Decision Aid for Education and Support About Cancer Treatment
Phase: NA
Conditions: Cancer, Childhood Cancer
Sponsor: Children's Hospital of Philadelphia

 
 
Title: Decision Aid for Education and Support about Cancer Treatment 
NCT Number: NCT06191679 
Document: Protocol  
 
Document Date: December 14, 2022 
 

 
 
 
 
 
 
 
 
ii
Title: 
Decision Aid for Education and Support about Cancer Treatment 
Short Title: 
DECIDES (B+) 
Regulatory Sponsor: 
The Andrew McDonough B+ (Be Positive) Foundation 
eIRB Number: 
20-017521 
Protocol Date: 
July 13, 2020 (V2.0) 
Amendment 1 Date: July 30, 2020 (V3.0) 
Amendment 4 Date: March 17, 2022 (V6.0) 
Amendment 2 Date: November 12, 2021 (V4.1) Amendment 5 Date: September 20, 2022 (V7.0) 
Amendment 3 Date: December 26, 2021 (V5.0) 
Amendment 6 Date: December 14, 2022 (V8.0) 
 
Principal Investigator 
Lamia P. Barakat, PhD 
Children’s Hospital of Philadelphia 
Division of Oncology, Department of Pediatrics 
Philadelphia, PA, 19104 
Phone 267-426-8135 
Email: barakat@email.chop.edu 
 
Co-Investigators 
Rochelle Bagatell, MD 
Janet Deatrick, PhD, RN, FAAN 
Anne Reilly, MD, MPH 
Lisa Schwartz, PhD 
 
 

iii 
 
 
 
 
TABLE OF CONTENTS 
Table of Contents .................................................................................................................. iii 
Abbreviations and Definitions of Terms.............................................................................. v 
Abstract ................................................................................................................................. vi 
Figure 1: Study Diagram ..................................................................................................... vii 
1 
BACKGROUND INFORMATION AND RATIONALE ....................................................................... 1 
1.1 
RELEVANT LITERATURE AND DATA ..................................................................................................... 2 
1.1.1 
Pediatric Research Participation Questionnaire (PRPQ-AYA) ...................................................... 2 
1.1.2 
AYA Cancer Clinical Trial Decision-Making .................................................................................. 2 
1.1.3 
DECIDES Development .................................................................................................................. 3 
1.2 
COMPLIANCE STATEMENT .................................................................................................................... 3 
2 
STUDY OBJECTIVES .............................................................................................................................. 3 
2.1 
PRIMARY OBJECTIVE (OR AIM) ............................................................................................................ 3 
2.2 
SECONDARY OBJECTIVES (OR AIM) ...................................................................................................... 4 
3 
INVESTIGATIONAL PLAN .................................................................................................................... 4 
3.1 
GENERAL SCHEMA OF STUDY DESIGN ................................................................................................. 4 
3.1.1 
Participant Identification ................................................................................................................ 4 
3.1.2 
Intervention Groups ........................................................................................................................ 4 
3.1.3 
Assessment Time Points .................................................................................................................. 5 
3.2 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ................................................................... 5 
3.2.1 
Duration of Study Participation ...................................................................................................... 5 
3.2.2 
Total Number of Study Sites/Total Number of Subjects Projected .................................................. 5 
3.3 
STUDY POPULATION ............................................................................................................................. 5 
3.3.1 
Inclusion Criteria ............................................................................................................................ 6 
3.3.2 
Exclusion Criteria ........................................................................................................................... 6 
4 
STUDY PROCEDURES ............................................................................................................................ 7 
4.1 
AYA AND CAREGIVER(S) ..................................................................................................................... 7 
4.1.1 
Participant Identification ................................................................................................................ 7 
4.1.2 
Baseline Assessment (T1) ................................................................................................................ 7 
4.1.3 
Assignment to Intervention Group .................................................................................................. 7 
4.1.4 
Post-Intervention Assessment (T2) .................................................................................................. 8 
4.1.5 
Semi-Structured Qualitative Interview (T3) .................................................................................... 8 
4.2 
ONCOLOGY HEALTH CARE PROVIDERS ................................................................................................ 8 
4.2.1 
Electronic Rating Scales ................................................................................................................. 8 
4.2.2 
Semi-Structured Qualitative Interview ............................................................................................ 8 
4.3 
SUBJECT COMPLETION/WITHDRAWAL ................................................................................................. 8 
5 
STUDY EVALUATIONS AND MEASUREMENTS .............................................................................. 8 
5.1 
ELECTRONIC HEALTH RECORD REVIEW ............................................................................................... 8 
5.2 
SELF-REPORT MEASURES ..................................................................................................................... 8 
5.3 
SEMI-STRUCTURED QUALITATIVE INTERVIEW ................................................................................... 11 
6 
STATISTICAL CONSIDERATIONS .................................................................................................... 12 
6.1 
PRIMARY ENDPOINTS ......................................................................................................................... 12 
6.2 
SECONDARY ENDPOINTS .................................................................................................................... 13 
7 
SAFETY MANAGEMENT ..................................................................................................................... 13 
7.1 
CLINICAL ADVERSE EVENTS .............................................................................................................. 13 
7.2 
ADVERSE EVENT REPORTING ............................................................................................................. 13 

iv 
 
 
 
 
8 
STUDY ADMINISTRATION ................................................................................................................. 13 
8.1 
TREATMENT ASSIGNMENT METHODS................................................................................................. 13 
8.1.1 
Randomization............................................................................................................................... 13 
8.2 
DATA COLLECTION AND MANAGEMENT ............................................................................................ 14 
8.3 
CONFIDENTIALITY .............................................................................................................................. 15 
8.4 
REGULATORY AND ETHICAL CONSIDERATIONS.................................................................................. 15 
8.4.1 
Risk Assessment ............................................................................................................................. 15 
8.4.2 
Potential Benefits of Trial Participation ....................................................................................... 16 
8.4.3 
Risk-Benefit Assessment ................................................................................................................ 16 
8.5 
RECRUITMENT STRATEGY .................................................................................................................. 16 
8.6 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION (AYA/CAREGIVERS) ........................... 16 
8.6.1 
Consent with Waiver of Documentation ........................................................................................ 17 
8.7 
INFORMED CONSENT (ONCOLOGY HEALTH CARE PROVIDERS) .......................................................... 17 
8.7.1 
Consent with Waiver of Documentation ........................................................................................ 17 
8.8 
PAYMENT TO SUBJECTS ...................................................................................................................... 18 
8.8.1 
Families (AYA and Caregivers) .................................................................................................... 18 
8.8.2 
Oncology Health Care Providers .................................................................................................. 18 
9 
PUBLICATION ........................................................................................................................................ 18 
10 
REFERENCES ......................................................................................................................................... 18 
 

v 
 
 
 
 
ABBREVIATIONS AND DEFINITIONS OF TERMS 
AE 
 
Adverse Event 
AYA 
 
Adolescents and Young Adults with Cancer 
BAA 
 
Business Associates Agreement 
CFR 
 
IRB Code of Federal Regulations 
CI 
 
Confidence Interval 
DECIDES 
 
Deciding about Enrolling on a Clinical Intervention trial:  
Decision aid for Education and Support 
DECIDES+ coach 
 
DECIDES intervention with coach-assisted support 
EPIC 
 
Electronic Health Record 
NCI 
 
National Cancer Institute 
PHI 
 
Protected Health Information 
SAE 
 
Significant Adverse Event 
T1 
 
Time Point 1: Baseline Assessment 
T2 
 
Time Point 2: Post-Intervention Assessment 
T3 
 
Time Point 3: Semi-Structured Qualitative Interview 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

vi 
 
 
 
 
ABSTRACT 
Context:   
Adolescents and young adults with cancer (AYA) have limited involvement in treatment 
decision-making, do not fully understand cancer treatments (including clinical trials), and 
are vulnerable to acute distress undermining their decision processes at diagnosis. Research 
on how to increase involvement of AYA in treatment decision-making may be critical for 
addressing observed disparities in AYA enrollment in clinical trials and cancer outcomes, 
but few empirical studies have examined decision process or addressed AYA engagement in 
the cancer treatment decision. 
 
Objectives:  
Specific aims of the proposed study are to establish DECIDES acceptability, usability, and 
feasibility, evaluate preliminary efficacy for improved decision-making processes, and 
identify implementation strategies for future dissemination. 
 
Study Design:  
This study will use mixed methods in a hybrid design to evaluate a web-based decision 
support intervention (DECIDES = AYA Deciding about Enrolling on a Clinical Intervention 
Trial: Decision Aid for Education and Support) to increase involvement and improve 
decision-making processes for AYA, their caregiver(s), and oncology health care providers. 
 
Setting/Participants: 
We expect to enroll up to 65 family units in order to produce 50 evaluable family units, 
consisting of AYA (ages 15-24 years that are within six weeks of receipt of a new or 
relapsed leukemia/lymphoma, solid tumor, or brain tumor diagnosis at the Children’s 
Hospital of Philadelphia) and their caregiver(s) (primary and secondary, if applicable) that 
are randomized to participate in Usual care (n=10 family units), DECIDES (n=20 family 
units), or DECIDES + coach (n=20 family units). AYA that are 18 and older may participate 
alone, without a caregiver. Approximately 25 oncology health care providers that participate 
in decision-making about cancer treatment with enrolled AYA and caregiver(s) will be 
invited to participate in this study. 
 
Study Interventions and Measures:  
DECIDES is a developmentally appropriate engaging and interactive web-based decision 
aid that has been designed to addresses health literacy and includes components to increase 
knowledge of cancer and cancer treatments (including clinical trials), address attitudes to 
cancer treatments (including clinical trials) and weigh perceived barriers and benefits of 
standard treatment or a cancer clinical trial relative to values. We will evaluate indicators of 
acceptability and feasibility, as well as barriers and facilitators to implementation, and 
compare decision-making involvement, shared decision-making, and decision processes for 
AYA, caregiver(s), and oncology health care providers.  

 
page vii 
  
 
 
 
FIGURE 1: STUDY DIAGRAM 
 
Randomization 
Post-Intervention Assessment (T2) 
Baseline Assessment (T1) 
Participant Identification 
Usual Care 
DECIDES + coach 
DECIDES 
Semi-Structured Qualitative Interview (T3) 
 
AYA and Caregivers (DECIDES and DECIDES + coach ONLY) 
ALL Oncology Health Care Providers  

 
  
 
 
 
1
1 
BACKGROUND INFORMATION AND RATIONALE 
Approximately 21,400 adolescents and young adults (AYA) ages 15 to 29 years were 
diagnosed with cancer in 2000, which is nearly 3 times that of patients diagnosed in the first 
15 years of life.(7) Contrary to younger age groups, 5-year survival and mortality reduction 
rates for AYA with cancer have remained stagnant. (7,9,19) Reasons for this disparity are 
multi-factorial and include reduced participation in therapeutic clinical trials, which may 
reduce direct medical benefits and hinder treatment advances.(10-12) The National Cancer 
Institute has advanced initiatives to increase AYA’s access to cancer clinical trials, but 
emerging evidence indicates that AYA do not experience shared decision-making(20) and are 
less likely to enroll when offered a clinical trial.(13,21)  
AYA Development and Medical Decision-Making. The American Academy of Pediatrics 
provides that children be involved in medical decision-making to the extent that they are 
capable.(78) Children as young as age nine may have the cognitive capacity to assent (i.e., 
engage in the decision-making process for clinical trials about participation); (79,80) however, 
factors other than age contribute to competence in medical decision-making.(81) Optimal 
AYA decision-making includes the ability to set adaptive goals, work on more than one goal 
at a time, and overcome obstacles that might arise while evaluating options.(82) AYA 
decision-making abilities may be similar to that of adults when they are properly educated 
about the diagnosis and provided information about treatment options; (86,83) although, the 
way in which participation is framed must be appropriate to cognitive capacity and level of 
maturity.(84,85) In these circumstances, even younger AYA can manifest fundamental 
abilities needed for informed decision-making about medical treatments, such as the ability 
to weigh future consequences of their decisions, and the cognitive maturity to make such 
decisions based on their experience with cancer, personal values as emerging adults, and 
their acceptance of the possibility of death.(86)  
AYA involvement in clinical trial decisions is important but limited. Our research found 
that AYA involvement in clinical trial decision-making at diagnosis was more limited than 
preferred;(1) a recent review of the literature echoes this finding.(22) Highlighting the critical 
importance of improving decision-making processes in addressing AYA clinical trial 
enrollment, and consistent with other studies,(23,24) AYA described presentation of 
information as ineffective in promoting understanding of treatment options, and caregivers 
and providers were challenged to maintain AYA engagement in treatment planning. 
Involvement in medical decision-making may have positive effects on AYA adaptation,(25-27) 
but understanding of complex AYA clinical trial decision-making processes is only 
emerging.(25-29) While most AYA have capacity,(30) shared decision-making with caregivers 
and providers varies.(25-29, 31) Snethen and colleagues(31) described developmental patterns of 
parent-child research decision-making,(31) and Whitney and colleagues(32) outlined a 
decisional priority model in which characteristics of cancer clinical trial decisions interact 
with potential for cure to inform AYA involvement. 
Unique aspects of AYA decision-making about cancer clinical trials. Newly diagnosed 
AYA and their caregivers are given extensive, complicated information on diagnosis, 
treatment, and clinical trials in context of intense emotions at diagnosis and short time 
allotted for decision-making.(33,34) Relapse initiates new worries and distress. Thus, 
deficiencies in understanding are prevalent among parents who enroll their child on a cancer 

 
  
 
 
 
2
clinical trial,(35,36) and adolescents and parents need support to distinguish clinical trials from 
standard treatment.(33,37-39) Youth with cancer and their parents are motivated to participate 
in research;(40-42) yet, AYA note enrollment barriers of fear of toxicity, preference for 
standard treatment, and lack of family support.(43,44)  
Decision interventions may support AYA involvement in cancer treatment decisions. 
AYA and their primary caregivers may benefit from the promise of decision support tools 
that increase understanding of cancer and cancer treatments, and clarify values vis-à-vis 
clinical trial enrollment.(25,45) Decision interventions, primarily designed to support shared 
(patient, caregiver, and health care provider) decision-making for decisions of equipoise, 
provide a framework for decision-making regarding cancer clinical trial enrollment.(45,46) 
Further, increased decision satisfaction and self-efficacy and decreased decision conflict and 
regret result from decisions that align with values.(6,47,48)  
Development and evaluation of interventions to improve decision-making for AYA and 
their families is critical.(49-51) The proposed study is highly innovative, as it is the first in 
the United States to use “best practice” mixed methods to test a rigorously developed 
decision support intervention for AYA and their primary caregivers(52) in the context of real 
time (versus hypothetical or retrospective) cancer treatment decision-making.(53,54) Findings 
from a recent Australian-based pilot study assessing a parent and adolescent cancer clinical 
trial decision aid (retrospective to the actual decision) indicate benefit and relevance, but 
further evaluation is needed to assess the impact on families making an active treatment 
decision including whether to enroll in a clinical trial.(55) 
1.1 Relevant Literature and Data 
Data from our series of mixed method studies examining pediatric clinical trial decision-
making informed DECIDES development and the proposed measurement strategy, study 
design, and value clarification exercise.(1,56-58) 
1.1.1 Pediatric Research Participation Questionnaire (PRPQ-AYA)  
This study capitalizes on our federally-funded measure, the Pediatric Research Participation 
Questionnaire, modified to assess attitudes to cancer clinical trials for AYA and their 
caregivers.(1,56-58) Results support a 4-factor structure, and reliability and validity, for 
caregivers (direct benefit, mistrust, trust in the health care team and safety of research, and 
opportunity cost) and AYA (mistrust/no perceived benefit, safety of research/perceived 
benefit, direct benefits/practical considerations; altruism, access to treatments, and practical 
issues, and social support for research participation). Perceived barriers and benefits are 
particularly relevant to AYA clinical trial decision-making and inform the DECIDES value 
clarification exercise.  
1.1.2 AYA Cancer Clinical Trial Decision-Making  
We evaluated AYA with cancer, primary caregiver, and oncology provider Phase III clinical 
trial decision-making experiences.(1) From content analysis, AYA perceived that they had no 
role (38.4%) or a minor role (30.8%) in the clinical trial enrollment decision; they conveyed 
a sense of resignation because they viewed themselves as relying on their parents to make 
treatment decisions at diagnosis. Caregivers and providers felt challenged to include AYA in 
the treatment decision-making process at diagnosis, and providers noted uncertainty in how 

 
  
 
 
 
3
to provide balanced information about treatment options and minimize coercion. AYA and 
caregivers who refused a Phase III clinical trial cited prolonged treatment with limited 
benefit, but many AYA and caregivers did not accurately remember whether the cancer 
treatment had been standard of care or on a clinical trial. 
1.1.3 DECIDES Development  
In collaboration with our stakeholders, and using The NCI Health Communication Model,(59) 
we followed the Informed Medical Decisions Foundation procedures(4-6) to develop 
DECIDES. First, we outlined content in storyboard format based on: 1) Health Belief Model 
and Theory of Reasoned Behavior;(2,3) 2) review of the literature on AYA with cancer; 3) 
results of our studies of AYA decision-making and the PRPQ measure of perceived benefits 
and barriers to clinical trial enrollment;( 1,56-58) (4) stakeholder input from our hospital’s 
AYA Patient Steering Committee, their primary caregivers, and a Scientific Advisory 
Committee; (5) recent AYA decision support for AYA recommendations;(18) and (6) 
decision aid development guidelines and decision support research in adult oncology.(4-
6) DECIDES is web-based with multi-model, graphically interesting content written for low 
health literacy. Content includes information to increase knowledge of cancer, treatment, 
and clinical trials, fact or fiction to address attitudes about cancer treatment and clinical 
trials, a value clarification exercise to consider goals for life vis-à-vis goals for treatment, 
and resources to increase knowledge and improve decision processes. Results of the value 
clarification exercise, and perceived treatment barriers and benefits, are emailed to the 
provider. The last step in DECIDES development entailed revision of the website 
components in an iterative process based on feedback from scientific experts and 
stakeholders.  
1.2 Compliance Statement 
This study will be conducted in full accordance all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws and 
regulations including 45 CFR 46. All episodes of noncompliance will be documented. 
The investigators will perform the study in accordance with this protocol, will obtain 
consent and assent, and will report unanticipated problems involving risks to subjects or 
others in accordance with The Children’s Hospital of Philadelphia IRB Policies and 
Procedures and all federal requirements. Collection, recording, and reporting of data will be 
accurate and will ensure the privacy, health, and welfare of research subjects during and 
after the study.  
2 
STUDY OBJECTIVES 
2.1 Primary Objective (or Aim) 
The primary objective of this study is to assess the acceptability and feasibility of DECIDES 
using mixed methods and use results to inform implementation strategies for future 
dissemination.  
Hyp 1a. Based on AYA, caregiver(s), and oncology health care provider ratings, and usage 
analytics, DECIDES will be acceptable and feasible during treatment decision-making 
within 6 weeks of diagnosis.  

 
  
 
 
 
4
Hyp 1b. Qualitative interviews with AYA and caregiver(s) (randomized to DECIDES and 
DECIDES + coach) and oncology health care providers will confirm acceptability and 
feasibility ratings and provide specific information regarding timing, utility, 
barriers/facilitators, ease of use, and modifications to DECIDES for future implementation.  
Hyp 1c (exploratory). DECIDES + coach will be rated more usable than DECIDES alone. 
2.2 Secondary Objectives (or Aim) 
The secondary objective is to evaluate preliminary efficacy of DECIDES using a 
randomized trial. 
Hyp 2a. AYA randomized to DECIDES and DECIDES + coach will report greater 
involvement in and shared decision-making than AYA assigned to Usual Care. 
Hyp 2b. AYA and caregiver(s) randomized to DECIDES and DECIDES + coach will report 
more positive decision-making processes (greater knowledge of their cancer and clinical 
trials, more balanced attitudes toward clinical trials, and more decision certainty, satisfaction 
and self-efficacy) compared with those assigned to Usual Care.  
Hyp 2c. For DECIDES and DECIDES + coach participants who are offered enrollment on a 
clinical trial, the enrollment decision (yes/no) will align with AYA values. 
3 
INVESTIGATIONAL PLAN 
3.1 General Schema of Study Design 
This is a 3-arm, mixed methods, hybrid design trial. We expect to enroll up to 65 family 
units to produce at least 50 evaluable family units that are randomized to participate in one 
of the following intervention groups: 
• Usual Care (n=10) 
• DECIDES (n=20) 
• DECIDES + coach (n=20)  
3.1.1 Participant Identification 
Oncology health care providers and the psychosocial services team in the Division of 
Oncology at the Children’s Hospital of Philadelphia will assist in the identification of AYA 
patients with newly diagnosed or relapsed leukemia/lymphoma, solid tumors, or brain 
tumors who are within six weeks of diagnosis/relapse. Potentially eligible AYA patients will 
be referred to the DECIDES study team to assess eligibility criteria. If applicable, eligible 
AYA and their caregiver(s) will be contacted for enrollment. Oncology health care providers 
of enrolled AYA and caregiver(s) will also be invited to enroll in the study. 
3.1.2 Intervention Groups 
Family units of AYA and caregiver(s) are randomized (after the completion of baseline 
assessment) to participate in Usual Care (access to oncology health care providers for 
information and education), DECIDES (usual care plus independent access to website), or 
DECIDES + coach (usual care plus coach-supported access to website). 

 
  
 
 
 
5
Oncology health care providers that enroll in the study are not randomized to participate in 
the intervention. 
3.1.3 Assessment Time Points 
All AYA and caregiver(s) that enroll to participate in the study will complete an electronic 
baseline assessment at time of enrollment (prior to randomization) and again at post-
intervention (i.e., approximately six-weeks after date of randomization). Additionally, AYA 
and caregiver(s) randomized to DECIDES or DECIDES + coach will also complete an audio 
or video-recorded semi-structured qualitative interview with a member of the study team via 
Microsoft Teams after the post-intervention assessment.  
Oncology health care providers of enrolled AYA and caregiver(s) will be invited to preview 
the DECIDES website, participate in an electronic rating scale and complete an audio-
recorded semi-structured qualitative interview with a member of the study team via 
Microsoft Teams. 
3.2 Study Duration, Enrollment and Number of Sites 
3.2.1 Duration of Study Participation 
Study participation is expected to last approximately two months for AYA and caregiver(s), 
beginning at the time of consent.  
Study participation is expected to last approximately 30-45 minutes for oncology health care 
providers, beginning at the time of consent. 
3.2.2 Total Number of Study Sites/Total Number of Subjects Projected 
This study will be conducted at the Children’s Hospital of Philadelphia and will enroll up to 
65 family units of (1) AYA alone [≥ 18 years old], (2) Dyads [AYA ages 15-24 years old + 
Primary Caregiver], or (3) Triads [AYA ages 15-24 years old + Primary Caregiver + Second 
Caregiver]. We expect to produce at least 50 evaluable family units.  
We will approach all oncology health care providers of enrolled AYA and caregiver(s) for 
participation in the study and expect to enroll approximately 25 of them. Oncology health 
care providers that have multiple AYA/caregiver(s) enrolled will only be asked to 
participate once in the study procedures. 
3.3 Study Population 
The study will include: 
• AYA (ages 15-24 years) newly diagnosed or relapsed with cancer that are receiving 
treatment for a leukemia/lymphoma, solid tumor, or brain tumor in the Division of 
Oncology of the Children’s Hospital of Philadelphia, and their caregiver(s) (primary 
and secondary, if applicable). AYA that are 18 and older may participate without a 
caregiver.  
• Oncology health care providers that participate in decision-making about cancer 
treatment with enrolled AYA and caregiver(s). 

 
  
 
 
 
6
3.3.1 Inclusion Criteria 
AYA 
1) Ages 15-24 years old. 
2) Newly diagnosed or relapsed with a leukemia/lymphoma, solid tumor, or brain tumor 
within six weeks of study enrollment. 
3) Ability to read and speak English. 
4) If <18 Years Old: Parental/guardian permission to participate (informed consent). 
CAREGIVER 
1) Parent or Legal Guardian of a participating AYA. 
2) Ability to read and speak English. 
ONCOLOGY HEALTH CARE PROVIDER 
1) Oncology health care provider involved in decision-making about cancer treatment with 
enrolled AYA patients and caregiver(s). 
 
2) Ability to read and speak English. 
3.3.2 Exclusion Criteria 
AYA 
1) Inability to read or speak English. 
2) Pre-existing cognitive deficits (based on provider assessment) that result in impaired 
reading or decision-making capacity (i.e., developmental disability). 
3) AYA patient is a ward of the state or any other agency, institution, or entity. 
4) If <18 Years Old: No Parental/Guardian permission to participate (informed consent). 
CAREGIVER 
1) Foster parent or child advocate (i.e., caregiver is not biological parent or legal guardian). 
2) Inability to read or speak English. 
ONCOLOGY HEALTH CARE PROVIDER 
1) Oncology health care provider that is not involved in decision-making about cancer 
treatment with enrolled AYA patients and caregiver(s). 
2) Inability to read or speak English. 

 
  
 
 
 
7
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations 
of these criteria must be reported in accordance with IRB Policies and Procedures.  
4 
STUDY PROCEDURES 
4.1 AYA and Caregiver(s) 
4.1.1 Participant Identification 
Health care providers and the psychosocial services team in the Division of Oncology at the 
Children’s Hospital of Philadelphia will assist in the identification of potentially eligible 
patients newly diagnosed with leukemia/lymphoma, solid tumor, or brain tumor during 
weekly team meetings. Potentially eligible AYA patients will be referred to the DECIDES 
study team. If AYA and caregiver(s) meet all eligibility criteria, they will be invited to 
participate in the study. Informed consent/assent for participation will be obtained by phone 
or in-person during an outpatient oncology clinic visit or inpatient hospital stay.  
4.1.2 Baseline Assessment (T1) 
After providing informed consent/assent to participate in the study, AYA and caregiver(s) 
will complete an electronic baseline assessment via REDCap. The assessment will be 
completed either in-person on an iPad during an outpatient oncology clinic visit or inpatient 
hospital stay, or a link to the REDCap assessment will be emailed to participants to 
complete remotely (if needed).  
4.1.3 Assignment to Intervention Group 
Following completion of the baseline assessment, AYA and caregiver(s) will be randomly 
assigned to participate in one of the following conditions:  
 
Usual Care                                                                                                                                              
AYA and caregiver(s) assigned to participate in the Usual Care group will have access to 
their oncology health care providers and other members of the health care team for questions 
related to cancer and cancer treatment (as per usual). 
 
DECIDES 
In addition to usual care, AYA and caregiver(s) assigned to participate in the DECIDES 
group will receive a flyer that includes goals of the decision support intervention and 
instructions for accessing the DECIDES website. AYA and caregiver(s) will receive a text 
message reminder to review DECIDES, and the oncology health care provider will be 
informed of enrollment and the value clarification exercise results.  
 
DECIDES + coach 
In addition to usual care, AYA and caregiver(s) assigned to participate in the DECIDES + 
coach group will work with a coach (clinical research coordinator for this study) to review 
the DECIDES website in-person. The coach will guide the value clarification exercise with 
AYA and caregiver(s) separately and together. AYA and caregiver(s) will receive a text 
message reminder to review DECIDES, and the oncology provider will be informed of 
enrollment and the value clarification exercise results.  

 
  
 
 
 
8
4.1.4 Post-Intervention Assessment (T2) 
All AYA and caregiver(s) (assigned to Usual Care, DECIDES, or DECIDES + coach) will 
complete an electronic post-intervention assessment via REDCap. The assessment will be 
completed either in-person on an iPad during an outpatient oncology clinic visit or inpatient 
hospital stay, or a link to the REDCap assessment will be emailed to participants to 
complete remotely (if needed).  
4.1.5 Semi-Structured Qualitative Interview (T3) 
AYA and caregiver(s) (assigned to DECIDES or DECIDES + coach) will complete an audio 
or video-recorded semi-structured interview remotely via Microsoft Teams with a member 
of the study team.  
4.2 Oncology Health Care Providers 
4.2.1 Electronic Rating Scales 
Oncology health care providers of enrolled AYA and caregiver(s) will preview the 
DECIDES website and complete the Systems Usability Scale (SUS) (36,71). This will be 
emailed to them to complete remotely or can be administered remotely by a member of the 
study team during the semi-structured qualitative interview.  
4.2.2 Semi-Structured Qualitative Interview 
Oncology health care providers of enrolled AYA and caregiver(s) will complete an audio or 
video-recorded semi-structured interview remotely via Microsoft Teams with a member of 
the study team. 
4.3 Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care. The study 
team will document whether or not each subject completes the study.  
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 Electronic Health Record Review 
Medical information will be abstracted from the AYA patients’ electronic health record 
(EPIC) for the following purposes:  
• Enrollment Decision 
• Demographics 
• Diagnosis, date of diagnosis, age at diagnosis 
• Intensity and types of treatments received (Using the Intensity of Treatment Rating-III) 
 
5.2 Self-Report Measures  
Demographics: Variables will be collected based on AYA and caregiver(s) self-report and 
review of the patients’ electronic health record. Demographic variables include age, gender, 
race/ethnicity, education/work, health care, and family history. 

 
  
 
 
 
9
Intensity of Treatment Rating Scale (ITR-3): The revised version of a reliable and valid 
method for classifying pediatric oncology treatment protocols. This scale, completed by a 
medical provider, categorizes the intensity of pediatric cancer treatment from least through 
most intensive based on treatment modality and stage/risk level for the patient. (99) 
Acceptability of the Decision Aid:  A study-team developed measure used to obtain 
acceptability ratings from AYA and caregiver(s) (assigned to DECIDES or DECIDES + 
coach only). This measure is based on The Ottawa Hospital’s measure of acceptability 
ratings regarding comprehensibility of components of a decision aid, its length, pace, 
amount of information, balance in presentation of information about options, and overall 
suitability for decision making. (6) 
Systems Usability Scale (SUS): This is a cost-effective, 10-item scale that is widely used to 
obtain a reference score for participants’ view of a product’s usability. This scale includes 
10 statements that are scored on a 5-point scale of strength of agreement. Final scores can 
range from 0 to 100, in which higher scores indicate better usability. AYA and caregiver(s) 
(assigned to DECIDES or DECIDES + coach only) and oncology health care providers will 
complete this scale. (36,71) 
Control Preferences: This scale assesses patient decision-making preferences and roles 
(i.e., patient’s preferred role [baseline] versus the role they actually played in making a 
treatment decision [post-intervention]). This scale has been adapted for use in this study to 
assess caregiver decision-making preferences and roles, as well (i.e., caregiver’s preferred 
role of patient [baseline] versus the role the patient actually played in making a treatment 
decision [post-intervention]). Decision-making preferences and roles are evaluated using 
three categories: 1) patient led, 2) shared, or 3) oncologist/caregiver led. (74,75) 
Physician Decision Making Scale: A 5-item scale that measures physician involvement in 
medical decision-making. Items are rated on a 3-point scale ranging from 1 (“Yes, 
definitely”) to 3 (“No”). Higher scores reflect lower involvement in decision-making. (100) 
Shared Decision-Making Questionnaire (SDM-Q-9): This is a brief, valid, and reliable 9-
item questionnaire that measures the degree to which patients are involved in the process of 
decision-making (for preference-sensitive decisions, in which there are several treatment 
options for a particular disease) from the perspective of the patient. The SDM-Q-Doc 
(Physician Version) has been adapted for use in this study to measure the degree to which 
patients are involved in the process of decision-making from the perspective of the 
caregiver. Items are scored on a 6-point scale ranging from “completely disagree” (0) to 
“completely agree” (5), and a total sum score is calculated (ranging in values between 0-45). 
(94) 
Adolescent and Young Adult Health Outcomes and Patient Experiences (AYA HOPE) 
Survey: Information needs are assessed using thirteen items from the AYA HOPE study 
survey. Participants indicate if they need more information on a range of topics related to 
cancer medical care and support services. The response options (“I need some more 
information” and “I need much more information” are collapsed and categorized as “unmet 
information need”; while the response options “I have enough information” and “Does not 

 
  
 
 
 
10
apply” are collapsed and categorized as “met information need”. Unmet information need 
(count) is categorized as low (0-3), intermediate (4-8), or high (9-13. (76,77) 
Knowledge of Clinical Trials: This is a 25-item true/false rating assessment used to assess 
participant understanding of clinical trials and informed consent processes. (64) 
Pediatric Research Participation Questionnaire (PRPQ): The PRPQ is a 12-item 
questionnaire for AYA (age 15-29) and caregivers (of AYA) about participation in a clinical 
trial. Items are rated on a 5-point scale, ranging from “not at all” (1) to “extremely” (5). (15,16) 
Decisional Conflict Scale: This is a valid and reliable 16-item scale, delivered in statement 
format (Version A), that measures personal perceptions of: uncertainty in choosing options; 
modifiable factors contributing to uncertainty (i.e., feeling uninformed, unclear about 
personal values, and supported in decision making); and effective decision making (i.e., 
feeling the choice is informed, values-based, likely to be implemented, and expressing 
satisfaction with the choice). Items are rated on a 5-point scale ranging from “strongly 
agree” (0) to “strongly disagree” (4). Higher scores indicate higher decisional conflict.  
Satisfaction with Decision Scale: This is a valid and reliable 6-item instrument that 
measures patient satisfaction with a health care decision. The scale provides an efficient 
measure to evaluate decision-assisting technologies or patient-provider interactions aimed at 
involving patients in decision-making. Higher scores indicate higher satisfaction with the 
decision that was made. (66) 
Decision Self-Efficacy Scale: This is a valid and reliable 11-item instrument that measures 
self-confidence in one’s abilities in decision-making (including shared decision-making). 
Items are rated on a 5-point scale, ranging from “not at all confident” (0) to “very confident” 
(4). Higher scores indicate higher self-efficacy. (67) 
Decision Regret Scale: This is a valid and reliable 5-item instrument that measures distress 
or remorse after a (health care) decision. Items are rated on a 5-point scale, ranging from 
strongly agree (1) to strongly disagree (5). Items 2 and 4 are reverse coded so that for each 
item, a higher score will indicate more regret. (72) 
PROMIS Profile: 25, 29, and Parent-Proxy The PROMIS measures assesses physical 
function mobility, depressive symptoms, fatigue, peer relationships, pain intensity, and pain 
interference. The PROMIS Pediatric Profile (25 items) is intended for use with those under 
age 18; the PROMIS Profile (29 items) is intended for use with those over age 18; and the 
PROMIS-Parent Proxy Profile (25 items) is a parent-report measure. (96-98) 
Distress Thermometer: The Distress Thermometer is from the National Comprehensive 
Cancer Network (NCCN) Practice Guidelines in Oncology for Distress Management. It is an 
illustration (thermometer) used with patients to rate the number that best describes how 
much distress they have been experiencing in the past week, ranging from “no distress” (0) 
to “extreme distress” (10).  
Affective Slider (AS): This is a digital self-reporting tool composed of two slider controls 
for the quick assessment of arousal (top) and pleasure (bottom) on a continuous scale. The 

 
  
 
 
 
11
AS does not require written instructions. The scale is intentionally displayed using a neutral 
chromatic palette to avoid bias in rating (due to emotional connotation of colors). (87) 
Affective Orientation (AO15): This is a valid and reliable 15-item measure used to assess 
how people use feelings and emotions to guide their behavior. Items are rated on a 5-point 
scale, ranging from strongly disagree (1) to strongly agree (5). Higher scores reflect greater 
awareness of emotions. (88) 
Developmental Task Questionnaire (DTQ): The adolescent version of the DTQ is a 9-
item self-report questionnaire that assesses adolescents’ perceived developmental status; 
whereas the young adult version includes 8 items that assess developmental tasks for 
emerging adulthood. Items are rated on a 3-point scale ranging from “not yet started” (1) to 
“already developed” (3). Both adolescents and young adults are also asked to rank how 
important it is for them to achieve each of the normative developmental tasks on a 3-point 
scale, ranging from “not important” (1) to “very important” (3). (89,92) 
Consideration of Future Consequences (CFC): This valid and reliable 12-item measure is 
used to assess the extent to which people consider distant versus immediate consequences of 
potential behaviors. Items are rated on a 5-point scale ranging from “extremely 
uncharacteristic” (1) to “extremely characteristic” (5). The CFC is scored so that higher 
numbers indicate a greater consideration of future consequences. (90) 
Psychosocial Maturity Inventory (PMI):  This is a 30-item self-report measure for AYA 
used to evaluate developmental aspects of maturity (i.e., self-reliance, self-concept, and 
work orientation). Items are rated on a 4-point scale, ranging from “agree strongly” (1) to 
“disagree strongly” (4). (95) 
Emotion Regulation Questionnaire (ERQ): This is a valid and reliable 10-item measure 
used to assess processes of emotion regulation (cognitive reappraisal and expressive 
suppression). Items are rated on a 7-point scale ranging from “strongly disagree” (1) to 
“strongly agree” (7). The average score of items in the cognitive reappraisal subscale is 
calculated and the average score of items in the expressive suppression subscale is 
calculated. Higher scores indicate the greater use of that particular emotion regulation 
strategy, whereas lower scores indicate less frequent use. (91) 
 Family Assessment Device (FAD): The Problem Solving subscale of the FAD includes 5 
items that are rated on a 4-point scale ranging from “strongly agree” (1) to “strongly 
disagree” (4), with higher scores indicating more problematic functioning. (93) 
5.3 Semi-Structured Qualitative Interview  
A semi-structured, qualitative interview guide designed by the study team for use with AYA 
and caregiver(s) (assigned to DECIDES or DECIDES + coach), and oncology health care 
providers. The purpose of the interview is to obtain further information from participants 
about the process of treatment decision-making and their experience using DECIDES, the 
decision aid. Participants will be interviewed by a study team member via remote video 
conference software (Microsoft Teams). All interviews will be audio and/or video recorded 
and professionally transcribed (by a CHOP-approved vendor with a BAA in place), and the 
interview data will be analyzed. 

 
  
 
 
 
12
Table 1. Measures 
Construct 
Measure 
Administration 
T1 
T2 
Demographics 
Electronic Health Record; AYA/Caregiver Self-Report 
AYA, CG 
 
Treatment Intensity 
Intensity of Treatment Rating Scale (ITR-3) (99) 
PR 
 
Acceptability (D) 
Acceptability of the Decision Aid (6)  
AYA, CG 
Usability (D) 
The Systems Usability Scale (36,71) 
AYA, CG, PR 
AYA Involvement in  
Shared Decision-Making 
Control Preferences (74,75) 
AYA, CG 
Physician Decision-Making Scale (100) 
AYA, CG 
Shared-Decision Making Questionnaire (SDM-Q-9) (94) 
AYA, CG 
Knowledge 
AYA Hope Survey: Information Need (76,77) 
AYA, CG 
Knowledge of Clinical Trials (64) 
AYA, CG 
AYA, CG 
Attitudes to Clinical Trials 
Pediatric Research Participation Questionnaire 
(PRPQ) (15,16)  
AYA, CG 
AYA, CG 
Alignment of Decision with Values 
AYA, CG 
Decision-Making 
Certainty 
Decisional Conflict Scale (65) 
AYA, CG 
Satisfaction 
Satisfaction with Decision Scale (66)  
AYA, CG 
Self-Efficacy Decision Self-Efficacy Scale (67) 
AYA, CG 
Regret 
Decision Regret Scale (72) 
AYA, CG 
Health-Related Quality of Life 
PROMIS Parent Proxy Profile-25 (98) 
CG 
CG 
PROMIS Pediatric Profile-25 (97) 
AYA (15-17) AYA (15-17) 
PROMIS-29 Profile (96) 
AYA(18-24) AYA(18-24) 
*Distress  
Distress Thermometer (73) 
AYA, CG 
AYA, CG 
*Valence and Arousal 
Affective Slider (87) 
AYA, CG 
*Awareness of Feeling Emotions Affective Orientation (AO15) (88) 
AYA, CG 
 
*Developmental Status 
Developmental Task Questionnaire (89,92)  
AYA 
*Psychosocial Maturity 
Consideration of Future Consequences (90) 
AYA, CG 
Psychosocial Maturity Inventory (95) 
AYA 
Emotion Regulation Questionnaire (91) 
AYA, CG 
*Problem-Solving 
Family Assessment Device (FAD): Problem-Solving (93) 
AYA, CG 
Semi-Structured  
Qualitative Interview (D) 
DECIDES Interview Guide 
 
AYA, CG, PR 
* = Covariate 
(D) = measure for participants randomized to DECIDES or DECIDES + coach only 
T1 = Pre-Intervention; T2 = Post-Intervention; AYA = Adolescent/Young Adult; CG = Caregiver; PR = Health Care Provider  
6 
STATISTICAL CONSIDERATIONS 
Demographic characteristics and all measurements will be summarized. 
6.1 Primary Endpoints 
Hyp 1a. We will perform descriptive analyses of responses to the acceptability 
questionnaire. Click behavior, participation rate, and time to DECIDES implementation will 
be summarized to describe feasibility.  

 
  
 
 
 
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Hyp 1b. We will use qualitative descriptive methods (61) to evaluate acceptability, usability, 
and feasibility. Interviews with AYA, caregiver(s) and oncology health care providers will 
be audio and/or video-recorded and transcribed. Constant comparative methods (using 
Atlas.ti) will be used to simultaneously gather and rigorously analyze data using two coders 
to ensure coding reliability. 
Hyp 1c. Feasibility measures such as participation rate and summary score for the Systems 
Usability Scale will be summarized for DECIDES alone and DECIDES + coach separately, 
along with 95% confidence intervals (CIs). We expect that participation rate and usability 
score will be higher for the DECIDES + coach group. 
6.2 Secondary Endpoints 
The secondary objective is to evaluate preliminary efficacy of DECIDES using a 
randomized trial. 
Hyp 2a and Hyp 2b. Because all measures are continuous, the primary analyses will be 
summarizing mean and 95% CI by groups and two-sample t test comparing groups for the 
post-intervention outcome measures. With the sample size of 20 family units for each 
DECIDES group and 10 family units for usual care, we will have 80% power to detect an 
effect size of 1.26 (that is, mean difference between the two groups is 1.26 x Standard 
Deviation). 
Hyp 2c. Each AYA and caregiver will have two value scores:  factors endorsed as 
supporting enrollment/ factors endorsed as not supporting enrollment. Consistency of value 
to enrollment decision will be evaluated with Tetrachoric correlation with 95% CI. 
7 
SAFETY MANAGEMENT 
7.1 Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  
7.2 Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, Significant Adverse Events 
(SAEs) are not expected. If any unanticipated problems related to the research involving 
risks to subjects or others happen during the course of this study (including SAEs) they will 
be reported to the IRB in accordance with CHOP IRB SOP 408: Unanticipated Problems 
Involving Risks to Subjects. Adverse Events (AEs) that are not serious but that are notable 
and could involve risks to subjects will be summarized in narrative or other format and 
submitted to the IRB at the time of continuing review.  
8 
STUDY ADMINISTRATION 
8.1 Treatment Assignment Methods 
8.1.1 Randomization 
We will enroll up to 65 family units to achieve 50 evaluable family units that are 
randomized to three groups with a 1:2:2 ratio for usual care, DECIDES, and DECIDES + 

 
  
 
 
 
14
coach. The randomization will be stratified by two age categories, under 18 years old and 18 
years or older, and we expect 50% of the AYA patients in each of the two strata. For each 
stratum, we use a blocked randomization of block size of 5. The statistician will generate the 
randomization sheet for assigning patients into intervention groups. 
 
8.2 Data Collection and Management 
The data collection and management plan is consistent with CHOP Policy A-3-6: 
Acceptable Use of Technology Resources that defines the requirements for encryption and 
security of computer systems.  
• Identifiable data will be collected as part of this study. This data includes full 
names/initials, dates of birth, addresses, telephone numbers, and e-mail addresses. 
However, participants will be identified by alphanumeric code only. This precautionary 
step allows for the electronic transfer of data without using data encryption techniques. 
At each stage of data collection and maintenance, measures are taken to ensure that all 
identifying information is taken out of data archives, and any hard copies of data that 
could identify participants are stored in locked file cabinets with restricted access, and 
that data files are password protected. Participant identification numbers are used that do 
not reveal the identity of participants (e.g., no use of birth dates, initials, social security 
numbers, etc.). Identifiable data will be stored in a locked cabinet at one of the research 
buildings at CHOP, and only members of the research team will have access to the data. 
If the results of this study are presented at scientific meetings or published in 
professional journals, they will not contain information that could be used to identify 
patients, parents, or family members.  
 
• Electronic survey data will be collected and stored using REDCap (Research Electronic 
Data Capture) database, a secure web-based software database supporting clinical and 
translational research databases. The database will be password-protected, stored, and 
backed up on a daily basis by CHOP’s Research Institute. REDCap provides data 
management functionality; including automated export procedures for seamless data 
downloads to Excel and commonly used statistical packages (SPSS, SAS, Stata, R). The 
database will incorporate range checks and between-variables consistency checks to 
ensure quality control. The system will signal the presence of questionable or potentially 
incorrect items. After data cleaning and quality assurance procedures are completed, 
pertinent sets of data will be exported into SPSS for statistical analysis.  
 
• Electronic interview data will be collected and audio and/or video-recorded using 
Microsoft Teams (Office 365), CHOP’s preferred HIPAA compliant video conference 
platform. Microsoft Teams utilizes 2-factor authentication, data encryption, and 
restriction on anonymous users joining a meeting, making it an appropriate application 
to facilitate sensitive video conversations and protect PHI. This application will be 
utilized to connect the study team personnel with study participants during the semi-
structured qualitative interview. Microsoft Teams provides an interoperable cloud-based 
video meetings service that connects multiple users across different devices and 
platforms. Every Microsoft Teams member on the study team has a private “meeting 
room” in the Microsoft Teams cloud to schedule and host video meetings. In the event 

 
  
 
 
 
15
that participants experience WIFI connectivity issues during the interview, Microsoft 
Teams provides a telephone number that participants can call directly into the Microsoft 
Teams private “meeting room” using their phone, as needed.  
 
• Interview recordings (audio and/or video recordings containing participant identifiers) 
will be transferred from Microsoft Teams to a CHOP password-protected desktop 
computer on the Principal Investigator’s shared drive through a secure upload. The study 
team will use a CHOP-approved vendor for professional transcription services (that has 
a BAA with CHOP in place). Transcribed interview data will be stored on a CHOP 
password-protected desktop computer, on the Principal Investigator’s shared drive, and 
loaded into ATLAS.ti© software to facilitate data organization and content analysis. 
After all analyses are complete, the files will be destroyed, and personal identifiers will 
not be retained with the data. All computerized study databases for questionnaire data 
will be kept on a secure Windows NT server located at one of the hospital’s research 
buildings. This server is also protected by a firewall to reduce the risk of unauthorized 
access to study information. 
 
8.3 Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
CHOP’s Institutional policies and HIPAA on subject privacy. Neither the Investigator nor 
other site personnel will use records and/or data collected for any purpose other than 
conducting the study. 
The following steps will be taken to maintain confidentiality: (1) subject identity will be 
coded using numbers keyed to a master list; (2) coded data will be entered directly into files 
that will be password protected, (3) all project staff will be trained in the importance of 
confidentiality, and will certify in writing to protect subject confidentiality; and (5) if the 
results of the study are published, data which might reveal the identity of any particular 
subject will be disguised. Subjects will be informed about the limits of confidentiality (e.g., 
in cases in which a subject is in danger to themselves or others). No identifiable data will be 
retained or used for future studies. The investigator will obtain a data use agreement 
between the provider (the PI) of the data and any recipient researchers (including others at 
CHOP) before sharing a limited dataset (PHI limited to dates and zip codes).   
8.4 Regulatory and Ethical Considerations 
8.4.1 Risk Assessment 
This is a low-risk study. Data collection involves contact with all participants either 
remotely over the phone or in person in clinic. As to be expected following the receipt of a 
new cancer diagnosis or relapse, the education and information related to cancer and 
treatment that is delivered via DECIDES may increase distress for AYA and caregiver(s).  
All participants will be informed of this risk prior to participation and will be informed of 
the right to discontinue participation if they are uncomfortable with the study. If participants 
become upset or report clinically significant levels of depression and/or anxiety (as defined 
by norms on the PROMIS scales), Dr. Lamia Barakat (clinical psychologist, Director of 
Psychosocial Services for the Cancer Center, and PI) will assess the level of distress of the 

 
  
 
 
 
16
patient and determine the need for additional psychosocial support. If additional 
psychosocial support is needed, Dr. Barakat will initiate follow-up for the patient’s social 
worker for further assessment and intervention. There is also a slight risk of breach of 
privacy and confidentiality, as with all studies, despite our very careful safeguards to protect 
data as described above. If required by law, confidential information may be revealed. 
8.4.2 Potential Benefits of Trial Participation 
This research does not offer direct medical or psychological benefits to participants. 
Participation in this study may indirectly improve AYA and caregivers understanding of 
cancer, cancer treatments (including clinical trials), and involvement in treatment decisions. 
The knowledge gained from this study may help researchers determine if the DECIDES 
website is helpful for AYA, caregivers, and oncology health care providers that are working 
together to make decisions about cancer treatment. 
8.4.3 Risk-Benefit Assessment 
As the risks of the research are appropriately characterized as “minimal risk”, they are 
reasonable in spite of the anticipated lack of direct medical or psychological benefit to 
subjects. The potential benefits from knowledge gained through this study and the indirect 
benefits of helping newly diagnosed or relapsed AYA, caregiver(s), and oncology health 
care providers making treatment decisions in the future outweigh the minimal risks 
associated with participation. 
8.5 Recruitment Strategy 
Oncology health care providers and the psychosocial services team in the Division of 
Oncology at the Children’s Hospital of Philadelphia will assist in the identification of 
potentially eligible patients newly diagnosed with leukemia/lymphoma, solid tumor, or brain 
tumor during weekly team meetings. Potentially eligible AYA patients will be referred to 
the DECIDES study team. If AYA and caregiver(s) meet all eligibility criteria, they will be 
invited to participate in the study. Informed consent/assent for AYA and caregiver 
participation will be obtained by phone or in-person during an outpatient oncology clinic 
visit or inpatient hospital stay.  
Following AYA and caregiver study participation, the study team will contact their 
oncology health care provider and if they meet all eligibility criteria, they will be invited to 
participate in the study. 
Recruitment and enrollment will be tracked using a password protected Excel spreadsheet. 
8.6 Informed Consent/Assent and HIPAA Authorization (AYA/Caregivers) 
Informed consent/assent will be obtained from AYA and caregiver(s) prior to the beginning 
of the study during outpatient visits, inpatient admissions, or verbally by phone. A study 
team member will discuss the procedures and consent forms with potential participants 
individually. In order to assure that the potential participant understands the study, the team 
member will review the consent, in its entirety, with the AYA and their caregiver(s) and will 
encourage them to ask questions throughout the process. The individuals will also be 
reminded that participation is voluntary and will not affect their care. There are no time 

 
  
 
 
 
17
constraints on the consent process. The potential participants will be allowed to take as 
much time as they need to ask questions and decide if they would like to participate.  
If consent/assent is being conducted in-person and the potential participant agrees to 
participate, the In-Person Signature Page of the consent forms will be signed and dated by 
the potential participant and the research team member and stored in a regulatory binder 
maintained by the study coordinator. A copy of the consent forms will be provided to the 
participant for their records. 
8.6.1 Consent with Waiver of Documentation 
If consent/assent is being conducted over the phone, we will use Consent with Waiver of 
Documentation (verbal consent/assent). The study team will complete the Documentation of 
Consent Page of the consent form, which will be stored in a regulatory binder maintained by 
the study coordinator. A digital or paper copy of the verbal consent form will be provided 
for participants’ records. Additionally, AYA who are 17 at time of consent and turn 18 
during the study period will be re-consented. At the start of the semi-structured qualitative 
interview, a re-consent conversation will be audio and/or video-recorded to confirm that 
AYA/caregiver(s) agree to recording of the interview). 
8.7 Informed Consent (Oncology Health Care Providers) 
Informed consent will be obtained from oncology health care providers of enrolled AYA 
and caregiver(s). A study team member will discuss the procedures and consent forms with 
potential participants individually. In order to assure that the potential participant 
understands the study, the team member will review the consent, in its entirety, and will 
encourage them to ask questions throughout the process. The individuals will also be 
reminded that participation is voluntary and will not affect their employment or performance 
evaluation, and their responses will not be shared with their supervisors. There are no time 
constraints on the consent process. The potential participants will be allowed to take as 
much time as they need to ask questions and decide if they would like to participate.  
If consent is being conducted in-person and the potential participant agrees to participate, 
the In-Person Signature Page of the consent forms will be signed and dated by the potential 
participant and the research team member and stored in a regulatory binder maintained by 
the study coordinator. A copy of the consent forms will be provided to the participant for 
their records. At the start of the semi-structured qualitative interview, the re-consent 
conversation will be audio and/or video-recorded to confirm that oncology health care 
providers agree to recording of the interview. 
8.7.1 Consent with Waiver of Documentation 
If consent is being conducted over the phone, we will use Consent with Waiver of 
Documentation (verbal consent). The study team will complete the Documentation of 
Consent Page of the consent form, which will be stored in a regulatory binder maintained by 
the study coordinator. A digital or paper copy of the verbal consent form will be provided 
for participants’ records. At the start of the semi-structured qualitative interview, the re-
consent conversation will be audio and/or video-recorded to confirm that oncology health 
care providers agree to recording of the interview). 

 
  
 
 
 
18
8.8 Payment to Subjects 
8.8.1 Families (AYA and Caregivers) 
To compensate for their time and effort, AYA and caregiver(s) will be paid as a single-
family unit via a pre-loaded bank card (hereafter referred to as a ClinCard) or an Amazon e-
gift card. Per Clinical Trials Financial Management policy, the ClinCard will be given in 
person or mailed to families after they are enrolled in the study, or an Amazon e-gift card 
will be delivered electronically If the ClinCard is sent via mail, families will be instructed to 
contact the study coordinator (via phone/email) to confirm receipt of the ClinCard before 
funds are disbursed. If the ClinCard is delivered in person, families will be asked to provide 
their signature as confirmation of receipt. Families that receive an Amazon e-gift card via 
email will be asked to confirm receipt of the e-gift card with the study coordinator. Both 
confirmation of ClinCard receipt and stipend payments will be tracked in an Excel file 
(managed by the study coordinator). Families will receive the following stipend amounts at 
the following time points, based on group assignment: 
Families randomized to Usual Care will receive $50 across two time points. 
▪ Time Point 1: $25 after completion of the baseline assessment. 
▪ Time Point 2: $25 after completion of the post-intervention assessment 
Families randomized to DECIDES will receive $70 across three time points.  
▪ Time Point 1: $25 after completion of the baseline assessment 
▪ Time Point 2: $25 after completion of the post-intervention assessment 
▪ Time Point 3: $20 after completion of the semi-structured qualitative interview 
Families randomized to DECIDES + coach will receive $70 across three time points.  
▪ Time Point 1: $25 after completion of the baseline assessment 
▪ Time Point 2: $25 after completion of the post-intervention assessment 
▪ Time Point 3: $20 after completion of the semi-structured qualitative interview 
8.8.2 Oncology Health Care Providers 
Oncology health care providers will not be compensated for their participation in the study. 
9 
PUBLICATION 
Results of the study will be disseminated via conference abstracts and peer reviewed journal 
publications. 
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