Predicting Childhood Cancer Survivors' Transition Readiness & Transfer Outcomes (SURV Transfer Outcomes) (Administrative Supplement to R01CA218389)
Phase: NA
Conditions: Cancer, Pediatric Cancer
Sponsor: Emory University

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Protocol Version 7   Date: 10-18-23 
 
Title: Predicting Childhood Cancer Survivors’ Transition Readiness & Transfer Outcomes  (SURV Transfer Outcomes) 
 
NCT#: NCT04257058 
 
Date: 10/18/2023 
 

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Protocol Version 7   Date: 10-18-23 
 
Predicting Childhood Cancer Survivors’ Transition Readiness & Transfer Outcomes  
(SURV Transfer Outcomes) 
Principal Investigator: 
Jordan Gilleland Marchak, PhD, ABPP 
Assistant Professor, Department of Pediatrics 
Emory University School of Medicine 
Pediatric Psychologist, Aflac Cancer & Blood Disorders Center 
Children’s Healthcare of Atlanta 
2015 Uppergate Drive 
Atlanta, GA 30122 
Phone: (404) 727-2293 
Email: jgillel@emory.edu 
Co-Investigators: 
Ann Mertens, PhD 
Professor of Pediatrics, Pediatric Cancer Epidemiologist, 
Director of Clinical Research  
Aflac Cancer & Blood Disorders Center 
Children’s Healthcare of Atlanta 
2015 Uppergate Drive 
Atlanta, GA 30122 
Phone: 404-785-0691 
Email: Ann.Mertens@choa.org 
 
Cam Escoffery, PhD, MPH, MCHES 
Associate Professor 
Department of Behavioral Sciences and Health Education 
Rollins School of Public Health, Emory University 
1518 Clifton Road, NE, 
Atlanta, GA 30322, USA 
Phone: (404) 727-4701 
Email: cescoff@emory.edu 
Study Coordinator: 
Ebonee Harris, MPH 
Clinical Research Coordinator, Survivor 

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Protocol Version 7   Date: 10-18-23 
Aflac Cancer and Blood Disorders Center 
Children’s Healthcare of Atlanta 
5461 Meridian Mark Rd, Ste. 400 
Atlanta, Ga 30342 
Phone: 404-785-7041 
Email: ebonee.harris@choa.org 
Heather Emery, MPH 
Hematology and Oncology Clinical Research   
Aflac Cancer and Blood Disorders Center 
Children’s Healthcare of Atlanta 
2015 Uppergate Drive 
Atlanta, GA 30122 
Phone: 404-785-6318 
Email: Heather.Emery@choa.org 
Clinical Research Associates: 
Rebecca Lewis, MPH 
Research Epidemiologist 
Hematology and Oncology Clinical Research 
Aflac Cancer and Blood Disorders Center 
Children’s Healthcare of Atlanta 
2015 Uppergate Drive 
Atlanta, GA 30122 
Phone: 404-785-9929 
Email: Rebecca.Lewis@choa.org 
Sponsor: 
Pediatric Research Center Program Pilot Grant 
National Cancer Institute  
Protocol Version Date: 
October 18, 2023 
TABLE OF CONTENTS PAGE 
I. Background and Significance 
3 
II. Goals/Aims Overview 
5 
III. Study Design 
5 
A. Outcomes 
6 
B. Setting & Participants 
7 
C. Procedures & Recruitment 
7 
D. Measures 
10 

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Protocol Version 7   Date: 10-18-23 
IV. Risks, Benefits, & Incentives 
13 
V. Data Management & Confidentiality 
13 
VI. Statistical Analysis Plan 
14 
VII. References 
15 
 
I. 
Background and Significance 
Recent data estimate that over 80% of children and adolescents diagnosed with cancer will become long-term 
survivors, thereby establishing a growing patient population with increasing medical and psychosocial needs. The 
Children’s Oncology Group (COG) recommends that survivors participate in continuous long term follow-up (LTFU) 
survivor care across the lifespan to monitor for late effects of treatment. Chronic health conditions and late effects 
of treatment impact over 60% of adult survivors of childhood cancer and over 25% of survivors have severe or 
life-threatening conditions. Ongoing survivor care and surveillance tests are essential for adolescents and young 
adult (AYA )survivors because many late effects do not emerge until years after treatment, and late effects of 
childhood cancer treatment place survivors at an 8.4 times higher risk for mortality as compared to age- and sex-
matched U.S. population. Despite these increased risks, less than 50% of young adult survivors ages 18-24 years 
are adherent with cancer-related medical care and less than 20% had a survivor visit at a cancercenter in the past 
2 years. Regrettably, childhood cancer morbidity and mortality risks increase over time, and thus, the majority of 
young adult survivors are non-adherent with their survivor care during the period in which they are becoming 
increasingly vulnerable to late effects. Although research into transition outcomes in survivor care has been 
repeatedly called for in the literature, no empirical studies characterizing successful childhood cancer survivor 
transition have been published to date.  
Figure 1. SMART Model- Social- 

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Protocol Version 7   Date: 10-18-23 
Given the lack of empirical literature evaluating successful transition of ecological model of AYA readiness for transition, 
Schwartz et. al (2013) pediatric cancer survivors to adult survivor care, we 
pulled from an empirically-based, stakeholder supported theoretical 
framework for childhood cancer survivor transition to guide the development 
of our aims. Schwartz et al. (2013) published on the validation process of the 
SocialEcological Model of Adolescent and Young Adult Readiness to Transition 
(SMART) (Figure 1). The SMART model synthesized the available empirical 
transition literature from other pediatric chronic illnesses and also analyzed 
the childhood cancer survivor transition review literature. The SMART model 
is comprised of “preexisting factors” which may impact transition readiness 
and transfer success but are not likely to be altered by any intervention (i.e., 
demographics, neurocognition, etc.), as well as “modifiable variables” which 
may be beneficial targets for intervention to improve transition outcomes 
(i.e., knowledge, self-efficacy, health beliefs, psychosocial functioning, etc). 
The SMART model also recognizes that transition to adult survivor care is a 
complicated process involving not only patient-factors, but parent and 
provider related factors as well.  
Overall, the proposed study addresses significant questions currently 
unanswered in the literature and takes an empirical approach to resolve these gaps in knowledge. At the end of 
this award, we will know which social-ecological factors to target to improve transition readiness and adherence 
to adult survivor health care. Moving forward, these findings will inform the development of extramural grant 
applications to fund the implementation and evaluation of evidence-based interventions designed to facilitate 
successful transition to adult survivor care. 
Preliminary Data. Our team has sought to assess and measure health self-management and perceptions of 
transition readiness by adapting the Readiness for Transition Questionnaire (RTQ) for use with AYA survivors of 
childhood cancers and their parents. The RTQ was originally developed by the PI for use with AYA kidney transplant 
recipients at Children’s Healthcare of Atlanta and was tailored to assess overall transition readiness (RTQ-Overall), 
AYA healthcare responsibility (RTQ-AR), and parent involvement in pediatric survivor healthcare (RTQ-PI). In a 
recent review of transition readiness measures, the RTQ was one of only 10 measures meeting criteria for 
“promising” assessment as defined by the American Psychological Association Division 54 EvidenceBased 
Assessment Task Force. To evaluate the use of the tailored RTQ within the AYA childhood cancer survivor 
population, we recruited AYA survivors (N=74) ages 14 to 21 and their parents (N=68). The preliminary 
psychometric properties of the RTQ appear to be supported within the AYA pediatric cancer survivor population, 
including internal consistency (Cronbach’s alphas=.80-.90), convergent validity, and construct validity.  
To evaluate healthcare responsibility among our young adult survivor patients, we collected pilot data from N=41 
childhood cancer survivors ages 18-21 years-old participating pediatric survivor care. Although these survivors 
will be transferring to adult care in the next 1-2 years, over half of patients reported that their parents were 
primarily responsible for their healthcare (56.2%) and that parents were almost always involved in the scheduling 
of survivor medical appointments (63.4%). As young adult patients transfer out of pediatric care, it will be 

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important to clearly understand the role of parents and family in the transition process and create interventions 
that target all parties involved in survivors’ health management. 
 
II. 
Goals/Aims Overview 
The objectives of this study are to clarify: what are the most salient social-ecological risk and resilience factors 
that should serve as targets for interventions and who are the survivors most at risk to be recruited for future 
interventions, how survivors want to receive educational interventions, and which educational interventions are 
most effective. Using a cross-sectional cohort study of 18-25 year old childhood cancer survivors and/or their 
parents, this study will determine predictors of transition readiness (Aim 1) and predictors of adherence to adult 
survivor-focused healthcare (Aim 2), as well as evaluate the quality (Aim 3) and efficacy (Aim 4) of electronic 
educational interventions for AYA survivors. The specific aims are to: 
Aim 1: Evaluate social-ecological factors among AYA childhood cancer survivors participating in pediatric survivor 
care to determine factors associated with decreased transition readiness (i.e., risk factors) and increased 
transition readiness (i.e., resilience factors), as well as characterize patterns of co-occurring risk factors associated 
with transition readiness. 
Aim 2: Evaluate social-ecological factors among AYA childhood cancer survivors following transfer to identify 
factors associated non-adherence (i.e., risk factors) and adherence (i.e., resilience factors) to adult survivor care, 
as well as characterize patterns of co-occurring risk factors associated with non-adherence to adult survivor care. 
Aim 3: Develop and assess quality of electronic multimedia materials to educate AYA survivors about lifelong 
survivor care through qualitative interviews with AYAs.  
Aim 4: Evaluate the impact of electronic educational materials on AYA survivors’ knowledge about late effects, 
perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care.  
 
III. 
Study Design 
This is a mixed methods study involving cohorts of 18-25 year old childhood cancer survivors and/or their parents 
to determine predictors of transition readiness among those engaged in pediatric survivor care (Aim 1), predictors 
of adherence to adult survivor-focused healthcare among those who have transferred out of pediatrics (Aim 2), 
and optimize content, format, and delivery of electronic educational media to increase knowledge about and 
motivation for survivor care among AYA survivors (Aims 3 & 4). Through our design and methods, we are seeking 
to clarify what are the most salient social-ecological risk and resilience factors that should serve as targets for 
interventions, as well as what patterns exist among co-occurring risk factors that maximize patients’ risk for poor 
transition outcomes. The planned approach to accomplish our specific aims will employ both quantitative and 
qualitative methods to test the following hypotheses: 
Aim 1 Hypotheses: 
• 
A1 Hypothesis 1: AYA healthcare responsibility, survivor health beliefs, and developmental maturity will be 
significantly related to increased perceptions of transition readiness.  

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Protocol Version 7   Date: 10-18-23 
• 
A1 Hypothesis 2: AYA psychosocial distress, poorer neurocognitive functioning, and deprived 
neighborhoodlevel social determinants will be significantly related to decreased perceptions of transition 
readiness.  
• 
A1 Hypothesis 3: The relationship between parental involvement in survivor healthcare and perceptions of 
transition readiness will be mediated by AYA healthcare responsibility.  
• 
A1 Hypothesis 4: When individual transition readiness risk factors are included in principal component 
analyses (PCA), 2 or more components will emerge indicating subgroups at risk for poor transition outcomes. 
Aim 2 Hypotheses:  
• 
A2 Hypothesis 1: Survivor health beliefs, developmental maturity, and healthcare responsibility will predict 
adherence to adult survivor care.  
• 
A2 Hypothesis 2: Parental involvement in survivor healthcare will predict adherence to survivor care; this 
relationship will be stronger for survivors with higher psychosocial distress, as well as lower levels of 
developmental maturity and neurocognitive functioning.  
• 
A2 Hypothesis 3: Access to care problems (e.g., geographical distance, insurance) and lower patient 
satisfaction will negatively predict adherence to initial survivor care.  
• 
A2 Hypothesis 4: When individual risk factors for non-adherence are included in principal component analyses 
(PCA), 2 or more components will emerge indicating subgroups at risk for poor transition outcomes. 
Aim 3 Hypothesis:  
• 
A3 Hypothesis: Stakeholder input and review of electronic media developed in this study using qualitative 
methods will increase acceptability and value to AYA survivors of childhood cancer  
Aim 4 Hypotheses:  
• 
A4 Hypothesis 1: Exposure to multimedia educational materials will significantly increase AYA survivors’ 
knowledge about late effects and surveillance. 
• 
A4 Hypothesis 2: Exposure to multimedia educational materials will significantly increase AYA survivors’ 
perceived benefits of, self-efficacy to, and intentions to engage in survivor care across the lifespan. 
A. Outcomes  
For Aim 1, our metrics of “transition readiness” will be determined by patient- and parent-reported scores from 
the Readiness for Transition Questionnaire (RTQ-Overall). The RTQ-Overall assesses perceived preparedness to 
transfer both healthcare responsibility (from parent to teen) and services (from pediatric to adult care), with 
higher scores indicating increased transition readiness. For Aim 2, we will operationalize “adherence to adult 
survivor-focused healthcare” as the attendance of at least one healthcare visit with an adult provider focused on 
survivorship within 18 months following transfer from pediatric care. This operationalization of adherence was 
chosen based on recommendation by COG that survivors of childhood cancer should be evaluated annually and 
has been previously utilized to classify survivor clinic attendance. For participants who report attending an adult 
survivor care appointment, we will obtain a medical record release to verify date and attendance at an 
appointment with the adult survivor care provider. For Aim 3, we will elicit stakeholder feedback on the content, 
clarity, style, and interest-level of the electronic educational materials. For Aim 4, AYA health beliefs, knowledge 

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about survivor care and late-effects, patient activation, and self-efficacy and intentions to engage in lifelong 
survivor care will be evaluated using patient reported outcome (PRO) measures. In addition, a 15-item multiple 
choice quiz will be utilized to assess participants’ knowledge of the content covered in the electronic educational 
materials. 
B. Setting & Participants 
The clinical research aspects of this project will occur through Children’s Healthcare of Atlanta’s Aflac Cancer 
Survivor Program (CSP). Eligible participants will be patients of the Aflac Cancer Survivor Program and identified 
for recruitment using Aflac CSP clinical databases. Participants’ CHOA electronic medical records will also be 
reviewed. The staff from the Aflac Cancer Center’s Clinical Research Office has extensive experience in 
coordinating and managing clinical research projects with childhood cancer survivors. The Aflac CSP was 
established in 2001 and currently follows over 850 pediatric cancer survivors each year. This program consists of 
a multidisciplinary team (oncology, endocrinology, and pediatric psychology) who see patients for annual 
longterm follow-up survivor care beginning when the survivor is two years off therapy. Per CHOA policy, the Aflac 
CSP must transition patients to adult providers prior to age 22; however, patients are provided with the option to 
transition between the ages of 19 and 21 years.  
For this study, we will be recruiting all eligible young adult survivor patients and/or one of their parents/caregivers. 
Participant inclusion criteria are as follows, patients must be 18-25 years of age, diagnosed with cancer at ≤ 18 
years of age, ≥ 2 years since the last cancer treatment, and seen at least once in the Aflac CSP in the past 2 years 
(Aims 1, 3, & 4) or transitioned out of the Aflac CSP to adult survivor care since 2013 (Aims 2, 3, & 4). Although 
our goal is to enroll patient-parent dyads for Aims 1 & 2, patients and/or parents will be recruited individually and 
either may choose to participate or not to participate. Patient ineligibility will not impact parent eligibility and 
vice versa. Patients and/or parents will be excluded from participation in the study if the participant is non-English 
speaking. Young adult survivors who are cognitively impaired and unable to complete the questionnaires will be 
excluded. Any eligible subjects for Aims 3 & 4 will be excluded if they do not consent to the recording of their 
interviews.  
Patients will be excluded from participation in the study if patient is non-English speaking (as survey battery is 
available in English only). No patients will be excluded because of gender. We anticipate that at least 50% of our 
population will be women. Within the oncology division of the Aflac Cancer Center where our research will be 
conducted, the reported ethnic/racial distribution of patients is: White (62%), Black or African American (26%), 
Asian (4%), Other (7%); 13% are persons of Hispanic or Latino origin. No patients will be excluded because of race 
or ethnicity. Adolescent and young adult survivors of childhood cancer who are 18-25 years of age during the 
study enrollment periods will be eligible to participate, along with their parents. No minors who are under the 
age of 18 years will be included in this study.   
C. Procedures & Recruitment 
Each family that has been identified from our institutional survivor database and screened for eligibility will be 
contacted via phone, email, or in survivor clinic by research staff to be recruited for the study using information 
from the medical record. Patient names, post mailing addresses, phone numbers, and emails will be collected 
from EPIC and program databases.  

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Aims 1 & 2. All eligible participants will be emailed by research staff and/or receive a printed recruitment letter in 
the postal mail before being contacted by phone. The initial recruitment email will be sent to eligible participants 
containing an email link to a secure electronic consent and survey battery via CHOA’s secure, webbased Research 
Electronic Data Capture (REDCap) platform. The printed recruitment letter will also contain information on how 
to access the secure electronic consent and survey battery via the Research Electronic Data Capture (REDCap) 
platform. Two additional follow-up recruitment emails will be sent at two week intervals. After three unsuccessful 
email attempts to recruit participants, email recruitment will be discontinued. One week following email and mail 
recruitment, research staff will initiate phone recruitment. After three unsuccessful phone attempts to recruit 
participants, phone recruitment will be discontinued. Phone script, letter text, and email text are attached with 
this protocol.  
The consent process will be completed online prior to completing any study questionnaires. The initial page of 
the REDCAP survey will contain a brief written consent outlining the purpose of the study, its voluntary nature, 
time commitment, incentive information, release of PHI, and contact information of PI and Emory IRB should a 
participant have questions. To record participants’ consent to participate, we will have them click a radio button 
labeled “Yes, I agree to take part” or “No, I do not want to take part”. We will also have participants insert the 
current date. Participants who select “Yes, I agree to take part” will be routed to the study survey battery following 
their typed signature. Participants who select “No, I do not want to take part” will exit the REDCap system and 
route to a screen that thanks them for their consideration. Copies of the electronic consent from REDCap are 
attached with this protocol.   
There will be instances where only one email address or phone number is available in our records (e.g., patient or 
parent). Once a participant consents and begins the survey, we will ask: 1.) patients for parents’ contact 
information in the survey and 2.) parents for patients’ contact information. Participants may elect not to share this 
additional contact information.  
Aims 3 & 4. We will utilize a mixed methods design to gather data to consider and revise our AYA electronic 
educational tools as outlined in Table 1.   
Table 1.  Overview of Specific Aims and Approach 
Aim 3. Develop & demonstrate quality of electronic multimedia materials to educate AYA survivors about LTFU care 
INITIAL DEVELOPMENT: Create infographics and videos 
 
Stakeholder Input & Review (N=20) 
Semi-structured interviews with AYA stakeholders via teleconference 
REVISION #1: Revise material based on stakeholder review 
 
Aim 4. Evaluate the impact of electronic educational materials on AYA survivors’ knowledge about late effects, perceived benefits, and self-efficacy 
and intentions to engage in LTFU care. 
Pre-test assessment of survivor health beliefs & knowledge via REDCap → 1 week → 
AYA Pre-test & Post-test (N=58) 
AYAs review electronic educational material → 2 weeks → 
Post-test assessment of survivor health beliefs & knowledge via REDCap 
 
AYA Exit Interview (up to N=25) 
Exit interviews via teleconference to assess impact on survivor health beliefs 

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REVISION #2: Revise material based on AYA performance & review 
 
DISSEMINATION: Share AYA educational material via implementation toolkits (R01 CA218389-01) & Post 
material on www.cancersurvivorlink.org educational platform & share with registrants via email 
For Aim 3, eligible stakeholders will be recruited (N=20 AYA survivors) via phone or in clinic by a member of the  
Aflac Cancer Survivor Research team, and survivors interested in participating will be verbally consented via 
WebEx. Example questions are outlined in Table 3. These stakeholder reviews will be used to inform revisions to 
the infographics and videos, which will be made prior to engaging in Aim 4. 
For Aim 3 and 4, all interviews will be recorded for transcription/qualitative data analysis.  
The consent and interview processes in Aim 3 will be completed sequentially during the subject’s webex 
interview; therefore, this consent discussion will be recorded. All Aim 3 subjects must verbally consent to this 
recording prior to the recorded consent process. Once the subject has consented to recording, the recording will 
begin. The study staff will follow Aim 3 telephone scripts for the entire consenting process. Telephone scripts for 
Aim 3 are included in this protocol.  
Once the interview recording begins, study staff will ask if the subject has provided recording consent (for 
documentation purposes). Next, all subjects will have to confirm their identity (for security and data validity 
purposes) by providing their name and date of birth. The information provided by the subject must match the 
information gathered in Epic for the main study consenting to begin. Subjects will then go over the main study and 
verbally consent for their participation in it. 
For Aim 4, we will recruit a total of N=58 AYA survivors to evaluate our revised electronic educational materials 
(eligibility requirements described above). Recruitment procedures will be the same as in Aim 3 except that in 
Aim 4, subjects will review and complete consent online as in Aims 1 & 2. The initial page of the REDCap survey 
will contain a brief online consent outlining the purpose of the study, its voluntary nature, time commitment,  

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incentive information, release of PHI, and contact information of PI and Emory IRB should a participant have 
questions. To record participants’ consent to participate, we will have them click a radio button labeled “Yes, I 
agree to take part” or “No, I do not want to take part”. We will also have participants insert the current date. 
Participants who select “Yes, I agree to take part” will be routed to the study survey battery following their typed 
signature. Participants who select “No, I do not want to take part” will exit the REDCap system and route to a 
screen that thanks them for their consideration. Copies of the online consent from REDCap are attached with this 
protocol.   
After consenting to Aim 4, participants will be asked to complete an online pre-test survey via REDCap.  The pre-
test will be the first step in a survey queue from REDCap. After subjects complete the pretest, the queue will 
allow them to review the materials that were created for Aim 4 within the REDCap platform. If the survey queue 
is started but not finished, study staff may contact the consented subjects via phone call, text or email in order 
to remind them to finish. Study staff will confirm receipt and review of material and schedule a post-test survey 
to be completed in REDCap two weeks after material is reviewed (the date when initial survey queue is 
completed).  
These pre- and post-tests will be designed to assess AYA health beliefs, knowledge about survivor care and 
lateeffects, and self-efficacy and intentions to engage in lifelong survivor care. We have selected scales to assess 
participants’ health beliefs and intentions (Table 3, and will generate a 15-item multiple-choice quiz to assess 
participants’ knowledge of the content covered in the electronic educational materials). The pre- and post-test 
should take approximately 20-25 minutes each to complete. Up to five reminders will be sent to ensure survey 
completion.  
At the time of initial consent for Aim 4, subjects will have the option to participate in telephone exit interviews 
via Zoom (N=25), lasting 30 minutes. All Aim 4 exit interviews will be recorded for transcription purposes and 
conducted 2-3 weeks following completion of the post-test. Example questions are outlined in Table 3. 
Following the completion of the AYA testing and interviewing, the electronic educational materials will be 
revised again using the quantitative and qualitative data collected as a guide to inform the revisions prior to 
dissemination. 
D. Measures 
Aims 1 & 2: Table 2 outlines the pre-existing factors and modifiable variables that we will assess and 
instruments we will use to measure these variables. After patients and parents have affirmed their willingness 
to participate via the electronic consent, they will be asked to complete a battery of self-report measures. The 
questionnaires will also be administered electronically using the REDCap platform. The surveys will take about 
20-35 minutes to complete. Copies of the survey batteries from REDCap for Aims 1 & 2 are attached with this 
protocol. 
 
The 
following 
are 
links 
to 
the 
REDCap 
Consent 
and 
Survey: 
https://redcap.choa.org/redcap/surveys/?s=KNRMDF7WYX 
(Aim 
1) 
https://redcap.choa.org/redcap/surveys/?s=TPJY93F7TJ  (Aim 2) 
Table 2. Methods and Measures (Aims 1 & 2) 
 
Constructs 
Method/Instrument 
Patient Factors 

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Demographics: Gender; Ethnicity; Age; Education; Employment 
Demographics Questionnaire 
Medical status & risk: Diagnosis; Treatment history & intensity; 
Late-effects risks, Global Health  
Medical record review 
Intensity of Treatment Rating Scale (ITR-3)  
PROMIS v.1.1 – Global Health  
Neurocognition: Executive Functioning; Perceived Cognitive 
Competence 
Neurocognitive Questionnaire (CCSS-NCQ-R) Health 
Competence Beliefs Inventory (HCBI)  
Developmental Maturity: AYA Autonomy; AYA Self-Efficacy 
Health Competence Beliefs Inventory (HCBI)  
PROMIS SF v1.0 – Self-Efficacy Manage Emotions 4a 
PROMIS SF v1.0 – Self-Efficacy Manage Soc Inter 8a 
Health Knowledge & Beliefs: Health Perceptions; Perceived Benefit 
of Survivor care; Perceived Vulnerability to Late-effects 
Health Competence Beliefs Inventory (HCBI)  
Benefits Scale for Survivor Screening  
Absolute Perceived Vulnerability  
Survivor Knowledge Questionnaire (SKQ) 
Psychosocial functioning: Anxiety, Depression, Social Isolation, 
Anger, & Post-Traumatic Stress Symptoms, Self-Esteem, Social 
functioning 
PROMIS v1.0 Anxiety 8a & Depression 8a  
PROMIS v1.1 Anger 5a 
PROMIS v.2.0 – Social Isolation  
Impact of Events Scale–Revised (IES-R)  
Posttraumatic Growth Inventory (PTGI) 
Rosenberg Self-Esteem Scale 
PROMIS Pediatric Peer Relationships 
AYA Healthcare Responsibility 
Readiness for Transition Questionnaire (RTQ)- Adolescent 
Responsibility  
Parent & Family Factors 
Parent Psychosocial functioning: Anxiety, Depression, Post- 
Traumatic Stress Symptoms, Self-Esteem, Social functioning 
PROMIS Anxiety/Depression  
Impact of Events Scale–Revised (IES-R)  
Posttraumatic Growth Inventory (PTGI) 
Rosenberg Self-Esteem Scale 
NIH Friendship - Fixed Form 
Parent Health Beliefs: Perceived Benefit of Survivor care; Perceived  
Vulnerability to Late-effects 
Benefits Scale for Survivor Screening Absolute 
Perceived Vulnerability 
Family Functioning: Parental Involvement in Healthcare; General 
family functioning 
RTQ-Parent Involvement   
Family Assessment Device (FAD)  
Family SES: Income; AYA Financial Support Parent education 
Demographics Questionnaire 
Provider & System Factors 
Patient Satisfaction: Accessibility & Convenience; Communication; 
Autonomy Support 
Patient Satisfaction Questionnaire (PSQ) Health 
Care Climate Questionnaire (HCCQ)  
Access to care issues: Insurance status; Geographic distance, 
neighborhood-level social determinants 
Demographics Questionnaire 
Aims 3 & 4: We will accomplish aims 3 and 4 by conducting a comprehensive formative evaluation of interactive 
infographics and videos designed to educate young adult survivors about the impact of childhood cancer 

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treatment on future health and subsequent need for survivor care across the lifespan. As part of our formative 
evaluation process, we will seek feedback and revisions from stakeholders (Aim 3), test the effectiveness of 
these materials with regard to improving knowledge, perceived benefits, self-efficacy, and intentions with AYA 
survivors through a pretest posttest design (Aim 4), and solicit AYA feedback for additional improvements 
through exit interviews (Aim 4).  
Table 3 outlines the modifiable variables we will measure along with the methods and instruments we will use 
to measure these variables. After patients have consented and before they review the learning materials, they 
will complete a pre-test online. Later, after viewing the materials, they will take a post-test online. The 
questionnaires will be administered electronically using the REDCap platform. The surveys will take about 20-35 
minutes to complete. Copies of the pre and post-test surveys from REDCap for Aims 3 & 4 are attached with this 
protocol.   
Table 3. Methods and Measures (Aims 3 & 4) 
Quantitative Measures 
 
Outcome 
Instrument 
No. of 
Items 
Aim 4. Change in Knowledge: Pre-test & post-test 
 
Survivor Care Knowledge 
Knowledge questions based on material developed in Aim 1 (Example Questions) 
- What are late effects of treatment? What determines risk for late effects? 
- How do survivors’ risks for recurrence/chronic diseases/second cancers change over time? 
- How many survivors experience late effects/chronic diseases during middle age? 
- What is the point of long-term survivor care? How long do I need to go for survivor care? 
- What is a Survivor Care Plan? Where do I get a Survivor Care Plan? 
15 
Aim 4. Changes in Health Belief Model and Patient Activation Constructs: Pre-test & post-test 
 
Benefit of survivor care 
Adapted Champion Benefits Scale for Mammography Screening  
5 
Barriers to survivor care 
Adapted Champion Barriers Scale for Mammography Screening  
11 
Susceptibility of late effects 
Adapted Champion Susceptibility Scale for Mammography Screening  
3 
Intentions for survivor care 
Adapted from Ajzen’s Theory of Planned Behavior 
2 
Self-efficacy 
Perceived Health Competence Scale (PHCS) 
8 
Qualitative Methods 
 
Aim 3. Stakeholder Review (Example questions) 
 
Stakeholder semi-structured 
interview 
- 
What was the main idea the materials were trying to get across? 
- 
Is the content complete? What is missing? Is the content current? What should be 
updated? - Will this appeal to survivors? How can we increase appeal? Is it acceptable and 
appropriate? 
- 
What information do survivors need to manage LTFU care? How can education help?  
- 
What should be changed to increase impact on survivors’ health beliefs?  
- 
If you could change one thing, what would it be? 
 
Aim 4. AYA Exit Interviews (Example questions) 
 

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Protocol Version 7   Date: 10-18-23 
AYA Exit Interviews 
- 
What did the materials say/show? Is the information clear? What was confusing? 
- 
How would you explain the need for LTFU care to a fellow survivor? 
- 
Is the style of the material current? What should be updated? 
- 
What do you like about this material?  What is off-putting? How can we increase appeal? 
- 
Did the material influence your opinions about LTFU care? If, so how? 
- 
What did you learn by reviewing this material? 
- 
If you could change one thing, what would it be? 
 
 
IV. 
Risks, Benefits, & Incentives 
This research will inform the development of behavioral interventions designed to help future young adult 
survivors remain adherence with survivor healthcare. Potential risk is minimal, and relates to data privacy where 
the study subject’s identity and/or medical information may become known by individuals not directly involved 
in the research. Participants may choose not to answer a question for any reason.         
Gift card incentives will be given to participants upon completion survey batteries for Aim 1 ($20) and Aim 2 
($20). An additional $20 gift card incentive will be given to Aim 2 participants who return a signed medical 
record release to authorize us to review their medical records of the adult providers they transitioned their 
survivor care.  
Stakeholders who complete a 1-hour, semi-structured interview will be provided with a $50 incentive (Aim3). 
Each participant in Aim 4 will receive a $25 gift card when they complete the pre-test and post-test surveys 
(total=$50), as well as a $25 gift card for completing an exit interview (total=$75). 
If participants would prefer to donate their incentives, we will provide them the option to donate it toward meal 
tickets for Aflac patient families in need. 
 
V. 
Data Management & Confidentiality 
Participant identifying information will be recorded in a secure Access database for the purposes of recruitment. 
Participants in Aim 1, Aim 2, and Aim 4 will complete all survey measures in Children’s Healthcare of Atlanta’s 
REDCap (http://project-redcap.org/), which is a secure, web-based application for building and managing online 
surveys and databases.  REDCap is HIPAA compliant and designed to support data capture for research studies, 
providing an intuitive interface for validated data entry; audit trails for tracking data manipulation and export 
procedures; automated export procedures for seamless data downloads to statistical software packages; and 
procedures for importing data from external sources. Unique participant identification numbers will be assigned 
and maintained throughout the database management system to ensure accuracy and protect confidentiality. 
Outside of the secure REDCap platform & Access database, files will be linked by subject number only. To calculate 
neighborhood-level social determinants, mailing addresses from the Access database will be linked to 9-digit zip 
codes using the ArcGIS software program on Woodruff Health Science library computers. On the basis of the 9-
digit zip codes, the Area Deprivation Index (ADI) rank will be assigned based on residential Census block group 
and the Environmental Justice Index (EJI) rank will be assigned based on residential Census tract using the ArcGIS 
program. All databases will be HIPAA-compliant and password protected. All statistical analyses for Aims 1 and 2 
will be conducted using SAS, SPSS® Statistics, or R. 

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Protocol Version 7   Date: 10-18-23 
Study data for Aims 3 and 4 will be collected and managed using WebEx and Zoom (AYA interviews) electronic 
tools hosted at Children’s Healthcare of Atlanta and Emory University.  AYA survivors’ qualitative responses to 
the teleconference interview questions will be audio-recorded using the secure and HIPAA compliant WebEx (or 
Zoom) platform and then transcribed. All subjects will confirm their identity prior to the consenting process. 
Unique participant identification numbers will be assigned to ensure accuracy and protect confidentiality. All 
databases will be HIPAA-compliant and password protected. All statistical analyses for Aims 3 and 4 will be 
conducted using SAS, SPSS® Statistics, or NVivo. 
No biological specimens will be collected as part of this research. Participants’ electronic medical records will be 
reviewed to abstract treatment data. Confidentiality within this study will be rigidly maintained. Computer files 
will use study identification numbers only and are password protected.  Only necessary personnel will have access 
to any of these files. Based on existing best practices for security and privacy in health information technology, 
we will identify the technologies and features to be employed to ensure privacy and security of personal 
information. This will address identity and access management, secure storage, secure messaging, encryption, 
and other security technologies and approaches. 
 
VI. 
Statistical Analysis Plan  
Aims 1 & 2: In 2015, the Aflac Cancer Survivor Program (Aflac CSP) saw over 200 AYA survivors aged 18-22 years 
(Aim 1). Additionally, the Aflac CSP has transitioned approximately N=165 survivor patients since 2013 (Aim 2). 
Based on our previous research with survivor patients > 18 years of age, we estimate that less than 2% of AYAs 
will be non-English speakers. During the year-long study period, we anticipate that there will be at least N=200 
AYA patients who are eligible for participation in Aim 1 and at least N=160 AYA patients who are eligible for 
participation in Aim 2. Previous studies with our AYA population have yielded initial recruitment rates and 
retention rates above 80%. Of the eligible AYA patients, we estimate that 75% [Aim 1: N=220 patient-parent dyads 
(440 participants), Aim 2: N=120 patient-parent dyads (240 participants), Aim 3: N= 20 patients, Aim 4: N=58] will 
participate in each aim of the study. In our univariate analysis, these sample sizes provide us with at least 80% or 
greater power to detect correlations of magnitude ≥ 0.25 and odds ratios of at least 2.5, depending on the 
prevalence of the risk factor, assuming that approximately 20-30% of patients meet our definition of successful 
transition. Power analyses were conducted using PASS v. 11 (Kaysville, UT) using a two-sided test for a single 
correlation and a two sample Z-test for proportions. Given these anticipated numbers, we can assess at most 15 
possible predictors for aim 1 and 12 predictors for aim 2 to ensure that we have at least 10 observations per 
predictor in our principal component analysis.  
The primary goals of this study are to determine characteristics that influence or predict transition readiness and 
transition to adult survivor care. Because there are many candidate predictors and overlap between variables 
with respective substantive meaning, predictors are likely to be highly correlated (i.e., neurocognition and 
developmental maturity). Therefore, we propose a three-step modeling process to identify general groups or 
constructs associated with the outcomes of interest. First, in a univariate analysis setting, we will investigate the 
relationship between each potential predictor and the continuous outcome transition readiness using simple 
linear regression and correlation analysis. Similarly, we will use Chi-square tests and/or logistic regression to 
identify factors associated with the binary outcome successful transition (yes/no). Due to the high 

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Protocol Version 7   Date: 10-18-23 
correlation/overlap with some of the potential predictors, principal component analysis (PCA) will be performed 
using those variables significant at the 0.1 level from step 1. The number of components retained in the model 
with will determined by eigenvalues and percent-variance explained. Finally, based on the results of the PCA, 
composite variables (which will contain multiple predictors) will be created by standardizing (convert to a z-score) 
each predictor variable and taking the mean value of the standardized predictor variables that uniquely load on 
a given component. We will examine the effect of each composite variable on the outcome transition readiness 
using linear regression and the outcome successful transition using logistic regression. All statistical analyses will 
be performed using SAS.   
Aims 3 & 4: Qualitative data analysis should be conducted until data “saturation”, or the point at which no new 
information is likely to be garnered from additional interviews/focus groups Given that previous research has 
indicated that over 85% of analytic themes are identified within the first 12 interviews, we are confident that we 
will reach saturation of new information with N=20 stakeholder interviews with AYA survivors in Aim 3, as well as 
N=25 AYA post-test interviews in Aim 4 In order to analyze our qualitative data, separate codebooks for analyzing 
data will be developed at each stage of the formative evaluation using thematic analyses based on guide 
questions and evaluation attributes. Following development of the codebooks, each response will be coded by 
two independent raters. Open coding methods will be used to analytically evaluate the data and comparisons will 
be made for data similarities and differences A qualitative analysis software package, NVivo, will be used to assist 
in the identification of patterns and relationships between concepts (i.e., acceptability, appropriateness). 
Frequencies of all codes will be tabulated and used to inform the revision of the electronic educational materials 
by types. Differences in the frequency of codes will be examined among subgroups of AYA small group participants 
(i.e., age, years post diagnosis, gender) using Chi-square and ANOVA analyses. Our team and the Winship Cancer 
Institute’s Intervention Development, Dissemination and Implementation (IDDI) core has vast experience with 
qualitative and mixed methods analyses. 
In Aim 4, paired t-tests or Wilcoxon signed-rank tests will be used to compare AYA HBM constructs and knowledge 
about survivor care and late-effects before and after reviewing the electronic educational material. Given 58 AYA 
survivors, we will have greater than 80% power to detect an average of a 1.5 point increase (or an effect size of 
0.40) in AYA average knowledge score after reviewing the electronic educational materials.  
After data are exported from REDCap, we will perform data cleaning and run descriptives on all variables. We will 
analyze pre and posttest differences on knowledge, HBM constructs, self-efficacy and intentions using paired t-
tests. Reliability analyses will be run for scales. Differences in HBM constructs, knowledge, PAM activation, and 
self-efficacy to manage cancer care and demographic or cancer history will be assessed by ANOVAs or 
independent t-tests to test moderator effects. Power was calculated using a paired t-test with an assumed 
standard deviation of paired difference of 4.0 points using a 0.05 level of significance and a medium correlation 
between pre- and post-test.  
 
VII. 
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