Promoting Follow-Up Care Self-Management for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
Phase: NA
Conditions: Cancer Survivor
Sponsor: Rutgers, The State University of New Jersey

Protocol Version 1.6 10.4.2017
CINJ# 131507
Rutgers, The State University of New Jersey
195 Little Albany Street
New Brunswick, NJ 08903-2681
cinj.org
p. 732-235-2465
Promoting Follow-Up Care Self-Management for Adolescent and Young Adult (AYA) 
Childhood Cancer Survivors                                                                                                                                   
Principal Investigator: Katie Devine, PhD, MPH
Assistant Professor
Rutgers Cancer Institute of New Jersey
195 Little Albany Street, Room 5571
New Brunswick, NJ 08903
Telephone: (732) 235-7549; Fax: (732) 235-6225
Email: katie.devine@rutgers.edu
Subinvestigators: 
Sharon Manne, PhD
Rutgers Co-investigator 
Shawna Hudson, PhD
Rutgers Co-Investigator
Margaret Masterson, MD
Rutgers Co-investigator 
Susan Stephens, MSW, LCSW, ACSW
Rutgers Research Personnel
Pamela Ohman-Strickland, PhD
Rutgers Co-Investigator (Biostatistician)
Karen Pawlish, ScD, MPH
Rutgers Co-Investigator
Rutgers Cancer Institute of New Jersey
Rutgers Cancer Institute of New Jersey 
Operations Center
Biostatistical Center
Office of Human Research Services
Biometrics Division
195 Little Albany Street
195 Little Albany Street
New Brunswick, NJ 08903 
New Brunswick, NJ 08903
Telephone: (732) 235-8675
            Telephone: (732) 235-6791
FAX: (732) 235-7690
FAX: (732) 235-7350
Supported by: 
NIH/NCI Cancer Center Support Grant P30CA072720 – CPC Pilot Award
Drug(s) Under Investigation: N/A
CONFIDENTIAL
This document is confidential and the property of the Rutgers Cancer Institute of New Jersey.  No part of it may be 
transmitted, reproduced, published, or used without prior written authorization from the study sponsor.
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Survivors                                                                                                                                                          
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TABLE OF CONTENTS
1.
PURPOSE/SPECIFIC OBJECTIVES .......................................................................................................................4
1.1 OBJECTIVES/HYPOTHESES............................................................................................................................................5
2.
BACKGROUND AND SIGNIFICANCE ..................................................................................................................5
3.
EXPERIMENTAL DESIGN AND METHODS........................................................................................................7
3.1 DURATION OF STUDY...................................................................................................................................................7
3.2 STUDY SITES ................................................................................................................................................................7
3.3 SAMPLE SIZE JUSTIFICATION........................................................................................................................................7
3.4 SUBJECT SELECTION AND ENROLLMENT CONSIDERATIONS.........................................................................................8
3.5.1 INCLUSION CRITERIA.................................................................................................................................................8
3.5.2 EXCULSION CRITERIA ...............................................................................................................................................8
3.5.3 SUBJECT RECRUITMENT............................................................................................................................................9
3.5.4 CONSENT PROCEDURES ..........................................................................................................................................10
3.5.5 SUBJECT COSTS AND COMPENSTATION...................................................................................................................10
4.
STUDY VARIABLES................................................................................................................................................10
4.1 INDEPENDENT VARIABLES OF INTERVENTIONS..........................................................................................................10
4.1.1 DRUG OF DEVICE INTERVENTIONS..........................................................................................................................11
4.2 DEPENDENT VARIABLES OR OUTCOMES MEASURES..................................................................................................12
4.3 RISK OF HARM ...........................................................................................................................................................12
4.4 POTENTIAL FOR BENEFIT............................................................................................................................................13
5.
DATA HANDLING AND STATISTICAL ANALYSIS.........................................................................................13
6.
DATA AND SAFETY MONITORING....................................................................................................................14
7.
REPORTING RESULTS ..........................................................................................................................................14
7.1 INDIVIDUAL RESULTS.................................................................................................................................................14
7.2 AGGREGATE RESULTS................................................................................................................................................14
7.3 PROFESSIONAL REPORTING........................................................................................................................................15
8. BIBLIOGRAPHY ..........................................................................................................................................................15
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Survivors                                                                                                                                                          
Katie Devine, PhD, MPH
Protocol Version 1.6 10.4.2017
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LIST OF ABBREVIATIONS   
AYA
Adolescent and Young Adult
CINJ
Cancer Institute of New Jersey
LITE
Long-term, Information, Treatment effects, and Evaluation program
IRB
Institutional Review Board
NCI
National Cancer Institute
NIH
National Institutes of Health
PI
Principal Investigator
CCSS
Childhood Cancer Survivor Study
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Survivors                                                                                                                                                          
Katie Devine, PhD, MPH
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1. Purpose/Specific Objectives
Childhood cancer survivors are a growing population in the US (currently over 379,000).6 
Unfortunately, these survivors are at risk for adverse health late effects from treatment such as 
cardiovascular disease and premature mortality.7-10 Survivors require lifelong follow-up care to 
identify, monitor, and treat medical and psychosocial late effects stemming from their cancer, its 
treatment, and lifestyle factors.11 However, over 70% of childhood cancer survivors do not 
obtain specific risk-based follow-up care.12 Adolescent and young adult (AYA) survivors of 
pediatric cancers are particularly vulnerable to lapses in follow-up care due to ineffective 
transitions from parent-guided management to self-management of care.11,13
The transition from parent-guided management to self-management of long-term follow-
up care involves assuming primary responsibility for tasks such as managing health records, 
making appointments, filling and taking prescriptions, and understanding late effects monitoring 
and cancer screening needs. It occurs during a critical developmental period when AYAs may be 
unaware or fail to recognize their health risks and need for regular follow-up.11 Barriers to 
successful transition include survivors’ lack of knowledge of their diagnosis and treatment, 
cancer-related anxiety and other emotional concerns, and failure or inability to assume personal 
responsibility for health.13-15 
A survivor-focused intervention is likely to have the greatest impact on health outcomes 
because giving AYA survivors the knowledge, skills, support, and self-efficacy to manage their 
follow-up care will apply to any setting (i.e., cancer center or community-based primary care). 
This project takes an innovative approach to improving AYA survivors’ self-management of 
long-term follow-up care through adaptation of an evidence-based problem-solving skills 
training (PSST) intervention and the addition of peer mentors to facilitate completion of the 
intervention. PSST has been shown to improve problem-solving skills in other cancer contexts,3-5 
and we will adapt the content of the program to address the needs of AYA cancer survivors using 
patient, parent, and provider input. We anticipate that the adapted program will focus on 
improving disease knowledge, health motivation, problem-solving skills, stress management, and 
communication with caregivers and providers, all of which are important constructs to promote 
transition readiness as outlined in the Social-Ecological Model of AYA Readiness for Transition 
(SMART).1 Peer mentors have been suggested as an innovative approach to support healthcare 
transitions,6 and many AYA survivors express a supportive care need to connect with other 
young adult survivors and seek advice from others who “get it.”7,8 
The goal of this project is to develop and evaluate a peer mentoring self-management 
intervention to improve self-management skills for AYA survivors. We will evaluate feasibility 
(i.e., enrollment, retention, satisfaction with the program) and preliminary efficacy (i.e., changes 
in survivors’ healthcare self-management skills, readiness to transition, and cancer-related 
anxiety). In Phase 1, we will use AYA survivor, parent, and provider interviews to adapt an 
evidence-based problem-solving skills training program to promote AYA self-management of 
care. We will recruit and train peer mentors to implement the PSST intervention. In Phase 2, we 
will conduct a pilot test of the program with 40 young adult survivors ages 18-25 years 
transitioning to self-management of follow-up care.
1.1 Objectives/Hypotheses
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Survivors                                                                                                                                                          
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Aim 1: Adapt PSST with peer mentoring to improve AYA self-management of long-
term follow-up care.
Qualitative research with AYA cancer survivors, parents, and healthcare providers will be 
conducted to adapt an evidence-based problem-solving skills training (PSST) program to 
address the needs of AYA survivors. 
Aim 2: Evaluate the feasibility of the self-management + peer mentoring program in a 
pilot RCT.
We will examine feasibility through study enrollment rates, retention rates, adherence to the 
intervention, reasons for study drop out, and patient and mentor satisfaction with the 
program.
Hypothesis 1: Based on literature, we expect enrollment >50% of eligible patients and 
retention >75%.
Hypothesis 2: We expect patients enrolled in the mentor program to complete >75% of 
intervention sessions
Aim 3: Assess preliminary outcomes of the peer mentoring program.
Hypothesis 3: Participants in the mentor group will demonstrate improvement in self-
management skills, transition readiness, and anxiety.
2. Background and Significance
The transition to adult self-management of health care is often ineffectively managed by 
AYAs.
Ineffective transition to adult self-management of care results in inadequate follow-up care and 
potential health problems. Although it is recommended that childhood cancer survivors obtain 
long-term follow-up care tailored to address the risks of their cancer, treatment, and lifestyle 
(called “risk-based follow-up care”), over 70% of young adult childhood cancer survivors do not 
obtain such care.9,10 Results from the largest cohort study of childhood cancer survivors, the 
Childhood Cancer Survivor Study (CCSS), show that even survivors at greatest risk for late 
effects demonstrate low rates of cancer screening.2,10,11 The transition to adulthood is a 
particularly challenging time when many AYAs are lost to follow-up.12,13 This is both a personal 
medical risk because late effects may go undetected or be misdiagnosed or mistreated, and a 
societal risk because lack of monitoring can lead to increased healthcare utilization and costs that 
may have been preventable. Barriers to adult-oriented health care transition for AYA survivors 
include survivor-related factors, such as inadequate knowledge of their cancer history and 
treatment, complex medical conditions, anxiety, and difficulty assuming personal responsibility 
for health.7,8,12,14,15 These survivor-related factors call for a survivor-focused intervention.  
Theoretically-driven interventions to improve self-management of care are needed.
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Survivors                                                                                                                                                          
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Although there is attention to AYA transition in the literature, a lack of transition-related 
theoretical frameworks has hindered the development and evaluation of targeted interventions to 
promote self-management of care.1 The Social-Ecological Model of AYA Readiness for 
Transition (SMART)1 proposes that there are modifiable factors that interact to promote AYA 
readiness for transition (Figure 1). Transition readiness refers to the capacity of the AYA and 
his/her support network to prepare for and complete the process of moving to adult-oriented 
care.1 Factors related to transition readiness include knowledge of health history, risks, and 
needs; self-management skills and self-efficacy for managing care; beliefs and expectations 
regarding the transition process or adult-oriented care (such as belief that adult provider will not 
understand patient’s needs); goals related to health 
transition; relationships with parents and providers; and 
psychosocial functioning of patients, parents, and providers 
(such as anxiety about the transition process or future 
health).1 Problem-solving skills training (PSST) is a generic, 
cognitive-behavioral intervention that can be readily adapted 
to target these constructs. For example, PSST can be used to 
help AYAs set transition and self-management goals, 
explore beliefs/expectations related to the goals or barriers to 
such goals, manage stress, and promote self-efficacy by 
breaking down large goals into small, achievable steps. We 
chose PSST as an intervention because it empowers 
individuals to improve self-management skills, which 
include maintaining health records, making appointments, 
filling and taking prescriptions, and understanding health 
risks and monitoring needs. PSST also has a strong evidence 
base and has been shown to be effective for increasing 
problem-solving skills for parents who are managing a 
child’s cancer treatment.3-5 We will use Phase 1 of this 
project to explore strategies for adapting PSST to address 
many of the modifiable components of the SMART model, 
including knowledge and communication with parents and 
providers. 
Peer mentoring meets a unique need for AYA childhood cancer survivors.
Qualitative and quantitative studies suggest that AYA survivors want to discuss their medical 
care needs with other AYA survivors.7,8,16,17 Although peer mentoring has been recommended as 
an innovative approach to facilitate health care transitions for AYAs,6 the only published 
intervention utilizing this approach for survivors is a peer-delivered counseling intervention for 
smoking cessation among adult childhood cancer survivors from the CCSS.18 Childhood cancer 
survivors who received the peer-delivered telephone counseling intervention were twice as likely 
to quit smoking as survivors who received the self-help print intervention, providing evidence of 
effectiveness of peer-to-peer programs for health behavior change in this population.18 
Figure 1. SMART model1,2
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Promoting Follow-Up Care Self-Management for Adolescent and Young Adult (AYA) Childhood Cancer 
Survivors                                                                                                                                                          
Katie Devine, PhD, MPH
Protocol Version 1.6 10.4.2017
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Peer mentoring programs delivered using technology can be implemented across a variety 
of settings.
The Adolescent and Young Adult Oncology Progress Review Group (AYAO PRG) 
recommended the development of standardized peer-to-peer programs as a strategy for 
supporting the psychosocial needs of AYA cancer patients and survivors.19 The AYAO PRG 
suggested that efficacious programs be disseminated by partnering with cancer centers, oncology 
professional societies, and community-based support groups that work with AYA survivors. By 
partnering with various organizations, peer mentoring programs can be initiated and maintained 
with minimal health care system support. Peer-to-peer programs are also likely to be relatively 
low cost, as demonstrated by the peer counseling smoking cessation intervention for childhood 
cancer survivors, which has recently been translated to a web-based intervention.18,20 The use of 
technology to deliver skills-building modules and peer mentoring aligns with AYAs’ preferences 
for technology, with 85% of young adults 18-29 owning smartphones.21 It also sets up the 
program for dissemination. Finally, since many childhood cancer survivors participate in 
volunteer activities and informal peer-to-peer outreach is commonly offered to cancer patients,18 
sustaining a peer-to-peer program on a large scale is plausible. 
3. Research Design and Methods 
This research will be conducted in two phases. In Phase 1, we will use provider, survivor, 
and caregiver interviews to adapt PSST to focus on AYA self-management of care. In Phase 
2, we will conduct a pilot test of the program with 40 young adult survivors ages 18-25 years 
and 20 peer mentors. 
3.1. Duration of Study
Phase 1: Participants will be asked to complete a one-time interview lasting approximately 
60 minutes. 
Phase 2: Participants will be asked to complete the intervention over a period of 6 weeks. 
Participants will be asked to complete 6-week online self-management educational modules 
and 6 weekly peer mentor calls to facilitate engagement with the online modules and offer 
specialized support.  
3.2 Study Sites
Phase 1: Interviews will be conducted at the Rutgers Cancer Institute of New Jersey or via 
phone. 
Phase 2: Peer mentors will be trained at the Rutgers Cancer Institute of New Jersey or via 
phone or online webinars. Participants will receive intervention materials online, via email, 
or via text messaging. 
3.3 Sample Size Justification 
Phase 1: Total sample size is 24-28, including 10 AYA survivors, 10 parents of AYA 
survivors, and 4-8 physicians who work with AYA survivors. Qualitative data will be 
analyzed on a continuing basis. Pooling data across participants, we expect 24-28 interviews 
will be adequate to achieve data saturation (that is, no new themes emerge from additional 
participants). 
Phase 2: 40 AYA survivors and 20 peer mentors will be recruited for the pilot trial to 
evaluate feasibility (primary objective) and preliminary outcomes (secondary objective). As 
this is a feasibility study, we recognize we are underpowered to detect small or medium 
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Survivors                                                                                                                                                          
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Protocol Version 1.6 10.4.2017
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effects. Published data suggest 5-9% of survivors are African American or Hispanic;22 data 
from the NJSCR show greater diversity, with 11.6% of patients diagnosed with cancer at age 
10-19 during the period of 2008-2012 reporting as African American, 19% reporting as 
Hispanic, and 5.7% as Asian American/Pacific Islander. We will oversample these groups.
3.4 Subject Selection and Enrollment Considerations 
3.5.1 Inclusion Criteria
Phase 1:
Patient eligibility includes: 
(1) age 18-25
(2) at least 1.5 years from treatment (which is a typical time for preparation to 
transfer to long-term follow-up care)
Parent eligibility includes: 
(1) caregiver of a pediatric cancer survivor age 18-25 who was primary caregiver 
at diagnosis 
(2) patient is at least 1.5 years from treatment 
Provider eligibility:
(1) health professional who works with childhood cancer survivors ages 18 to 25
Phase 2:
Peer mentor eligibility includes:
(1) age 21-29
(2) at least 1.5 years from treatment
(3) self-reported primary responsibility for care and “complete readiness” using 
the Readiness for Transition Questionnaire23 
Patient eligibility includes: 
(1) age 18-25
(2) at least 1.5 years from treatment 
(3) currently does not independently self-manage follow-up care according to 
self-report (i.e., reports low readiness to assume total responsibility for care [score of 1 
or 2 out of 4 on overall readiness item OR scores <3 on any of the 10-item 
responsibility scale) using the Readiness for Transition Questionnaire23)
3.5.2 Exclusion Criteria
Phase 1:
Patient exclusion criteria includes:
(1) physician- or self-reported cognitive delay or impairment that would prevent 
self-management of healthcare
Parent exclusion criteria includes:
(1) patient has physician- or caregiver-reported cognitive delay or impairment 
that would prevent self-management of healthcare
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Survivors                                                                                                                                                          
Katie Devine, PhD, MPH
Protocol Version 1.6 10.4.2017
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No provider exclusion criteria
Phase 2:
Patient exclusion criteria includes:
(1) physician- or self-reported cognitive delay or impairment that would prevent 
self-management of healthcare
(2) patients with cancer diagnoses that are not typically considered pediatric 
cancer, including basal and squamous cell skin cancer, breast, colorectal, lung, 
melanoma, merkel cell skin cancer, ovarian, testicular, kidney cancer 
diagnosed at age >17, and nasopharyngeal diagnosed at age > 17. 
3.5.3 Subject Recruitment 
Phase 1: We will recruit 10 AYA survivors of childhood cancers and 10 caregivers 
through the Rutgers Cancer Institute Long-Term Information Treatment-Effects 
Evaluation (LITE) program. Invitational letters from Dr. Masterson, the Director of the 
LITE program, will be sent to patients on the CINJ LITE mailing list. Flyers will be 
posted and handed out in clinic. Potentially eligible participants will be approached at 
routine LITE clinic visits to describe the study, answer any questions, and assess 
interest in participating. If a parent does not accompany an AYA survivor to the LITE 
visit, we will ask interested AYA survivors to share a flyer with their parent(s). AYAs 
and parents do not have to be dyads to enroll in the study. We will also recruit 4-8 
healthcare providers (e.g., physicians, nurse practitioners, social workers, psychologists) 
who regularly work with AYA pediatric cancer survivors. These providers will be 
recruited through the Rutgers Cancer Institute of New Jersey as well as through the 
AYA and Survivorship Working Groups of the Children’s Oncology Group because 
they will have greater expertise and experience with AYA survivors than community 
providers.
Phase 2: Peer mentors will be recruited via advertisements in the CINJ LITE clinic and 
newsletter, AYA cancer support groups, and online forums/social media, such as 
stupidcancer.org. Following the Children’s Oncology Group’s approach to recruiting 
patient advocates, potential mentors will complete an application including two letters 
of recommendation. The PI or study staff will interview candidates to evaluate 
interpersonal skills, level of commitment to the program, and counseling or related 
experience. Participants for the randomized trial will be recruited using the New Jersey 
State Cancer Registry (NJSCR). All participant information and surveillance data from 
the NJSCR is collected and maintained by the NJSCR following Standard Operating 
Procedures (see IRB#Pro20140000992 NJSCR SEER Data Repository). Patient contact 
procedures, tracking, and data release also follows NJSCR Standard Operating 
Procedures. Per Standard Operating Procedures, NJSCR staff will contact the physician 
of record for eligible cases to notify the physician about the study and that staff will be 
contacting the patient. An introductory letter and flyer will be mailed to potential 
participants. NJSCR staff will make follow-up phone calls to provide additional 
information and, for patients who express interest in participating, to obtain permission 
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Survivors                                                                                                                                                          
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to send their contact information to Dr. Devine’s study staff, who will then contact the 
patient for further details and discussion of consent.
3.5.4 Consent Procedures
The study will be explained to the potential participant by the Principal Investigator or 
trained study staff via phone. The PI or study staff will review essential elements of 
consent and answer any questions. Interested and eligible participants will be emailed a 
link to an online consent form prior to starting the program. To consent, potential 
participants will be instructed to click “submit the form” button in order to consent.
3.5.5 Subject Costs and Compensation
Phase 1: Participants who drive to the Rutgers Cancer Institute of New Jersey to 
complete an interview will incur parking costs. Participants will be given $25 for 
completion of an interview.
Phase 2: Peer mentors will be asked to travel to the Rutgers Cancer Institute of New 
Jersey for training; they will be compensated $100 for their time and travel. Peer 
mentors and participants will be asked to use their personal phone for communication 
via phone and text, which may incur costs depending on the participants’ phone plan. 
Peer mentors will be compensated $100 per participant mentored to cover costs and 
effort. Participants will receive $25 per assessment completed (for a total of $50). 
4. Study Variables
4.1 Independent Variables or Interventions 
Phase 1: Semi-structured interview guides will be used to conduct interviews. The goal of the 
interviews is to understand patient, parent, and provider perspectives on the challenges faced by 
AYAs in managing their health care and on how PSST materials can be adapted to address the 
challenges of self-management of care.
Phase 2: Independent variables include demographics (age, gender, socioeconomic status, 
education, employment status, living at home or independently) and cancer diagnosis and 
treatment history (i.e., diagnosis, time since treatment completion, types of treatment received). 
Diagnosis and date of diagnosis will be obtained from NJSCR records and the remaining 
information from self-report.
Peer Mentoring Intervention. Based on initial interviews and feedback on the PSST 
intervention, we identified five major themes to be addressed in our program. The intervention 
will include two components: (1) online self-management educational modules using the Rutgers 
Canvas online course platform and (2) weekly video-conference calls on Doxy.me between the 
peer mentor and participant. Table 1 shows the content of the five online modules based on 
preliminary work. Participants are expected to complete one module per week in addition to a 
call with their mentors. Each module takes approximately 30 minutes to complete and ends with 
a personalized assignment for the participant to complete on his/her own (e.g., obtain 
survivorship care plan, make an appointment, practice communication skills). 
Participants will be matched with a peer mentor of the same sex and cancer type to the 
extent possible.24,25 The objectives of the first mentor call are to build rapport, exchange stories 
regarding current long-term follow-up care, and identify the participant’s self-management 
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strengths, weaknesses, and goals. During this call, the mentor will explain that the mentee is 
expected to complete one online module per week prior to their next scheduled mentor call (one 
a week for six weeks). The dose was chosen based on other peer mentoring programs that 
employed weekly Skype calls.24,25 Weekly video-conference calls will be made on HIPAA 
compliant Doxy.me (https://doxy.me/) that implements security and encryption protocols to 
assure that data integrity and privacy is maintained. In addition to weekly calls, the mentor will 
encourage the participant to work through the assignment and modules via a weekly text 
message (using TigerText,26 a HIPAA-compliant program) to offer encouragement, support, and 
relevant resources. Mentor-mentee calls will be recorded and text messages will be archived for 
supervision and content analysis.  
Given that AYAs are high consumers of technology21 and tend to have many different 
educational, work, and social scheduling demands, we believe using online educational modules 
and technology to connect the peer mentor and participants will be the most efficient delivery 
system for this group. To capitalize on AYAs’ regular use of technology, peers will provide 
support and facilitate completion of educational modules via 6 weekly phone calls and secure 
text messaging. We will utilize the TigerText service that will allow for secure messaging 
between participants and peer mentors, as well as between the study personnel, peer mentors, 
and participants. 
 
Table 1. Content of self-management modules
Modul
e
Proposed Content
Transition Readiness 
Construct
1
Understanding Treatment History and Survivorship Care Plan
Name diagnosis, treatments received, risks for late health effects
Obtain (if needed) and store Survivorship Care Plan
Identify necessary health screenings and frequency
Knowledge
Goals/motivation
2
Managing Your Health Care
Review self-management tasks (e.g., make appointments, obtain 
screenings)
Establish and maintain relationship with primary care doctor
Logistics of insurance and healthcare tasks
Identify barriers to obtaining care and problem solve
Review motivation and confidence to assume responsibility for care
Self-Management Skills
Self-efficacy
Relationships/communicati
on
Goals/motivation
3
Negotiating Family Involvement in Your Care
Discuss challenges of parents who do not relinquish control & 
communication skills
Discuss supportive ways to include family
Relationships/communicati
on
4
Dealing with Emotions about Your Health and Follow-Up Care
Coping with uncertainty of future health
Communicating with providers & families about adult-oriented healthcare
Self-Management Skills
Relationships/communicati
on
5
Staying Healthy in the Context of Life Transitions
Recognize that health must be maintained in the context of other 
important life transitions (e.g., education, career, relationships) 
Skills & resources for healthy diet, exercise, sexual health/fertility, 
education, career
Identify value in prioritizing health
Goals/motivation
Self-Management Skills
Self-efficacy
Peer Mentor Training. Peer mentors will attend a one-day training workshop conducted by the 
PI and study staff (similar to other peer mentor programs24,27). Peer mentors will be given the 
Peer Mentor Handbook, a manual adapted from the National Mentoring Research Center, which 
details their roles, responsibilities, and an outline for each mentor call. Presentations, interactive 
discussions, and role plays will be used to teach mentors how to facilitate their mentee’s use of 
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Survivors                                                                                                                                                          
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the online self-management modules, and how to provide informational and emotional support to 
their mentees. Ethical issues, including confidentiality and setting boundaries with peers, will be 
discussed. Peer mentors will also be instructed in how to securely transfer audio recordings of 
their calls with mentees and destroy the original file from their devices. In addition to the in-
person training, we will email these instructions. Peer mentors will have regular weekly phone 
supervision with the PI or trained study staff once assigned mentees to review mentoring calls 
and discuss any challenges experienced. During this supervision call, the PI or research staff will 
verbally confirm that peer mentors have destroyed any transferred audio recordings for the study. 
4.1.1 Drug or Device Interventions 
N/A
4.2 Dependent Variables or Outcome Measures
Phase 1: The primary outcome measure is qualitative interview data. Interviews will be 
transcribed for analysis (see Data Handling and Statistical Analysis section for details). 
Participants will also be asked to complete the questionnaires selected for Phase 2 and provide 
feedback to the study staff regarding how well the questionnaires capture self-management of 
survivorship care.
Phase 2: The following standardize measures will be administered at baseline and immediately 
post-intervention (~6 weeks), except where noted:
Transition readiness. The Readiness for Transition Questionnaire – Survivor Version 
(RTQ)23 is a 22-item scale evaluating transition readiness for cancer survivors. Respondents are 
asked to rate the degree to which they are responsible for various aspects of their health care, 
such as knowing their survivorship care plan, scheduling visits, and filling prescriptions. They 
are separately asked to rate the degree to which their parents are responsible for managing the 
same aspects of their care. Two questions ask about the survivors’ overall perception of their 
readiness to transfer to an adult-approach to health care. The RTQ has demonstrated adequate 
reliability.23
The Transition Readiness Inventory (TRI), developed using the SMART framework,28 is 
a comprehensive measure of multiple components of transition readiness. While the RTQ 
focuses on responsibility for behaviors, the TRI focuses on behaviors and knowledge, attitudes, 
and beliefs. Specifically, the TRI yields a total score and provides scales for the following targets 
of our intervention: knowledge, self-management skills, self-efficacy for managing care, 
goals/motivation, and communication with family and providers around survivorship care. The 
TRI has shown adequate reliability and content validity,28,29and evidence of predictive validity of 
engagement in adult healthcare.29 We will utilize the total TRI score.
Anxiety. PROMIS Depression and PROMIS Anxiety measures are validated 8-item 
measures of depressive symptoms and anxiety. We will examine cancer-related anxiety using the 
Fear of Recurrence Scale,30 which has been used with young adult survivors of childhood 
cancers.31 Finally, we will adapt items to examine anxiety related to healthcare transition and 
cancer late effects. We will also use the Cancer Related Worry Scale to assess participants’ 
concerns related to their cancer past and future.  
Impact of Cancer. Three subscales from the Impact of Cancer – Childhood Cancer 
Survivors Scale32 will evaluate perceptions of impact on body and health, memory and thinking, 
and personal growth. Participants will be asked to complete all three subscales; mentors will be 
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asked to complete body and health and personal growth only to evaluate if mentoring has 
positive effects on these outcomes.
Perseverance. The Short GRIT Scale33 is an 8-item measure of perseverance for long-
term goals. We will examine the total score as a correlate of transition readiness and adherence 
to follow-up care.
Barriers to follow-up care & adherence. We will evaluate insurance status, current 
provider, and other barriers to care with the Follow-Up Care Use and Health Outcomes of 
Cancer Survivors (FOCUS) measure. Participants will report on appointments, cancer 
screenings, and other adherence markers.
Treatment Integrity. Peer mentors will record their video/phone conversations with 
participants for supervision with the PI. Additionally, 10% of tapes will be randomly selected for 
treatment integrity review using a checklist of the core components of each session.
Mentor/Participant Alliance. A brief measure of personality (Ten Item Personality 
Inventory34) will be administered to participants and mentors at baseline only to examine 
whether personality matching relates to perceived relationship alliance. A brief measure of the 
alliance between the mentor and participant (Working Alliance Inventory – Short Form35) will be 
completed by mentors and participants at post-intervention only.
Satisfaction with Intervention. At the 6 week post-intervention assessment, participants 
will be asked to complete a survey regarding their satisfaction with the intervention received and 
recommendations for improvement. For the intervention group receiving the online modules and 
peer mentor, items from a standardized set of internet-based intervention evaluation tools will be 
used - Internet Intervention Utility Questionnaire, Impact Questionnaire, and Adherence 
Questionnaire.36,37 The Utility Questionnaire measures perceived usefulness, enjoyment, and 
ease of use. The Impact Questionnaire measures perceived effectiveness in improving targeted 
skills. The Adherence Questionnaire measures barriers to engagement. Objective user data (i.e., 
log-ins, posts, modules completed) will be obtained unobtrusively from Canvas. Peer mentors 
will be given an interview (i.e., Peer Mentor Interview) at the end of the program to assess their 
thoughts about the program (what went well, did not work well, etc.) The participants will also 
be asked to do a brief (~20 minute) phone exit interview with the PI or the study staff to gather 
qualitative feedback on how to improve the program in the future (see Participant Exit Interview 
Guide). 
4.3 Risk of Harm 
Phase 1: Risks are considered minimal and include breach of confidentiality. Every effort will be 
made to ensure confidentiality of data. 
Phase 2: Risks are considered minimal and include breach of confidentiality. Every effort will be 
made to ensure confidentiality of data. Peer mentors will be instructed in the importance of 
maintaining confidentiality and supervised by the PI. Surveys will ask about self-management 
skills, transition readiness, anxiety, barriers to care, and adherence to follow-up 
recommendations. Although discomfort related to such questions is unlikely, participants can 
choose not to answer any question for any reason and may withdraw at any time. 
4.4 Potential for Benefit
Phase 1: There is no direct benefit to participants.
Phase 2: There may or may not be a direct benefit to participants. All participants will receive 
information regarding self-management that may be useful to participants but the study will 
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evaluate the feasibility of implementing the interventions as well as participant-reported 
satisfaction and relevant quality of life outcomes.
5.   Data Handling and Statistical Analysis
Phase 1 (Aim 1): 
Data Management: Digital recordings will be transferred off of the recorders to the PI’s secure 
shared drive as soon as possible following the interview and then erased from the recorder. 
Transcription will be completed as soon as possible, removing any identifiable information. All 
transcriptions will be labeled with a subject number rather than any identifiable information. 
Digital recordings will be deleted after they are described and checked for accuracy. Paper 
questionnaires will be labeled with an ID number and stored separately from consent forms in a 
locked cabinet in the PI’s locked office. The key linking subject names and subject numbers will 
be stored electronically on the PI’s password-protected CINJ internal shared drive and destroyed 
at the end of the study.
Data Analysis: Qualitative data will be analyzed using content analysis, following the framework 
approach described by Pope and colleagues.38 Specifically, themes will be identified based on 
the a priori theoretical framework (SMART model). Data will be constantly compared to 
evaluate fit to the model and new themes that emerge from participants’ data will be added to the 
model. An index of themes will be created and applied systematically to the data using NVivo, a 
qualitative data analysis software. Data analysis will continue until theme saturation occurred 
(that is, no new themes emerge from additional participants). Participant feedback on 
questionnaires will be used to determine if any changes are needed to the outcome measures for 
Phase 2 of the study.
Phase 2 (Aims 2 & 3): 
Data Management: The Rutgers Cancer Institute of New Jersey has a contract and Business 
Associate Agreement with TigerText to supply HIPAA-compliant secure messaging services and 
archiving of messages. TigerText will be used for secure text messaging with participants and 
between mentors/mentees. TigerText uses AES-256/SSL encryption and exercises a number of 
physical, technical, and administrative safeguards to protect all messages and data. At the 
application layer, TigerText uses Secure Socket Layers (SSL) to encrypt all communication 
between the web browser and the data center, and a processing pipeline that ensures performance 
and data privacy between customer accounts. TigerText partners with Sonian to archive the 
messages between participants, which will be used for supervision of mentors and for content 
analysis to determine how mentors and mentees communicated during the study. The archived 
message data will be accessed and downloaded by the PI or project coordinator using the secure 
TigerText web portal and stored electronically on the PI’s password-protected CINJ internal 
shared drive. These data will be labeled with an ID number rather than participant name or other 
identifier. All interactions in the TigerText system are included in the audit logs to ensure that 
administrators are properly using the web portal and it’s services. 
Databases for participant recruitment and tracking and participant survey data will be developed 
in collaboration with the CINJ Population Science Research Support Core using HIPAA-
compliant DatStat software. The Core provides access to the DatStat software, facilitates initial 
study setup, and assists in the event of any technical problem in using the DatStat software. 
Approval for use of this software in research studies has been provided by the Rutgers 
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Biomedical and Health Sciences Institutional Review Board (IRB). (The approval process 
included: obtaining a Technology Professional Service Agreement and a Business Associate 
Agreement from DatStat; the approval of a Security Questionnaire from the Rutgers Office of 
Information Technology; and the completion of a Security Risk and Assessment Tool by the 
Rutgers CINJ Office of Information Technology.) The software allows for research study 
personnel to be assigned data access and privileges specific to their role on the study. Study team 
members are given access to the minimum amount of data needed to perform their role on the 
study. 
Online surveys will be completed by participants using a secure website (hosted on DatStat 
servers). DatStat secure servers are registered with site certificates provided by AddTrust that 
provide for advanced encryption over the wire. As each user moves through the survey form, 
his/her responses are encrypted while in-transit between the browser and DatStat's server using 
SSL (Secure Sockets Layer) and 40, 56, or 128-bit Public Key Encryption. All servers used for 
data collection are highly fault-tolerant and equipped with redundant, hot-pluggable power 
supplies, redundant network interfaces, and RAID 5 hot-swappable disk storage. All primary 
servers are plugged into a monitored, uninterruptible power supply (UPS). DatStat servers are 
stored in a locked server cabinet/rack, which are housed in a state-of-the-art, well-ventilated data 
center. Physical access to servers and data backup is restricted to a minimal number of 
information technology professionals. The servers are secured with physical and firewall 
security. 
Participants will complete surveys online or via paper (depending on participants’ choice). Paper 
surveys will be identified using only a subject number and will be entered into the database by 
study staff and kept in a locked filing cabinet accessible only be authorized study staff. We will 
keep a separate electronic key linking codes and subject names on the PI’s department drive. 
This key will be destroyed at the end of the study. De-identified data will be kept indefinitely. 
Audio files of video/phone calls between peer mentors and mentees will be recorded using the 
peer mentor’s handheld audio recorder. The peer mentor will then use Rutgers Large File 
Transfer Service (LiFT) to securely upload the files for the study team to review. This service 
allows both internal and external users to upload files securely with their email and password. 
The peer mentors will be instructed to destroy the files after they have successfully uploaded 
files to Rutgers LiFT for study team to review. Peer mentors will receive training on how to 
securely transfer the files and delete the files from their devices during the mandatory in-person 
peer mentor training. The study team will download the files via the secure LiFT service and 
store them on the Rutgers secure shared drive accessed via a password-protected computer. For 
participant exit interviews, study staff will record the interview, transfer to the secure shared 
drive (access limited to pertinent research team members). Recordings will be transcribed as 
soon as possible, removing any identifying information from the written document. Recordings 
will be destroyed upon completion of the study procedures. 
Data Analysis: We will examine feasibility through study enrollment rates, retention rates, 
reasons for study drop out, adherence to the intervention, and patient and mentor satisfaction 
with the program. Descriptive analyses (frequencies, means) will be used to evaluate our 
hypotheses regarding expected enrollment (>50%), retention (>75%), and completion of 
intervention sessions (>75%). We based these predictions using the literature describing barriers 
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to recruiting AYA participants39 and the team’s collective experience in intervention 
development and implementation.
To assess the preliminary outcomes of the peer mentor self-management program, we 
will evaluate whether participants in the program demonstrate improvement in transition 
readiness and the impact of cancer, and reductions in symptoms of depression and anxiety. We 
will also explore adherence outcomes. We will compare scores on outcome measures at the end 
of 6-week assessment using dependent/paired t-tests. Since the primary purpose of this project is 
to evaluate feasibility, we recognize that we do not have adequate power to detect small to 
medium statistical effects. Exit interviews will be reviewed to identify strengths of the 
intervention, weaknesses of the intervention, and ideas to improve the intervention.
6. Data and Safety Monitoring 
This study is minimal risk. The PI and co-investigators will monitor for adverse events and 
report any events according to RBHS IRB guidelines. 
7. Reporting Results
7.1 Individual Results
N/A
7.2 Aggregate Results
Aggregate results will be reported in scientific publications. Plain language summaries will also 
be made available at the end of the study. After participants complete the final assessment, we 
will have a separate form that they can voluntarily complete with preferred contact information 
(i.e., mail, email) to receive a summary of aggregate results. This information will be stored 
confidentially until the summary is provided, at which time the contact information will be 
destroyed. 
7.3 Professional Reporting
It is expected that the results of this research will be submitted for publication in a timely manner 
following the conclusion of the study. The PI and all co-authors must review any abstract or 
manuscript prior to submission. 
8. Bibliography
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Sahler O, Fairclough D, Phipps S, et al. Using problem-solving skills training to reduce 
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Bethesda, MD: Department of Health and Human Services, National Institutes of Health, 
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