Mychoice: Testing an Interactive mHealth Tool to Enhance Communication and Informed Decision Making About Clinical Trial Participation in Cancer Patients
Phase: NA
Conditions: Conflict, Decisional Conflict
Sponsor: Fox Chase Cancer Center

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Protocol Title 
mychoice:  Testing an interactive mHealth tool to enhance communication and informed 
decision making about clinical trial participation in cancer patients  
 
 
 
 
 
 
 
 
Principal Investigator(s) 
Linda Fleisher, Ph.D., MPH – Fox Chase Cancer Center, Cancer Prevention and Control:  Principal 
Investigator 
Sarah Bauerle Bass, Ph.D., MPH – Department of Social and Behavioral Sciences, Temple 
University College of Public Health: Co-Principal Investigator 
 
 
Co-Investigator(s): 
Carmen Guerra, MD – University of Pennsylvania Hospital: Co-Investigator 
Deric Savior, MD – Temple University Hospital: Investigator 
Amy Leader, Ph.D., MPH- Thomas Jefferson University Hospital: Co-Investigator  
 
Participating/Collaborating Institutions: 
Fox Chase Cancer Center 
Temple University Hospital 
University of Pennsylvania Hospital 
Thomas Jefferson University Hospital  
Statistician: 
Jingwei Wu – Temple University College of Public Health, Department of Epidemiology and 
Biostatistics 
 
 
Funding Source: 
Merck Pharmaceuticals 
 
Initial Version Date: 08/01/2017 
Revised Version Date: 12/21/2017 
Revised Version Date: 2/12/2018 
Revised Version Date: 3/26/2018 
Revised Version Date: 4/4/2018 
Revised Version Date: 4/24/2018 
Revised Version 6/5/2018 
Revised Version: 02/14/2019 

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Revised Version: 05/23/2019 
Revised Version: 07/25/2019 
 
Table of Contents 
1.0 Introduction ............................................................................................................................ 34 
2.0 Objectives ................................................................................................................................ 34 
3.0 Background/Rationale ............................................................................................................ 46 
4.0 Study Design............................................................................................................................ 78 
5.0 Risks to Participants ................................................................................................................ 15 
6.0 Potential Benefits to Participants ........................................................................................... 15 
7.0 Provisions to Maintain the Confidentiality of Data ................................................................ 15 
8.0 Costs to Participants ........................................................................................................... 1615 
9.0 Consent Process .................................................................................................................. 1615 
10.0 Off-Study Criteria .................................................................................................................. 16 
11.0 Drugs and Devices ................................................................................................................. 16 
12.0 Multi-Site Research Study ................................................................................................. 1716 
13.0 Statisical Analysis .............................................................................................................. 1716 
14.0 Data Safety Monitoring Plan ............................................................................................. 1918 
15.0 Adverse Event Reporting .................................................................................................. 1918 
16.0 Quality Assurance Procedures and Participant Confidentiality ........................................ 1918 
17.0 Participant Informed Consent........................................................................................... 1918 
18.0 References ........................................................................................................................ 2018 
19.0 Appendices ........................................................................................................................ 2218 
 
 
 
 
 

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1.0 Introduction 
 Evidence shows that although clinical trials are aimed at producing new strategies for 
reducing cancer morbidity and mortality, participation remains suboptimal for all 
populations, especially those from racial and ethnic groups [1-3].  Although some 
interventions have been found to be effective at enhancing participation, few studies 
have tested tailored communication activities using innovative communication 
techniques (perceptual mapping) with aims to address barriers and facilitators for 
patients and facilitate more engaged discussions with their providers in real world 
settings.   We therefore aim to fill that gap by testing a culturally diverse and patient 
guided mHealth decision tool called mychoice, which allows patients to explore their 
concerns and questions related to clinical trial participation, as well as create a 
customized and personalized set of questions to enhance patient-provider 
communication and increase informed decision making. This study employs a mixed-
methods approach using both qualitative and quantitative data to evaluate the 
effectiveness of the mychoice intervention for patients and to explore the provider and 
organizational factors that impact implementation. A randomized controlled trial will be 
performed with 270 participants in order to determine the acceptability and feasibility 
of the intervention, as well as its effects on self-efficacy in discussing clinical trial 
participation with providers, leading to enhanced informed decision-making.  Results 
will also investigate whether the tool has enhanced effects on minority patients, 
particularly African Americans.  A secondary aim of the study is to evaluate the 
implementation of the intervention in clinical settings.  Implementation evaluation will 
occur using surveys of medical staff whose patients are participating in the study. These 
surveys will assess institutional facilitators and barriers to study implementation.  We 
will also conduct cognitive de-briefing interviews after the intervention is completed 
with key stakeholders at the participating institutions, which will inform a larger 
implementation study in the future. 
 
2.0 Objectives 
 The primary objective of the study is to assess the effectiveness of the mychoice 
mHealth tool on perceived patient self-efficacy and decisional conflict, and whether 
these results are enhanced in minority patients. 
 
 The secondary objective of the study is to describe the acceptability and feasibility of 
implementing mychoice in oncology services at three leading cancer centers in 
Philadelphia.   
 
 Purpose of the study: mychoice was conceptualized and developed with a Fox Chase-
Temple NODAL grant, using extensive formative research, including the use of 
commercial marketing techniques (perceptual mapping and vector modeling) and 

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patient engagement, and customized to address the significant barriers for African 
American patients to consider clinical trials.  The tool went through user testing and 
received excellent reviews, and now is ready for an efficacy test.  This study represents 
the next step in personalized clinical trial education research. It completes the mychoice 
communication tool to make it multi-cultural and thus appropriate for all patients, and 
tests its effectiveness with diverse cancer patients to improve knowledge and 
preparation to discuss clinical trials within real world settings. We will also explore 
organizational factors that impact implementation of a technology-based intervention, 
an innovative aspect that will provide critical understanding on feasibility to ensure 
scalability in a large medical setting. Results could inform how a tool like mychoice could 
be implemented in a cancer center and enhance communication about clinical trials 
between patients and doctors. 
 
 Specific Aims:  
o AIM 1:  Test the perceived usefulness and effectiveness of mychoice to 
increase patients’ self-efficacy and decrease decisional conflict.  
o AIM 2:  Describe the acceptability and feasibility of implementing mychoice 
in oncology services at three leading cancer centers in Philadelphia by 
identifying provider and organizational factors influencing its integration in 
the clinical space.   
 
 The following hypotheses are proposed for Specific Aim 1: 
o H1:  Compared to a non-tailored education aid, mychoice will improve self-
efficacy in making a decision about participating in clinical trials for all 
patients as well as a subsample of underrepresented patients (non-white). 
o H2: Compared to a non-tailored education aid, mychoice will reduce 
decisional conflict about clinical trial participation for all patients, as well as a 
subsample of underrepresented patients (non-white). 
 
3.0 Background/Rationale 
 Background:  Evidence shows that ethnic and racial minorities are significantly 
underrepresented in clinical trials, which are critical to producing new strategies for 
reducing cancer morbidity and mortality for all populations [4-22].    Recognizing the 
complexity of barriers to participation in clinical trials, research has focused on 
potential strategies to enhance participation. Interventions have shown that 
provider referrals of minority patients, community outreach, acknowledging and 
addressing issues of trust, flexibility in intervention methods, and population 
targeted materials are effective [23-26]. Few studies, however, have tested tailored 
communication activities to address barriers and facilitators for patients using 
innovative communication techniques in real world settings – meaning ways these 

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activities can be integrated into the healthcare workflow - or addressed the unique 
needs of racial and ethnic minorities.   
The mychoice communication tool begins to prepare patients to participate in a 
personal and tailored discussion with their provider about clinical trials as a potential 
treatment option. It is also customized to address the concerns of those least likely 
to participate, instead of providing a more general look at clinical trials- a common 
trait of other available tools. Previous research has shown that patient education 
before the first oncologist visit improves knowledge, attitudes, and preparation for 
decision making about clinical trials [27] and integrating these tools into the clinical 
encounter is critical. In addition, using innovative communication techniques 
(perceptual mapping and vector modeling) to validate and explore salient messages 
across diverse cancer patients provided new insights into tailoring messages and 
personalizing patient/provider communication.  Insight gained from validation of the 
intervention will improve the decision making process, and inform a large scale 
integration of mychoice to affect patient perceptions and increase willingness to 
participate in clinical trials, especially in minority patients. 
In addition, we will assess barriers to implementation when introducing the tool in 
diverse cancer centers, each with different protocols and patient populations, to 
inform a future proposal.  Using the Consolidated Framework for Implementation 
Science (CFIR), one of the predominant implementation science research 
frameworks, we will focus on five domains: intervention characteristics, outer 
settings, inner setting, characteristics of individuals (patients and providers), and 
process [28].  Implementation science is becoming an important component of 
intervention implementation and we aim to use this framework to ensure success.   
o Preliminary Data: To address the issue of clinical trial participation, we 
developed mychoice (IRB #14-811) to target unique barriers of 
underrepresented populations and prepare them for a discussion about clinical 
trials with their providers [29-38]. The intervention was developed with 
stakeholder (both patients and providers) involvement and includes real life 
stories of cancer patients. The intervention, initially focused on African American 
cancer patients, was based on mixed-methods formative research including in-
depth interviews (Phase I), a survey of African American cancer patients using 
perceptual mapping and vector modeling to guide the development of the 
communication messages within the intervention (Phase 2), and message and 
user testing of the mHealth tool with African American cancer patients who had 
never participated in clinical trials (Phase 3). 
In Phase 1 we conducted in-depth interviews with 16 African American cancer 
patients. Investigators reviewed and developed themes/subthemes, which 
resulted in eight themes:  knowledge, benefits, disadvantages, social support, 
decision influencers, provider beliefs, personal history, and value of clinical trials. 
Results from these interviews were used, along with a thorough literature 

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review, to inform the development of a quantitative survey that was used in 
Phase 2. 
Phase 2 was completed with 41 African American adult cancer patients, just over 
half (53.7%) of whom indicated they had never participated in a clinical trial.  
Surveys occurred either in person or over the phone and participants were asked 
to report how much they agreed or disagreed on a 0-10 scale (0=strongly 
disagree, 10=strongly agree) with statements regarding clinical trials’ 
helpfulness, benefits, barriers, value, support from those around them, and 
beliefs about healthcare providers. T-tests revealed significant perceptual 
differences between individuals who had participated in a clinical trial and those 
who had not. Based on the perceptual maps that were generated, the research 
team developed message strategies to address those issues found to be 
important in the maps.   
The resulting mychoice mHealth prototype was then developed, working with an 
app development company and in consultation with our research staff and 
oncologists. This iterative process included many changes to content, visuals and 
narrative. In addition, since patient-provider communication and informed 
decision making was a main theme, we chose to make the mHealth tool 
interactive to provide patients with an easy way to ask providers questions that 
were tailored to their interests. The tool combines text, animation, and videos of 
real patients discussing the identified themes.  User testing of the mychoice 
prototype showed that the communication tool was easy to use and understand 
and was perceived to be very helpful in preparing patients to discuss clinical 
trials.  Feedback from the user testing with predominately African American 
patients indicated that the patient videos should be more diverse showing a 
broad representation of races and ethnicities.   In addition, a more culturally 
diverse, rather than a targeted intervention for only African Americans, would be 
more representative of real world settings.  Therefore, the patient videos are 
being expanded for the current version.   
 Significance: Participation in clinical trials is a serious and complex decision, and 
many patients of all races and backgrounds have limited knowledge and 
understanding of clinical trials as a treatment option. Although much research has 
been conducted to explore the barriers to participation, there has been a call for 
more intervention research to address these barriers [39]. A fundamental aspect of 
patient focused interventions is an exploration of their personal questions and 
concerns, without which it is difficult for patients to become empowered to 
participate in an informed or shared decision making process. However, there 
remains limited empirical research to suggest which messages are most salient to a 
diverse range of patients to improve decision making, and how decision tools can be 
tailored to enhance the patient-provider communication dyad.  This research will 
provide insight into that process when the decision is participation in clinical trials.   
 

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4.0 Study Design 
a) Recruitment methods 
o We will recruit a total of 270 patients (100 130 at FCCC via the medical 
oncology, radiation oncology, and surgery units and 100 at TUHS via the 
cancer center).  The remaining 40 70 patients will be recruited at Thomas 
Jefferson University Hospital and The University of Pennsylvania We 
anticipate that approximately 20% of the participant pool will be non-white 
which should provide sufficient number to perform sub-analyses of effects.  
We will monitor this during recruitment, however, and if we find that we are 
not reaching this number of non-white participants, we will change the 
protocol to focus on recruiting only non-white participants. 
o There are three ways that patients will be recruited for the study at FCCC.  
This is shown in Figure 1.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
o (1) First, at FCCC, Dr. Fleisher will collaborate with FCCC oncologists to 
identify patients who might be offered a clinical trial but who have not 
participated in a clinical trial previously.  A patient information card and a 
flyer have been developed for oncologists to provide to patients (see 

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Appendices A and B).   Oncologists will suggest the study to patients at 
regular visits and be instructed to either go to the Resource and Education 
Center at Fox Chase, or find a study representative in the waiting area at a 
table who is wearing a mychoice pin. Mychoice study staff will be in the 
waiting areas of participating oncologists on days/times that are busiest.  If 
staff are not available that day, they can go to the REC.  If the patient 
approaches a study staff, they will meet the patient in a designated private 
space, consent them, and give them the option of doing the study then on 
either a provided iPad or go to the REC to do the study on a computer.  
o (2) Study staff will also be available in the common areas of FCCC at a table.  
Patients can come up to the table and ask about the study.  We will also have 
a small “wheel” that is a game that patients can play to win small prizes 
(candy, umbrella, $5 gift cards). All patients who come up to the table can 
play and win a small prize; there is no requirement to enroll in the study to 
play. If they are interested in the study, we will provide an information card 
and answer any questions they have.  They can then complete consent and 
do the study then (as above) or have the option to complete the study at 
home.   
o (3) Another way for patients to participate is through a referral by REC staff.  
When patients go to the REC, staff will provide information to the patients 
about the study.  If they are interested, REC staff will go through the above 
steps to consent a patient and provide them an iPad or computer to 
complete the study. 
o (3) The last way for patients to participate will be by self-referral.  Cards and 
posters will be available throughout the waiting areas.  On this card are the 
study email and phone number. Patients could use these to contact study 
staff who will explain the study and verbally consent people over the phone 
and then provide the option to come to do the study at home or at the REC. 
Because this consent is occurring over the phone, staff will use a script 
(provided) to explain the study and screen for eligibility. A waiver of 
document of consent has been provided to assist with this process. After 
they have verbally been consented for the study, they will be sent a link to 
the study through the RedCAP system and provided information on how to 
complete the study. They will be directed to review the study consent and 
indicate their willingness to participate by entering their name as an e-
signature.  They then will be asked to do the same with the HIPAA waiver.  
Once they agree, they will be directed to the baseline survey. 
o Patients recruited at TUH, Jefferson, and HUP will follow the same 
recruitment strategies, but will only be recruited by Physician Referral and 
Self-Referral. There are no REC staff at these institutions, so recruitment 
strategies will rely solely on study staff and physicians. Study staff will be in 
the waiting rooms prepared for any referrals during busy clinic days.  

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o All study materials, including the pre and posttest and the patient education 
materials, are programmed in REDCap.  If completing the study in person, 
once the patient agrees to be in the study and is set up in the RedCAP 
system, study staff will explain this process and have them sign in the 
REDCap system to indicate they agree to participate (script for staff to follow 
in Appendix C) and to the HIPAA waiver. Study assignment will be random 
and programmed into the system 
o The email link will provide a contact name, phone number, and email should 
the participant have any questions or concerns. If they choose to come to the 
REC because they do not want to do the study at home, we will make an 
appointment with them to meet them at a designated day/time. 
o The REDCap link will include pre/post-tests (Appendices D and E) for all 
patients, and the appropriate patient education materials based on 
randomization. (Note: Baseline surveys take approximately 15 minutes and 
post-test surveys take approximately 5 minutes, based on testing.)  The pre 
and posttests as well as the consent form will be integrated into the 
materials through REDCap.   All patients will then be contacted by telephone 
or email one month post consult by the research staff to conduct a follow-up 
survey (Appendix F – Treatment Arm; Appendix G – Control Arm).  In some 
cases (i.e. at TUH) follow-ups will be done in person when the patient has 
returned for an appointment. 
o The experimental condition will receive the mychoice mHealth Tool (Screen 
shots (http://mychoice.sandstorm.notss.com) of the tool are provided in 
Appendix G.) The entire tool is available at the URL. The control condition will 
receive the NCI material on clinical trials: Taking Part in Cancer Treatment 
Research Studies (https://www.cancer.gov/publications/patient-
education/CRS.pdf).  Both will be provided on the device through the RedCAP 
system.  Participants in the experimental condition will receive a pair of ear 
buds (which they can keep) to listen to audio/video segments and will 
receive a printed version of the questions they identify as important to them.      
o Patient participants will receive a total of $50 compensation, provided as a 
$25 gift card at initial testing and an additional $25 upon follow-up survey.  
These will be provided in person if they choose to complete the study in 
person or via mail if they choose to complete the study at home.  Recruiters 
and physicians interviewed about implementation will not receive 
compensation. 
b) Inclusion and exclusion criteria 
o Eligibility criteria for participation in the RCT are:  1. 18 years of age or over; 
2. Active diagnosis of invasive cancer (any diagnoses); pre or post 
chemo/radiation/surgery; 3. Able to speak and read English  
o Exclusion:  Participated in a therapeutic trial in the past 
 
 

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c) Procedures involved in the human research 
o Study Design: (Figure 2) 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The primary outcomes are decision-related self-efficacy and decisional conflict.  
Secondary measures will include patient-related outcomes such as increased 
knowledge, use of mychoice, increased patient activation, and perceptions of the 
provider encounter.   Table 1 on the following page describes the study measures. 
 
o Randomization. Upon completing the informed consent form, patients will be 
randomized to either mychoice group or control group by RedCAP at a 1:1 ratio. The 
system will randomly assign participants as they enter into the system after they have 
been consented to the study.   
 
 
T1 – At 
Fox 
Chase or 
self-
referral 
T2 – 1 
month 
post 

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Table 1. RCT Study Measures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Measure 
Source 
Description 
Pre 
Post 
1 month 
follow-
up 
Demographics 
NIH 
Age, education, insurance, income, race, ethnicity, 
gender, living situation (8 items) 
X 
 
 
Cancer and Clinical Trial Experience (personal and family/friends) 
  
Cancer type, stage (6 items) 
X 
 
 
Technology Use 
HINTS 
Mobile, smartphone, computer, tablet (5 items) 
X 
 
 
Health Literacy 
SILS 
1 item 
X 
 
 
Clinical Trial Perceptions  
Bass, Fleisher 
Test perceptions over time using perceptual mapping – 
knowledge, benefits, concerns, 
perceptions/experiences with cancer treatment, 
beliefs about health care providers and your health (48 
items pre; 31 post; 43 follow up) 
X 
 
X 
Patient Activation (Decisional Engagement Scale) 
Hoerger, et al (DES-10) 
2- scales  decision making preference (1 item), Comfort 
with interacting with physician (10 items) 
X 
 
X 
Patient Self-Advocacy Scale 
       Brashers eta l. 
Perceptions and self-reported behaviors about 
information seeking and provider relationship (12 
items) 
X 
 
 
Knowledge of Clinical Trials 
Campbell 
Knowledge of clinical trials (reduced items; 16) 
X 
X 
X 
Self-Efficacy  
PEPPI 
Confidence in communicating with Physician (10 items) 
X 
X 
X 
Decision preparation scale (PrepDM) 
Bennett, et al 
Value of mychoice in preparation to make a decision 
(10 items) 
 
X 
 
Perceived Shared Decision Making (CollaboRATE) 
Barr, et al 
Patient perceptions of effort to discuss concerns  
 
 
X 
Shared Decision Making 
SDM Q-9 Kriston et al 
Patient perception of shared decision making with 
provider (12 items) 
 
 
X 
Decisional conflict   
Ottawa 
Decision conflict (revised; 13 items) 
X 
X 
X 
Clinical Trial Intention 
Adapted from Ottawa Patient Decision 
Aid 
If offered, would be considered (1 item) 
X 
X 
X 
Satisfaction with patient materials 
CISRC adapted 
Helpfulness and recommendations of materials (app or 
standard brochure) (3 items post; 13 items follow-up) 
 
X 
X 
Experience with clinical trial discussions  
 
Self-reported experience about clinical trial discussions 
with provider (6 items) 
 
 
X 
Satisfaction with Decision 
Enswistle, et al 
Satisfaction with decision about clinical trials (6 items) 
 
 
X 

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To assess implementation issues and address Specific Aim 2, we will use the Consolidated 
Framework for Implementation Research (CFIR) to guide the implementation evaluation, 
focusing on the acceptability and feasibility of implementing the mychoice study as well as the 
integration of this tool in ongoing practice.  This evaluation is descriptive in nature. To evaluate 
the acceptability and feasibility of the proposed mychoice study, we will collect data from the 
initial planning meetings, review of recruitment logs and files, as well as surveys from 
physicians who have patients that are participating in the study.   Meeting notes will be kept 
and used to design the recruitment process, procedures, and logs.   Prior to the start of 
recruitment (using REDCap; Appendix H) and at project end (will be developed based on how 
intervention is implemented in sites), an online survey will be conducted with each physician 
who has patients who are participating in the study.  The survey will assess level of 
commitment to the project and potential barriers.   The survey will include key constructs from 
CFIR, such as perceptions of intervention strength, relative advantage, trialability, patient 
needs, self-efficacy, and champions.   During the recruitment period and throughout the study, 
recruiters will keep logs of the number of identified patients, number of consented patients, 
and notes regarding challenges and opportunities in the recruitment process.   At the end of the 
recruitment, the PIs will conduct debriefing interviews with the stakeholders (guide to be 
developed based on implementation) at each site to more fully explore the challenges and 
opportunities for ongoing implementation and sustainability (Figure 3).  Table 2 describes the 
measures for the implementation evaluation.   
Figure 3. Implementation Process Study Design 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table 2. Implementation Constructs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
o Timeline: This is a 33 month project (4/2017-12/2019)  
 
 
 
 
 
 
 
 
 
 
 
4/17-9/17 
4/17-
1/18-
7/18-
8/19-
CFIR Constructs 
Baseline Survey 
End of Study 
Debrief Interviews 
Meeting Notes 
I. Intervention Characteristics 
  
 
 
 
Source 
X 
X 
 
 
Evidence Strength & Quality 
X 
X 
X 
X 
Relative Advantage  
X 
X 
X 
X 
 Complexity 
X 
X 
X 
X 
II. Outer Setting 
  
 
 
 
Needs & Resources of  Those Served by the 
Organization  
X 
X 
X 
X 
III. Inner Setting 
  
 
 
 
 Culture 
X 
X 
  
 
Implementation Climate 
X 
X 
X 
X 
Tension for Change 
X 
X 
  
 
Readiness for Implementation 
X 
X 
  
 
Leadership Engagement 
X 
X 
  
 
Available Resources 
X 
X 
  
 
IV. Characteristics of Individuals 
  
  
  
 
Knowledge & Beliefs about the Innovation 
X 
X 
X 
X 
Self-Efficacy 
X 
X 
X 
X 
V. Process 
  
  
  
 
Planning 
  
  
X 
X 
Engaging 
  
  
X 
X 
Formally Appointed Internal Implementation 
Leaders 
  
  
X 
X 
Champions 
  
  
X 
X 
 Key Stakeholders 
  
  
X 
X 
 Executing 
  
  
X 
X 
Reflecting & Evaluating  
  
  
X 
X 

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12/17 
6/18 
7/19 
12/19 
Months:  
1-6 
1-9 
10-15 
16-28 
29-33 
 
 
 
 
 
 
Revisions based on initial user 
testing  
X 
X 
 
 
 
Review by key stakeholders  
X 
X 
 
 
 
New patient testimonials to 
increase diversity 
X 
 
 
 
 
Final Production  
X 
X 
 
 
 
 
 
 
 
 
 
Create Study Instruments  
 
X 
 
 
 
Finalize data management system 
 
X 
X 
 
 
 
 
 
 
 
 
Recruitment process established at 
sites  
 
 
 
 
 
1. Fox Chase  
 
 
X 
 
 
2. Temple  
 
 
X 
 
 
3. Jefferson  
 
 
 
X 
 
4. Penn  
 
 
 
X 
 
 
 
 
 
 
 
IRB review and approval at study 
sites  
 
 
 
 
 
1. Fox Chase 
 
 
X 
 
 
2. Temple  
 
 
X 
 
 
3. Jefferson  
 
 
 
X 
 
4. Penn  
 
 
 
X 
 
 
 
 
 
 
 
Recruit 270 Patients  
 
 
 
X 
 
 
 
 
 
 
 
Conduct pre-intervention 
implementation surveys with 
participating staff  
 
 
 
X 
 
Conduct baseline, intervention, 
and post test 
 
 
 
X 
 
Conduct one-month follow-up 
surveys  
 
 
 
X 
 
Conduct post intervention 
implementation surveys 
 
 
 
X 
 
 
 
 
 
 
 
Data Analysis – Patient Surveys  
 
 
 
 
X 
Tracking analysis-metrics in 
mychoice 
 
 
 
 
X 

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5.0 Risks to Participants 
 Participating in this study does not pose direct physical risk to patients. Participants 
may have questions about clinical trials after taking the surveys, in which case they 
will be instructed to talk with their oncologist about medical or eligibility questions 
related to clinical trials. Participants may also be directed to the Resource and 
Education Centers at TUHS for additional information about clinical trials.  
 
6.0 Potential Benefits to Participants 
 Participating in the study does not pose direct physical benefit to participants. This is 
not a therapeutic study, but rather an evaluation of an educational app. The results 
of the research will be used to modify the app thereby making it a more appropriate 
and useful decision-making tool to help African American, and other cancer patients, 
make better informed decisions concerning clinical trial participation. 
7.0 Provisions to Maintain the Confidentiality of Data 
 All information collected for this study will be kept confidential.  Subjects will be told 
that all information will be kept in strict confidence.  All deidentified survey data will 
be downloaded from RedCAP and stored on computer files or in locked filing 
cabinets to which only select members of the research staff will have access.  
 RedCAP survey data and user data from the mHealth tool will be identified only by 
participant number and will be downloaded into SAS for analysis.   
 ipads have been purchased for this study and will be used to implement the 
intervention, along with computers used either at the REC or in the participant’s 
home.  All ipads and REC computers are password protected with only study staff 
having that information. No files will be saved or downloaded on the ipads or 
computers, and no data will be accessible on the ipads or computers that would 
identify patients.  Participants will go to a RedCAP study URL which will then 
randomize them to condition.  All data from the surveys will be gathered by the 
RedCAP system and not on the ipad or computer itself.   
 All participating sites will direct patients to the RedCAP URL to begin the study.  No 
data will be shared with them and they will not have access to the data.  Only study 
PIs and the study coordinator will have this access.   
 For medical staff personnel, surveys will also be sent via email where they will be 
provided a RedCAP link.  When conducting interviews, a digital recorder will be used 
to capture the interview.  These will be transcribed and then destroyed.  No 
identifying information will be recorded on the transcriptions. 
In-depth implementation 
interviews with site stakeholders  
 
 
 
 
X 

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 All data will be housed behind the firewall at Fox Chase Canacer Center using 
RedCAP.  The PIs and study coordinator, will have access to this data and will 
download de-identified data for analysis to share with the biostatistician to be used 
in SAS. A special study ID and password will be required to enter into RedCAP.  In 
addition, any additional files will be password protected and kept on secure, fire-
wall protected servers at Temple University and Fox Chase Cancer Center . 
8.0 Costs to Participants 
 There are no costs to participants.  The study will take approximately 1 hour initially 
(10 minutes consent, 15 minutes pre-test, 30 minutes education tool, 5 minutes post 
test).  The one month follow survey will take approximately 30 minutes.   
 For medical staff participants, surveys will take less than 5 minutes; post-
intervention interviews will take approximately 30 minutes. 
 
9.0 Consent Process 
 The study coordinator will introduce the study and review the consent document 
either in person or over the phone. If providing consent over the phone, the staff 
member will read the consent to the participant (script provided).  If they verbally 
agree, they will be directed to the link in their email for the study.  The study 
consent document is then also embedded into the RedCAP baseline survey that will 
be on the iPad or computer.  Participants will read through the consent and provide 
consent by entering their name and hitting a designated button.  They then will be 
asked to do the same for the HIPAA consent. These consents will be recorded and 
the participant will be allowed to proceed to the baseline survey.  If the participant 
has any questions about the study or consents, the site recruiter will be available in 
person or over the phone.  Staff will have copies of the consent should the 
participant like to have a copy to take home; those doing at home can download a 
pdf of the consent to have a copy. The scripts for the staff person to explain this is 
included (App C). A telephone screening consent script is also provided. 
 Participants will be able to decide to continue or discontinue at any time.  
 All participants will be English speaking. 
 
10.0 Off-Study Criteria 
 Not applicable 
 
11.0 Drugs and Devices 
 Not applicable. 
 

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12.0 
Multi-Site Research Study 
 •        Fox Chase Cancer Center serves as the primary site, with participating sites 
including sites Temple University Hospital, Thomas Jefferson University Hospital, and 
Hospital of the University of Pennsylvania. Dr. Fleisher serves as the PI at FCCC 
overseeing study recruitment at all coordinating sites. Each site will have their own 
IRB oversight and coordinating investigator as well as their own study documents (e-
consent and protocol) to meet their institutions requirements. Dr. Fleisher and the 
study coordinator at FCCC will oversee the other sites regulatory by documenting 
the study team’s Human Subjects training and expiration dates. They will also track 
all sites Continuing Reviews to ensure compliance across all 4 coordinating sites.  
 Dr. Fleisher and the study coordinator at FCCC will also oversee protocol 
management by conducting monthly meetings and periodic review of each site’s 
protocol. The study coordinator will conduct on-site visits monthly to review 
recruitment and study progress. All sites will participate in a monthly full team call to 
discuss updates and address any recruitment/implementation issues. 
 Each site will be provided an Operations Manual that incorporates important 
protocol specific information to provide support onsite. Each member of the study 
staff will have 3 training sessions prior to their recruitment start date. We will also 
conduct periodic recruitment training to reinforce operations and protocol 
compliance.  
 Data management will take place at FCCC via REDCap weekly by the Study 
Coordinator. The Study Coordinator will review quality and completeness of the data 
on a weekly basis and provide feedback to each site PI and recruitment staff.  
13.0 Statistical Analysis 
 General analyses: After screening for potential differences across sites on the key 
outcome variables, all data will be graphed and tabulated by group (i.e., mychoice 
vs. control) for review of distributional properties and anomalous values prior to the 
main analyses. Continuous and normally distributed variables will be summarized 
with means and standard deviations. All parameter estimates will be bound by 95% 
confidence intervals. Tests of significance will be based on adjustments for alpha to 
protect family-wise error rates at 5% using the method of Benjamini and Hochberg 
[40]. Data will be analyzed using an intent-to-treat (ITT) approach where subjects are 
analyzed according to their treatment assignment at randomization, regardless of 
level of participation or engagement. Because an ITT analysis is planned, we will 
evaluate models suitable for non-ignorable (missing not at random) data within a 
sensitivity analysis framework in order to determine the extent to which analysis 
conclusions depend on the assumptions being made about unobserved values. We 
will perform model-based analyses with direct maximum likelihood methods, 
including those for data missing not at random (MNAR) if necessary. We will screen 
for violations of assumptions for all statistical tests involved. All analyses for specific 
aims will be conducted using SAS 9.4. 

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 H1 Analysis: The principle endpoint will be 1-month follow-up, i.e., one month after 
completion of either the mychoice or control education. We will conduct a mixed-
effect regression models for each repeatedly measured continuous outcome (i.e., 
self-efficacy and decisional conflict at post intervention and 1-month follow-up) on a 
dummy grouping variable (mychoice, as compared to Control), adjusting for baseline 
level of this outcome  and covariates discovered to be unbalanced between the two 
groups, and moderators of interest.  In these models, we will treat time as a 
categorical variable and examine the fixed effects for time, intervention group, and 
their interactions.  We will specify the covariance structure within patients using an 
unstructured model to account for the in-patient correlation over time.  
 
In addition, the dichotomous race (White vs. non-White) variable and the non-
White-Treatment interaction will be entered in each regression model as predictors, 
to understand possible different effects of mychoice for non-White vs. White 
participants. A significant, positive regression coefficient of the non-White 
Treatment interaction indicates non-white participants’ benefits more from the 
treatment than their White counterparts.   
 Power: Power analyses were performed using G*Power 3.1, with 2-sided tests and 
an adjusted alpha level of .025 (= .05/2) for multiple group comparisons. We 
performed power analyses for comparisons on primary and secondary outcomes for 
Aim 1.  Effect size (mean difference between groups divided by the pooled standard 
deviation) is a common measure for assessing the magnitude of a treatment effect 
on continuous outcomes.  The number of participants needed for Aim 1 is selected 
to sufficiently power the detection of a difference between groups on the outcomes 
adjusting for covariates and moderators at 1-month follow-up.  
 
To detect a moderate treatment effect size of 0.47 SD on either the self-efficacy and 
decisional conflict scales, our trial would need 88 patients per group, presuming 
alpha = .025 and beta = .20 (power = 80%). Of note, this effect size is comparable to  
prior studies (please cite some papers). Including a 20% adjustment for dropout and 
loss of degrees of freedom when adjusting for possible additional confounding 
variables, a total of 220 patients are needed.  By using mixed-effects repeated 
measures regression analysis, our power is likely to be even higher. Therefore our 
estimated power provides a conservative lower-bound of the likely actual power of 
our sample size.   Also, we will need an additional 50 patients to do exploratory 
analysis on potential differences in effect by recruitment type, bringing the total 
needed to 270. 
 H2 Analysis: Descriptive statistics will be employed for the analysis of the 
quantitative feasibility and acceptability data. All qualitative data collected through 
the meeting notes and debriefing interviews will analyzed the Krueger method of 
analyzing narrative data will be used; familiarization, identifying a thematic 
framework indexing, charting, mapping and interpretation [80]. Recordings will be 
listened to and transcriptions read to become familiar with what participants said. A 

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thematic framework, based on the CFIR constructs will be developed to create 
categories and quotes will be indexed according to categories to reduce data.  Major 
themes of the analysis will be reviewed across institutions.  Recruitment logs will be 
reviewed and compared against study recruitment goals to determine potential 
barriers.   
14.0 Data Safety Monitoring Plan 
o This is a minimal risk study.  We will monitor the study and any participant 
complaints or issues.  In general, we believe data will be accurate based on 
self-reported attitudes. 
 
15.0 Adverse Event Reporting 
 In accordance with FCCC guidelines, this protocol will employ the following 
mechanisms for adverse event reporting: 1) alert the FCCC review committees of 
any and all reports of adverse events; 2) inform all members of the study team of 
any all reports of adverse events.  If 3 or more adverse events are reported, the 
study team will assess potential causes of the adverse events and, if events are 
clearly linked to study participation, discontinue the study.  
 
16.0 Quality Assurance Procedures and Participant Confidentiality 
 Information about study subjects will be kept confidential and managed according to 
the requirements of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA). Those regulations require a signed subject authorization informing the 
subject of the following: The protected health information (PHI) that will be 
collected from patient; who will have access to that information and why; who will 
use or disclose that information; the rights of a research subject to revoke their 
authorization or use their PHI. In the event that a participant revokes authorization 
to collect or use PHI, the investigator, by regulation, retains the ability to use all 
information prior to the revocation of subject authorization.  To ensure 
confidentiality, only a participant identifier will be recorded and used with collected 
electronic data.  All records will be secured in a locked location.  
 While we will not access private health information during the study accrual, but 
may access information on their participation in a clinical trial when we are analyzing 
data while the IRB is still open.  As a result we will maintain the HIPAA waiver in the 
consent process.  
 
17.0 Participant Informed Consent 
 See separate informed consent document 
 

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18.0 References 
1.   
Baquet, C.R., et al., Clinical trials: the art of enrollment. Semin Oncol Nurs, 24(4): p. 262-
9, 2008. 
2. 
Comis R, Crowley J. Baseline study of patient accrual onto publically sponsored U.S. 
cancer clinical trials: an analysis conducted for the global access project of the national patient 
advocate foundation, 2006. 
3. 
Michaels, M.S., S; ENACCT and Community-Campus Partnerships for Health, 
Communities as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy. 2008: 
Silver Springs, MD. 
4. 
Weinberg, A.D. Eliminating Disparities in Clinical Trials. cited 2009 June 4th, 2009; 
Version 2: Available from: http://www.bcm.edu/edict/home.html. 
5. 
Colon-Otero, G., et al., Disparities in participation in cancer clinical trials in the United 
States: a symptom of a healthcare system in crisis. Cancer, 112(3): p. 447-54, 2008. 
6. 
Gadegbeku, C.A., et al., Factors associated with enrollment of African Americans into a 
clinical trial: results from the African American study of kidney disease and hypertension. 
Contemp Clin Trials, 29(6): p. 837-42, 2008. 
7. 
Katz, R.V., et al., Participation in biomedical research studies and cancer screenings: 
perceptions of risks to minorities compared with whites. Cancer Control, 15(4): p. 344-51, 2008. 
8. 
Shavers, V.L., C.F. Lynch, and L.F. Burmeister, Factors that influence African-Americans' 
willingness to participate in medical research studies. Cancer, 91(1 Suppl): p. 233-6, 2001. 
9. 
Mills, E.J., Seely, D., et al.  Barriers to participation in clinical trials of cancer:  a meta-
analysis and systematic review of patient-reported factors.  The Lancet Oncology, 7(2):141-148, 
2006. 
10. 
Todd, A.M., Laird, B.J., et al.  A systematic review examining the literature on attitudes 
of patients with advance cancer toward research.  Journal of Pain and Symptom Management, 
37(6):1078-1085, 2009.  
11. 
Evelyn B, Toigo T, Banks D, et al. Participation of racial/ethnic groups in clinical trials and 
race-related labeling: a review of new molecular entities approved 1995-1999. Journal of the 
National Medical Association. 93(12 Suppl):18S-24S, 2009 
12. 
Stewart JH, Bertoni AG, Staten JL, Levine EA, Gross CP. Participation in surgical oncology 
clinical trials: gender-, race/ethnicity-, and age-based disparities. Annals of surgical 
oncology.14(12):3328-3334, 2007 
13. 
Rivera-Goba, M.V., Dominguez, D.C., Stoll, P., Grady, C., Ramos, C., Mican, J.M.  
Exploring Decision-Making of HIV-Infected Hispanics and African Americans Participating in 
Clinical Trials.  Journal of the Association of Nurses in AIDS Care, 22(4):295-306, 2011. 
14. 
Symonds, R.P., Lord, K., Mitchell, A.J., Raghavan, D.  Recruitment of ethnic minorities 
into cancer clinical trials:  experience from the front lines.  British Journal of Cancer, 107:1017-
1021, published online May 2012. 
15. 
Schmoltzer, G.L.  Barriers and facilitators to participation of minorities in clinical trials.  
Ethnicity and Disease, 22(2):226-30, 2012. 
16. 
Advani, A.S., Atkeson, B., Brown, C.L., Peterson, B.L., Fish, L., Johnson, J.L., Gockerman, 
J.P., Gautler, M.  Barriers to the Participation of African-American Patients with Cancer in 
Clinical Trials.  Cancer, 97(6):1409-1506, 2003. 

IRB # 17-8013 
Page 21 of 22 
 
Page 21 of 22 
 
17. 
Goldberg, D.  The case for eliminating disparities in clinical trials.  Journal of Cancer 
Education, 24(Suppl 2):S34-38, 2009. 
18. 
Gross, C.P.  Racial disparities in clinical trial enrollment.  Lancet, 372(9651):1713-1714, 
2008. 
19. 
Newman, L.A., Roff, N.K., et al.  Cancer clinical trials accrual:  missed opportunities to 
address disparities and missed opportunities to improve outcomes for all.  Annals of Surgical 
Oncology, 15(7):1818-1819, 2008. 
20. 
Ford, J.G., Howerton, M.W., et al.  Barriers to recruiting underrepresented populations 
to cancer clinical trials: a systematic review.  Cancer, 112(2):228-242, 2008. 
21. 
Gul, R.B., Ali, P.A.  Clinical trials:  the challenge of recruitment and retention of 
participants.  Journal of Clinical Nursing, 19(1-2):227-233, 2010. 
22. 
Markman, M., Petersen, J., et al.  An examination of the influence of patient race and 
ethnicity on expressed interest in learning about cancer clinical trials.  Journal of Cancer 
Research and Clinical Oncology, 134(1):115-118, 2008. 
23. 
Adderley-Kelly, B., Green, P.M.  Strategies for successful conduct of research with low-
income African American populations.  Nursing Outlook, 53(3):147-152, 2005. 
24. 
Knobf, M.T., Juarez, G., et al.  Challenges and strategies in recruitment of ethnically 
diverse populations for cancer nursing research.  Oncology Nursing Forum, 34(6):1187-1194, 
2007. 
25. 
Lai, G.Y., Gary, T.L., et al.  Effectiveness of strategies to recruit underrepresented 
populations into cancer clinical trials.  Clinical Trials, 3(2):133-141, 2006. 
26. 
Davis, S., Fleisher, L., TerMaat, J., Muha, C., Laepke, K.  Treatment and Clinical Trials 
Decision Making: Impact of the Cancer Information Service Outreach Program.  Part 5.  Journal 
of Health Communications, 3:71-85, 1998. 
27.        Meropol, N. J., Albrecht, T., Wong, Y., Bowen, A., Iii, B., Buzaglo, J., … Schluchter, M. 
Randomized Trial of a Web-based Intervention to Address Barriers to Clinical Trials Background. 
2013; J Clin Oncol; 34(5):469-78. 
28.        Damschroder L, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering 
implementation of health services research findings into practice: a consolidated framework for 
advancing implementation science. Implementation Science, 2009; 4:50. 
https://doi.org/10.1186/1748-5908-4-50 
29. 
Bass SB, Fleisher L, Washington A, Nicholson A, Maurer L, Geynisman D.  Use of 
perceptual mapping to encourage informed decision making on clinical trials in African 
American cancer patients.  Society of Behavioral Medicine.  Washington, D.C.: March 2016. 
30. 
Fleisher L, Bass, SB, Washington, A Maurer, L.  Development of an mHealth tool to 
encourage clinical trial participation in African American Cancer Patients.  Society of Behavioral 
Medicine.  Washington, D.C.:  March 2016. 
31. 
Bass SB (with L Fleisher and C Heckman on panel).  Building a better app:  using 
formative research to guide the development of e-Health interventions.  International Society 
of Research in Internet Innovations.  Seattle, WA: April, 2016.  
32. 
Fleisher, L, Bass, SB, Washington, A, Geynisman, D, Nicholson, A, Maurer, L.  African 
American cancer patients’ informed decision making for clinical trial participation:  Using 
perceptual mapping survey findings to understand critical communication messages and guide 

IRB # 17-8013 
Page 22 of 22 
 
Page 22 of 22 
 
intervention development.  AACR Conference on the Science of Cancer Health Disparities in 
Racial/Ethnic Minorities.  Atlanta, GA:  2015 (poster presentation) 
33. 
Fleisher, L, Bass, SB, Washington, A, Geynisman, D, Nicholson, A, Maurer, L.  African 
American cancer patients informed decision making for clinical trial participation:  Using 
perceptual mapping survey findings to understand critical communication messages and guide 
intervention development. 2015 AACR Conference on the Science of Cancer Health Disparities 
in Racial/Ethnic Minorities.  Atlanta, GA: 2015, November. 
34. 
Geynisman, DM, Fleisher, L, Bass, SB, Washington, A, Nicholson, A, Maurer, L.  African 
American Cancer Patients and Clinical Trials:  Perception Differences between Participators and 
Non-Participators.  American Society of Clinical Oncology.  Chicago, IL.  May, 2015. 
35. 
Bass SB, Fleisher, L,   Washington, A, Nicholson, A, Maurer, L, Geynisman, D.  Use of 
Perceptual Mapping and Vector Modeling to Develop Message Strategies to Encourage 
Informed Decision Making for Clinical Trial Participation among African American Cancer 
Patients.  2015 World Congress of Psycho-Oncology.  Washington, D.C., August 2015.   
36. 
Bass, SB, Fleisher, L, Shwarz, M, King, A, Washington, A, Greener, J, Maurer, L, 
Geynisnum, D.  Perceptions of clinical trial participation in African American cancer patients:  An 
in-depth qualitative analysis.  American Public Health Association, Nov. 2014, New Orleans, LA. 
37. 
Bass, SB, Fleisher, L, Washington, A, Shwarz, M, Nicholson, A, Peters, J.  Maurer, L, 
Geynisman, D. Perceptions of Clinical Trial Participation in African American Cancer Patients: An 
In-Depth Qualitative Analysis. APHA Annual Meeting – November 2014. 
38. 
Perceptions of Clinical Trial Participation in African American Cancer Patients. 
Geynisman, D, Fleisher, L, Bass, SB, Washington, A, Shwarz, M, Nicholson, A, Greener, J, 
Maurer, L.   ASCO – May 2015. 
39. 
Denicoff, B. A. M., Mccaskill-stevens, W., Grubbs, S. S., Bruinooge, S. S., Comis, R. L., 
Devine, P., … Meropol, N. J. (2013). The National Cancer Institute – American Society of Clinical 
Oncology Cancer Trial Accrual Symposium : Summary, 9–17. 
40. 
Benjamini Y, Hochberg Y.  On the adaptive control of the false discovery rate in multiple 
testing with independent statistics.  J Educ Behav Stat 2000; 25:60-83 
 
 
19.0 Appendices 
A: Patient Card 
B: Flyer 
C. Script for electronic informed consent 
D: Baseline Survey 
E: Post Test Survey 
F: Follow-up Survey – Treatment Arm 
G: Follow-up Survey – Control Arm 
H: Physician Survey – Pre Intervention