Teens Living With Cancer Fitness Improvement Training (TLCFIT): A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
Phase: NA
Conditions: Survivorship, Fatigue
Sponsor: Rutgers, The State University of New Jersey

Protocol Version 1.9 – 8/30/2017
CINJ# 131323
Rutgers, The State University of New Jersey
195 Little Albany Street
New Brunswick, NJ 08903-2681
cinj.org
p. 732-235-2465
Title: “TLC FIT”: A Novel Mobile Health Fitness Program 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 (Mentor)
Margaret Masterson, MD
Rutgers Co-investigator 
Jerod Stapleton, PhD
Rutgers Co-Investigator
Shawn Arent, PhD, CSCS
Rutgers Co-Investigator 
Pamela Ohman-Strickland, PhD
Rutgers Co-Investigator (Biostatistician)
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: 
This project is funded by NCI (K07 CA174728). Dr. Devine’s start-up funds will pay for 
additional costs not covered by the grant.
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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“TLC FIT”: A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood 
Cancer Survivors
Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
CINJ# 131323
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TABLE OF CONTENTS
1.
PURPOSE/SPECIFIC OBJECTIVES .......................................................................................................................4
2.
BACKGROUND AND SIGNIFICANCE ..................................................................................................................5
3.
PARTICIPATING INSTITUTIONS..........................................................................................................................7
4.
EXPERIMENTAL DESIGN AND METHODS........................................................................................................8
4.1 PROCEDURES................................................................................................................................................................8
4.2 DURATION OF STUDY.................................................................................................................................................10
5.
PATIENT SELECTION CRITERIA.......................................................................................................................11
5.1 INCLUSION CRITERIA..................................................................................................................................................11
5.2 EXCLUSION CRITERIA ................................................................................................................................................11
5.3 INCLUSION OF WOMEN AND MINORITIES...................................................................................................................12
5.4 PARTICIPATION OF CHILDREN....................................................................................................................................12
5.5 SOURCES OR METHODS OF RECRUITMENT.................................................................................................................12
5.6 STUDY ENROLLMENT PROCEDURES...........................................................................................................................12
6.
STUDY PARAMETERS/MEASURES....................................................................................................................13
7.
DATA COLLECTION AND RECORDS TO BE KEPT .......................................................................................15
7.1 RESEARCH CHARTS....................................................................................................................................................15
7.2 REPORTS.....................................................................................................................................................................16
8.
DATA AND SAFETY MONITORING....................................................................................................................16
9.
STATISTICAL CONSIDERATIONS......................................................................................................................16
9.1 PRIMARY AND SECONDARY HYPOTHESES AND ENDPOINTS.......................................................................................16
9.2 SAMPLE SIZE JUSTIFICATION......................................................................................................................................17
9.3 METHODS FOR MASKING, RANDOMIZATION AND STRATIFICATION...........................................................................17
9.4 STATISTICAL ANALYSIS .............................................................................................................................................17
9.5 COMPLIANCE AND MISSING DATA .............................................................................................................................18
10.
HUMAN SUBJECTS ...............................................................................................................................................18
10.1 SUBJECT POPULATION..............................................................................................................................................19
10.2 POTENTIAL RISKS.....................................................................................................................................................19
10.3 CONSENT PROCEDURES............................................................................................................................................20
10.4 POTENTIAL BENEFITS...............................................................................................................................................20
10.5 RISK-BENEFIT RATIO ...............................................................................................................................................20
10.6 GENDER AND MINORITIES........................................................................................................................................21
11.
ECONOMIC/FINANCIAL CONSIDERATIONS................................................................................................21
12.
PUBLICATION OF RESEARCH FINDINGS .....................................................................................................21
REFERENCES...................................................................................................................................................................22
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“TLC FIT”: A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood 
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Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
CINJ# 131323
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LIST OF ABBREVIATIONS   
TLC FIT
Teens Living with Cancer – Fitness Improvement Training
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
PA
Physical Activity
HRQOL
Health-Related Quality of Life
CCSS
Childhood Cancer Survivor Study
SCT
Social Cognitive Study
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“TLC FIT”: A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood 
Cancer Survivors
Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
CINJ# 131323
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The K07 is a 5-year training grant and part of the training plan is for Dr. Devine to learn how to 
design and implement the studies outlined in the proposal (i.e., development of a mobile 
application “app” and evaluation of a behavioral intervention incorporating the newly developed 
app). In this application, we have described the general procedures of the project but the exact 
project details will be finalized during the grant period. We will modify the protocol on an 
ongoing basis as needed to reflect the development of project materials (i.e., mobile app) or any 
changes in procedures. We will obtain IRB approval for all study procedures and materials prior 
to their utilization in the project. 
1. Purpose/Specific Objectives
The goal of this project is to develop and evaluate the feasibility of “TLC FIT” (Teens Living 
with Cancer Fitness Improvement Training), a technology-enhanced fitness program for 
adolescent and young adult (AYA) survivors of childhood cancers. Advances in treatment 
have fortunately led to a growth in the number of childhood cancer survivors in the US. 
Unfortunately, these survivors are at-risk for negative late effects from treatment, including 
cardiovascular disease and early death. Physical inactivity can exacerbate these risks. 
Adolescent survivors of childhood cancers in particular have reported significant declines in 
physical activity that persist following treatment. In preliminary work, we designed an eight-
session group-based fitness program for AYA survivors using social cognitive theory. This 
program incorporated the FitBit, a novel commercially available electronic accelerometer, 
which allowed for self-monitoring of activity. The FitBit also provided an internet-based 
website for social networking among participants. The program was feasible and acceptable 
to participants, and they suggested lengthening the program to 12 weeks. Further, 
participants reported low levels of engagement with the FitBit website and a strong interest in 
on-the-go access to program materials outside of weekly group sessions. Therefore, the next 
step is to significantly enhance the technology by creating a cancer-specific smartphone 
application (app) that motivates participants to engage in and sustain behavior change. Phase 
1 of this project involves the development of the mobile app. Following app development 
and validation, in Phase 2 we will conduct a randomized pilot trial (n = 88) of TLC FIT to 
evaluate feasibility and effectiveness.
1.1 Primary Objectives
Aim 1: Develop and evaluate the usability of cancer-specific and motivational tools in 
the mobile app (Phase 1).
AYA survivors will help design the functionality requirements for the initial prototype. An 
experienced app development company will program the app with identified tools such as 
goal setting, self-monitoring, exercise instructions, and social networking. Usability testing 
will be conducted in an iterative manner with AYA survivors, refining the app based on user 
feedback (total n = 20).
Aim 2: Evaluate the feasibility of the technology-enhanced (electronic accelerometer + 
app + 8 weekly group sessions) fitness program in a pilot randomized clinical trial 
(Phase 2). 
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“TLC FIT”: A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood 
Cancer Survivors
Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
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Hypothesis 1: AYAs will agree to participate in the program, demonstrate engagement in the 
program via > 80% attendance at group-based sessions, and use one or more components of 
the app at least weekly.
1.2 Secondary Objectives
Aim 3: Determine the effectiveness of the technology-enhanced fitness program on 
participants’ cardiorespiratory fitness and muscular fitness.
Hypothesis 2: Participants in the intervention group will demonstrate greater improvement in 
cardiorespiratory fitness (objective submax treadmill test) and muscular fitness (objective 10-
repetition tests) from baseline than wait-list control participants at the post-intervention 
assessment. 
Aim 4: Examine the effects of the program on secondary outcomes of health-related 
quality of life (HRQOL) and fatigue.
Hypothesis 3: Participants in the intervention group will demonstrate greater improvement in 
HRQOL (PedsQL Generic Core Scale) and fatigue (PedsQL Multidimensional Fatigue Scale) 
from baseline than the wait-list control group at the post-intervention assessment.
2. Background and Significance
Physical inactivity is a significant problem for childhood cancer survivors. Advances in 
therapy have resulted in survival rates of almost 80% for children diagnosed with cancer,1 and 
there are now over 350,000 childhood cancer survivors in the US.2 These survivors are at risk for 
negative late effects from treatment, and almost two-thirds will develop at least one chronic 
health condition.3,4 Premature cardiovascular morbidity and mortality, physical inactivity, and 
obesity are serious concerns.5-10 A sedentary lifestyle is a risk factor for health problems and may 
exacerbate late effects of treatment, increasing the risk of cardiovascular disease, osteoporosis, 
and early mortality.6 Physical activity (PA) is well known to reduce risk for cardiovascular 
disease and early mortality.11,12 In healthy children and adolescents, increased PA is associated 
with benefits such as improved cardiorespiratory fitness, muscular fitness, bone health, and body 
composition.13 PA is also positively associated with quality of life.14-16 Because survivors of 
childhood cancers are inherently at risk for serious late health effects, programs to promote PA 
are especially important for this population. A recent systematic review of PA in childhood 
cancer survivors indicated the need for evidence-based behavioral interventions to promote 
physical activity.17 Despite a need and interest in PA promotion programs for this group,18 there 
are very few controlled studies of PA interventions for adolescent and young adult (AYA) 
survivors.10,16,19 The proposed work will evaluate the effectiveness of a highly-engaging 
technology-enhanced PA intervention program designed specifically for AYA survivors.
Adolescents and young adults (AYAs) are especially important to target. AYA survivors are 
recognized as a unique group that warrants further attention to treatment and survivorship issues 
as they transition from pediatric to adult health care settings.20 There are many barriers to 
successful transition, and AYA survivors may be lost to follow-up or receive inadequate care if 
the transition is not successful,21 reducing opportunities for counseling regarding the benefits of 
PA and other health promotion behaviors. A report from the Childhood Cancer Survivor Study 
(CCSS) indicated that adult survivors of childhood cancers are less likely to meet CDC 
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guidelines for PA and more likely to report an inactive lifestyle than siblings.22 Because health 
behaviors adopted by AYAs are likely to be “carried over” into adulthood,19,23 intervention 
during this time period is likely to improve PA trajectories into adulthood and reduce disparities 
between adult survivors and siblings. Further, intervening earlier may produce better outcomes, 
as AYAs are unlikely to have chronic de-conditioning like older adults and more likely to have 
plasticity of body tissues.24  
Factors associated with physical activity in AYA survivors of childhood cancers. As 
pictured in Figure 1, treatments for childhood cancers, including radiation and various 
chemotherapies (e.g., anthracyclines, vincristine), can lead to adverse acute and long-term health 
effects, including deficits in fitness and health-related quality of life (HRQOL).6,25 These adverse 
changes reduce AYAs’ beliefs in their abilities to engage in physical activity (self-efficacy for 
PA) and may prompt reduced support for PA from parents and peers, leading to reductions in 
physical activity. Sedentary habits can exacerbate functional deficits and fatigue, becoming a 
self-perpetuating cycle.24 Social Cognitive Theory (SCT)26,27 proposes that behavior is 
reciprocally influenced by multiple personal/cognitive and environmental/social factors. 
Emphasis is placed on self-efficacy, or belief in one’s capability to conduct the intended 
behavior (physical activity) and overcome perceived barriers to a behavior, and outcome 
expectancies, or beliefs that the behavior will have the desired effect (e.g., improve fitness). 
Social modeling, or learning through observation of others’ experiences, and social support for 
the activity are also key components. For AYA survivors, self-efficacy and support for PA are 
critical components to target. Specifically, self-efficacy is positively associated with physical 
activity in young adult cancer survivors and healthy AYAs.28-30 Greater family and peer support 
for PA have been associated with increased PA.31-36 Peer support is particularly important for 
adolescents.35,36 Certain demographic factors, including male gender and younger age, are also 
consistently correlated with PA.22,30,32 The proposed intervention is guided by Social Cognitive 
Theory and will evaluate the role of self-efficacy and support for PA in AYA survivors of 
childhood cancers. What is learned will contribute to the broader understanding of health 
promotion for AYA survivors.
2.1 Supporting Data and Rationale. Guided by Social Cognitive Theory, we developed an 8-
week group intervention with four primary components: (1) educational modules, (2) physical 
exercise, (3) goal-setting and self-monitoring, and (4) social support. Each session was detailed 
in a manual. This program incorporated the “FitBit,” a small electronic accelerometer that 
uploads data wirelessly to a personalized account for monitoring PA. Because participants could 
modify their behavior based on viewing activity levels using FitBit, this technology was used as 
part of the intervention but not as an outcome measurement. Participants met weekly and 
provided social support in-person as well as through a private forum on the FitBit website.
Nine participants completed baseline and post-intervention measures (100% retention). 
On average, participants attended 6 out of 7 weekly exercise sessions (the 8th week was an 
Figure 1. Model of cancer-related deficits and social cognitive determinants of physical activity (PA)
Treatment-Related Effects
↑ Cardiotoxicity
↓ Muscle Mass
↓ Balance/Postural Control
↑ Gait abnormalities/Neuropathy
↓ Pulmonary Functioning
Functional Outcomes
↓ Cardiorespiratory Fitness
↓ Muscle Function
↑ Fatigue
↓ HRQOL
Social Cognitive
↓ Self-Efficacy for PA
↓ Support for PA
Physical Activity
↓ Physical Activity
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“TLC FIT”: A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood 
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Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
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assessment only). There were no serious adverse events during the study. Our preliminary work 
demonstrated feasibility in enrolling participants, retaining participants, and completing the 
various assessment measures. There was evidence of improvement in time spent in physical 
activity, muscle strength, health-related quality of life, and fatigue that warrants further study. 
Participants reported high satisfaction with the program and FitBit. Despite increases in PA by 
actigraphy, we did not see large improvements in cardiovascular fitness (Mile Run/Walk). As a 
result, we will modify session structure to devote more attention to aerobic training. Further, 
participant feedback indicated interest in more fitness sessions (12 instead of 8), increased 
intensity of cardiovascular exercises, and additional structure to individualized exercise plans 
outside of session. These suggested refinements to the program are included in this proposed 
study. 
Interest in mobile app development. Although participants reported that the FitBit website 
and group forum were easy to use, they reported logging in only “rarely” or “sometimes” 
because going to a computer to log in was a barrier. Participants are more likely to engage if 
access is immediate and available wherever they are. Hence, a primary goal of developing a 
mobile app is to increase engagement with study materials outside of the weekly sessions. In 
response to a survey, six out of 9 (67%) participants expressed “quite a bit” or “extreme” interest 
in trying an app to promote PA. Of the three who did not express high levels of interest, two 
indicated that they were uninterested because they do not currently own a smartphone, but 
expressed high interest if they were to be given a smartphone or iPod touch as part of the 
intervention. Of those who expressed an interest, participants indicated a high level of interest in 
functions like messaging/texting with a coach, tracking calories consumed and burned, goal 
setting, goal tracking, and messaging/texting with other survivors. Additional suggested features 
included a list of exercises for individual workouts, making steps and activities viewable by all 
group members for motivation and support, and awarding a weekly prize or badge for being the 
most active. 
3. Participating Institutions 
Project planning, recruitment, data collection, data management, and data analyses will take 
place at the Rutgers Cancer Institute of New Jersey. Because this is a K07 award, Dr. Devine 
has selected a team of mentors to provide training in their respective areas of expertise and 
facilitate the successful completion of the proposed project. ITX Corporation will program 
the app based on the requirements defined by the research team. They have completed 
necessary paperwork to partner with Rutgers Cancer Institute of New Jersey researchers on 
this project. Hackensack University Medical Center will participate as a site with IRB 
approval from the HackensackMeridian IRB.
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Cancer Survivors
Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
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4. Experimental Design and Methods 
Overall Study Design: The primary goal of the proposed study is to 
develop and evaluate the feasibility and effectiveness of TLC FIT, a 
technology-enhanced intervention to promote physical activity in 
AYA childhood cancer survivors. Phase 1 includes development and 
usability testing of the smartphone application (Aim 1). Employing 
user-centered design methods,37,38 we will work with AYA 
survivors (“end users”) to design and refine prototype versions of 
the app. Technology consultants (contract to be determined) will 
create the app using theoretically-based features identified as 
desirable in our previous work. We will recruit a total of 20 AYA 
survivors to assist in the development and usability testing of the 
mobile app. This will be an iterative process such that AYAs will 
give ideas about desired features, assist in critiques of prototypes, 
and later test a working version of the product. Next, in Phase 2 we 
will conduct a pilot RCT (n  = 88) of the 12-week TLC FIT (8 group 
meetings + electronic accelerometer + app) versus wait-list control 
(WLC) group (Aims 2-4). We will evaluate the feasibility of the 
fitness program, including recruitment, retention, and adherence to 
the intervention (Aim 2), and test the hypothesis that technology-
enhanced intervention will increase AYAs’ muscle strength and 
cardiorespiratory fitness (Aim 3). We will also explore the effects of 
the program on secondary outcomes of HRQOL, and fatigue (Aim 
4). A randomized wait-list control design is particularly appropriate 
for this feasibility study, as all recruited individuals receive the 
intervention, allowing intervention adherence and program 
satisfaction data to be obtained from all study participants. Such a design can also increase 
the appeal of random assignment to study participants. The Phase 2 study design is presented 
in Figure 2.  
4.1 Procedures
Phase 1. Development of smartphone application
We gathered information about functionality requirements for the smartphone app in our 
preliminary work with AYA cancer survivors. We will recruit a total of 20 AYA survivors 
for this phase of the study. We will use individual or small group interviews conducted by 
the PI or a trained research assistant to gain additional input about desired features for the 
app. We will also get feedback on mock designs for the app. We will record these interviews 
and they will be transcribed for analysis by a member of the research team. The exact 
number of interviews conducted will depend on the data gathered; we will analyze the data as 
we go and we will stop interviewing when we reach saturation (i.e., no new themes emerge 
from the data). 
Next, we will work with the technology consultants to develop a prototype based on AYA 
preferences. The exact content of the app will be determined in the development phase but it 
will reflect the content of the original TLC FIT program (based on Social Cognitive Theory) 
TLC FIT 
Figure 2. Phase 2 Study Schema
Baseline Assessment 1
Randomization (0 mos.)
TLC FIT
(in person)
Wait-List 
Control
Assessment 2 (~2 mo)
 Assessment 4 (~6 mo)
Assessment 5 (~9 mo)
TLC FIT
(app only)
Wait-List 
Control
Assessment 3 (~3 mo)
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Cancer Survivors
Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
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and include tailored cancer-specific fitness information (e.g., potential effects of 
radiation/chemotherapy and issues to consider when exercising based on up-to-date COG 
guidelines). Users will create a private login. Data from an electronic accelerometer will be 
directly imported into the app and used to unlock achievement awards. Individuals will set 
personal goals, monitored in real-time. Instruction videos of the trainer demonstrating 
exercises will allow for instruction 24/7. A qualified trainer with experience working with 
adolescents and young adults will be used for this study. Engagement with the app will 
unlock achievements and there will be optional social support messaging between individuals 
in the study. The PI and/or trainer will initiate challenges and prompt participants to continue 
working on goals between sessions. All user data will be continuously stored in an encrypted 
and cached environment on the device itself. When an internet connection is available, the 
device will securely transmit the data to our servers for downloading by researchers.
The app will be created using an iterative development process. Product development is 
broken into logical pieces, prioritized, and completed in iterations. Usability testing is 
conducted after each piece. Usability testing at this stage involves observation of participants 
completing defined tasks, time to complete tasks, errors in use, and subjective assessment of 
satisfaction, ease of learning the app, and memorability of the app.38 This can be done in 
person or remotely via computer and phone. Usability tests are completed using a rapid 
iterative procedure, in which design changes are made after receipt of one set of participants’ 
feedback (usually four participants) and then tested with the next set of participants. The app 
is refined to eliminate issues that impede usability. The final usability tests would include a 
field trial of using the app for up to one week and providing feedback regarding use in daily 
life. Having a smartphone is not required to participate; we will loan iPod touches to anyone 
who does not have a personal smartphone for the duration of the study. We have planned for 
12-18 months for total development time. We expect it will take 3-6 months to design and 
refine the health and cancer-specific content for the app, 3-4 months to design the app, and 3 
months to conduct usability testing with the app. Our goal is to minimize frustration with 
technology. Individual participation may include a one-time interview or usability test 
(approximately 1-2 hours) or a field trial of using the app for up to a week. 
 
Phase 2: Pilot RCT
Recruitment will occur in waves, such that 10-20 participants will be randomized within 
cohorts, and each arm will have 5-10 patients at a time. After obtaining informed 
consent/assent, participants will complete baseline assessments (Time 1) conducted either in 
group formats or individually as done in our preliminary study. The assessments will be 
conducted by trained research personnel. Participants will then be randomized to either TLC 
FIT (8 group sessions + electronic accelerometer + App) or wait-list control (WLC). 
Randomization will be stratified by cohort (since enrolled in waves) and age (13-17 vs. 18-
25). All participants will be asked to complete assessments at Time 2 (~2 months, after the 
in-person sessions are completed for the TLC FIT group), Time 3 (~3 months; after the full 
in-person plus app intervention for TLC FIT group), Time 4 (,~6 months), and Time 5  (~9 
months; after the waitlist control participants receive the intervention). Waitlist control 
participants will also be asked to complete the objective fitness tests during the last session of 
the in-person groups; they will be given feedback on their results but no additional monetary 
compensation for these tests. Assessments and the group fitness program will be conducted 
in at the Center for Health and Human Performance (directed by Co-Investigator Dr. Shawn 
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Arent) at the Institute for Food, Nutrition, and Health on Rutgers Cook Campus in New 
Brunswick. This is a facility equipped with appropriate equipment and space for group 
exercise. The trainer will be a qualified professional trainer or member of the Center for 
Health and Human Performance with appropriate experience and expertise who will be 
closely supervised by Dr. Arent and the PI.
TLC FIT (Technology-Enhanced Intervention): TLF FIT is composed of the group fitness 
program, use of an electronic accelerometer, private Facebook group and the mobile app. The 
group fitness program is manualized and will be led by a qualified trainer. The PI will teach 
the trainer the manualized program and treatment integrity will be evaluated during the 
program. The group program has four primary components: (1) cancer-specific and general 
educational modules, (2) physical exercise, (3) goal-setting and self-monitoring, and (4) 
social support. The original program consisted of eight weekly group sessions; however, 
participants expressed interest in adding exercise sessions, which would likely increase the 
impact on participants’ fitness. Therefore, the program is now 8 weekly group sessions 
lasting 90 minutes each plus 4 weeks of using the app without in-person groups. In-person 
sessions will consist of approximately 20 minutes of education regarding fitness and 
administrative tasks, 10 minutes of goal-setting/monitoring, and 60 minutes of instructor-led 
exercise and cool-down (~30 minutes of aerobic exercise and 30 minutes of muscle 
strengthening and balance exercises). Exercises are age-appropriate and the intensity of 
participation is individualized – that is, any exercise can be modified to be more or less 
strenuous for each participant based on participants’ ratings of perceived exertion as well as 
any physical limitations due to cancer treatment (such as hip problems). The trainer will have 
experience in assisting teens and young adults in modifying exercises to a level appropriate 
to their current fitness and physical abilities. Participants will wear a commercially available 
electronic accelerometer daily throughout the intervention to self-monitor progress. Data 
from the accelerometer will be electronically extracted into the app for easy monitoring and 
sharing of goals/progress. Social support for physical activity will be fostered through group 
interactions at each session and group messaging within the app and Facebook private 
groups. During the follow-up period, participants continue to use the app, set physical 
activity goals, and monitor progress. We will remotely download data regarding app use 
weekly throughout the intervention and follow-up.
4.2 Duration of Study
The K07 training grant is a 5-year grant. The app development and refinement (Phase 1) will 
occur in years 1-2 and the pilot RCT (Phase 2) will occur in years 3-5.
Phase 1: App Development. We have planned for a period of 12-18 months for 
development, usability testing, and refinement. Information will be gathered from 
childhood cancer survivors about desired features of the app via interview. During 
development, feedback about the quality of the program and design elements will be 
sought. Once a usable app is developed, individuals will be asked to field test the app for 
a brief period (e.g., a few days or a week, depending on needs identified during 
development) to evaluate usability in a real-world setting prior to beginning Phase 2.
Phase 2: Pilot RCT. Recruitment will occur in waves, such that cohorts of 10-20 
participants will be randomized simultaneously, and each arm will have 5-10 patients at a 
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time. Following individual consent/assent and completion of a baseline assessment, 
individuals will be randomized either to the Technology-Enhanced Intervention (TLC 
FIT) arm or the Waitlist Control (WLC) arm (see Figure 2). Individual data collection 
will last approximately 9 months, with assessments conducted at approximately 2, 3, 6, 
and 9 months following randomization. Individuals randomized to the waitlist will 
receive the intervention after the 6-month assessment. Recruitment and data collection for 
Phase 2 are expected to span two to three years.
Overview of Study Duration
5. Patient Selection Criteria
5.1 Inclusion Criteria
Phase 1: A patient is eligible for enrollment if all of the following criteria are met:
5.1.1
Any diagnosis of cancer prior to age 21
5.1.2
Current age 13-25
5.1.3
Off treatment 
5.1.4 For patients < 18 years, parents must give informed consent and patient must give 
assent. Patients > 18 must give informed consent. 
Phase 2: A patient is eligible for enrollment if all of the following criteria are met:
5.1.5
Any diagnosis of cancer prior to age 21
5.1.6
Current age 13-25
5.1.7
Off treatment for at least 6 months 
5.1.8 For patients < 18 years, parents must give informed consent and patient must give 
assent. Patients > 18 must give informed consent. 
5.2 Exclusion Criteria
Phase 1: A patient is not eligible for enrollment if any of the following criteria are met:
5.2.1
Non-English speaking
5.2.2 Significant developmental delay per patient, parent, or physician report
5.2.3
Pregnant (per patient report)
Study Year
1→
2→
3→
4→
5→
Quarter
1
2
3
4
1
2
3
4
1
2
3
4
1
2
3
4
1
2
3
4
Phase 1: App Development
Training in App Development
IRB & study prep
App development/Refinement
Phase 2: Pilot RCT
IRB & study prep
Recruitment
Data Collection
Data Analysis
Manuscript Prep
Write/Submit Grant
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Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
CINJ# 131323
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Phase 2: A patient is not eligible for enrollment if any of the following criteria are met:
5.2.4
Any medical contraindication to exercise according to a physician or physician’s 
designee
5.2.5
Non-English speaking
5.2.6
Current physical activity level exceeding CDC guidelines for activity (60 min of 
moderate-vigorous exercise/day for 5+ days/wk including 3+ days of vigorous 
intensity activities and muscle-strengthening exercises on 3+ days/wk and bone-
strengthening exercises on 3+ days/wk for children <18 and 150 min of moderate-
vigorous exercise or 75 min of vigorous exercise/wk and 2+ days of muscle-
strengthening activities for adults > 18). The CDC guidelines are used to 
determine exercise prescription in our intervention; individuals already exceeding 
the guidelines would be unlikely to benefit from participating. 
5.2.7 Significant developmental delay per patient, parent, or physician report
5.2.8
Pregnant (per patient report)
For Phase 2, if participant becomes pregnant during the course of the study, she 
will be removed from further participation
5.3 Inclusion of Women and Minorities
Males and females and members of all ethnic groups are eligible for this study. We expect 
the distribution of sex and race/ethnicity to reflect that of the Rutgers CINJ. 
5.4 Participation of Children
This study includes children, as the primary goal is to evaluate an intervention specifically 
designed for adolescents and young adults ages 13-25. To protect children who are 
considered a vulnerable population, we will obtain both individual assent and parent consent 
for participation in the study for all children under the age of 18. We will also clearly explain 
and document that participation in the study in no way influences medical care. The PI and 
mentor, Dr. Manne, have significant experience and expertise in working with children of 
this age range and their families. Co-Investigator Arent has experience conducting exercise 
interventions with children.  
5.5 Sources or Methods of Recruitment
Patients will be recruited through the Rutgers CINJ LITE (Long-term, Information, 
Treatment effects, and Evaluation) program, which provides long-term evaluation, support, 
and health education for childhood cancer survivors, through their routine office visit or mail. 
Patients will also be recruited through physician or staff referral in the Division of Pediatric 
Hematology/Oncology. Patients will also be recruited through flyers posted or available in 
relevant places (e.g., community support centers for teens and young adults with cancer). 
Flyers will be posted in the LITE clinic space and advertisements will be posted in the 
Rutgers CINJ LITE newsletter to recruit; these materials will be submitted and approved by 
the IRB prior to use. We will make information about the study available via webpage, 
www.cinj.org/fitsurvivor. We will also post advertisements with a link to the study webpage 
or IRB-approved flyer on social media sites, including Facebook and Twitter. The study team 
will also periodically (approximately 4-6 times per year) hold informational meetings for 
potentially eligible participants to learn about the program and ask questions. Study 
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Katie Devine, PhD
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CINJ# 131323
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information will be sent to the faculty and staff via Rutgers email lists or online news media, 
such as the Faculty & Staff Bulletin and Rutgers Today or Research News. 
5.6 Study Enrollment Procedures 
For Phase 1, potential participants may be recruited during their Rutgers CINJ LITE office 
visit. The PI or trained study staff will approach potentially eligible patients and families to 
provide a brief description of the study, answer any questions, and obtain informed 
consent/parental permission and assent (for children 13-17). Participants will be given as 
much time as needed to read the consent/assent materials and ask any questions. Dr. 
Masterson, the Director of the Rutgers CINJ LITE program and a Co-Investigator on this 
study, and Susan Stephens, LCSW, the primary social worker for the LITE program, will 
assist in recruiting by identifying potentially eligible patients from patient records. For those 
who are not due for a routine LITE visit, the study team will mail an invitation with an insert 
noting available interview dates and follow-up with a phone call to answer any questions and 
arrange for an in-person meeting to obtain consent/parental permission/assent and conduct 
the interview about desired features for the app. Phone calls can be made up to three times 
per week, with a maximum of one message per week, for up to three weeks. A recruitment 
flyer will be handed out or hung in clinic or sent via mail with the study invitation. For 
participants who contact the PI or research staff regarding participation via email or phone, 
research staff will respond in the same mode of contact. Participants will be paid $20 for 
each interview or usability session completed. 
For Phase 2, we will use the existing LITE program mailing list to mail invitational letters to 
all LITE parents and/or patients ages 13-25 informing them of the study. The LITE program 
maintains a clinical contact list to send periodic newsletters and mailings to patients. This 
letter will be written from Dr. Masterson, the patient’s physician and Medical Director of the 
LITE program who has routine contact with these patients, and the PI of the study, to invite 
potential participants to contact the research team to ask questions or enroll in the study as 
well as inform potential participants of in-person informational meetings to be held by the PI 
and study team at Rutgers CINJ. We will follow-up by phone to answer any questions and 
determine interest in participating. Phone calls can be made up to three times per week, with 
a maximum of one message per week, for up to three weeks. We will arrange for in-person 
meetings to obtain informed consent/assent; if it is not possible to schedule, we will mail 
consent/assent forms, discuss via phone, and have participants return completed forms via 
mail. Initial invitations will include a post card that the recipient may return to indicate that 
they are not interested in the study and we will remove them from the mailing list. Because 
we will recruit in cohorts, we will hold informational meetings about four to six times per 
year. These meetings are to provide information about the study, answer any questions, and 
obtain consent/parental permission/assent to individuals ready to enroll. All materials will be 
submitted to the IRB for approval prior to use. Informed consent/parental permission and 
assent (for children 13-17) will be obtained prior to any study procedure. Participants will be 
given as much time as needed to read the consent/assent materials and ask any questions. If 
any participant turns 18 during the study period, the participant will be re-consented using 
the appropriate approved consent form as soon as possible. Participants will be paid $20 for 
completion of each assessment, for a total of $100. Any participant who completes all 
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Katie Devine, PhD
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CINJ# 131323
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assessments will be entered into a raffle to win a fitness gift basket, including items such as 
water bottles, healthy snacks, and fitness equipment (valued at $150).
6. Study Parameters/Measures 
Phase 1: App Development. We will interview participants individually or in small focus 
groups regarding desired content and functional features of the app. The PI or a trained 
research assistant will conduct interviews in person or via phone using a guide. Interviews 
will be recorded and transcribed by a member of the team for content analysis. Usability 
testing will involve assessment of satisfaction, ease of learning the app, and memorability of 
the app. Usability testing may be done in person or via telephone while the participant is 
interacting with the application online. At the time of accrual, a medical chart review will be 
conducted by trained study personnel to assess type of cancer, treatment history (surgery, 
chemotherapy, radiation therapy), time since treatment completion, and general demographic 
information (i.e., gender, age, race, and ethnicity).  
Phase 2: Pilot RCT. All measures selected for this study have demonstrated adequate validity 
and reliability (see Table 1). With the exception of the demographic survey, all measures will 
be administered at baseline (Time 1), Time 3 (~3 months), Time 4 (~6 months), and Time 5 
(~ 9 months). Only the muscular fitness tests, cardiorespiratory fitness test, body composition 
measures, accelerometry, and self-reported physical activity and sedentary behavior will be 
administered at Time 2 (~2 months). The primary outcomes are muscular fitness and 
cardiorespiratory fitness as measured by the 10-repetition max tests and submaximal 
treadmill testing (Aim 3). Secondary outcomes include health-related quality of life 
(HRQOL) and fatigue (Aim 4). We will also examine other constructs from Social Cognitive 
Theory, including exercise motivations, barriers to PA, body esteem, and psychological 
functioning. Finally, we will examine measures of physical activity (objectively measured 
via accelerometers or “actigraphs”), sleep, and anthropometric body measurements. 
Accelerometers have been extensively validated as measures of physical activity in children 
and adolescents.39 Data regarding usage of the intervention app and electronic accelerometer 
will also be collected. Physical fitness measures are expected to take 40-45 minutes to 
complete plus the 7-days of actigraph wear during usual activities. Surveys are anticipated to 
take up to 45 minutes to complete. At the time of accrual, a medical chart review will be 
conducted by trained study personnel to assess cancer type, treatment history (surgery, 
chemotherapy, radiation therapy), time since treatment completion, and general demographic 
information (i.e., gender, age, race, and ethnicity).  
Table 1. Measures
Construct
Measure 
Description
Type
Time to 
Complete
Muscle Strength 
10-Repetition Max Test (Upper & 
Lower Body)
Primary Outcome; Yields maximum 
resistance that can be lifted throughout the 
full range of motion using good form for 
10 times for upper and lower body 
O
15-20 
min
Cardiorespiratory 
Fitness 
Submaximal Treadmill Test40,41
Standardized graded treadmill test; yields 
estimated VO2 max
O
20 min
Health-Related 
Quality of Life
PedsQL Generic Core42,43
Physical, Emotional, Social, and Cognitive 
domains
P
5 min
Fatigue
PedsQL Multidimensional Fatigue 
Scale.44
Fatigue
P
5 min
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Cancer Survivors
Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
CINJ# 131323
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Note. Type of Measure: O = Objective; P = Patient-reported. The BodPod body composition test will be optional for 
participants who agree to it; evaluating changes in body composition is exploratory and will provide pilot data for 
future studies.
Table 2. Assessment Schedule
Time of Assessment
Measure
Baseline
(0 Mo.)
Time 2
(~2 Mo)
Time 3
(~3-Mo)
Time 4
(~6-Mo)
Time 5
(~9-Mo)
10-Repetition Max (Upper & Lower)
√
√
√
√
√
Submaximal Treadmill Test
√
√
√
√
√
Height, Weight, Waist Circumference
√
√
√
√
√
BodPod body composition [optional]
√
√
√
Actigraphy
√
√
√
√
√
Demographic/Medical Information
√
Modified IPAQ-SF
√
√
√
√
√
Sedentary Habits
√
√
√
√
√
Barriers to Exercise Scale
√
√
√
√
Motivation for Exercise Item
√
√
√
√
PedsQL: Generic Core
√
√
√
√
PedsQL: Multidimensional Fatigue Scale
√
√
√
√
PROMIS Anxiety & PROMIS Depression
√
√
√
√
Child & Youth Self-Perception Inventory
√
√
√
√
Pittsburgh Sleep Quality Index
√
√
√
√
Accelerometry (actigraph): 7-day 
activity
Objective measure of activity counts and 
time spent in sedentary, light, moderate, 
and vigorous activity
O
7-day 
wear
FitBit Tracker physical activity data
Used as part of intervention, steps counts 
and time in various levels of activity will 
be collected weekly
O
---
Physical Activity
Modified International Physical 
Activity Questionnaire (IPAQ-SF)45
Self-reported physical activity within past 
7 days
P
< 5 min
Sedentary Activity
Sedentary Habits Questionnaire
Sedentary habits within past 7 days
P
< 5 min
Height & Weight
Height & weight measurements
O
< 5 min
Waist Circumference
Waist circumference
O
< 5 min
Body Composition
BodPod46 
[Optional 
for 
participants 
who 
agree]
The Bod Pod is a gold standard in body 
composition measurement. It is an air 
displacement plethysmograph which uses 
whole-body densitomtry to determing 
body composition (fat and fat-free mass) 
in adults and children. This will be 
optional for participants who sign an 
additional consent for this test.
O
< 5 min
Barriers to PA
Barriers to Exercise Scale47
Barriers to PA
P
< 5 min
Exercise Motivation
Motivation for Exercise Item
Motivation for exercise
P
2 min
Psychological 
Symptoms
PROMIS Anxiety and PROMIS 
Depression measures48 – Pediatric 
and Adult forms depending on age
Symptoms of depression and anxiety
P
5 min
Body Esteem
Child & Youth Self-Perception 
Inventory49
Body self-esteem and overall self-esteem
P
10 min
Sleep Quality
Pittsburgh Sleep Quality Index50
Sleep quality
P
5 min
Demographics
Information Survey
Age, gender, race/ethnicity, 
socioeconomic status
P
< 5 min
Intervention 
Feedback
Feedback Questionnaire
Given after intervention to assess 
satisfaction and ideas for improving 
intervention
P
5 min
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Cancer Survivors
Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
CINJ# 131323
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Feedback Questionnaire
√a
√b
Note. a For intervention group only; b For waitlist control group only. If individuals miss or need to reschedule 
assessments, they should be completed within 4 weeks of the scheduled time point.
7. Data Collection and Records to be Kept 
7.1 Research Charts
Hard copies of data for each patient enrolled will be kept in a locked filing cabinet in the PI’s 
locked office.  Electronic files of interviews from Phase 1 will be downloaded from the 
recording device to a folder on the PI’s secure departmental drive as soon as possible after 
the interview. It will then be erased from the recorder and only authorized study personnel 
will have access to the electronic files. Interviews will be transcribed as soon as possible and 
any identifying information will be removed in the written transcript. The electronic file will 
be destroyed at the end of study procedures (i.e., after transcription is complete and verified 
to be accurate by the PI). In Phase 2, patients will be registered for the trial using OnCore. 
All data (i.e., surveys, medical review sheet, fitness data) for each participant will be 
identified with an identification number rather than patient information and the key linking 
patient name and identification number will be kept locked in a separate file. Signed 
informed consent/permission and assent forms will also be kept in a locked cabinet 
separately from research files. Only authorized research personnel will have access to these 
files. We will also maintain an electronic database of potentially eligible patients we have 
contacted and track if any person returns a postcard asking to be removed from our contact 
list. This database will be stored on the PI’s departmental drive and password protected. The 
key that links patient names and identification numbers will be destroyed after all procedures 
are complete and data is checked, by the close of the study.
7.2 Reports
Publications and annual reports for submission to the IRB will be written by the Cancer 
Institute of New Jersey PI using the data captured in the electronic database and the OnCore 
system. 
8. Data and Safety Monitoring
The PI will convene a Data and Safety Monitoring Board (DSMB) composed of a behavioral 
scientist and a clinician to be named. The PI will conduct quarterly reviews of data and 
patient safety and send these reports to the DSMB for review. All unexpected and/or serious 
adverse events occurring during the active portion of the intervention or up to 30 days after 
the last fitness program session, will be reported to the Rutgers CINJ Office of Human 
Research Services and the IRB in accordance with IRB policy.  
9. Statistical Considerations
9.1 Primary and Secondary Hypotheses and Endpoints
Aim 1: Develop and evaluate the usability of cancer-specific and motivational tools in 
the mobile app (Phase 1).
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“TLC FIT”: A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood 
Cancer Survivors
Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
CINJ# 131323
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AYA survivors will help design the functionality requirements for the initial prototype. An 
experienced app development company will program the app with identified tools such as 
goal setting, self-monitoring, exercise instructions, and social networking. Usability testing 
will be conducted in an iterative manner with AYA survivors, refining the app based on user 
feedback (total n = 20).
Aim 2: Evaluate the feasibility of the technology-enhanced (electronic accelerometer + 
app + 8 weekly group sessions) fitness program in a pilot RCT (Phase 2). 
Hypothesis 1: AYAs will agree to participate in the program, demonstrate engagement in the 
program via > 80% attendance at group-based sessions, and use one or more components of 
the app at least weekly.
Aim 3: Determine the effectiveness of the technology-enhanced fitness program on 
participants’ cardiorespiratory fitness and muscular strength. 
Hypothesis 2: Participants in the intervention group will demonstrate greater improvement in 
cardiorespiratory fitness (objective submaximal treadmill testing) and muscular strength 
(objective 10-repetition max testing) from baseline than wait-list control participants at the 
post-intervention assessment (Time 3). 
Aim 4: Examine the effects of the program on secondary outcomes of health-related 
quality of life (HRQOL), and fatigue.
Hypothesis 3: Participants in the intervention group will demonstrate greater improvement in 
HRQOL (PedsQL Generic Core Scale) and fatigue (PedsQL Multidimensional Fatigue Scale) 
from baseline than the wait-list control group at the post-intervention assessment (Time 3).
9.2 Sample Size Justification 
The focus of this work is to determine feasibility and estimate the effect size. Since this is a 
feasibility study, we intend to enroll 88 patients and expect 10% attrition, resulting in 80 
patients with evaluable data. With a sample size of 40 per group and alpha set at .05, we 
calculate that we will have 80% power to detect a medium effect size (Cohen’s d = .32) for 
differences between groups in muscular strength scores using ANCOVA. While we 
recognize that this study is underpowered for small effects, the primary aim is feasibility.
9.3 Methods for Masking, Randomization and Stratification
A randomization scheme will be determined prior to the start of recruitment in accordance 
with the Standard Operating Procedures of the Biometrics Division of the Rutgers Cancer 
Institute of New Jersey. Randomization will be stratified by cohort (due to recruitment in 
waves) and age (13-17 and 18-25). Randomization will occur after baseline measures are 
completed. Trained personnel who conduct the assessments will be masked to the assignment 
(intervention vs. WLC) of the participants.
9.4 Statistical Analysis
Preliminary data analysis will include descriptive statistics, assessment of reliability of 
surveys (Cronbach’s alpha), and evaluation of distributions of each variable. If distributions 
are skewed or fail to meet assumptions for parametric analyses, transformations or non-
parametric procedures will be used as appropriate. Strategies for handling missing data will 
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Cancer Survivors
Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
CINJ# 131323
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be chosen based on the type, nature, and extent of the problem, and could range from 
replacing a single item on a scale with the mean of the subscale, dropping a 
subscale/measure, or multiple imputation for the primary endpoint.
Aim 1: Participants will initially provide input for development based on individual 
interviews, which will be transcribed and analyzed to identify desirable components for 
inclusion in the app. For usability testing, participants are given a defined set of tasks to 
complete and observed to determine the ease with which participants can navigate tools and 
success in utilizing various aspects of the app (e.g., error rates, time to complete tasks). 
Participants will also provide qualitative and quantitative feedback regarding satisfaction 
with features, ease of use, and likeability of the app. Usability tests will be completed using a 
rapid iterative procedure, in which design changes are completed after receipt of a set of 
participants’ feedback and then tested with the next set of participants. The app will be 
refined to eliminate issues that impede usability. A total n of 20 participants is anticipated to 
achieve saturation on issues identified during testing.
Aim 2: Feasibility will be evaluated using enrollment rates, assessment completion rates, 
attendance at weekly sessions, adherence to exercise prescription outside of sessions, and 
usage of the electronic accelerometer and app. The primary hypothesis is that AYAs will 
agree to participate in the intervention and demonstrate engagement via > 80% attendance at 
group-based sessions and use one or more components of the app at least weekly. Descriptive 
analyses (means, frequencies) will be used.
Aim 3: This aim is to determine the effectiveness of the program on the primary 
outcomes, objectively-measured cardiorespiratory fitness and muscular fitness. The primary 
hypothesis is that participants in the intervention group will demonstrate greater 
improvement in cardiorespiratory fitness (measured via the Submaximal Treadmill test) and 
muscular fitness (measured via the objective 10-repetition max tests) from baseline than 
wait-list control participants at the 3-month assessment (after the intervention group 
completes TLC FIT). To test this hypothesis, the two groups’ outcome scores at the post 
assessment will be compared using ANCOVA, controlling for baseline scores. To account 
for enrollment in cohorts, cohort will be included as a covariate and removed if not 
significant. The primary analysis will be performed on an “intent-to-treat” basis; i.e., once a 
subject is randomized, data on that subject will be analyzed according to assignment, 
regardless of the degree to which the subject participates. 
Aim 4: This aim will evaluate the effects of the program on the secondary outcomes of 
HRQOL and fatigue. We will test the hypothesis that participants in the intervention group 
will demonstrate greater improvement in HRQOL and fatigue from baseline than the wait-list 
control group at the 3-month assessment using ANCOVA.
9.5 Compliance and Missing Data
Based on preliminary work and other similar published interventions, 10% dropout is 
expected and the sample size was calculated to account for this rate. Phone, email, and/or text 
message reminders regarding assessments will be used to minimize dropout rate. Compliance 
with the intervention program will be evaluated by examining attendance at sessions and 
utilization of the app. All subjects will be asked to complete assessment regardless of their 
attendance at weekly sessions.
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Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
CINJ# 131323
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10. Human Subjects
10.1 Subject Population 
Phase 1 participants will be 20 AYA survivors of childhood cancer and Phase 2 participants 
will be 88 AYA survivors of childhood cancer. Inclusion criteria for Phase 1: (1) any 
diagnosis of cancer prior to age 21; (2) current age 13 to 25; (3) off-treatment. Exclusion 
criteria for Phase 1 are: (1) non-English speaking; (2) significant developmental delay per 
patient, parent, or physician report; and (3) pregnant per patient report. Inclusion criteria for 
Phase 2: (1) any diagnosis of cancer prior to age 21; (2) current age 13 to 25; (3) off-
treatment for at least 6 months. Exclusion criteria for Phase 2 are: (1) medical 
contraindication to exercise according to physician or physician’s designee (form to be 
completed by patient’s primary physician, oncologist, or physician’s designee); (2) non-
English speaking; (3) current activity level exceeding CDC guidelines for activity (60 min of 
moderate-vigorous exercise/day for 5+ days/wk including 3+ days of vigorous-intensity 
activities and 3+ days of muscle-strengthing activities and 3+ days of bone-strengthening 
activities for children <18 and 150 min of moderate-vigorous exercise or 75 min of vigorous 
exercise/wk and 2+ days of muscle-strengthening activities for adults > 18); (4) significant 
developmental delay per patient, parent, or physician report; and (5) pregnant per patient 
report. The CDC guidelines are used to determine exercise prescription in our intervention; 
individuals already exceeding the guidelines would be unlikely to benefit from participating. 
The Rutgers CINJ LITE program maintains a contact list of approximately 300 CCS, who 
receive regular newsletters and other mailings.  Nearly half of the patients in the LITE 
program were seen at CINJ for follow-up care in 2010 and 2011.  The approximate age 
distribution of LITE participants is: 0-8 years old = 6%; 9-12 years = 17%; 13-17 years = 
29%, and aged 18 or older = 50%. This suggests that approximately 79% of LITE patients or 
237 patients will be eligible for screening. With a conservative enrollment rate of 30% (we 
had 39% in our preliminary work using one source of survivors; other similar studies have 
reported enrollment rates from 27-85%51-54), we could enroll about 71 patients per year, 
reaching our accrual goal of 88 in 18 months. 
10.2 Potential Risks
Potential risks are considered minimal. In Phase 1, the risks are the same as encountered in 
daily life. The interviews will focus on app design and development and individuals’ 
perceptions of its usefulness in daily life. In Phase 2, increased physical activity may result in 
muscle soreness or injury; however, each participant will be required to have their physician, 
oncologist, or physician’s designee complete a form prior to enrollment clearing the 
participant for engagement in a physical activity program. Physical fitness testing will be 
done by trained personnel. Dr. Arent, a mentor and Co-Investigator on this project, is a 
certified strength and conditioning specialist and will provide expert guidance to Dr. Devine 
for hiring and training qualified personnel. It should be noted that the fitness tests utilize 
standard exercise testing protocols. To protect the participants against risks of injury, the 
trainer will have adequate experience and training in working with AYAs, with a preference 
for certification in working with cancer survivors. All exercises will be age-appropriate and 
the intensity can be modified according to individual comfort. Further, the trainer will have 
each participants’ emergency contact information with them during all sessions in the event 
that an injury occurs. Adolescents and young adults may feel uncomfortable answering 
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Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
CINJ# 131323
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questions regarding physical or emotional functioning, and will be free not to answer any 
question. Participants are permitted to refuse to participate in any aspect of the research, and 
may withdraw from the study at any time for any reason. To minimize risk of breach of 
confidentiality when using the app, data will be stored in an encrypted and cached 
environment on the device itself and securely transmitted to our servers for downloading by 
researchers. All data storage and transmission will be encrypted and logged for audit-ability 
to meet the applicable HIPAA standards. Questionnaire data will be coded with an ID 
number and stored in locked filing cabinets that are only accessible to appropriate research 
personnel. The key linking ID number and personal identification will be kept separately 
from research files. The mHealth app and private Facebook group will be kept private only to 
individuals in the study. Messaging between participants will be monitored by the PI and 
trainer, who will remove any negative or questionable comments as soon as discovered (i.e., 
if a participant sends a message teasing another participant or using a curse word, it will be 
removed as soon as discovered). Confidentiality will be further maintained by reporting only 
group data in study publications and presentations. 
10.3 Consent Procedures 
Patients and parents will be informed of the study by the study team via letter, flyers, in 
person at clinic, or telephone. The PI or a trained member of the study team will explain the 
study to the potential subject and answer all questions. We will obtain informed assent from 
patients ages 13-17 and consent from their parents; we will obtain informed consent from 
patients ages 18-25. Participants will be given a signed copy of consent/assent documents, 
along with the phone numbers of the investigators to call if they have questions. 
10.4 Potential Benefits
There are no direct benefits for participating in Phase 1, design of the mobile app. Although 
not guaranteed, the potential benefits of participating in Phase 2, the randomized trial of the 
technology-enhanced intervention, include improved cardiorespiratory fitness, muscular 
fitness, health-related quality of life, and fatigue. All participants, including those in the 
waitlist control, will have the opportunity to participate in the exercise program for free. This 
study has the potential to yield important information regarding health promotion behaviors 
for AYA survivors of pediatric cancers, an important but understudied population.
10.5 Risk-Benefit Ratio
The minimal risk involved in this study is reasonable in relation to the anticipated benefits of 
the research. Alternatives to participating are not participating; choosing not to participate 
does not affect patients’ medical care. Results of the proposed research will inform the 
feasibility and preliminary effectiveness of a technology-enhanced fitness intervention to 
improve physical fitness in AYA survivors of pediatric cancers. Information on the 
incorporation of a mHealth application is particularly novel and will guide our understanding 
of the application of mHealth technology to this area of research. Data from this study will be 
used to generate a sample size estimate and refine research procedures for a future R01 
application that will evaluate the efficacy of a technology-enhanced fitness intervention for 
AYA cancer survivors. The benefit of improved health outcomes outweighs the minimal 
risks associated with participation. This approach may also inform interventions to improve 
motivation for other healthy behaviors in this population. 
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“TLC FIT”: A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood 
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Katie Devine, PhD
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10.6 Gender and Minorities 
There are no exclusion criteria based on gender or minority status. We expect to enroll 
participants of both genders and minority status. 
11. Economic/Financial Considerations
This study will be financed through a pending grant from the National Cancer Institute. Dr. 
Devine will use some of her start-up funds to pay for costs not covered through the K07 
grant.
12. Publication of Research Findings
The policies and procedures of the Rutgers University legal department (see: Investigator’s 
Handbook) will govern publication of the trial.  It is expected that the results of this trial will 
be submitted for publication in a timely manner following the conclusion.  The Cancer 
Institute of New Jersey PI, and all co-authors prior to submission or use, must review any 
abstract or manuscript. 
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“TLC FIT”: A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood 
Cancer Survivors
Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
CINJ# 131323
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Cancer Survivors
Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
CINJ# 131323
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Cancer Survivors
Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
CINJ# 131323
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“TLC FIT”: A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood 
Cancer Survivors
Katie Devine, PhD
Protocol Version 1.9 – 8/30/2017
CINJ# 131323
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