Integration of Multimodal Cancer Predisposition Genetic Counseling Practices Within the Pediatric Oncology Setting: Digital Care Plans for Patients With CPS
Phase: NA
Conditions: Genetic Predisposition
Sponsor: Children's Hospital of Philadelphia

 
 
 
Title: Integration of Multimodal Cancer Predisposition Genetic 
Counseling Practices Within the Pediatric Oncology Setting: Digital Care 
Plans for Patients With CPS  
NCT Number: NCT05736497 
Date: June 18, 2024 
 

 
 
 
 
 
 
 
 
ii 
 
Title: 
Integration of Multimodal Cancer Predisposition Genetic Counseling 
Practices Within the Pediatric Oncology Setting: Digital Care Plans 
for Patients With CPS 
Short Title 
Care Plans for Cancer Predisposition 
eIRB Number:  
21-019151 
Protocol Date: 
June 18, 2024 
Amendment 1 Date: December 1, 2022 
Amendment 3 Date: September 28, 2023 
Amendment 2 Date: May 12, 2023 
Amendment 5 Date: May 9, 2024 
Amendment 7 Date: November 7, 2024 
Amendment 4 Date: November 17, 2023 
Amendment 6 Date: June 18, 2024 
 
Suzanne P. MacFarland, MD 
The Children’s Hospital of Philadelphia 
3501 Civic Center Blvd, CTRB #3054 
Philadelphia, PA, 19104 
Phone 215-300-6428 
email: macfarlands@chop.edu 
 
  
 
 

  
 
 
 
 
 
 
 
iii 
Table of Contents 
Table of Contents ............................................................................................................................... iii 
Abbreviations and Definitions of Terms ............................................................................................ v 
Abstract ................................................................................................................................................ vi 
Protocol Synopsis .............................................................................................................................. vii 
Table 1: Schedule of Study Procedures ............................................................................................ ix 
Table 2: Cancer Prediposition Syndromes ........................................................................................ x 
1 
BACKGROUND INFORMATION AND RATIONALE ....................................................................... 1 
1.1 
INTRODUCTION ..................................................................................................................................... 1 
1.2 
NAME AND DESCRIPTION OF INVESTIGATIONAL INTERVENTION .......................................................... 1 
1.3 
RELEVANT LITERATURE AND DATA ..................................................................................................... 2 
1.3.1 
Lifelong Impact of Cancer Predisposition ...................................................................................... 2 
1.3.2 
Technology-Based Interventions ..................................................................................................... 2 
1.4 
COMPLIANCE STATEMENT .................................................................................................................... 3 
2 
STUDY OBJECTIVES .............................................................................................................................. 3 
2.1 
PRIMARY OBJECTIVE ............................................................................................................................ 3 
2.2 
SECONDARY OBJECTIVES ..................................................................................................................... 3 
3 
INVESTIGATIONAL PLAN .................................................................................................................... 3 
3.1 
GENERAL SCHEMA OF STUDY DESIGN ................................................................................................. 3 
3.1.1 
Screening Phase .............................................................................................................................. 3 
3.1.2 
Study Treatment Phase (start of the study intervention) ................................................................. 4 
3.2 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ................................................................... 4 
3.2.1 
Duration of Subject Study Participation ......................................................................................... 4 
3.2.2 
Total Number of Subjects Projected ................................................................................................ 4 
3.3 
STUDY POPULATION ............................................................................................................................. 4 
3.3.1 
Inclusion Criteria ............................................................................................................................ 4 
3.3.2 
Exclusion Criteria ........................................................................................................................... 5 
4 
STUDY PROCEDURES ............................................................................................................................ 5 
4.1 
PATIENT IDENTIFICATION ..................................................................................................................... 5 
4.2 
STUDY TREATMENT PHASE .................................................................................................................. 5 
4.2.1 
Pre-Test Assessment (T0) ................................................................................................................ 5 
4.2.2 
PrePARE Care Plans and Text Messages ....................................................................................... 5 
4.2.3 
Post-Test Assessment (T1) ............................................................................................................... 5 
4.2.4 
Follow-Up Assessment (T2) ............................................................................................................ 6 
4.3 
SUBJECT COMPLETION/WITHDRAWAL ................................................................................................. 6 
5 
STUDY EVALUATIONS AND MEASUREMENTS ............................................................................. 7 
5.1 
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS .................................................. 7 
5.1.1 
Medical Record Review ................................................................................................................... 7 
5.2 
EFFICACY EVALUATIONS ...................................................................................................................... 7 
5.2.1 
Measures (Parent and AYA Self-Report) ......................................................................................... 7 
6 
STATISTICAL CONSIDERATIONS ...................................................................................................... 9 
6.1 
PRIMARY ENDPOINT ............................................................................................................................. 9 

  
 
 
 
 
 
 
 
iv 
6.2 
SECONDARY ENDPOINTS ...................................................................................................................... 9 
6.3 
STATISTICAL METHODS ........................................................................................................................ 9 
6.3.1 
Baseline Data .................................................................................................................................. 9 
6.3.2 
Efficacy Analysis ............................................................................................................................. 9 
6.4 
SAMPLE SIZE AND POWER .................................................................................................................. 10 
7 
STUDY INTERVENTION ...................................................................................................................... 11 
7.1 
DESCRIPTION ...................................................................................................................................... 11 
7.1.1 
PrePARE Care Plan Development ................................................................................................ 11 
7.1.2 
Text Messaging Intervention ......................................................................................................... 11 
8 
SAFETY MANAGEMENT ..................................................................................................................... 12 
8.1 
CLINICAL ADVERSE EVENTS .............................................................................................................. 12 
8.2 
ADVERSE EVENT REPORTING ............................................................................................................. 12 
9 
STUDY ADMINISTRATION ................................................................................................................. 13 
9.1 
DATA COLLECTION AND MANAGEMENT ............................................................................................ 13 
9.2 
CONFIDENTIALITY .............................................................................................................................. 13 
9.3 
REGULATORY AND ETHICAL CONSIDERATIONS ................................................................................. 14 
9.3.1 
Data and Safety Monitoring Plan .................................................................................................. 14 
9.3.2 
Risk Assessment ............................................................................................................................. 14 
9.3.3 
Potential Benefits of Trial Participation ....................................................................................... 14 
9.3.4 
Risk-Benefit Assessment ................................................................................................................ 15 
9.4 
RECRUITMENT STRATEGY .................................................................................................................. 15 
9.5 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION ............................................................ 15 
9.5.1 
Main Study ..................................................................................................................................... 16 
9.5.2 
Consent/HIPAA Authorization Plan for Subjects Who Reach Age of Majority ............................ 16 
9.5.3 
Individuals with Limited English Proficiency ............................................................................... 16 
9.5.4 
Waiver of Documentation of Consent ............................................................................................ 16 
9.6 
PAYMENT TO SUBJECTS/FAMILIES ...................................................................................................... 16 
9.6.1 
Reimbursement for travel, parking and meals .............................................................................. 16 
9.6.2 
Payments to parent for time and inconvenience (i.e. compensation) ............................................ 16 
9.6.3 
Payments to AYA subject for time, effort and inconvenience (i.e. compensation) ........................ 17 
9.6.4 
Gifts ............................................................................................................................................... 17 
10 
PUBLICATION ............................................................................................................................... 17 
11 
REFERENCES ................................................................................................................................. 17 
 

  
 
 
 
 
 
 
 
v 
Abbreviations and Definitions of Terms 
 
 
 
AE 
 
Adverse event 
AYA 
CHOP 
CPS 
PrePARE 
 
 
Adolescent/Young Adult 
Children’s Hospital of Philadelphia 
Cancer Predisposition Syndrome 
Predisposition Planning, Adjustment, Recommendations, 
and Education 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
 
 
 
 
 
 
vi 
Abstract 
Context:   
As over 15% of pediatric cancers are associated with a cancer predisposition, it is 
increasingly becoming standard of care for children with cancer, as well as those with 
suspected hereditary risk, to be evaluated for germline cancer predisposition. 
Unfortunately, the increase in pediatric genetic testing has exceeded the pace of research 
supporting effective cancer surveillance in positive cases. Additionally, guidelines for cancer 
predisposition management are not easily accessed or understood by families; thus, there 
is often a disconnect between the understanding and retention of such information relayed 
to families. Thus, we will develop innovative, scalable digital health solutions to augment 
genetic counseling resources to support patients and families, including a digital care plan 
and targeted text-message alerts for families with an existing Cancer Predisposition Syndrome 
(CPS). 
 
Objectives:  
Develop and evaluate acceptability, feasibility, and preliminary efficacy of digital care plan and 
accompanying text message reminders for children and adolescents with a known CPS. 
Study Design:  
Quasi-experimental design with pre- post- testing of same cohort.  
Setting/Participants: 
This is a 2-year, single-site study that is being conducted at the Children’s Hospital of 
Philadelphia (CHOP). A total of 100 families with a child with a CPS (diagnosis for five years or 
less) will be approached in the Cancer Predisposition Clinic at CHOP.  
 
Study Interventions and Measures:  
We will develop and implement a digital care plan and targeted text-message alerts with pre- 
and post-test evaluation of understanding of existing cancer predisposition guidelines, 
decisional satisfaction, and distress. Data will be collected at 3 time points: T0: prior to digital 
care plan; T1: 3 months after implementation; T2: 6 months follow up. 
 

 
 
 
 
 
 
 
 
 
 
vii 
Protocol Synopsis 
Study Title 
Integration of Multimodal Cancer Predisposition Genetic 
Counseling Practices Within the Pediatric Oncology Setting: 
Digital Care Plans for Patients With CPS 
Funder 
National Institute of Health 
Study Rationale 
As over 15% of pediatric cancers are associated with a cancer 
predisposition, it is increasingly becoming standard of care 
for children with cancer, as well as those with suspected 
hereditary risk, to be evaluated for germline cancer 
predisposition. Unfortunately, the increase in pediatric 
genetic testing has exceeded the pace of research supporting 
effective cancer surveillance in positive cases. Additionally, 
guidelines for cancer predisposition management are not 
easily accessed or understood by families; thus, there is often 
a disconnect between the understanding and retention of 
such information relayed to families. Thus, we will develop 
innovative, scalable digital health solutions to augment 
genetic counseling resources to support patients and families, 
including a digital care plan and targeted text-message alerts 
for families with an existing Cancer Predisposition Syndrome 
(CPS). 
Study Objective(s) 
Develop and evaluate acceptability, feasibility, and preliminary 
efficacy of PrePARE and accompanying text message reminders 
for children and adolescents with a known CPS. 
Test Article(s) 
 
Digital care plans and text message reminders for families with 
a known CPS 
Study Design 
 
Quasi-experimental design with pre- post- testing of same 
cohort, before and after delivery of care plan and accompanying 
messages. 
Subject Population 
key criteria for 
Inclusion and 
Exclusion: 
Inclusion Criteria 
1. Parent of child with CPS diagnosed within 5 years +/- 
proband if age 12-26 
2. Proband received care at CHOP Cancer Predisposition clinic  
3. If proband history of cancer, appropriate per oncologist  

 
 
 
 
 
 
 
 
 
 
viii 
4. English speaking 
Exclusion Criteria 
1. Cognitive impairment limiting participation 
Number Of Subjects  
Anticipated total of 180 subjects will be recruited at CHOP.  
Study Duration 
Each subject’s participation will last approximately 6 months. 
Study Phases 
Screening 
Study Treatment 
Follow-Up   
(1) Screening: screening for eligibility by record review and 
consultation with medical team (2) Obtaining consent and 
baseline survey (3) Receipt of PrePARE Care Plan and 
enrollment in text message system (4) Repeat survey 3 months 
after implementation and (5) Repeat survey at 6 months after 
implementation 
Efficacy Evaluations 
Understanding of existing cancer predisposition guidelines 
Safety Evaluations 
The PI will monitor the safety of the subjects and data and 
determine the need for additional psychosocial support. 
Statistical And 
Analytic Plan 
Mean and SD for the pre- and post-test (measured at 3 and 6 
months) scores and the change scores will be calculated, and 
paired t test will be used 
DATA AND SAFETY 
MONITORING PLAN 
PIs will be responsible for data quality management and 
ongoing assessment of safety 

 
ix  
 
 
 
 
 
 
 
Table 1: Schedule of Study Procedures  
 
 
Table 1: Introduction of digital supports to clinical care, workflow Year 1 and 2. Blue indicates standard of care timepoints, orange 
indicates study interventions, and green indicates data gathering points. 

 
page x 
  
 
 
 
Table 2: Cancer Prediposition SYNDROMES 
Cancer Predisposition Syndrome (CPS) 
Li-Fraumeni Syndrome 
PTEN Hamartoma Tumor Syndrome 
Beckwith-Wiedemann Syndrome 
Familial Adenomatous Polyposis 
Juvenile Polyposis Syndrome 
Hereditary Pheochromocytoma & Paraganglioma 
Peutz-Jegher Syndrome 
Noonan Syndrome 
DICER1 Syndrome 
Gorlin Syndrome 
 
 
 
 
.

 
  
 
 
 
1 
Background Information and Rationale 
Introduction 
The long-term goal of this research is to develop interventions that will ultimately transform 
delivery of care for children and adolescents undergoing testing for, and living with, cancer 
predisposition syndromes (CPS). This proposal will focus on the development and initial 
evaluation of novel interventions. We specifically propose a connected health approach 
whereby we will develop and test technology-based tools that include an open access 
individualized digital care plan system for those with a CPS known as PrePARE (Predisposition 
Planning, Adjustment, Recommendations, and Education), and accompanying text messages to 
support individualized surveillance. This proposal represents a novel extension of our digital 
health program of research, which has included the adaptation of UPenn’s OncoLife care plan 
system for childhood survivors (https://smartalacc.oncolink.org/).  
The successful completion of this study will create novel, scalable, and generalizable digital 
supports for families to augment genetic counseling services, inform best practices for genetic 
counseling, and inform a future multisite trial to further evaluate the impact of the new tools. 
Name and Description of Investigational Intervention 
We will develop individualized digital care plan system for those with a CPS known as 
PrePARE, and accompanying text messages to support individualized CPS surveillance. 
Name 
Description 
PrePARE Care Plans 
Using the digital platform of OncoLife, PrePARE will be a 
care plan to incorporate recommendations that are patient-
specific. Content will reflect surveillance recommendations 
including imaging, laboratory studies, physical exam, 
endoscopy recommendations, and lifestyle modifications. 
It will be personalized to the diagnosis, and in the case of 
cancer history, will also include survivorship guidelines. 
Text Message 
Intervention 
Text messages will be sent to caregivers (and probands 
12+ if they opt in) with information reinforcing content from 
their individual care plans such as healthy lifestyle tips and 
coping resources. Text messages will also prompt 
caregivers (and probands 12+ if they opt in) to make 
appointments based on individualized recommendations 
and will send appointment reminders confirmation 
requests. Additional text messages reminding participants 
to schedule and attend medical appointments will be sent 
by study team via CHOP issued device.  

 
  
 
 
 
2 
 
Relevant Literature and Data 
There is growing evidence that ≥15% of childhood cancer patients harbor a germline 
(heritable) cancer predisposition, some of which are associated with a 10,000-fold increased 
cancer risk.1,2 The increase in combined somatic and germline (tumor/normal) sequencing 
conducted at cancer diagnosis, as well as increased referral for testing in children with 
suspected cancer predisposition who have not yet developed cancer, has led to a rapid increase 
in identification of cancer predisposition in children. Many of these cases would not have been 
identified just a few years ago, prior to testing advances and changes in referral guidelines. 
However, the increase in pediatric genetic testing has exceeded the pace of deployment of 
genetic counseling resources. Moreover, positive results usually indicate the need for lifelong 
follow-up, including complex cancer surveillance, which can be difficult to understand and 
implement. Unfortunately, there are not enough genetic counselors to support cancer 
surveillance in patients who test positive for CPS. Thus, there is a critical need for innovative 
and scalable interventions that efficiently allocate resources and optimize care for pediatric 
patients and their families receiving testing for cancer predisposition. 
Lifelong Impact of Cancer Predisposition  
Results of genetic testing may reveal findings that are essential for long term health, requiring 
preventative and/or intervention measures. Despite the increase in pediatric genetic testing, 
and consensus on recommendations for those with significant findings,3 there has not been a 
standardized approach to disseminating information about findings and implications for long 
term health and well-being. Guidelines for cancer predisposition management are not easily 
accessed or understood by families; thus, there is often a disconnect between the 
understanding and retention of such information relayed to families.4 The delivery of digital 
interventions to enhance self-management of cancer survivors, as we have tested in our robust 
research program serves as a comparable framework for next steps in delivery of resources for 
families with cancer predisposition to address these limitations of care and fill research gaps of 
this burgeoning area. These resources will also be modifiable for other genetic syndromes 
requiring lifestyle modifications and surveillance.   
Technology-Based Interventions 
Digital health interventions are critical for “connected health”, which leverages technology to 
meet a patient’s needs in a proactive and efficient manner.5 Texting interventions have 
demonstrated significant improvements in knowledge, health-related behaviors and clinic 
attendance of adolescents and adults with other chronic health conditions,6-11 and in lifestyle 
modifications including adherence to pediatric health maintenance guidelines.12 Texting is low-
cost, highly available, brief, and can be written informally at a low reading level, making it 
applicable across diverse populations.13-16 Care plans, used in cancer survivorship and created 
using algorithm-based digital platforms, are personalized documents that describe diagnoses, 
screening and prevention, and health maintenance, and have been shown to improve 
knowledge, engagement, and confidence.17,18 Care plans for cancer predisposition have not 
been used and tested. Taken together, interventions that leverage technology have promise to 
fill a gap in counseling services and to be modifiable for other settings. 

 
  
 
 
 
3 
 
 
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.  
Study Objectives 
The long-term goal of this research is to develop interventions that will ultimately transform 
delivery of care for children and adolescents living with CPS. In individuals with an existing 
cancer predisposition syndrome, it will evaluate the use of a digital care plan and text message 
intervention to improve knowledge of and adherence to surveillance guidelines. 
Primary Objective  
The primary objective of this study is to develop and evaluate preliminary efficacy of PrePARE 
care plans and accompanying text message reminders for families with a known CPS with pre- 
and post-test evaluation at two times points after baseline [3 months and 6-months]. 
Knowledge of existing cancer predisposition guidelines will be assessed. Decisional satisfaction 
and distress will also be measured. 
Secondary Objectives  
The secondary objective is to evaluate acceptability and feasibility of the care plans and text 
message reminders. A survey of acceptability will be administered. Feasibility will be assessed 
with absence of technical difficulties and CRC ability to create care plan in under 15 minutes. 
 
Investigational plan 
General Schema of Study Design 
Screening Phase 
Potential subjects will be screened using the protocol inclusion and exclusion criteria.  
Parental/guardian permission (informed consent) and, if applicable, child assent, will be 
obtained prior to any study related procedures being performed. Patients will be approached 
in the in person in the Cancer Center or by phone. 

 
  
 
 
 
4 
Study Treatment Phase (start of the study intervention) 
During year 1, we will develop the digital interventions- PrePARE care plans and text message 
reminders. We will begin participant recruitment and implementation of the digital 
interventions in year 2. 
 
Study Duration, Enrollment and Number of Sites 
This is a 2-year, single-site study with recruitment and study related procedures developed in 
collaboration with the Cancer Predisposition Program at CHOP. Development of the PrePARE 
care plans and targeted text messages takes place during year 1. We will then enroll 100 family 
units with child proband(s) with a known CPS (diagnosed within 5 years) beginning in year 2. 
Duration of Subject Study Participation 
Study participation is expected to last approximately 6 months, beginning at the time of 
consent. Participants will complete electronic assessments either remotely or in clinic (T0). 
The patient/family will then receive the PrePARE care plan and will be enrolled in the text-
message alert system. They will complete repeat surveys at 3 (T1) and 6 months (T2) after 
implementation. All assessments are expected to last approximately 30 minutes each. 
Total Number of Subjects Projected 
We will approach a total of 100 families of a child with a CPS in the Cancer Predisposition 
Clinic. Patients will be eligible if they have had a diagnosis of a CPS for five years or less. 
Eligible participants of the families include up to two primary caregivers of each proband, and 
probands, themselves, if at least 12 years or older up to age 26. The families will designate the 
primary caregiver to represent the family or up to two caregivers can participate. We expect 
participation from all 100 primary caregivers who consent. Based on prior studies, we expect 
60 secondary caregivers will participate. The age of the child proband(s) in the family unit 
determines whether the child proband(s) are eligible to enroll. We expect 20 total AYA will 
participate. 
We aim for a caregiver to participate from each family unit. But, we will not exclude any 
eligible probands that choose to participate even if a caregiver wishes not to. In these cases, a 
parent must provide consent for the child(ren) (under 18) to participate, and the probands 
under age 18 must provide assent. 
Study Population 
The study population will include 100 family units with child proband(s) with a known CPS 
diagnosed within 5 years. 
Inclusion Criteria  
Parents 
1) Parent or Legal Guardian of a patient with a known cancer predisposition syndrome 
diagnosed within the last 5 years (see table 2 for list of common CPS) 
2) Their child has received care at CHOP or other medical institutions (does not need to be 
receiving follow-up care at CHOP) 
3) Appropriate to approach per oncology team/cancer predisposition team 

 
  
 
 
 
5 
4) No cognitive impairment limiting ability to complete measures 
5) Ability to read and speak English fluently 
AYA probands 
1) Child proband with a known cancer predisposition syndrome diagnosed within the last 5 
years 
2) Ages 12+ 
3) Received care at CHOP or other medical institutions (does not need to be receiving follow-
up care at CHOP) 
4) Appropriate to approach per oncology team/cancer predisposition team 
5) No cognitive impairment limiting ability to complete measures 
6) Ability to read and speak English fluently 
Exclusion Criteria 
1) Not meeting any of inclusion criteria 
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.   
Study Procedures 
Patient Identification 
Eligible families will be identified by patient information found in clinic rosters of the Cancer 
Predisposition Program and electronic health records. Team members of the clinic are co-
investigators on this study and will be readily available to identify eligible families. Families 
will then be approached by phone, email or in clinic to confirm study eligibility and (if 
appropriate) obtain informed study consent.   
Study Treatment Phase 
Pre-Test Assessment (T0) 
Following consent/assent, all participant(s) are asked to complete an electronic self-report 
assessment either remotely or in clinic via REDCap. The pre-test will take place prior to receipt 
of the PrePARE care plans and enrollment in the text message alert system. MyCHOP may be 
utilized for communication with enrolled participants. MyCHOP is a secure, online portal in 
which physicians and patients can communicate. 
PrePARE Care Plans and Text Messages 
Upon consent to study, families will receive their PREPARE care plan and will be enrolled in 
the text message alert system. A trained CRC will create the care plans and enroll families in 
the text message system. 
Post-Test Assessment (T1) 
Three months after implementation of the PrePARE care plan and text message alerts, all 
participants are asked to complete an electronic self-report assessment either remotely or in 
clinic via REDCap. MyCHOP may be utilized for communication with enrolled participants. 
MyCHOP is a secure, online portal in which physicians and patients can communicate. 

 
  
 
 
 
6 
Follow-Up Assessment (T2) 
Six months after implementation of the PrePARE care plan and text message alerts, all 
participants are asked to complete an electronic self-report assessment either remotely or in 
clinic via REDCap. MyCHOP may be utilized for communication with enrolled participants. 
MyCHOP is a secure, online portal in which physicians and patients can communicate. 
Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care. It will be 
documented whether or not each subject completes the study.  

 
  
 
 
 
7 
Study Evaluations and Measurements 
Screening and Monitoring Evaluations and Measurements 
Medical Record Review 
Descriptive measures to be obtained from electronic health record (EHR) to include date of 
birth, genetic testing results, surveillance visits and appointments and, where applicable, 
cancer diagnoses and treatment history (start, end, modalities). 
 
Efficacy Evaluations 
Measures (Parent and AYA Self-Report) 
Demographic and Disease-related Information A self-report measure will request the 
following information on both the primary parent, second parent, and child proband(s): date of 
birth, race/ethnicity, education level, family income, gender, and sex. Diagnostic and treatment 
data to be evaluated will include underlying cancer diagnosis, treatment history (start, end, 
modalities), and genetic testing results. In the event that there is missing data on the 
demographic and disease-related information self-report measure, the study team will extract 
the aforementioned medical information about the child proband(s) and primary/second 
parent(s) via the child proband’s Electronic Health Record (EHR). 
Satisfaction with Decision Scale19 This is a 6-item scale that measures satisfaction with 
decision to have germline testing. Items are rated on a 5-point Likert scale ranging from 1 
(“Strongly Disagree”) to 5 (“Strongly Agree”). 
Impact of Events Scale (IES)20 This 15-item measure assesses cancer-related anxiety through 
two subscales (intrusive thinking and avoidance). Responses are measured on a 4-point Likert 
scale with the following anchors: 0 “not at all”, 1 “rarely”, 3 “sometimes”, and 5 “often”. Scores 
range from 0 to 35 for intrusion, 0 to 40 for avoidance, and 0 to 75 for the total IES. Higher 
scores indicate greater cancer-related anxiety. 
Multidimensional Impact of Cancer Risk Assessment (MICRA)21 This 6-item measure 
assesses the specific impact of result disclosure after genetic testing. The Distress subscale 
(Items 1-4, 7, and 8) will be used to assesses the amount of cancer-specific distress after 
receiving genetic test results. Items are rated on a 4-point Likert scale with the following 
anchors: 0 “Never”, 1 “Rarely”, 3 “Sometimes”, and 5 “Often”. 
Survey of Acceptability22  Respondents provide ratings on a 5-point Likert scale asking about 
satisfaction, perceived appropriateness, positive effect, demand, and potential for future use; adapted 
from prior studies. 
Knowledge Measure  This measure will assess participant knowledge of the content within the care 
plans.  
 
 

 
  
 
 
 
8 
 
*Timing: T0 = pre-test measure, T1 = 3 months post-intervention, T2 = 6 months post-intervention 
Outcomes 
Table 3: Efficacy Outcome Measures  
*Timing:  
Total 
time 
(min) 
Cancer 
risk/surveillance 
knowledge 
Knowledge measure itemized to reflect content in care plan (per AYA STEPS 
study, PI Schwartz and Hill-Kayser)23,24 We have a track record of developing 
knowledge measures for prior digital health interventions, which have been 
shown to be responsive to intervention (see prelim).  
T0, T1, 
T2 
8 
Decision 
satisfaction 
Satisfaction with Decision Scale: 6 item Likert Scale19 
T0, T1, 
T2 
3 
Distress 
Impact of Events Scale: cancer-related anxiety per 2 subscales (intrusion and 
anxiety): 15 item Likert Scale;20 Multidimensional Impact of Cancer Risk 
Assessment (MICRA) distress subscale: 6 item Likert Scale21 
T0, T1, 
T2 
10 
Acceptability 
Rating on 5-point Likert scale to assess satisfaction, perceived appropriateness, 
positive effect, demand, and potential for future use; adapted from prior 
studies22 
T1, T2 
(only if 
missed in 
T1) 
8 
Feasibility and 
Adherence  
Absence of technical difficulties tracked by team and vendors; PrePARE and 
texts: CRC ability to create care plan in under 15 min  
T0, T1, 
T2 
NA 

 
  
 
 
 
9 
STATISTICAL CONSIDERATIONS 
Descriptive statistics will be calculated for all variables for each subsample (single/paired 
caregivers, probands).Where possible, total scores will be calculated based on scoring 
instructions of established questionnaires or at an item-level, where applicable. Acceptability 
and feasibility of the digital tools will be summarized using descriptive statistics. The biological 
variable sex will be assessed as a potential confounder and effect modifier in all analyses, 
although we don’t expect many differences by sex based on data from similar studies. 
Primary Endpoint 
The primary outcome is change in knowledge score for all participating family members. Mean 
and SD for the pre- and post-test (measured at 3 and 6 months) scores and the change scores 
will be calculated, and paired t test will be used to test if there is significant change in the 
knowledge score. The post-test score measured at 6 months, and further longitudinal analyses 
will be conducted to evaluate the change scores at 3 and 6 months simultaneously using mixed 
effects model. Other secondary analyses will evaluate change scores from all family members, 
and mixed effects model will be used to account for within-family correlations. Covariates will 
be evaluated as noted in Aim 1. We will enroll 100 families. We also estimate 10 to 15% 
attrition from T0 to T1, leaving ~75 families with evaluable participants. Primary analyses of 
75 participants (almost all primary caregivers) with post-test measures will provide 80% 
power to detect a moderate effect size of 0.33 (mean change is 0.33 SD), assuming a two-sided 
type I error of 0.05. The secondary analysis including all family members (n=180) will have 
higher power while the magnitude of the power gain will depend on the observed within-
family correlation in the knowledge score. Percent of appointments attended will be calculated. 
Secondary Endpoints 
Secondary endpoints include greater decisional satisfaction, and reduced distress at 3 and 6 
months compared to baseline and will be assessed via the same methods and the primary 
endpoint of knowledge. Additionally, acceptability ratings and feasibility will be documented 
with standard descriptive statistics such as means and frequencies.  
Statistical Methods 
Baseline Data  
Baseline and demographic characteristics will be summarized by standard descriptive 
summaries (e.g. means and standard deviations for continuous variables such as age and 
percentages for categorical variables such as gender). 
Efficacy Analysis 
Mean and SD for the pre- and post-test (measured at 3 and 6 months) scores and the change 
scores will be calculated, and paired t test will be used to test if there is significant change in 
the knowledge score. The post-test score measured at 6 months, and further longitudinal 
analyses will be conducted to evaluate the change scores at 3 and 6 months simultaneously 
using mixed effects model. Other secondary analyses will evaluate change scores from all 
family members, and mixed effects model will be used to account for within-family 
correlations. Covariates will be evaluated as noted in Aim 1. 

 
  
 
 
 
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Sample Size and Power 
We will enroll 100 families. We also estimate 10 to 15% attrition from T0 to T1, leaving ~75 
families with evaluable participants. Primary analyses of 75 participants (almost all primary 
caregivers) with post-test measures will provide 80% power to detect a moderate effect size of 
0.33 (mean change is 0.33 SD), assuming a two-sided type I error of 0.05. The secondary 
analysis including all family members will have higher power while the magnitude of the 
power gain will depend on the observed within-family correlation in the knowledge score. 
Percent of appointments attended will be calculated. 
 

 
  
 
 
 
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Study INTERVENTION 
Description 
PrePARE Care Plan Development 
In 2007, Dr. Hill-Kayser (Penn Site PI) co-launched OncoLife—an internet-based tool for the 
creation of adult survivorship care plans (SCPs).23 OncoLink, is freely accessible online with 
over 80,000 users. The OncoLife tool requires input of demographics, diagnosis, and 
treatments received to create a comprehensive, individualized SCP addressing surveillance 
recommendations, late effects, and lifestyle recommendations.25 Smart-ALACC (Smart Adult 
Living After Childhood Cancer) was created as a version for AYA survivors of childhood 
cancer.24 
The creation of PrePARE, a care plan tool for cancer predisposition, will use the digital 
platform of OncoLife, and will follow the development procedures that were used to adapt 
OncoLife to create Smart-ALACC. Adapting Smart-ALACC to create a care plan tool for pediatric 
cancer predisposition will require three steps: 1) Content will be developed to reflect 
recommendations for surveillance (imaging, laboratory, and physical exam as required up to 
every 3 months), follow-up care, family testing, cancer prevention, adjustment and well-being. 
The content will reflect published guidelines and existing literature, clinical experience, and 
data from our related studies. 2) The user interface will be modified to include specific data 
entry options to facilitate individualized care plans. 3) The additions to the interface will be 
mapped using PHP and Symfony to the content within the eZ CMS so that care plans can be 
seamlessly developed. Care plans will be created with the ability to combine PrePARE with 
SCPs if the proband has a history of cancer.  
The genetic counselor will train the clinical research coordinator to create the care plans and 
review them with families. PrePARE care plans will incorporate age-based surveillance 
recommendations and, where applicable, cancer survivorship recommendations. 
Text Messaging Intervention 
Text messages will be sent using Twilio via REDCap. Twilio is a third-party web service that 
acts as a conduit between the caregivers and the associated REDCap project. Twilio SMS text 
messages will be routed through Twilio's servers and REDCap goes to great lengths to ensure 
that SMS transcriptions do not stay in Twilio's logs, but are removed shortly after being 
completed. This is done for security and privacy concerns (e.g., HIPAA), in which the 
participant’s phone number and their response do not get permanently logged on Twilio's 
servers, but instead remain securely in REDCap. 

 
  
 
 
 
12 
SAFETY MANAGEMENT 
Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  
Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, 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. 
  

 
  
 
 
 
13 
STUDY ADMINISTRATION 
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. 
Any missing demographic data (i.e., not completed in subjects’ surveys) about the child 
proband(s) and primary/second parent(s) will be extracted from the child proband’s 
Electronic Health Record, if available. 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 CHOP in the offices of the PI, Dr. 
MacFarland. 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 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.  
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) a Certificate of Confidentiality 
(CoC) will be obtained; (2) subject identity will be  coded using numbers keyed to a master list; 
(3) coded data will be entered directly into files that will be password protected; (4) 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 

 
  
 
 
 
14 
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). 
Regulatory and Ethical Considerations 
Data and Safety Monitoring Plan 
The CHOP PIs will monitor and review the study progress, subject safety, and the accuracy and 
security of the emerging data. 
Risk Assessment 
This is a low risk study. Participants will complete self-report demographic and patient 
reported outcomes. Given the potentially personal nature of cancer and genetic testing and 
predisposition, some questions may potentially cause some distress for some respondents. All 
participants will be informed of this risk and the nature of the questions prior to participation 
and will be informed of the right to skip questions or discontinue participation if they become 
uncomfortable with the study. If participants become upset, they will be referred to the site PIs 
or a psychosocial professional (site will determine best referral source), who will assess the 
level of distress of the patient and determine the need for additional psychosocial support. 
Breach of confidentiality and loss of autonomy for minors are additional potential risks of 
participation. To minimize these risks, during the consent process, participants will be 
informed of the voluntary and confidential nature of the research. Minors will be told they do 
not have to participate even if their parent wants them to, and their answers will not be shared 
with anyone outside the study team, including their guardian, unless required by law. All 
participants will be informed of their right to withdraw from participation in the study at any 
time and the freedom to decline answering any question. 
Potential Benefits of Trial Participation 
Potential benefits for study participants include access to digital interventions that have the 
potential to support families in coping with the lifelong burden of a cancer predisposition 
syndrome. For patients with a CPS, there is potential that the PrePARE and text message 
interventions will improve understanding of, and adherence with, ongoing surveillance 
guidelines. From Dr. Schwartz’s prior experience, these interventions have been implemented 
in the past with little to no associated distress. 
At least 15% of patients with a diagnosis of cancer have an underlying cancer predisposition 
syndrome, and many families live with the long-term risk of cancer related to a known familial 
cancer predisposition syndrome. Ongoing cancer surveillance according to accepted guidelines 
significantly improves outcomes for these individuals. Tools to improve the implementation of 
cancer predisposition guidelines have the potential not only to improve understanding and 
decrease stress around testing and follow up, but also to have survival benefit for patients. 

 
  
 
 
 
15 
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 parents and children in the future outweigh the minimal risks associated with 
participation. 
Recruitment Strategy 
Eligible families will be identified by patient information found in clinic rosters of the Cancer 
Predisposition Program and electronic health records. Team members of the clinic are co-
investigators on this study and will be readily available to identify eligible families. Families 
will then be approached by phone or in clinic to confirm study eligibility and (if appropriate) 
obtain informed study consent.   
Our Cancer Predisposition Program is among one of the few national well-established 
programs of its kind and is growing at a rate of 50% more patients per year, with 360 new 
patients in the last year. In the near future, as we move toward germline testing for all new 
pediatric cancer patients, it is expected that more than 600 patients will be seen each year. 
Referrals come internally and externally. As per Table 1, of the current eligible patients, we 
expect 140 individuals available for recruitment (and growing). Thus, we believe our 
recruitment and retention goals are extremely feasible given precedent and number of eligible 
patients.  
Informed Consent/Assent and HIPAA Authorization 
Participants will be identified through existing patient tracking mechanisms within the Cancer 
Center. Eligible participants will be recruited either in person or by phone, facilitated by email 
contact, with approval of treating oncologist if applicable. Consent will be obtained by a 
member of the study team in a private location in the hospital, by phone, or electronically. 
Consent will be documented via signature on IRB-approved consent documents. In some cases, 
a family may prefer to sign the consent form through our secure RedCap database by accessing 
a link provided by the study team if consenting remotely, or a study provided IPAD if in person. 
If completing the REDCap electronic consent form, subjects will be asked to provide an 
electronic signature as a part of their consent. There will also be an option for assent to be 
provided via electronic signature. 
Every potential participant will go through a detailed and careful consenting process, with 
frequent prompts and structured questions asked throughout to ensure they understand the 
procedures and risks. The subjects will be reminded that participation is voluntary and will not 
affect their care. Potential participants will be informed that they can take as much time as 
needed to decide about study participation, and they will be informed that they may 
withdrawal from the study at any time. As per 45 CFR 46.608, any patient 12 years or older 
will be required to give assent prior to participation, if able. If a potential participant is unable 
to understand the study protocol, they will not participate in the study.  

 
  
 
 
 
16 
After the potential participant successfully completes this process, written informed consent or 
verbal consent (if by phone) or electronic consent will be obtained. A copy of the signed 
informed consent document is given to each participant for his/her records. If consent is 
obtained verbally, participants will receive a copy of their completed consent form by email. 
After signing the electronic consent form, subjects will have the options to have the signed 
consent form emailed to their email address or download a PDF of their signed consent form 
for future reference. 
Main Study 
Eligible participants will be recruited either in person or by phone, facilitated by email contact, 
with approval of treating oncologist if applicable. Consent will be obtained by a member of the 
study team in a private location. 
Consent/HIPAA Authorization Plan for Subjects Who Reach Age of Majority 
If a participant turns 18 before the next scheduled assessment, he/she will be asked to sign a 
new consent form. 
Individuals with Limited English Proficiency  
LEP subjects will not be included in the study as the questionnaires and care plans are only 
available and validated in English. 
Waiver of Documentation of Consent 
The Investigator requests a Waiver of Documentation of Consent and Assent (verbal 
consent/assent) for subjects recruited over the telephone. If the prospective participant 
chooses to enroll in the study, a member of the study team will complete the entire consent 
document, which will be stored in a regulatory binder by the study coordinator. A copy of the 
signed informed consent document will be emailed or mailed to each participant for his/her 
records.  
Payment to Subjects/Families 
Reimbursement for travel, parking and meals 
Participants will not be reimbursed for travel, parking, or meals.  
Payments to parent for time and inconvenience (i.e. compensation) 
To compensate for their time and effort, participants will be paid via a pre-loaded bank card 
(hereafter referred to as a ClinCard). Per Clinical Trials Financial Management policy, the 
ClinCard will be given in person or mailed to participants after they are enrolled in the study. If 
the ClinCard is sent via mail, participants will be instructed to email the study coordinator to 
confirm receipt of the ClinCard before funds are disbursed. If the ClinCard is delivered in 
person, participants will be asked to provide their signature as confirmation of Payments to 
subject for time, effort and inconvenience (i.e. compensation) receipt. Both confirmation of 
ClinCard receipt and stipend payments will be tracked for all study participants in an Excel file 
(managed by the study coordinator).  
Payments may also be made via amazon e-gift card. The amazon e-gift card will be emailed and 
participants will be instructed to confirm receipt of gift card with study coordinator. 

 
  
 
 
 
17 
Stipend amounts are as follows: 
Parent(s) of child proband(s) will receive $20/time point (T0, T1, and T2). Parent(s) of 
additional child proband(s) will receive an additional $10/time point (T0, T1, and T2). 
Payments to AYA subject for time, effort and inconvenience (i.e. compensation) 
To compensate for their time and effort, participants will be paid via a pre-loaded bank card 
(hereafter referred to as a ClinCard). Per Clinical Trials Financial Management policy, the 
ClinCard will be given in person or mailed to participants after they are enrolled in the study. If 
the ClinCard is sent via mail, participants will be instructed to email the study coordinator to 
confirm receipt of the ClinCard before funds are disbursed. If the ClinCard is delivered in 
person, participants will be asked to provide their signature as confirmation of Payments to 
subject for time, effort and inconvenience (i.e. compensation) receipt. Both confirmation of 
ClinCard receipt and stipend payments will be tracked for all study participants in an Excel file 
(managed by the study coordinator).  
Payments may also be made via amazon e-gift card. The amazon e-gift card will be emailed and 
participants will be instructed to confirm receipt of gift card with study coordinator. 
Stipend amounts are as follows: 
AYA proband(s) will receive $20/time point (T0, T1, and T2). 
Gifts 
N/A 
PUBLICATION 
Results of the study will be disseminated via conference abstracts and peer reviewed journal 
publications. No individually identifiable PHI will be published. 
References 
1. 
Brodeur GM, Nichols KE, Plon SE, Schiffman JD, Malkin D. Pediatric Cancer 
Predisposition and Surveillance: An Overview, and a Tribute to Alfred G. Knudson 
Jr. Clin Cancer Res. 2017;23(11):e1-e5. 
2. 
Kamihara J, Bourdeaut F, Foulkes WD, et al. Retinoblastoma and Neuroblastoma 
Predisposition and Surveillance. Clin Cancer Res. 2017;23(13):e98-e106. 
3. 
AACR Childhood Cancer Predisposition Workshop. Clin Cancer Res. 
2017(Pediatric Oncology Series). 
4. 
McGill BC, Wakefield CE, Vetsch J, et al. "I remember how I felt, but I don't 
remember the gene": Families' experiences of cancer-related genetic testing in 
childhood. Pediatric blood & cancer. 2019;66(8):e27762. 
5. 
Caulfield BM, Donnelly SC. What is Connected Health and why will it change your 
practice? QJM: An International Journal of Medicine. 2013;106(8):703-707. 
6. 
Rami B, Popow C, Horn W, Waldhoer T, Schober E. Telemedical support to 

 
  
 
 
 
18 
improve glycemic control in adolescents with type 1 diabetes mellitus. Eur J Pediatr. 
2006;165(10):701-705. 
7. 
Matthews M, Doherty G, Sharry J. Mobile phone mood charting for adolescents. Br 
J Guidance Couns. 2008;36:119-129. 
8. 
Petrie KJ, Perry K, Broadbent E. A text message programme designed to modify 
patients' illness and treatment beliefs improves self-reported adherence to asthma 
preventer medication. Br J Health Psychol. 2011;17(1):74-84. 
9. 
Nguyen B, Shrewsbury VA, O'Connor J, et al. Twelve-month outcomes of the Loozit 
randomized control trial: A community-based healthy lifestyle program for 
overweight and obese adolescents. Arch Pediatr Adolesc Med. 2012;166:170-177. 
10. 
Branson CE, Clemmey P, Mukherjee P. Text message reminders to improve 
outpatient therapy attendance among adolescents: A pilot study. Psychological 
services. 2013;10(3):298. 
11. 
Ting TV, Kudalkar D, Nelson S, et al. Usefulness of cellular text messaging for 
improving adherence among adolescents and young adults with systemic lupus 
erythematosus. The Journal of rheumatology. 2012;39(1):174-179. 
12. 
Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y, Dobson R. Mobile phone 
text messaging and app-based interventions for smoking cessation. Cochrane 
Database Syst Rev. 2019;10:CD006611. 
13. 
Lenhart A. Teens, smartphones & texting. Washington, DC: Pew Research Center's 
Internet & American Life Project;2012. 
14. 
Militello LK, Kelly SA, Melnyk BM. Systematic review of text-messaging 
interventions to promote healthy behaviors in pediatric and adolescent populations: 
Implications for clinical practice and research. Worldviews Evid Based Nurs. 
2012(2):66-77. 
15. 
US Department of Health and Human Services Text4Health Task Force. Health text 
messaging recommendations to the secretary. In:2011. 
16. 
Franklin VL, Waller A, Pagliari C, Greene SA. A randomized controlled trial of 
Sweet Talk, a text-messaging system to support young people with diabetes. Diabet 
Med. 2006;23:1332-1338. 
17. 
Shalom MM, Hahn EE, Casillas J, Ganz PA. Do survivorship care plans make a 
difference? A primary care provider perspective. Journal of Oncology Practice. 
2011;7(5):314-318. 
18. 
Schwartz LA, Psihogios AM, Henry-Moss D, et al. Iterative development of a 
tailored mHealth intervention for adolescent and young adult survivors of childhood 
cancer. Clinical Practice in Pediatric Psychology. 2019;7(1):31. 
19. 
Holmes-Rovner M, Kroll J, Schmitt N, et al. Patient Satisfaction with Healthcare 
Decision: The Satisfaction with Decision Scale Medical Decision Making. 
1996;16(1):58-64. 
20. 
Horowitz M, Wilner N, Alvarez W. Imact of Event Scale: A Measure of Subjective 
Stress. Psychosomatic Medicine. 1979;41(3):209-218. 

 
  
 
 
 
19 
21. 
Cella D, Hughes C, Peterman A, et al. A brief assessment of concerns associated 
with genetic testing for cancer: The multidimensional impact of cancer risk 
assessment (MICRA) questionnaire. Health Psychology. 2002;21(6):564-572. 
22. 
Bowen DJ, Kreuter M, Spring B, et al. How we design feasibility studies. Am J Prev 
Med. 2009;36(5):452-457. 
23.  
Hill-Kayser CE, Vachani C, Hampshire MK, Jacobs LA, Metz JM. An internet tool 
for creation of cancer survivorship care plans for survivors and health care providers: 
design, implementation, use and user satisfaction. Journal of Medical Internet 
Research. 2009;11(3). 
24. 
Hill-Kayser C, Szalda D, Vachani C, et al. Feasibility and Acceptability of 
Survivorship Care Plans for Adolescent/Young Adult Survivors of Childhood 
Cancer. International Journal of Radiation Oncology• Biology• Physics. 
2019;105(1):E602-E603. 
25. 
Hill-Kayser CE, Vachani CC, Hampshire MK, Lullo G, Jacobs LA, Metz JM. Impact 
of internet-based cancer survivorship care plans on health care and lifestyle 
behaviors. Cancer. 2013;119(21):3854-3860.