
Phone: (614) 293-4121 
 
Fax: (614) 293-5611 
 
Email: ryan.baltic@osumc.edu 
 

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Table of Contents 
 
1.0 Overview 
2.0 Background and Rationale 
3.0 Methods 
4.0 Interventions 
5.0 Data Handling and Analysis 
6.0 Ethical and Regulatory Considerations 
 
 
 
 

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1.0 Overview  
1.1 Title 
Comparative Effectiveness of Interventions to Improve Screening among Rural Women: Rural Interventions 
for Screening Effectiveness (RISE) 
1.2 Introduction 
A multi-disciplinary research team from The Ohio State University and Indiana University School of Nursing 
will develop and implement an intervention testing the comparative effectiveness of a tailored interactive 
computer program delivered via DVD (TIDVD) vs. a TIDVD + telephone-based patient navigation (PN) 
intervention (TIDVD + PN) vs. Usual Care (UC) to increase guideline-based screening rates for Breast 
Cancer(BC), Cervical Cancer(CC), and Colorectal Cancer(CRC) among women age 50 to 74 living in 32 
rural counties of Ohio (OH) and Indiana (IN).  
1.3 Aims and Hypotheses 
The specific aims are to:  
Aim 1: compare the effectiveness of a tailored and interactive DVD (TIDVD) vs. TIDVD +  
     
          telephone-based PN intervention (TIDVD + PN) vs. UC, to increase guideline-based cancer          
          screening rates at 12 months post randomization for BC, CC, and CRC among 1058      
          women age 50 to 74 living in rural northwest Ohio and northeast Indiana 
Hypothesis 1: Women in the TIDVD+TPN group will have higher rates of within guideline adherence to 
all screening tests via MRR at 12 months compared to those who receive the TIDVD alone 
or UC. 
Aim 2: compare the cost effectiveness of the TIDVD and the TIDVD + PN intervention vs. UC, for    
     
            adherence to each screening outcome or combination of screening tests.   
Hypothesis 2: The TIDVD + TPN intervention will be more cost-effective than the TIDVD intervention or        
UC for adherence to each or combination of screening tests. 
 
We will also identify associations between theoretical variables (community, social, and individual) and 
screening outcomes, including interactions with the interventions. If found to be cost effective, either or both 
interventions have the potential to be immediately disseminated to increase BC, CC, and CRC screening 
rates and ultimately reduce cancer disparities for underserved rural women. This project will use an overall 
theoretical framework to understand health disparities that includes individual, social and community level 
variables, and a conceptual model for the intervention which uses a multiple behavior theoretical approach, 
all of which have demonstrated efficacy in improving adherence to single screening test behaviors, as well 
as other preventive health behaviors. 
 
2.0 BACKGROUND AND RATIONALE  
2.1 Magnitude of the Problem 
The cancer burden among rural and underserved populations is significant. Residents living in rural areas 
in the U.S. experience higher cancer incidence and mortality rates, as well as lower screening rates.1-5 The 
breast cancer mortality rates in the 32 targeted Ohio and Indiana counties are 9.7% and 5.8% greater, 
respectively, than that for the U.S., while the cervical cancer mortality rate is 12.5% greater, and the 
CRC mortality rates are 10.4% and 6.1% greater, respectively, than that for the U.S. This results in 106 
excess deaths in these counties per year. Reasons for cancer disparities among rural populations are 
due to many social determinants of health including lower socioeconomic status (SES),  lower  educational  
levels,  lifestyle  factors,  genetics, limited access to   healthcare, lack of health insurance, or a 
combination of these factors.3-6 Screening adherence rates for BC, CC, and CRC cancers, for which there 
are validated screening tests available, are lower for those with less education, a proxy for SES.7,8 The 
rural counties targeted for this project (Figure 1), include mainly White, poorer, and less educated 
populations with limited access to health care. Thus, it is essential to intervene in these rural counties to 
reduce cancer disparities. Many rural women do not complete screening at recommended intervals.5  In a 
recently completed  observational study among rural women in Ohio, medical record validated completion 
of screening within recommended guidelines was: 32% for mammography, 36% for Pap test, and 30% 
for a CRC test.9  Only 8.6% had completed all three tests within guidelines.9This suggests the need for 
cost effective interventions to provide rural women with the latest information about screening 
recommendations and needed tests.10,11 
 
 

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2.2 Justification for the Study 
The significance of this study is enhanced by the potential to develop a stronger more efficacious intervention 
through the combination of two previously tested interventions (tailored interactive programs and patient 
navigators). This research will test the hypothesis that the addition of a Patient Navigator (PN) to the tailored 
program will be more effective than a tailored approach alone or UC.  This study will determine the cost-
effectiveness of interventions that vary in complexity, time, and cost. We will determine if adding a telephone-
based PN will be worth the additional costs by comparing the TIDVD intervention with and without PN vs. 
UC.  
2.3 Intended/Potential Use for Study Findings 
If either or both interventions are shown to be cost-effective compared to UC to improve screening rates, 
they can be quickly/easily disseminated to rural areas where access to health care is suboptimal, and 
cancer mortality rates for CC, BC, and CRC are higher than non-rural areas. 
 
3.0 METHODS  
3.1 Research Design  
3.1.1 Participants 
Our study will target women aged 50 to 74 who reside in 32 rural counties in northwest OH and northeast 
IN (Figure 1). In these counties (2010), there were 173,812 women in the appropriate age category, 96% 
who are White (non-Hispanic). We will enroll 1058 women 50-74 years in the designated counties, stratified 
by Rural Urban Commuting Area (RUCA) code.  U.S. Preventive Services Task Force cancer screening 
guidelines will be used for all screening tests to determine eligibility (Table 1). 
 
Figure 1. Map of Intervention Counties 
 
 
 
 
 
 
 

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Table 1. United States Preventive Services Task Force Screening Guidelines 
3.1.2 Eligibility criteria. To be eligible, women must:  
 
1) be aged 50-74 years (inclusive);  
 
2) be non-adherent to one or more recommended screenings for BC, CC, or CRC by MRR;  
 
3) reside in one of 32 rural counties in IN or OH; 
 
4) provide informed consent; 
 
5) able to speak/read English; and 
      6) have access to a DVD player or computer that can play DVDs.  
  
3.1.3 Exclusion Criteria.  Women will be excluded if they: 
1) have a personal or family history of any hereditary/genetic cancer syndrome such as BRCA1 and 
BRCA2 polymorphisms, hereditary nonpolyposis colon cancer, or familial adenomatous polyposis;  
2) have a personal history of inflammatory bowel disease (Crohn’s disease or colitis), colon polyps, 
or a history of cancer except non-melanoma skin cancer; 
3) have more than one first degree relative with a history of colorectal cancer or one first degree relative 
who was diagnosed with colorectal cancer before the age of 60; 
4) plan to move outside of the country within the next year; 
5) reside in a nursing home or other institution; or 
6) are pregnant or intend to become pregnant during the study period. 
 
Figure 2: Study Schema 
 
Site 
Guideline 
BC 
Women ages 50-74: mammogram every 2 yrs. 
CC 
Women ages 50-65: Pap test every 3 yrs. or Pap test and HPV co-testing every 5 yrs. 
Discontinue after age 65 for women with 3 consecutive negative cytology results or 2 
consecutive negative HPV results in last 10 yrs. 
CRC 
Women ages 50-75: stool test (FOBT/FIT) annually or colonoscopy every 10 yrs. For 
those at increased risk; colonoscopy is recommended. 

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3.2 Recruitment Process: 
3.2.1 Sample Selection 
Eligible female residents of each of the 32 study counties will be randomly selected from a customized 
list provided by Marketing Systems Group (white pages, commercial and United States Postal Service 
(USPS) lists) that includes female county residents age 50-74, inclusive (N=173,812). In order to ensure 
a sufficient number of truly rural women are enrolled, the sample selection will be stratified by Rural-
Urban Commuting Area (RUCA) code which is assigned at the census tract level. An equal number of 
women will be sampled from tracts with RUCA codes of 4-6 and 7-10. Codes 4 through 6 represent 
micropolitan areas in and around towns with 10,000-50,000 residents where some residents may commute 
to a larger urban core. Codes 7 through 10 indicate small towns (population 2,500-9,999) and rural areas 
with little commuting to larger urban clusters. Mr. Young will provide selected names monthly to the 
OSU Behavioral Measurement Shared Resource (BMSR). We estimate that 55% of the women will be 
eligible and 70% of eligible women will participate; thus to achieve our sample size of 1058, we will need to 
mail approximately 2,750 letters. 
In addition to mailing and calling, promotional materials encouraging women in these regions to volunteer to 
participate in the study will be placed within the target communities. Promotional materials 
(flyers/brochures/postcards) may be displayed within public spaces where women in the age group may 
frequent, such as libraries, senior centers, health departments, etc. to promote the study and increase 
credibility. OSU CCTS Recruitment and Retention Services and potentially IU CTSI Research Recruitment 
Program will be employed to promote the study. We are requesting the use of Research Match 
(ResearchMatch.org) and Study Search (studysearch.osumc.edu) for participant recruitment on this protocol. 
Through these promotional materials and advertisements, potentially eligible women will be encouraged to call 
study staff via a toll-free number to determine eligibility and schedule a call with an interviewer to complete the 
consent process and baseline survey.  
Targeted Facebook ads will be posted to 50-year-old and older women’s Facebook pages who live in counties 
of interest. These ads will be promoted by the OSUMC Communications and Marketing team through The 
Ohio State University and Wexner Medical Center Facebook pages.  
3.2.1.a Phase 2 Sample Selection (beginning January 2018) 
The recruitment area will be expanded to additional rural counties in both Indiana and Ohio (see map – Figure 
3) in order to improve enrollment rates. Promotional materials will be sent to locations in these communities 
and Facebook ads will target these additional counties. Mail/call lists of female residents may be purchased 
for these additional counties as well. Craigslist advertisements will be developed and placed on community 
pages for the geographic areas from which we are recruiting. 
 
Figure 3. Map of Recruitment Area 
       

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3.2.2 Contact 
Selected women will be mailed a letter and information sheet introducing the study, followed by a telephone 
call by BMSR trained interviewers approximately one week after mailing the letter. The interviewers will attempt 
to contact their assigned list of potential participants by phone. They will make at least 10 attempts (calling at 
different times of the day, weekday, and weekends) to reach the listed county resident. After 10 attempts, if 
they have not been able to reach the participant, they will send a “no contact” letter to request that the 
participant contact the project office. Potentially eligible women may also contact us via a toll-free number or 
the study email address to participate. With prior approval from the potential participant, text messaging may 
be employed. Email may be used to communicate with and respond to potentially eligible women once they 
initiate communication with the project and permission is obtained to do so.  The content of the emails or text 
messages will depend on the information requested by or needs of the participant. The project staff will not 
initiate communication by email or text without the permission of the potential participant. 
Figure 3 summarizes communications between study staff, participants, and clinics. 
Women who click targeted ads will be taken to a REDCap landing page (go.osu.edu/RISE) with a brief 
description of the study, eligibility criteria, and a brief set of questions to partially assess eligibility and determine 
best time for an interviewer to contact her to complete the consent process and baseline survey. 
3.2.3 Consent for Participation  
Once the participant is reached, the study will be explained, permission to verify eligibility will be obtained, the 
eligibility screener will be administered and if eligible, informed verbal consent will be obtained. After the verbal 
consent process is completed, the baseline telephone survey (1a) will be administered. 
3.2.4 Eligibility Verification 
After completion of the baseline telephone survey, participants will be mailed a medical record release form 
with a stamped, pre-addressed envelope to mail the medical record release form back to the OSU study office. 
Those who do not return the release form within two weeks will be re-contacted by the interviewer. Study staff 
will review and verify screening tests received by MRR and if the woman is still eligible, she will be enrolled 
and randomized to one of 3 study arms. The trained interviewers will be familiar with screening, determining 
eligibility, administering telephone surveys, and have a keen understanding of rural culture.   
3.3 Randomization 
Once eligibility is confirmed via medical record review, participants will be randomly assigned to one of 3 
study arms -1)TIDVD alone, 2)TIDVD + PN, or 3)UC. A centralized web-based system at OSU will be used 
to randomize participants to one of the 3 study arms. Randomization will be stratified by age (50-64 vs. 
65-74) and by seven screening categories representing which screening test(s) each woman needs (BC, 
CC, CRC, BC+CC, BC+CRC, BC+CC+CRC, or CC+CRC). 
3.4 Data Collection and Measurements 
Trained interviewers will collect data via REDCap (Research Electronic Data Capture) at baseline, 2 and 12 
months from date of enrollment, and these data may also be collected using paper-based surveys 
(Teleform).  We will collect information on outcomes as well as covariates and mediators. Self-report of 
cancer screening will be obtained at baseline, 2 and 12 months with MRR data collected at baseline and 12 
months to verify screening status. Most recent height and weight measurements will be collected from chart 
review. Variables such as demographics that will not change will be measured only at baseline. The 12 
month survey will also include open-ended questions to assess why women are adherent to specific cancer 
screening tests and not adherent to other screening tests. Constructs to be measured are described below 
and when each will be collected in Table 2.   
3.4.1 Participant Surveys 
Participants will complete surveys which will address demographics, medical history, health insurance, 
personal cancer screening history, cancer screening knowledge and beliefs, perceived cancer risk, benefits 
and barriers of cancer screening, self-efficacy, social support, and satisfaction with intervention materials.  
Surveys will be administered at baseline via telephone (1a) and paper (1b), two months into the intervention 
(TIDVD and TIDVD+PN arms) via phone (2) and at 12-months via paper (3).   
 
Figure 4: Contact Flow Diagram 

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Table 2. Data Collection: Constructs and Time Points 
  
Data Collection Timing 
Baseline 
2-month 
12-month 
1a 
1b 
2 
3 
Demographics 
x 
General Health/Co-Morbidities 
x 
Social Support 
x 
x 
Personal Cancer History 
x 
x 
Cancer Risk/Worry 
x 
x 
x 
Cancer Knowledge/Attitudes/Beliefs 
x 
x 
x 
Screening: Behavior/Barriers/Benefits/Self-Efficacy 
x 
x 
x 
Staging 
x 
x 
x 
Screening Intention 
x 
x 
x 
Satisfaction with DVD 
x 
Satisfaction with Navigator 
x 
Contamination 
x 
Medical Record Review 
x 
x 
1a) Baseline Telephone     1b) Baseline Paper     2) 2-month Phone     3) 12-month Paper 
3.4.2 Community-Level Variables 
Effect of community (neighborhood) factors, using geographic information system (GIS), on outcomes of 

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receipt of needed screening tests will be evaluated. Participant addresses will be geocoded and 
accessibility to health care will be determined by measuring the number of facilities within a given 
distance of each geocoded address. Geocoded addresses will be spatially joined to a U.S. Census 
Topologically Integrated Geographic Encoding and Referencing (TIGER) zipcode shapefile containing 
demographic data. An area deprivation index score will be created using the health care accessibility 
variable and 21 U.S. Census data variables, including social and economic conditions (e.g. education, 
employment/occupation, housing conditions, income/ poverty, racial composition, residential stability).12-15
 
3.5 Incentives 
A total of $25 in incentives will be distributed to participants as a sign of gratitude for taking the time to 
complete and return the surveys. Amounts and timing are detailed in Table 3. 
Table 3. Gift Card Distribution 
Time 
Action 
Amount 
Pre-enrollment 
Complete phone survey and send medical record release 
$5 
Baseline 
Complete and return paper survey 
$10 
Month 12 
Complete and return paper survey 
$10 
 
3.6 Training of Interviewers  
Interviewers will be trained, supervised, and monitored by the BMSR staff, in collaboration with the PIs and 
the Program Managers. Training manuals for interviewers developed for prior studies will be modified for the 
proposed study and will include: 1) overview of study objectives; 2) description of interventions; 3) protection 
of human  subjects,  HIPAA,  and  confidentiality  issues;  4)  cultural  sensitivity;  5)  roles  and  
responsibilities; 6)  documentation  and  reporting  requirements;  7)  data  monitoring  and  quality  
assurance  procedures; 8) handling problems/questions during recruitment/data collection; 9) effective 
interviewing techniques; and 10) use of the REDCap telephone interview system. Following practice 
sessions, interviewers will role-play and receive feedback until they have reached 100% compliance with 
recruitment and data collection integrity. 
 
 
3.7 Quality Assurance  
Performance of interviewers will be closely monitored by the project manager and the BMSR supervisors. 
Approximately 10% of all interviews and recruitment calls will be monitored for quality assurance purposes. 
Feedback will be provided to the interviewers to correct performance weaknesses. 
3.8 Medical Record Review (MRR) 
Participants will be asked to sign and return a MRR form to the study office after the baseline interview. 
The signed release will remain valid for the duration of the study. Dates and results of completed BC, CC, 
and CRC screening tests and confirmation of participant date of birth (DOB) will be requested from health 
care providers named by participants during the baseline and 12-month interviews. We are confirming DOB 
to ensure that records are obtained for the correct woman. The MRR form signed by the participant along 
with a request from our research office will be presented to the medical facility (secure fax, phone, secure 
email, or in- person) where the cancer screening tests were ordered or performed. This request will inform 
the clinic/facility staff about the study and request information from the medical record about the participant’s 
cancer screening history to be sent to a secure fax or mailed to the study office at OSU. Women who 
report never being screened and/or cannot produce provider names or locations will be asked to complete 
MRR forms in order to contact locations that they may visit for screenings during the study period. Non-
responders will be contacted again, if necessary, to obtain this information. We anticipate that at least 85% 
of the participants will return a signed MRR form, and 95% of clinics will respond to our request for information 
(based on our prior studies).16 
4.0 Interventions 
4.1 Conceptual Model for the Intervention 
A multiple health behavior change intervention is especially appealing when addressing behaviors that 
are conceptually similar, such as cancer screening behaviors. Cancer screening behaviors have many 
commonalities and have been found to be correlated with common variables predicting screening for 
all 3 tests.17 For example, the theoretical principles used to make behavior change for each cancer 
screening test include self-efficacy, and the use of change processes that move an individual through stages 
of change.18-20 The interventions proposed will focus on the needed cancer screening tests concurrently 

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and teach principles of behavioral change (e.g. self-efficacy). Several studies have found that interventions 
targeting multiple behavior 
change (but none have focused on 3 screening test behaviors) have been 
effective in simultaneously changing up to five behaviors. In 2005, a randomized controlled trial was 
effective in helping CRC patients change multiple behaviors.21 More recently, researchers found that an 
intervention targeting multiple behaviors was successful in decreasing sedentary behavior in CRC 
survivors.22 Johnson coined the word coaction to reflect the synergistic effect one behavior can have on 
another.23 He concluded that regardless of study design or other variability, coaction was consistently 
found in multiple behavior studies. 
Figure 5: Conceptual Model 
 
The conceptual model (Figure 5 ) uses constructs from the Theory of Reasoned Action, Theory of 
Planned Behavior, as well as other well-established behavioral theories.24-27 This model will build on 
previous work by identifying an individual’s beliefs about variables known to predict behavior change.24,28,29 
These variables will have intervention messages tailored to each women’s input. Our goal is to provide a 
unified intervention that supports adherence to all 3 cancer screening tests, depending on individual 
screening needs. Responses are tailored to specific tests needed by the individual. Ability to carry out tests 
will vary based on which test is being discussed and the program will tailor messages appropriate to the 
test(s) needed.28-30 Variables that may affect beliefs directly or indirectly such as demographics, health care 
provider input, and social conditions and policies are identified in Figure 4. This model will be used to identify 
intervention effects and to test model development. Intervention “engagement” has been identified by 
researchers and theorists as a critical component of intervention effectiveness and will be measured and 
included in the analyses.31 
This study will test two interventions (TIDVD and PN) in comparison to UC. The following sections describe 
the two interventions separately as well as the intervention pre-testing. Overall, both interventions (TIDVD 
and PN) will address any combination of screening tests needed by an individual woman. Women will be 
categorized into one of seven groups based on baseline adherence status for each of the three screening 
tests. The ability of either the intervention arm to simultaneously address any combination of the three 
screening tests (BC, CC, or CRC) represents a holistic approach to preventive care that may be cost 
effective. For example, for women who need both mammography and CRC screening, both  the  TIDVD  
and  PN  interventions  will  provide  messaging  about  common  benefits  of  BC  and  CRC screening, 
and, if appropriate, build on the success of CC screening (Table 4). If a woman indicates abnormal signs or 
symptoms at any time, she will be referred to her health care provide or a health care clinic. We will identify 
any abnormal screening tests that occur in the follow-up surveys and a PN will contact women (in any study 
arm) to assure they are able to follow-up with further testing. Since this will be done after the intervention is 
concluded and outcome data (screening adherence) are collected, this action will not interfere with the study 
results. The two interventions, TIDVD and PN, are described in detail below. 
 

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Table 4. Sample TIDVD Messages Tailored to Screening Adherence at Baseline
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.2 Tailored DVD  
The TIDVD will include a CC screening component and barriers unique to rural women that are identified 
during focus groups. The TIDVD will be mailed to a participant and played on a regular DVD player, Blu-
ray player, or computer. The participant interacts in real time with the DVD by answering questions posed 
by the DVD program and using arrow keys on the remote to highlight and enter their response.  All possible 
tailored messages and videos are included in the TIDVD program with algorithms that provide 
individualized messages and videos tailored to individual data. The TIDVD format was selected for three 
reasons. First, the majority of women in rural areas have a DVD player. Secondly, the DVD can be 
programmed such that women can answer questions using the remote control allowing delivery of tailored 
messages in real time. We can program a DVD to deliver health messages with visual aids such as graphs, 
video clips, and storytelling.  Once data are obtained from the individual, the program delivers a message 
developed specifically to the data provided in real time. For example, a message about the barrier of 
embarrassment with CRC screening would be delivered only if the participant indicated she was 
embarrassed about the test. W e are tailoring on multiple barriers, as well as age and rural residence.32-34 
Third, DVD can be duplicated quickly with minimal expense and mailed to participants. The tailored program 
begins with a generic introduction that explains the use of arrow keys on the remote control to enter responses 
and asks a few basic questions to determine adherence to each of the 3 screening tests, as well as age 
(in decade), race, and family history. Responses to questions are stored in memory and integrated into 
responses (obtained throughout the program) to queries about belief constructs (perceived risk, benefits, 
and self-efficacy). Throughout the TIDVD program, women will receive programmed tailored messaging 
bundled to their screening status on BC, CC, and CRC (Table 6). Risk messages are tailored to both 
perceived and objective risks. For barriers, a list of potential barriers will be presented and women will indicate 
up to three barriers for the relevant test. The DVD program ends with the narrator encouraging viewers to 
make an appointment for any of the screenings needed. Screens will be narrated along with the critical 
information appearing as written text, allowing women with low literacy to use the program. On average, 
our previous interactive CRC DVD program required 10 minutes to complete, so we anticipate this TIDVD 
program covering BC, CC, and CRC screening information to take no longer than 30 minutes to complete if 
the participant chooses to watch all components of all three screening sections. Program coding will be done 
using DVD Studio Pro.  
4.3 Tailored DVD + PN  
The second intervention group will receive a TIDVD intervention followed by a telephone call from a PN.  
4.3.1 PN Intervention  
PNs will attempt to contact participants by telephone within 1 week after mailing the DVD.  PNs will make 
at least 10 attempts at different times and on different days, including weekends, if needed. This timeframe 
will allow women to have received the DVD and watched it. If not viewed, the PN will encourage women 
to view the DVD and will assist to facilitate this. The PN will reinforce the DVD message and address 
barriers to receiving needed screening tests, including those not mentioned in the DVD. PNs will complete 
electronic encounter forms during each participant contact and have a file for each navigated participant. 
The encounter forms will include: 1) days/times of contact attempts; 2) a summary of the telephone call with 
documented cancer screening barriers; 3) navigator actions to address screening barriers; and 4) time 
spent on the call. PNs will track any other actions taken to assist participants (e.g. arrange transportation) 
 
Needs only CRC screening You    
already    understand    the benefit   of   
mammography   and Pap tests but 
might not know that CRC starts as a 
single cell which can 
grow 
and 
divide  for a long time before you 
would be aware you had cancer. Just 
like BC or CC,  if  CRC  isn’t  found  
early,  it can spread to other parts of 
your body making it hard to treat and 
may cost you your life. The good 
news is that all cancers can be 
found early – before they spread; 
when   almost   all   women   are 
completely cured. 
 
Needs BC and CRC screening You    
already    understand    the benefit of  
having  Pap  tests  but might not know 
that BC and CRC start as a single cell 
which can grow and divide for a long 
time before you would be aware you 
had these cancers.  If BC or CRC isn’t 
found early, it can spread to other parts 
of your body making it hard to treat and 
may cost you your life. The good news 
is that these cancers can be found early 
– before they spread and when almost 
all women are completely cured. 
 
Needs BC, CRC, and CC Many 
women don’t realize that BC, CRC 
and CC all start as a single cell which 
can grow and divide for  a  long  time  
before you would be aware you had 
cancer. If this cancer  isn’t found  
early,  it  can  spread  to other parts 
of your body may cost you your life.  
The good news is that these cancers 
can be found early  –  before  they 
spread  and  when  almost  all women 
are completely cured. 

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and track the time taken to complete those actions. PN information will be directly submitted to a 
database that will alert them when a follow-up action needs to be placed for a participant (e.g. an alert will 
be sent to the PN to call the participant to remind them of a cancer screening appointment). PNs will make 
as many contacts as needed to assist participants to complete screening tests. 
4.3.2 PN Qualifications and Training 
The success of a PN intervention is dependent upon the navigator’s ability to communicate with a wide 
range of people and in the culturally accepted vernacular. Personal skills such as the ability to be 
empathetic, patient, and caring are important when it comes to helping participants understand and 
comply with cancer screening tests. PNs will be trained by Dr. Katz and Ms. Tatum, and will include 
information about cancer screening, treatment, and ways to overcome barriers to health care. Navigators 
will be trained jointly by OSU and IU staff, and training will include an explanation of the PN role as serving 
as a link between the participants and the health care system to guide participants to complete needed 
cancer screening tests. The following criteria will be assessed prior to allowing the PN to begin: 1) ability 
to communicate; 2) knowledge/understanding of cancer screening; and 3) understanding of the community 
and cultural setting.  
4.3.3 Community Resources/Referral Network for the PN Intervention  
In Year 1, a listing of community resources needed to address barriers and needs of participants with no 
primary care provider, no regular source for screening tests, abnormal test results and cancer will be 
assembled by the project staff and PNs. We will involve local and state American Cancer Society (ACS) 
offices as well as our State Agricultural Extension Offices located in each county in this effort. This listing 
will include medical resources, financial resources, transportation, local agencies, etc. For example, if a 
participant needs transportation, the PN will only query the data base for local transportation systems. Under 
the direction of Dr. Katz, low literacy educational resources will also be identified so that PNs can provide 
appropriate materials (e.g. from NCI, ACS, etc.). Most importantly, after outcome assessment, the PN 
will contact any women who received an abnormal screening test, regardless of study arm, to assure 
proper follow-up has occurred with her provider. 
4.4 Intervention Pretesting  
Usability testing will occur using both individual user feedback and CAB member discussions. The CAB 
will be actively involved in development and evaluation of the PN and TIDVD interventions to ensure clarity, 
relevance and sensitivity. Usability will be evaluated by assessing ease of use, content (leveling and 
appropriateness), aesthetic appeal, and cultural relevance. We will present prototypes to members of the 
target population either individually or in group sessions as components are designed. The information 
gathered during testing sessions will be used to revise both interventions as needed. 
4.5 Usual Care (UC)  
Women randomized to UC will receive brochures developed by the research team using national guidelines 
and/or existing, current brochures developed by those organizations that explain and provide encouragement 
for BC, CC, and CRC screening. Women will receive these after the active intervention phase is complete.  
4.6 Potential Risks 
No risks are anticipated from baseline or follow-up surveys. Risks anticipated with receiving the intervention 
materials (brochures, DVD, PN call(s)) or encouraging participants to obtain BC, CC, and/or CRC screening 
exams are minimal, e.g., embarrassment or unnecessary fear of cancer.  
4.7 Protection against Potential Risks 
We anticipate no risks. Only persons directly involved with the study will have access to data identifying 
individuals.  Records and forms will be kept in locked file cabinets when not in use. No names will be stored on 
computer files for data analysis, and no individuals will be identified in the results of this study. Access to 
computer-stored information will require simultaneous knowledge of the data format, computer language, file 
name and password.  Participants will be told that they do not have to answer any questions they do not want 
to answer. 
4.8 Potential Benefits 
The participants may not benefit directly from the study, however, benefits to the subjects may come in the form 
of increased awareness and use of cancer screening tests for the detection of BC, CC, and/or CRC.  The 
subjects and society in general will benefit through the knowledge gained in promoting knowledge about cancer 
control with the future benefits of lower mortality from cancer.  The benefits far outweigh the risks of this study, 
since even the possible risks, mainly unnecessary fear of cancer, might prompt participation in screening, which 
is in itself of benefit to the subject. 

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5.0 Data Handling and Analyses 
5.1 Statistical Analysis 
5.1.1 Sample Size  
Estimates of effect size (Table 5) for the intervention at 12 months is based on our experience in projects 
promoting screening among underserved populations. We estimate 10% attrition at 12 months, when our 
primary outcome will be assessed. Attrition of 10% is conservative because we will have medical record 
data on most of the persons who drop out which will reduce the effect of drop out on the primary 
outcomes. We based power calculations on 2-sided tests when comparing the two intervention arms 
(TIDVD vs. TIDVD+PN) because we could not be certain which group would perform better. Because of 
the overwhelming evidence in the literature35,36 that the UC arm does not have better screening rates than 
tailored DVD or PN interventions, we based the power calculations on 1-sided tests for comparisons to 
the control group (TIDVD vs. UC; TIDVD+PN vs. UC). The planned statistical analyses are consistent with 
these power calculations. Specifically, we will use two sided tests for TIDVD vs. TIDVD+PN, and the 
1-sided tests for comparing interventions to the UC arm, using the 1-sided p-value from the Z statistic 
in contingency table analysis and from the likelihood ratio test in logistic regression analysis. To 
achieve 80% power for the contingency table analyses, and the likelihood ratio tests of logistic 
regression for the primary outcome of adherence to all needed screening tests at 12 months by MRR, 
a sample size of 356 per each intervention group and 180 in the UC group will be needed, which will 
require 396 per intervention group and 200 in the UC group at baseline to account for attrition. For 80% 
power for the secondary outcome of adherence to any needed (BC or CC or CRC) test, regardless of 
the number of screening tests needed, a sample size of 376 per each intervention group and 200 in the 
UC group will be required at 12 months. We will require 418 per intervention group and 222 in the 
UC group at baseline to account for attrition and to achieve at least 80% power for both outcomes. The 
total sample size is 1058 participants enrolled with 418 randomized to each intervention arm and 222 
randomized to the UC arm. 
Table 5.  Sample Size* 
Effect sizes for 
screening at 12 
months 
Control 
(UC) 
12 
Months 
TIDVD 
12 
months 
TIDVD+ 
PN 
12 
months 
N needed per 
TIDVD 
and 
TIDVD+PN at 
baseline 
for 
80% power at 
12 months 
N needed in 
control 
arm (UC) at 
baseline 
for 
80% power at 
12 months 
Projected N 
per  TIDVD 
and 
TIDVD+PN 
intervention 
arms at 12 
months 
Projected N 
in 
control 
arm (UC) 
at 
12 
months 
Power 
TIDVD 
vs. 
TIDVD+ 
PN 
Power 
TIDVD 
vs. 
control 
(UC) 
Power 
TIDVD+ 
PN vs. 
Control 
(UC) 
Cervical 
35% 
50% 
70% 
NA 
NA 
NA 
NA 
NA 
NA 
NA 
Breast 
35% 
45% 
65% 
NA 
NA 
NA 
NA 
NA 
NA 
NA 
Colon 
30% 
40% 
55% 
NA 
NA 
NA 
NA 
NA 
NA 
NA 
All needed 
screenings (primary 
outcome) 
10% 
20% 
30% 
396 
200 
356 
180 
82% 
83% 
99% 
Any (at least 1) 
needed screening 
(secondary outcome) 
25% 
35% 
45% 
418 
222 
376 
200 
80% 
80% 
99% 
*Estimates of effect sizes for the secondary outcome (at least 1 needed test adhered to by 12 months) was based on the most conservative single test
(i.e., colon cancer screening). Effect sizes for the primary outcome were based on an estimated reduction of 5% in the number of participants who
would adhere to all needed tests compared to only one of the needed tests. Power columns are based on the most stringent required sample size, i.e.,
when N=418 per each intervention arm and N=222 controls at baseline and projected 376 per each intervention arm and 200 controls at 12 months. 
 
5.1.2 Primary Outcome  
The primary outcome of adherence to screening guidelines at 12 months for Hypotheses 1 and 2 will 
combine MRR and self-report by using MRR when available and self-report otherwise. We anticipate 
obtaining MRR and verification on screening tests at the 12-month survey. Participants will be asked to 
provide contact information on both their primary care physician and any specialist who provided a 
screening test, reducing the chance of missing a test that was conducted but not reported to the primary 
care physician. For those who are lost to follow-up, a signed MRR form will enable us to obtain the 
adherence outcome for those participants. Thus, we anticipate adherence for the overwhelming majority of 
patients will be based on MRR. Dr. Monahan will supervise these analyses with assistance from Mr. Young. 
For hypotheses 1 and 2, the differences in binary adherence (Hypothesis 1, all needed screenings; 
Hypothesis 2, any needed screening) across the three randomized arms will be tested initially with pair-
wise chi-square tests. Binary logistic regression analysis will be used to compare the two interventions 

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and the UC group on the binary dependent variable (adherence), while adjusting for any potentially 
confounding covariates. The models will be controlled for any demographic covariate (e.g., age, 
education) for which the randomized groups differ significantly at baseline using a liberal significance 
level of 0.20 to achieve conservative adjustment. As a sensitivity analysis, multiple imputation will be used 
to impute the adherence outcome for participants who are lost to follow-up and did not sign a MRR. 
We plan to include screening history as a covariate in our analysis by using the total number of past 
screenings for each test since the participant turned 50. All variables in the logistic regression models will 
be tested using the likelihood ratio test.37 Adjusted odds ratios (ORs) and profile-likelihood-estimated 95% 
confidence intervals for those ORs will be provided. Our proposed theoretical model includes only 
variables that can be measured and used in modeling. The conceptual model (Figure 2) uses constructs 
from the Theory of Reasoned Action, and Theory of Planned Behavior, as well as other well-established 
behavioral theories.25-28 Our model has taken these theories into consideration and added important 
constructs such as engagement. Therefore, we will perform theoretical modeling using structural equation 
modeling using the MPLUS software, as described in the next section. We have labeled this section as 
exploratory analyses because it is not part of the primary aims; however, the results will provide insightful 
findings about the context of the intervention effects including how all the theoretical variables interact with 
each other, both in terms of mediation and moderation effects. 
5.1.3 Exploratory Aims  
Associations between theoretical variables (community, social, and individual) and the binary screening 
outcomes will be identified with non-linear mixed models, accounting for two levels of assessment. The 
first level includes variables measured at the person level such as individual demographic and screening 
history variables, as well as beliefs which are measured for each participant in this study. The second 
level includes community variables measured at the county level such as number of providers, number of 
screening facilities, deprivation index, and median income level. Moderators of intervention effects on 
adherence will be identified by testing interaction terms in the model. The theoretical model in Figure 
4 , including mediation effects, will be tested with structural equation models using the MPLUS software.38 
Most recently recorded height and weight will be collected from any medical providers an individual provides 
to us to contact for cancer screening history. Height and weight will be used to calculate body mass index 
(BMI) to compare the association of BMI status and the concordance of self-report and medical record review 
as it relates to screening adherence for breast, cervical and colorectal cancers. Demographic and behavioral 
factors (such as age and smoking status) may modify associations between BMI and concordance of self-
report and medical record review-confirmed cancer screening adherence; relationships between those 
variables and BMI and cancer screening adherence will be investigated. 
5.2 Evaluation of Cost-Effectiveness  
Dr. Eric Seiber will assume responsibility for the cost-effectiveness analyses. The proposed economic 
evaluation of interventions can be seen as addressing three questions: 
1) what are the full costs associated with the implementation of the interventions (cost-identification analysis); 
2) what are the net costs associated with the interventions (is each intervention actually cost-saving?); 
and 
3) what is the cost-effectiveness of each intervention? 
5.2.1 Cost of the Interventions  
The first question is answered by a careful accounting of the operational costs of the interventions, 
excluding those costs that are purely attributable to the research. Some of these are fixed costs associated 
with hiring and training PN’s (which may recur if there is turnover in the position), and others are ongoing 
costs associated with the delivery of services. In the model implemented in this study, the PN’s spend full 
time in that activity. Thus, the costs of implementation are straightforward and obtainable. Even though the 
PN is full-time, we will want to collect data concerning at least the broad categories of time use, so that we 
can estimate the cost of specific components (e.g., arranging transportation) more accurately. The best way 
to do this will be a structured time log. We will use a developed Participant Encounter Form and a 
Tracking Log of Direct Participant Contacts that will provide the majority of this information. The procedures 
outlined above will establish the aggregate cost of implementation. However, it will also be useful to 
measure cost on a per-unit basis. This will be done by calculating average cost per active participant 
per month and average cost per participant for cancer screening completion, for each test, type of test, and 

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all needed tests. 
5.2.2 Cost Savings  
The second question is whether each intervention is actually cost-saving, and is essentially an attempt to 
calculate the numerator in a typical cost-effectiveness analysis:39 the change in cost attributable to each 
intervention. Using the terminology of Gold et al., a full assessment would require measuring the changes in 
use of health care resources, changes in use of non-health care resources, changes in use of informal 
caregiver time, and changes in use of participant time for cancer screening.39 In order to avoid distortions in 
the measured impact of an intervention due to pricing differences, all cancer screening tests will be assigned 
cost based on their Medicare allowable payment, regardless of how the service was actually paid for. 
Medicare payments are often used as a proxy for cost in cancer studies.40,41 While this is not a pure cost 
measure, it is comparable and avoids other potential distortions like differences in cost to charge ratio for 
different payors. 
5.2.3 Cost Effectiveness  
The third  question, the cost-effectiveness of each intervention, will be the most difficult to address. 
Because of the nature of the interventions and the limited time for observation, it is not likely that the 
interventions will have a significant impact on standard measures of effectiveness used in cost- 
effectiveness analysis, such as quality-adjusted life years (QALYs). Cost-effectiveness analysis (CEA) 
implies a comparison of whether the cost per unit of outcome in one situation exceeds that in another. 
Unless the outcome measures are comparable, this is not possible. We will be able to examine outcomes 
of the interventions and the UC group (completed cancer screening tests). Our analysis will emphasize 
the first two questions (cost of the intervention itself, calculation of net cost). CEA will consist of measuring 
the incremental cost of achieving the observed incremental outcomes, but not a cost-effectiveness ratio 
in standard terms. Cost Utility: From our cost effectiveness estimates, we will conduct a QALY-based 
(Quality Adjusted Life Year) cost utility analysis. Calculating QALYs will require both utility (quality) weights 
and estimates of the life years saved. Both utility weights and the life years saved from the health outcomes 
will be drawn from the published literature. The Markov modeling will be conducted in TreeAge. Dr. Xu will 
conduct these analyses. 
 
5.3 Process Evaluation  
Dr. Mira Katz will conduct the process evaluation for the study using a mix of quantitative and qualitative 
methods focusing on the following 3 areas. 
5.3.1 TIDVD Intervention 
The process evaluation will include such key components as reasons for viewing/not viewing the 
TIDVD; participant satisfaction with the TIDVD and engagement with the intervention. The data collected 
on the 2 month survey will be used for this evaluation. 
5.3.2 PN Intervention 
The PN data collection form documents each participant’s encounter(s) and lists the potential barriers and 
actions so the PN can easily document each participant-reported barrier and the associated PN actions. 
Analysis will be primarily descriptive but can address not only the frequencies of each barrier, but their 
clustering within individuals and distribution by geographic and demographic characteristics. Little is known 
about the range of barriers faced by rural women and the effective actions which can be taken to address 
cancer screening barriers. This data collection activity will provide rich descriptive data on these issues. 
Reports will include the number of participants reached with the content of the conversation, calls or 
contacts scheduled or rescheduled, and those who refused. 
5.4 Quality Assurance for Intervention Fidelity  
Evaluation of intervention processes is needed to ensure consistency of intervention delivery. Modifications 
will be made as necessary and recorded to ensure appropriate intervention delivery and maintenance of 
protocol integrity. Evaluation questions will assess user experience/satisfaction with the intervention. A 
random sample of participants per month will be called by the project manager to confirm receipt of the DVD 
and PN calls.  The 2-month process evaluation survey will contain questions about the DVD or DVD+PN to 
serve as a rough manipulation check allowing us to document whether participants viewed the DVD or spoke 
to navigators. The BMSR will provide quality checks on 10% of the PN calls to document that the telephone 

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call was made, if cancer screening barriers were reported, and the actions discussed match the PN 
document. 
5.5 Data Management 
We will use REDCap as our data entry system. It will be used to complete the baseline and follow-up 
questionnaires, will work directly with the OSU CCTS Research Informatics Services Core and will be used 
as a central location for data processing and management. Vanderbilt University, with collaboration from a 
consortium of institutional partners (including OSU) and the NIH National Center for Research Resources, 
has developed a software toolset and workflow methodology for electronic collection and management of 
research and clinical trial data. REDCap data collection projects rely on a thorough study-specific data 
dictionary defined in an iterative self-documenting process by all members of the research team with planning 
assistance from the CCTS Research Informatics Services Core. As part of the data dictionary development 
process, individual fields can be denoted as “identifiers”. When exporting a de-identified dataset, these 
variables are omitted. Additionally, the data export tool also allows shifting of dates for a limited data set 
export. REDCap provides a secure, web-based application that is flexible enough to be used for a variety of 
types of research, provides an intuitive interface for users to enter data and has real time validation rules 
(with automated data type and range checks) at the time of entry. It offers easy data manipulation with audit 
trails and ad hoc reporting functionality for reporting, monitoring and querying patient records, and an 
automated export mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus). REDCap is 21 
CRF Part 11 capable. Currently, REDCap installations support electronic signatures by positively identifying 
the user through a unique username and password combination. The provisioning of accounts and user 
access to specific database(s) is integrated with the OSU Medical Center LDAP authentication service, and 
the provisioning of access and specific user rights are managed by CCTS staff.  
Each participant will be assigned a unique participant identification code (PID) when first recruited that will 
follow their electronic information in REDCap, throughout the study. Each participant will have their own 
folder that will contain a copy of their consent documentation form, Patient Data Sheet, Medical Records 
Release form, and any letters sent to the participant. The folders will be stored in locked filing cabinets in a 
locked office. No information about a study participant will be given to third parties unless that subject has 
given written or witnessed consent to do so.  
All paper forms will be scanned into the system where optical character recognition (OCR) software interprets 
each data item and exports the data to a Microsoft SQL Server database maintained by the OSU CCTS. 
Teleform performs basic range checks and data edits immediately following OCR.  Records with data not 
meeting pre-specified edit checks or failing to be recognized by the OCR engine will be placed in a suspended 
file for verification by quality control staff. The CCTS SQL Server database is maintained on striped and 
mirrored disks to insure data integrity and undergoes incremental backups to tape daily. The system resides 
inside the OSUWMC firewall and is protected in a locked and secured room.  
Information will be obtained and maintained on all individuals screened for this study.  If available we will 
keep demographic data on those individual who are ineligible and eligible but refuse.  The data will be used 
to ensure that we do not contact individuals who are ineligible for the study or who have told us they do not 
want to participate in the study.  The data will also be used to characterize/compare this group individual to 
those who are eligible and agree to participate; it is important to determine if those who are ineligible and 
especially those who refuse to participate, are in way inherently different from the women who participate in 
the study.   
5.6 Record Retention 
All research records (including identifying information) will be maintained until data analysis and all 
manuscripts have been completed, or for the length of time designated by the institutional requirements 
(OSU, IU) and the NCI.  Paper records will be maintained in a secured storage facility and electronic data 
will be stored in a password protected database until is appropriate to destroy the data.  The IRBs at OSU 
and IU and the NCI will be notified of our intent to destroy the data. Data will be sent to Indiana University (IU) 
as necessary for the purpose of conducting data analyses for the study. The data will be sent in a secure 
manner to IU (using OSU secure container or similar software) by Mr. Young.  If required by NCI, de-identified 
data may be shared with the NCI and their data repositories. 
5.7 Management Plan 
Overall study responsibility belongs to Drs. Paskett and Champion, Co-PIs of the study. Dr. Paskett and 
her staff will be responsible for day-to-day study oversight including obtaining human subjects approval, 

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drawing/recruiting the sample, conducting interviews and the PN intervention, and data management 
activities. Dr. Champion and her staff will be responsible for the refining and troubleshooting the TIDVD 
and supervising the data analyses. Dr. Katz will assist in training the PNs and overseeing the process 
evaluation. Dr. Rawl will assist with refinement of the DVD program and study measures. Dr. Grever 
will serve as the team clinician to advise about medical-related issues and to provide expertise related 
to clinical environments which serve these women. Dr. Seiber will lead the cost analysis with assistance 
from Dr. Xu, and Dr. Monahan will lead data analysis with assistance from Mr. Young. 
6.0 Ethical and Regulatory Considerations 
6.1 Regulatory Approval 
Prior to initiating the research project and conducting any research project activities the PIs will obtain written 
approval to conduct the research project from the appropriate institutional regulatory bodies. Should changes 
to the research project protocol become necessary, the PIs will submit protocol amendments in writing to the 
IRBs for approval prior to implementation.    
6.2 Informed Consent 
As noted in section 3.2.3, consent will be sought and obtained via phone and verbal consent process completed 
prior to initiating any research project procedures. Each element of the consent will be verbally explained to the 
potential participant. The woman will be given an opportunity to ask questions and have the questions answered 
to her satisfaction. Once the individual understands each element of the verbal consent, including the purpose, 
requirements, benefits, risks, confidentiality, right to withdraw, and contact person, then and only then will it will 
be documented that the individual consented to participate in the study.  
6.3 Data and Safety Monitoring Plan 
We have developed a Data and Safety Monitoring Plan for this study. The purpose of the data and safety 
monitoring plan is to ensure the safety of participants, the validity and integrity of data, and the appropriate 
termination of studies for which significant benefits or risks have been uncovered or when it appears that the 
study cannot be concluded successfully. Risks associated with participation in research must be minimized to 
the extent practical and the method and degree of monitoring should be commensurate with risk. The essential 
elements of the Data and Safety Monitoring Plan include: 
1. Monitoring the progress of the study and the safety of participants 
2. Plans for assuring compliance with requirements regarding the reporting of adverse events (AE) 
3. Plans for assuring that any action resulting in a temporary or permanent suspension of the study is reported 
to the appropriate agencies 
4. Plans for assuring data accuracy and protocol compliance. 
 Prior to the initiation of the project, all project staff will receive standardized training to ensure that the activities 
of the study are conducted in a uniform, safe, confidential and secure manner. A tracking system will be put in 
place to document data collection activities, and reports will be generated on a weekly and monthly basis to 
monitor the study activities.  Conference call meetings of the research team will take place on a monthly basis 
to monitor the activities of the project and to continually reassess the progress of the project including 
assessments of data quality, timeliness, participant recruitment, accrual, retention and monitoring of the risk 
versus benefits throughout the study period. In addition, face to face meetings among the local institutional 
study staff will take place once per week to discuss the activities of the project. 
All AEs will be reported according to the policy outlined by the Institutional Review Board (IRB) at the OSU and 
IU. The appropriate forms will be completed and sent in accordance to the timeline set forth by the IRBs.  All 
AEs will be reported to and reviewed by the study team. The research project manager will conduct a10% 
eligibility verification.  If a violation is noted, the research manager will document the violation and inform the 
research project and OSU and IU investigators of the matter. The appropriate action will be taken to rectify the 
violation and to determine what or if any corrective actions need to take place. All protocol violations will be 
documented and reported to the IRBs.  Also, any privacy violations will be reported to the IRBs and the 
institutional privacy offices. All privacy violations, adverse events, and protocol violations will be reported to and 
reviewed by the principal investigators (Drs. Electra Paskett and Victoria Champion) and the research team, 
who will be responsible for reporting to the appropriate regulatory bodies at OSU and IU.  
The IRB will be provided feedback more frequently if there should be any adverse events or other 
recommendations. The investigators are responsible for reporting to the NIH project director any action resulting 
in temporary or permanent suspension of the research project at OSU. These actions will be reported to the 
NCI program director within 72 hours of notification.  All documents or correspondence that are generated in 
the course of correcting or appealing the suspension status must also be forwarded to the program director 

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within 72 hours of it being presented to the institutional body that put for the directive to temporarily or 
permanently suspend the research project.  During this time no research project activities can occur.  
The principal investigators are responsible for submitting reports; annual reports will be sent to the OSU and 
IU IRBs, and as required by the NIH project office. Information included in the reports will include the number 
of individuals enrolled in the study, dropout rates and any protocol deviations. 
 
 
 

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