Optimizing Fertility Preservation and Decision Quality in Male AYA With Cancer: A Family-centered Intervention
Phase: NA
Conditions: Infertility, Male
Sponsor: Leena Nahata

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PROTOCOL TITLE: 
Fertility Preservation Discussions And Decisions (FP – DAD) 
 
PRINCIPAL INVESTIGATOR: 
Name: Dr. Leena Nahata 
Department/Center: Center for Biobehavioral Health, Nationwide Children’s Hospital 
Telephone Number: 1 614 722 4425 
Email Address: Leena.Nahata@nationwidechildrens.org 
 
Mentors:  
Name: Dr. Cynthia Gerhardt 
Department/Center: Center for Biobehavioral Health, Nationwide Children’s Hospital 
Email Address: Cynthia.Gerhardt@nationwidechildrens.org 
 
Name: Dr. Sarah O’Brien 
Department/Center: Center for Innovation in Pediatric Practice, Nationwide Children’s Hospital 
Email Address: Sarah.Obrien@nationwidechildrens.org  
 
Name: Dr. Gwendolyn Quinn 
Department/Center: Department of Obstetrics and Gynecology, New York University School of 
Medicine 
Email Address: gwendolyn.quinn@nyulangone.org  
 
Name: Dr. Joseph R. Rausch 
Department/Center: Center for Biobehavioral Health, Nationwide Children’s Hospital 
Email Address: Joseph.Rauch@nationwidechildrens.org  
 
Name: Dr. James Klosky 
Department/Center: Department of Pediatrics and Aflac Cancer & Blood Disorders Center, Emory 
University School of Medicine 
Email Address: james.klosky@emory.edu  
 
VERSION NUMBER/DATE: 
V6, 25 August 2021 
 
REVISION HISTORY 
 
Revision 
# 
Version # and 
Date 
Summary of Changes 
Consent 
Change? 
1 
2.0 
09/28/2020 
We updated information on the current status of our study, outlined 
procedures for connecting a remote participant in, and updated the 
description of our surveys/methods to reflect changes made to those 
areas. We also changed the name of the study. 
Yes 
2 
3.0 
12/15/2020 
We updated information to include procedures for connecting an entire 
family in via Webex 
No 
 
3 
4.0 
01/08/2021 
We included an additional questionnaire to give to families during visit 
2.  
No 

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4 
5.0 
06/03/2021 
We updated our remote consent processes to include REDCap. 
No 
5 
6.0 
We included questionnaires to give to families during visit 3. 
No 
6 
7.0  
12/16/2021 
We updated information to include procedures if only one family 
member participates. We also updated the participant incentive. 
Yes 
 
Confidentiality Statement: This document is confidential communication. Acceptance of this document 
constitutes agreement by the recipient that no unpublished information contained herein will be published or 
disclosed without prior approval of the Principal Investigator or other participating study leadership and as 
consistent with the NIH terms of award.  
Statement of Compliance 
The trial will be carried out in accordance with International Council on Harmonization Good Clinical Practice 
(ICH GCP) and the following: 
o United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812). 
 
Additionally, National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have completed Human 
Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to 
the IRB for review and approval. Approval of both the protocol and the consent form(s) is obtained before any 
participant is consented. Any amendment to the protocol will require review and approval by the IRB before the 
changes are implemented to the study. All changes to the consent form(s) will be IRB approved; a determination 
will be made regarding whether a new consent needs to be obtained from participants who provided consent, 
using a previously approved consent form. 
 
Investigator Signature 
The signature below constitutes the approval of this protocol and provides the necessary assurances that this study 
will be conducted according to all stipulations of the protocol, including all statements regarding confidentiality, 
and according to local legal and regulatory requirements and applicable US federal regulations and ICH 
guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator: 
  
Signed: 
  
Date:   
Name:  
Leena Nahata, MD 
Titles:  
Associate Professor of Clinical Pediatrics, Pediatric Endocrinology 
Principal Investigator, Center for Biobehavioral Health  
Affiliation:  The Ohio State University and Abigail Wexner Research Institute at Nationwide Children's Hospital 
Address:  
700 Children's Drive 
Columbus, OH 43205 
Telephone:  614-722-4425 
Email:  
Leena.Nahata@nationwidechildrens.org 
 
 
 

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Table of Contents 
Statement of Compliance ........................................................................................................................................ 2 
Investigator Signature ............................................................................................................................................. 2 
1.0 
Study Summary ............................................................................................................................................ 4 
2.0 
Objectives .................................................................................................................................................... 4 
3.0 
Background .................................................................................................................................................. 5 
4.0 
Study Endpoints ........................................................................................................................................... 7 
5.0 
Study Intervention ........................................................................................................................................ 7 
6.0 
Procedures Involved*................................................................................................................................... 8 
7.0 
Data and Specimen Banking* .................................................................................................................... 11 
8.0 
Sharing of Results with Subjects* ............................................................................................................. 12 
9.0 
Study Timelines* ....................................................................................................................................... 12 
10.0 Inclusion and Exclusion Criteria* .............................................................................................................. 12 
11.0 Vulnerable Populations* ............................................................................................................................ 13 
12.0 Local Number of Subjects ......................................................................................................................... 13 
13.0 Recruitment Methods ................................................................................................................................. 13 
14.0 Withdrawal of Subjects* ............................................................................................................................ 13 
15.0 Risks to Subjects* ...................................................................................................................................... 14 
16.0 Potential Benefits to Subjects* .................................................................................................................. 14 
17.0 Data Management* and Confidentiality .................................................................................................... 14 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ............................................................ 16 
19.0 Adverse Events & Serious Adverse Events ............................................................................................... 17 
20.0 Unanticipated Problems ............................................................................................................................. 18 
21.0 Provisions to Protect the Privacy Interests of Subjects .............................................................................. 19 
22.0 Compensation for Research-Related Injury ............................................................................................... 20 
23.0 Economic Burden to Subjects .................................................................................................................... 20 
24.0 Consent Process ......................................................................................................................................... 20 
25.0 Process to Document Consent in Writing .................................................................................................. 20 
26.0 Setting ........................................................................................................................................................ 20 
27.0 Resources Available................................................................................................................................... 21 
28.0 Multi-Site Research* ................................................................................................................................. 22 
29.0 Protected Health Information Recording ................................................................................................... 22 
30.0 Confidential Health Information ................................................................................................................ 23 
31.0 References .................................................................................................................................................. 25 
 
 
 

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Study Summary 
Study Title 
Fertility Preservation Discussions and Decisions (FP-DAD) 
Grant Number 
K08CA237338, National Cancer Institute 
Study Design 
Randomized Clinical Trial 
Primary Objective 
To examine feasibility, acceptability, and preliminary efficacy of a family-
centered psychoeducational intervention designed to improve fertility 
preservation (FP) uptake. 
Secondary Objective(s) 
To examine feasibility, acceptability, and preliminary efficacy of a family-
centered psychoeducational intervention designed to improve FP decision 
quality and family communication. 
Research Intervention 
A family-centered psychoeducational intervention, which involves a FP 
decision tool, which is used by a trained interventionist to facilitate 
communication about FP between patients and caregivers. 
IND/IDE #  
NA, Behavioral Intervention  
Study Population 
AYA (aged 12-25-years) newly diagnosed with cancer and 70 caregivers 
will be enrolled in the study. 
Sample Size 
40 
Study Duration for 
Participants 
1 year +/- 1 month 
Study Specific 
Abbreviations/ 
Definitions  
IRB – Institutional Review Board; PI – Primary Investigator; RA – 
Research Assistant; BTO – Behavioral Trials Office; DSMB – Data Safety 
Monitoring Board; OHRP – Office of Human Research Protocols; CITI - 
Collaborative Institutional Training Initiative; QC – Quality Control;  
eCRF – Electronic Case Report Form; AYA – Adolescent and Young 
Adult; QoL – Quality of Life; HBM- Health Belief Model; FP – Fertility 
Preservation; PACS – Parent Adolescent Communication Scale; BSDQ – 
Brief Subjective Decision Quality 
 
 
 
Objectives 
Aims: This randomized clinical trial (RCT) will test the feasibility, acceptability, and preliminary efficacy 
of a novel family-centered, psychoeducational intervention with known and newly identified factors to 
improve fertility preservation (FP) uptake, decision quality, and family communication among male 
adolescents and young adults (AYAs) newly diagnosed with cancer. The primary aim of this project is to 
examine preliminary efficacy of the psychoeducational intervention with regard to FP uptake.  
 
Hypotheses: The primary hypothesis is that compared to standard of care control group (routine fertility 
consult at diagnosis, n=20), AYAs in the intervention arm (routine fertility consult at diagnosis + FP 
Decision Tool and Facilitated Conversation by trained interventionist; n=20) will have higher rates of FP 
uptake. The secondary hypotheses are that families in the intervention group will report better FP decision 
quality and report improvements in family communication, compared to those in the control arm. 
 
Rationale: Nearly 9,000 males under age 20 are diagnosed with cancer in the U.S. each year1. With 5-year 
survival rates exceeding 80%, the population of male childhood cancer survivors is now close to 200,0002. 
Unfortunately, approximately 50% of male survivors have impaired fertility3-5, which can impede 
psychosexual development and diminish quality of life (QoL)6. Sperm banking is an established and 
effective method of FP for pubertal males7, yet only 25% of eligible adolescents bank sperm prior to 

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treatment8-12. As these AYAs complete therapy and approach their reproductive years, many survivors 
and their parents regret missed opportunities for FP and report distress about potential infertility13-16.  
 
Significant knowledge gaps exist with regard to pediatric FP:  
1. Most research examining FP decisions has focused on females17,18, despite a higher prevalence of 
cancer and treatment-related infertility in males19; 
2. Many studies examining FP predictors have been conducted years after therapy and are subject to 
recall bias15,20;  
3. Little attention has been paid to decision quality (satisfaction/regret) soon after FP decisions are 
made;  
4. Although parents make most healthcare decisions even in late adolescence/young adulthood, 
family factors including parent-child communication about FP, have not been examined.  
 
FP interventions have primarily focused on patient-provider communication and increasing knowledge21-
23, but in a recent study, half of 13-21-year old males who were told they were at risk for infertility still 
declined FP before treatment24. Notably, parents’ recommendation to bank was one of the strongest 
predictors of FP25,26. However, research has shown that parents do not prioritize fertility in the setting of 
their child’s new cancer diagnosis27,28. AYA survivors and parents in our recent pilot study had discordant 
attitudes about FP, with parents significantly underestimating the impact of potential infertility on their 
sons. Thus, knowledge is critical, but other individual and family factors must be identified to explain 
gaps between those pursue and decline FP. The relative ease but underutilization of sperm banking, as 
well as the psychosocial implications of infertility, demonstrate a need for novel family-centered 
interventions at the time of diagnosis to optimize FP uptake and decision quality for this unique and 
vulnerable population25,26. Such interventions have improved parent-child communication about sexual 
health topics and have shown promise in other conditions such as multiple sclerosis. However, research 
at the time of diagnosis has been limited by concerns that the burden of participating could be too heavy 
at such a tumultuous time. Previous research has shown that participating in FP focused research at the 
time of diagnosis is rated as beneficial or neutral by AYAs and families29. In our ongoing observational 
pilot (IRB17-00883) our recruitment rate is 93% for Visit 1 and 81% for Visit 2, which shows that a study 
of this kind is feasible at the time of diagnosis. 
 
 
Background 
A rapidly growing population of male childhood cancer survivors are at risk for infertility and distress. As 
the number of male cancer survivors rises, it is essential to minimize treatment late effects2,30. One of the 
most prevalent and significant complications among males is infertility3-5,30,31, which can impair 
psychosocial development and reduce quality of life6. National guidelines emphasize offering fertility 
preservation (FP) prior to initiation of cancer therapy32, and sperm cryopreservation is an established and 
generally noninvasive FP method for pubertal males. Early research suggested only males receiving high 
doses of alkylating agents should bank sperm33. However, variable sperm counts following equivalent 
doses of cyclophosphamide and scenarios in which patients have to move quickly from “low risk” 
treatments (which transiently impair sperm production) to “high risk” treatments, support the premise that 
all males receiving chemotherapy and/or gonadal radiation should consider FP at diagnosis3,5,32,34. Despite 
studies showing ~50% of male childhood cancer survivors have fertility impairment3,4,33,35, reports from 
many centers show only ~25% of pubertal males bank sperm prior to treatment8-12. As survivors enter 
their reproductive years, many regret missed opportunities for FP and experience distress about potential 
infertility11,13-16,36. Thus, interventions to improve FP uptake would have great potential for reproductive 
and psychological benefit.  
 

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Individual 
and 
family 
factors 
associated with sperm banking 
decisions remain poorly understood. 
Young 
age, 
cost, 
inadequate 
knowledge, and urgency to start 
treatment are common barriers to FP 
among AYA males with newly 
diagnosed cancer9,37-40. As a result, 
most fertility counseling and FP 
interventions 
have 
targeted 
healthcare providers and systems or 
provider-patient interactions21-23,41. 
While these are critical factors, less 
than half of male AYA advised 
about FP in a recent study actually banked sperm24, indicating knowledge is not sufficient. Other 
individual and family factors influencing FP decisions must be identified. The Health Belief Model 
(HBM) is often used to explain or predict an individual’s health-related behavior and uptake of health 
services42,43, and has informed effective interventions44. In the HBM (Figure 1), uptake of a procedure 
(FP) is dependent on the interplay of sociodemographic characteristics, fertility knowledge, perceived 
benefits and barriers (to FP), perceived risk, and cues to action (provider and parent recommendation). 
Studies in healthy women at risk for infertility have shown that the HBM effectively predicts FP uptake 
and engagement in fertility-optimizing behaviors45,46. More recently, the HBM has shown applicability to 
AYA males when FP decisions were studied retrospectively (after treatment began); higher perceived 
benefits of FP were associated with FP attempts26. The HBM was the guiding principle in developing the 
family-centered, psychoeducational decision tool intervention used in this study.   
 
The role of parents/caregivers in FP decisions is also understudied. This is relevant for 4 main reasons:  
1. Parents are the primary medical decision makers for their children into young adulthood. They 
act as gatekeepers and often manage what and how their children receive information about their 
illness and treatment. Research shows parents play an important role in decisions to bank 
sperm26,47-49.  
2. Parents report challenges in how and when to discuss fertility with their children14,48. A recent 
study found parents of children and AYAs (up to 20 years old) struggled to broach this topic14. 
Sperm banking discussions frequently include sensitive issues, such as sexual milestones including 
masturbation to collect a semen sample (and use of pornographic material), sexual 
history/experiences, and acceptability of biological versus alternative methods of parenthood26,50. 
These topics are inherently challenging, and some parents may even oppose healthcare providers 
initiating discussions due to religious, cultural, or personal views48,51.  
3. Many parents poorly estimate their sons/daughters’ reproductive desires and worries, and 
struggle with separating their own desires from those of their children52. A 2012 study in 
adolescent females recently diagnosed with cancer showed parents underestimated their daughters’ 
reproductive concerns28. Similarly, AYA males recently diagnosed with cancer ranked fertility in 
the top three life priorities, whereas parents were more concerned with their sons’ health27. Further, 
while many parents want to be grandparents in the future, they are often more willing to consider 
alternate means of family building (e.g. adoption) than their sons53. Discordance, and/or parents’ 
lack of awareness of their sons’ reproductive goals and concerns, may ultimately lead to lower 
decision quality.  
4. Notably, a recent study among 13-21-year old males within one week of initiation of cancer 
treatment demonstrated parents’ recommendation to bank sperm, as compared with the medical 

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team, was the most robust predictor of a FP attempt26,49. Thus, an intervention designed to increase 
caregiver-child communication should be examined within an established health behavior 
framework to examine its preliminary efficiency at increasing rates of FP in AYAs.  
 
 
We completed an observational pilot study (IRB17-00883) testing feasibility and initial effects of a 
decision tool examining individual and family factors that impact FP decisions. The pilot informed the 
development of the decision tool that will be used in this study intervention, as well as the interviews 
used at the 1-month and 1-year follow-up. Recruitment rates were above 90% for visit 1, further 
demonstrating the feasibility of this type of study at the time of diagnosis.  
 
 
Study Endpoints 
The overarching goal of this project is to examine preliminary efficacy of the psychoeducational 
intervention in a pilot RCT. The primary endpoint is FP uptake following the intervention. The secondary 
endpoints are the Brief Subjective Decision Quality (BSDQ) questionnaire scores at 1-month and 1-year 
post-intervention and the change in Parent Adolescent Communication Scale (PACS) scores from baseline 
to 1-month and 1-year post-intervention.  
 
 
Study Intervention 
Intervention Description: The intervention will be administered by a trained interventionist who has 
participated in ENRICH/ECHO, an oncofertility communication training program. The interventionist 
will administer the digital FP Decision Tool to families in the intervention arm and will facilitate a guided 
discussion about responses and discrepancies. The FP Decision Tool asks 25 questions examining each 
AYA’s thoughts or feelings regarding parenthood and fertility preservation. The parent version asks the 
same 25 question, plus an additional 9 questions asking the parent to rate their son’s feelings on certain 
topics (i.e. whether their son wants to have a child, whether their son would be as happy with an adopted 
child versus a biological child). Items are coded based on the domains of the HBM (perceived benefits, 
perceived barriers, perceived threats, self-efficacy, and cues to action). The decision tool was developed 
using the HBM and is based on factors associated with FP uptake and decision quality in the literature, as 
well as new factors identified in the preliminary work of this research group. 
 
AYAs and parents independently complete the electronic tool; an automated Quick View report is 
generated, highlighting misconceptions and parent-AYA discrepancies. The interventionist uses this 
information to facilitate a conversation with AYA and their caregiver(s). Specifically, the interventionist 
uses standardized prompts/language to: 1) address knowledge gaps/misconceptions, 2) share participants’ 
fertility-related values and goals with one another*, 3) highlight discrepancies between responses*, and 
4) promote family communication and consensus building. The facilitated conversation will be audio 
recorded. 
 
Intervention Rationale: The intervention is designed to take participant’s answers and provide a 
conversation tailored to their questions and needs. It will be carried out by one interventionist that has 
completed ENRICH/ECHO (oncofertility communication) training to ensure the intervention will not 
unnecessarily burden patients and families. Additionally, the intervention is designed to be short (less than 
20 minutes). It is expected that participants will be present for the entire intervention in order to have their 
baseline data included in analyses. 
 
Interventionist Training and Tracking: The interventionist will have a degree in a health-related field such 
as psychology or nursing. They will be trained in ENRICH/ECHO, an oncofertility communication 
training program. This training program include several modules to assist oncology health professionals 

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effectively communicate key information regarding reproductive health to AYA. Additionally, the 
interventionist will be extensively trained in the use of the FP Decision Tool, the interactive report, and 
the communication intervention by Drs. Nahata and Gerhardt.  
 
Intervention Fidelity: Consistent delivery of the study interventions will be monitored throughout the 
intervention phase of the study. A random selection of audiotapes of the interactions will be reviewed by 
trained research staff on an ongoing basis who will complete a checklist of the five points to be covered 
in the facilitated conversation to monitor intervention fidelity. The five points are: 1) address knowledge 
gaps/misconceptions by referring families back to the fertility navigator, 2) share participants’ fertility-
related values and goals with one another, 3) highlight discrepancies between responses, and 4) promote 
family communication and consensus building. 
 
 
*Not applicable if only one family member is participating. 
 
 
Procedures Involved* 
Study Design: This single-site study is an RCT of a family-centered psychoeducational decision tool 
intervention. Participants will be male AYA (ages 12-25-years) newly diagnosed with cancer and their 
caregivers. Families will be randomized (1:1) to either receive 1) standard of care fertility consult or 2) 
standard of care fertility consult + the family-centered psychoeducational decision tool and facilitated 
communication. 
This study seeks to improve FP in AYA males newly diagnosed with cancer by designing and evaluating 
the feasibility, acceptability, and preliminary efficacy of a family-centered psychoeducational intervention 
to optimize FP uptake and decision quality. To this effect, we will employ a blinded design. Both control 
and experimental groups will be pulled from one population (males with new cancer diagnoses) to control 
for biases and individual differences. Participants will be randomized and staff who consent families and 
conduct data collection activities will be blind to treatment group. The CBH Behavioral Trials Office 
(BTO) will maintain the randomization sequence and randomization to study group will be implemented 
through the data management software REDCap, which allows the randomization sequence generated by 
the statistician to be allocated via REDCap Randomization Module. In this module, the randomization 
sequence and group assignments are protected from the view of selected staff who use the REDCap 
program. Only BTO staff will have REDCap permissions to see the randomization sequence. Only the 
interventionist will have REDCap permissions to randomize and see the allocated group assignment when 
they log-on to REDCap. Outcome assessors (RAs) and investigators will be blinded to the intervention 
and will not have access to treatment allocation information in REDCap. 
 
 

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Baseline (Visit 1): At baseline (Visit 1), research staff will approach families in-person (at inpatient or 
outpatient clinic) or via phone, Webex, or email. Families (AYAs and parents) will receive a short briefing 
on the purpose of the study, provide informed consent, and staff will administer baseline measures after 
the family has consented to participate in the study. All measures will be completed by the child and both 
caregivers (when available). In the event that one family member is unable to participate or declines 
participation, the other family member(s) will be allowed to enroll separately. If a caregiver is only 
available remotely, a REDCap link to the survey will be provided electronically, and the caregiver will be 
included in the intervention remotely (e.g. via phone). If the entire family is only available remotely, 
participants will be contacted via phone and will be emailed a Webex link and REDCap links to participate 
in the study. The activities completed at Visit 1 are: 
• Informed Consent: Informed consent (and assent for participants 12-17 years of age) is obtained 
by study staff before data collection procedures or randomization. For adolescents between 12-17 
years of age, informed consent will be obtained by a parent or legal guardian, and assent will be 
provided by the adolescent. Those who are between 18-25-years of age will provide informed 
consent for themselves to participate.  
• Demographics: Research staff ask participants to answer questions about age, race, ethnicity, 
religion, education, income, whom they live with, and their relationship to their child. AYAs will 
be asked to answer an additional four questions about their communiation with their parents. These 
questions were taken from the Parent-Adolescent Communication Scale (PACS). 
• Randomization: Families who consent to participate will be randomized (by the interventionist) to 
the control arm or intervention arm (family-centered psychoeducational intervention) after 
completing baseline measures. If the family is randomized to the control arm, the interventionist 
will inform the family that they were randomized to the control group and debrief the family. If 
the family is randomized to the intervention arm, the interventionist will inform the family that 
they were randomized to the treatment group and conduct the intervention immediately following 
randomization. 
 
1-month Follow-up (Visit 2, Baseline + 1 to 2 months): At the 1-month follow-up (Visit 2) research 
staff will contact control and intervention families in-person (at inpatient or outpatient clinic) or via phone 
or email. Families (AYAs and parents) will be reminded about the study and be asked to complete follow-
up activities. All measures will be completed by the child and both caregivers (when available). If the 
child and/or second caregiver did not complete Visit 1, they will be invited to complete Visit 2. The 
activities completed at Visit 2 include: 
• FP Decision Survey: Participants will complete a brief survey about their FP decision. Items will 
include questions such as who participants talked to about their FP decision and who made the 
final decision regarding FP. Surveys will not be scored but questions will be used to guide analyses. 
• Brief Subjective Decision Quality measure (BSDQ): A six-item scale used to measure decision 
satisfaction and administered to AYA and both parents. Item will be scored into a composite 
decision satisfaction score (0-7). 
• The Parent-Adolescent Communication Scale (PACS): A twenty-item scale used to measure 
perceived communication between AYA and parents will be administered to AYA and both 
parents. AYA will rate communication with both mother and father. Parents will only rate 
communication with son. Item scored into three scales: openness, problems, and a composite 
communication score. 
• Parenthood Goals Survey: A sixteen-item survey used to examine parental and AYA views on 
parenthood. This survey is a modified version of the FP Decision Tool. This survey will be given 
to families in both the control and intervention group. 
• Feasibility and Acceptability Survey: For the intervention group only, AYA and parents will fill 
out a twelve-item scale that will be used to assess satisfaction with the intervention structure and 

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content. The scale will include a final open-ended question asking for comments/suggestions about 
the intervention. The parent survey will include an additional item specific to how the intervention 
helped them help their child.  
• Brief Interview: Study staff will also complete a brief, 15-minute semi-structured interview 
separately with each participant. The interview will focus on what participants discussed in relation 
to FP, how they made their decision, how they feel about their decision, and how they feel overall 
about their fertility counseling experience. The final question will give families the opportunity to 
share any additional thoughts. Interviews will take place away from other participants to allow 
each interviewee to speak freely. Interviews will be audio recorded and transcribed verbatim and 
coded for thematic content by trained research staff. 
 
1-year Follow-up (Visit 3, Baseline + 1-year (+/- 1 month): At the 1-year follow-up (Visit 3) research 
staff will contact control and intervention families in-person (at inpatient or outpatient clinic) or via phone 
or email. Families (AYAs and parents) will be reminded about the study and research activities. All 
measures will be completed by the child and both caregivers (when available). The activities completed 
at Visit 3 include: 
• Brief Subjective Decision Quality measure (BSDQ): A seven-item scale used to measure decision 
satisfaction and administered to AYA and both parents. Item will be scored into a composite 
decision satisfaction score (0-7). 
• Parenthood Goals Survey: A sixteen-item survey used to examine parental and AYA views on 
parenthood. This survey is a modified version of the FP Decision Tool. This survey will be given 
to families in both the control and intervention group. 
• Brief Interview: Study staff will also complete a brief, 15-minute semi-structured interview 
separately with each participant. The interview will focus on what participants found helpful in 
making their decision, how their feelings about their decision have changed over time, what they 
would have liked to have known prior to their decision, and information and or support related to 
fertility that will help them moving forward.  Interviews will take place away from other 
participants to allow each interviewee to speak freely. Interviews will be audio recorded and 
transcribed verbatim and coded for thematic content by trained research staff. 
 
Risk Minimization: The benefits of this research outweigh the minimal risk, both for participants and 
certainly for society, which would benefit substantially from development of feasible interventions to 
assist in FP decisions for newly diagnosed cancer patients, thus making a favorable risk-benefit ratio. 
Additionally, previous research has found that participation in family-centered research focused on FP, 
before treatment begins, is viewed as beneficial or neutral by participants29. However, the following 
procedures are implemented to further minimize risk. 
1. Approval of all procedures connected with this study is obtained and maintained from the 
Institutional Review Board at NCH. 
2. Informed consent (and assent for participants 12-17 years of age) will be obtained, prior to any 
study procedures. Caregivers will provide informed consent for their children aged 12-17 years. 
Participants over the age of 18 will consent for themselves to participate.  
3. Participants will be reminded of the voluntary nature of their involvement. 
4. All study personnel who will be working with data or protected health information will be properly 
trained, which includes completing the online Collaborative Institutional Training Initiative (CITI) 
certification and undergoing a day-long instructional seminar at the hospital for protecting human 
subjects and engaging in best practices for responsible conduct of research. Additionally, per NIH 
policy, clinical trial staff who are involved in the design, conduct, oversight, or management of 
the trial will be trained in Good Clinical Practice (GCP).  

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5. Staff will receive extensive training in administration of all questionnaires as well as professional 
behavior with families. The interventionist will have additional training in ENRICH/ECHO, an 
oncofertility communication training program. 
6. Staff will be trained to contact the PI immediately if an adverse event occurs, and corrective action, 
including IRB notification, will occur, if necessary. 
7. Once enrolled in the study, participants (patients and parent(s)) will receive a study ID number. 
This number will be entered on their survey, be it paper or online (i.e., using REDCap, an online 
survey system that is housed securely on the NCH research drive). The only link between the 
participant’s name and study ID will be an electronic tracking sheet, which will be password 
protected and stored on the secured research network drive of the hospital. The tracking sheet will 
contain the following protected health information: name, medical record number, date of birth, 
address, phone number, email address, diagnosis, and dates of study visits. Only direct study 
personnel will have access to this file. Participants will be identified in all datasets by their study 
ID. 
8. If participants find any of the questions upsetting, the study team will be available to discuss the 
concerns or reconnect the participant to their assigned psychosocial provider at Nationwide 
Children’s Hospital. Participants may also skip any questions that they do not want to answer.  
9. Online questionnaire data and voice recordings will be housed behind a secure firewall on the 
NCH research internet server. Any data that is not collected in a digital format will be kept in a 
locked cabinet within a locked office at the hospital. Only study personnel will have access to this 
information.  
 
Data Collection Procedures: Data described in Section 6.0 will be collected for all participants. Data will 
be collected by trained research staff using an online survey tool (e.g., REDCap) or paper and pen 
questionnaires. Some data may be obtained from the participant’s electronic medical record. Data 
collected at Visit 1 will be collected before the intervention begins, and data collected at Visits 2 and 3 
will be collected after the intervention ends.  
 
End of Study Definition: A participant is considered to have completed the study if they completed the 
baseline assessment, as well as the 1-month and 1-year follow-up assessments. 
 
Lost-to-Follow-up Definition: A participant will be considered lost to follow-up if they fail to return for 
scheduled visits and study staff are unable to contact the participant after at least 3 attempts via phone or 
email. 
 
 
Data and Specimen Banking* 
Data Storage: Online questionnaire data will be housed behind a secure firewall on the NCH research 
internet server. Electronic recordings will be stored on NCH computers. Data collected on paper will be 
entered into electronic study databases and original files will be kept in a locked cabinet within a locked 
office at the hospital. Only direct study personnel will have access to this information. 
 
Data Description: Data described in Section 6.0 will be collected for each participant. 
 
Data Sharing: It is NIH policy that the results and accomplishments of the activities that it funds should 
be made available to the public (see https://grants.nih.gov/policy/sharing.htm). If data are shared, the PI 
will ensure all mechanisms used to share data will include proper plans and safeguards for the protection 
of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly 
de-identified and will not be traceable to a specific study participant). Plans for archiving and long-term 

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preservation of the data will be implemented, as appropriate. In addition, this study will be conducted in 
accordance with the following publication and data sharing policies and regulations: 
• National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access 
to the published results of NIH funded research. It requires scientists to submit final peer-reviewed 
journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon 
acceptance for publication. 
• This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-
Funded Clinical Trial Information and the Clinical Trials Registration and Results Information 
Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information 
from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to 
publish results in peer-reviewed journals.   
 
 
Sharing of Results with Subjects* 
Individual subject results will not be shared directly with participants. Overall study results may be shared 
with participants via study newsletters or similar.   
 
 
Study Timelines* 
Participants will be enrolled in this study for approximately 1 year. 
 
We expect it will take 48 months to enroll all participants and that the primary analysis will be completed 
within one year after enrollment is completed.  
 
 Inclusion and Exclusion Criteria* 
Eligibility:  After an initial and new cancer diagnosis, an automatic referral is placed for a fertility consult 
and Dr. Nahata is immediately notified of the age and sex of the patient. The patient and family then 
consult with a fertility navigator to discuss fertility options, per standard of care. During the fertility 
consult the fertility navigator will assess pubertal status/eligibility for sperm banking, provide verbal and 
written information about infertility risk and FP options (masturbation/sperm extraction), and then 
introduce the study. The patient’s eligibility is communicated to study staff. If the participant is eligible, 
study staff will approach the family for recruitment purposes. 
 
Inclusion Criteria: Child participants must meet all the inclusion criteria to be eligible for the study. The 
inclusion criteria are: 
• Male 
• Aged 12-25 years  
• Expected to have adjuvant therapy (chemotherapy and/or gonadal radiation) for newly diagnosed 
cancer 
• Pubertal (at least Tanner stage 2-3, eligible for sperm banking as determined in the fertility consult) 
• Proficient in English 
 
Primary caregivers of eligible children are also invited to participate if they have participated in the fertility 
consult. These caregivers may include biological parents, adoptive patterns, other primary caregivers (e.g. 
grandparents), or same sex parents. 
  
Exclusion Criteria: Child participants meeting any of the exclusion criteria at baseline will be excluded 
from the study. The exclusion criteria are: 
• Cognitive deficit that precludes completing measures  
• Parents are non-English speaking 

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 Vulnerable Populations* 
This study will include children who have not obtained the legal age to consent. The following safeguards 
will be followed to protect their rights and welfare: study staff will not approach without at least one parent 
present, staff will make it clear that if the child feels overwhelmed or uncomfortable they may stop 
participating at any time, and, when appropriate, staff may approach parents separately from the child to 
ensure that child is able to complete study measures. 
 
 Local Number of Subjects 
This study will enroll 40 male AYAs and 70 caregivers, at the single-site, Nationwide Children’s Hospital. 
There are approximately 30 males newly diagnosed with cancer in our target age range each year. Taking 
into account our inclusion/exclusion criteria, infrastructure of the fertility consult service, and recruitment 
rates in our pilot (>90%), we anticipate completing our recruitment goals within the allocated timeframe.  
 
 Recruitment Methods 
At Nationwide Children’s Hospital (NCH), every patient with a new cancer diagnosis has an automatic 
referral placed to the multidisciplinary Fertility and Reproductive Health Team. The oncofertility 
navigator meets with the patient and family to assess pubertal status and achievement of sexual milestones 
(masturbation), review infertility risk, present FP options, and discuss logistics (including cost). After the 
oncofertility navigator completes the consult and introduces the study to the family, the study team will 
approach those who are eligible and invite their participation. Study staff will primarily recruit in person, 
in clinic. As the first assessment will occur immediately after the fertility consult (before cancer 
treatment), most AYA have two parents present. If participants are unavailable at times of appointments 
or admissions, study staff may contact families via telephone or email. 
 
If a participant is not present during the time of in person recruitment, but is available remotely, study 
staff will obtain contact information from the present participants and will initiate a phone call. The study 
staff will then go through recruitment with the participant over the phone or via Webex. 
 
Incentives: Families will receive the following incentives for their participation (participants approached 
in person will receive their incentive at the conclusion of a visit. Participants approached remotely will 
receive incentives via mail): 
• Baseline: $10 ClinCard for each participant 
• 1-month follow-up: $20 ClinCard for each participant 
• 1-year follow-up: $30 ClinCard for each participant 
 
Retention: Based on our previous work, engagement at 1-month post intervention is 100% due to patients 
actively being on treatment for their cancer diagnosis, routine clinical follow-up appointments, and other 
treatment-related in and outpatient encounters taking place at Nationwide Children’s Hospital. Therefore, 
we anticipate similarly high retention in this study. However, additional strategies will be used to keep 
families engaged throughout the study, including the 1-year post-intervention follow up. These include: 
• Coordinating follow-up appointments with already scheduled clinic visits 
• Routine correspondence with their medical team, and checks of the NCH electronic medical record 
for updated contact information or upcoming appointments within the hospital  
• Check-in phone calls, emails, and/or text messages 
 
 Withdrawal of Subjects* 

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Participants may be withdrawn if the intervention causes distress and it is determined by the interventionist 
and/or medical team that is not in the participant’s best interest to continue. If the participant withdrawals 
from the intervention, study staff will encourage completion of study data collection, per intent-to-treat 
methodology. 
 
 Risks to Subjects* 
It is expected that completing study questionnaires and interviews will introduce minimal risk to 
participants, yet the study team acknowledges that the new cancer diagnosis will be a stressor for AYAs 
and parents. Participants may experience some discomfort and/or embarrassment when completing survey 
items or interviews about FP. Given the study design, all patients and caregivers will have already received 
information about FP during the clinical fertility consult, per standard of care. Parents or AYAs may 
experience distress when asked about parent-child communication, although we do not expect this to have 
severe or long-lasting effects on the respondent. In preliminary work, parents and AYA have completed 
measures, similar to those in this study, within 10 minutes and provided positive feedback about the 
experience, emphasizing their perceived importance of addressing this topic. Loss of confidentiality is 
also a potential risk, although no more so than in any other research study. The study team will take every 
precaution to prevent this. 
 
 Potential Benefits to Subjects* 
Participants may or may not receive direct benefits from participating in this study. Questionnaires may 
help patients and families make FP decisions and the family-centered, psychoeducational decision tool 
may increase caregiver/child communication. This study also has strong potential to improve care for 
other AYA with cancer and their families, by optimizing FP rates and decision quality. 
 
 Data Management* and Confidentiality 
Data Collection & Management: Data collection will be the responsibility of the study staff under the 
supervision of the PI. The PI will be responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 
All source documents will be completed in a neat, legible manner to ensure accurate interpretation of data. 
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant consented/enrolled in the study. Data recorded in the electronic case 
report form (eCRF) derived from source documents will be consistent with the data recorded on the source 
documents. 
 
Clinical data (including AEs) and clinical laboratory data will be entered into secure study databases, if 
needed. The data system includes password protection and internal quality checks, such as automatic range 
checks, to identify data that appear inconsistent, incomplete, or inaccurate. Clinical data will be entered 
directly from the source documents. 
 
 
Only authorized study staff will have access to study data.  
 
Sample Size Determination: The sample was determined based on the medium-large effects found in our 
previous work and work by Klosky et al. and is sufficient to find similar sized effects; thus our proposed 
sample size will enable us to detect effect sizes previously found in the literature26,54-56.  
 
A sample size of n=20 per group will provide 80% power to detect large effect sizes of w=.45 for the chi-
square analysis and d=.91 for the independent samples t-test. Because this is a pilot study, the focus will 
be on generating reliable effect size estimates for our primary outcome (FP uptake) comparing the 

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intervention to standard care, rather than on statistical significance (using two-sided type I error rates 
(alpha values) of no more than .05). The proposed sample size is sufficient for gleaning this information. 
 
Data Analysis Plan: Analyses will be conducted according to intent-to-treat methods, in which all 
randomized participants are included. Summary statistics will be calculated and qualitative methods used 
to evaluate the feasibility of recruiting and enrolling children.   
 
Chi-squared and t-tests will be used to evaluate primary and secondary outcomes. A chi-square analyses 
will examine the primary outcome of FP uptake (Y/N) as a function of treatment group status An 
independent samples t-test will examine whether the secondary outcomes of decision quality (numerical 
score on the BSDQ and family communication (numerical score on the PACS and difference scores on 
the PACS for AYA and parents) change between 1-month and 1-year follow-ups. Pearson’s r correlations 
will be run to see if FP uptake (Y/N) is related to decision quality or family communication. 
The two groups (intervention and control) will be examined in an exploratory manner to assess potential 
differences in factors known to affect FP decisions such as demographics (e.g. age), urgency to start 
treatment, knowledge, provider recommendation, and parent recommendation, as well as novel factors 
such as quality of parent-child communication. We will also examine these baseline factors as covariates 
within an analysis of covariance to see if might have a substantial impact on our effect size estimates for 
the larger RCT. 
 
Quality Control of Data: Internal quality management of study conduct, data collection, documentation 
and completion will be conducted, under the direction of the PI. Quality control (QC) procedures will be 
implemented as follows: 
• Informed consent: Study staff will review both the documentation of the consenting process as 
well as a percentage of the completed consent documents. This review will evaluate compliance 
with GCP, accuracy, and completeness. Feedback will be provided to the study team to ensure 
proper consenting procedures are followed. 
• Source documents and the electronic data: Some data will be initially captured on source 
documents and will ultimately be entered into the study database. Some data will be entered 
directly into an electronic data capture system. To ensure accuracy of data initially captured on 
source documents, site staff will compare a representative sample of source data against the 
database, targeting key data points in that review. Some data will be entered directly into study 
databases. Electronic databases will be programed to alter study staff and/or participants of out of 
range values and/or potential errors.  
• Protocol Deviations: The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level 
of concern. This protocol defines a protocol deviation as any noncompliance with the clinical trial 
protocol, International Council on Harmonization Good Clinical Practice (ICH GCP), or Manual 
of Procedures (MOP) requirements. The noncompliance may be either on the part of the 
participant, the investigator, or the study site staff. As a result of deviations, corrective actions will 
be developed by the site and implemented promptly, if needed. These practices are consistent with 
ICH GCP: 
o Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3 
o Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1 
o Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2. 
 
It is the responsibility of the PI to use continuous vigilance to identify and report deviations as required 
by the IRB and the funder, as well as oversee quality control of data. The site investigator is responsible 
for knowing and adhering to the reviewing IRB requirements. Should independent monitoring become 

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necessary, the PI will provide direct access to all trial related sites, source data/documents, and reports for 
the purpose of monitoring and auditing by the funding agency, and inspection by local and regulatory 
authorities. 
 
Handling of Data: The following data will be collected for each participant 
• Demographics (e.g. age, race, ethnicity). 
• Medical information (e.g. cancer type, treatment levels, infertility risk), collected via medical chart 
review. 
• Information about decision and FP-related thoughts and feelings, collected via decision 
tool, parenthood goals surveys, andintervention. 
• Participant report of communication with son or parents, collected via PACS survey. 
• Participant report of decision satisfaction, collected via BSDQ. 
• Participant report of feasibility and acceptability of participation in research. 
• Open-ended interviews, recorded and transcribed verbatim. These interviews will focus on 
how participants made their decision, how they feel about their decision, alternatives they 
had considered, more information or support they would like to have had prior to their 
decision, what they would find helpful moving forward related to their fertility and future 
parenthood, and how participating in the study impacted them. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be collected and maintained in REDCap, a secure electronic data capture system on the NCH research 
internet server. Some data may be collected on paper and will be entered into REDCap. Individual 
participants and their research data will be identified by a unique study identification number. Other types 
of data (e.g., audio recordings from the interviews and intervention) may be kept in a locked cabinet within 
a locked office at the hospital or on an NCH computer. Only direct study personnel will have access to 
this information. The study data entry, study management systems, and related study files will be secured 
and password protected. 
 
Study documents will be retained for a minimum of 2 years after the formal discontinuation of clinical 
development of the study intervention. These documents will be retained for a longer period, if require by 
local regulations. 
 
 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
Safety oversight for the study will be under the direction of the NCH IRB, as well as a Data Safety 
Monitoring Board (DSMB). The DSMB will consist of two faculty members from NCH. The first is a 
Professor of Pediatrics and Psychology at The Ohio State University and Director of the Biobehavioral 
Outcomes Core at NCH. She is a leading researcher in psychosocial outcomes among children and 
adolescents with significant health challenges, who has experience developing and executing intervention 
research with pediatric populations, as well as conducting multi-site studies involving complex multi-
method longitudinal assessments. The second is an Associate Professor at The Ohio State University, an 
attending physician in Hematology/Oncology at NCH, director of the AYA Oncology Program, and a 
member of the Fertility and Reproductive Health team at NCH. He has been heavily involved in clinical 
research through the Children’s Oncology Group, specifically in the enrollment and management of 
patients on clinical trials.  
 
The DSMB will be responsible for safeguarding the interests of trial participants, assessing the safety and 
efficacy of the intervention(s) during the trial, and for monitoring the overall conduct of the clinical trial. 
The DSMB will periodically review study results, evaluate the study interventions and procedures for 

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adverse effects, and judge whether the overall integrity and conduct of the trial remain acceptable. 
Moreover, the DSMB may formulate and put forth recommendations to the study team, relating to the 
selection/recruitment/retention of participants and their management, and compliance to protocol 
specified regimens and the procedures for data management and quality control. 
 
Summary reports regarding number of enrolled participants, and safety and risk (including any adverse 
events and unanticipated problems), will be generated at six-month intervals for the DSMB. Adverse 
events will be reported to the DSMB and IRB when they occur to determine if new procedures need to be 
implemented. 
 
Safety information will be collected during routine interactions (phone calls, in-person visits, data 
collection timepoints) with participants.  
 
Once the study begins, the study team will meet weekly to review the progress of the study (including 
information such as recruitment rate, reasons for declining participation, reasons for attrition), review data 
entry, assure data accuracy, detect potential errors at an early stage, and monitor staff compliance with 
training, regulatory, and confidentiality procedures.  
The research will be suspended if the DSMB determines that is the best course of action, based on the data 
provided for review.  
 
 Adverse Events & Serious Adverse Events 
Definitions: This protocol defines an adverse event (AE) as any negative physical or emotional condition 
that was not present at baseline. This protocol defines a serious adverse event (SAE) as any AE that results 
in hospitalization, permanent disability, or death. 
 
Severity: All AEs and SAEs are assessed by the principal investigator, and if necessary, another 
professional with clinical experience in the study population to determine their severity.  
 
For AEs and SAEs, the following guidelines are used to describe severity: 
• Mild: Events require minimal or no treatment and do not interfere with the participant’s daily 
activities. 
• Moderate: Events result in a low level of inconvenience or concern with the therapeutic measures. 
Moderate events may cause some interference with functioning. 
• Severe: Events interrupt a participant’s usual daily activity and may require systemic drug therapy 
or other treatment. Severe events are life-threatening or incapacitating.  
 
Relationship to the Intervention: All AEs and SAEs are assessed by the principal investigator, and if 
necessary, another professional with clinical experience in the study population to determine their 
relationship to study intervention. The evaluation of relatedness considers etiologies such as natural 
history of the underlying disease, concurrent illness, concomitant therapy, study-related procedures, 
accidents, and other external factors.  
 
The degree of certainty about causality is graded using the following categories: 
• Related: The event is known to occur with the study procedures, there is a reasonable possibility 
that the study procedures caused the event, or there is a temporal relationship between the study 
procedures and the event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study procedures and the event. 

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• Not Related: There is not a reasonable possibility that the study procedures caused the event, there 
is no temporal relationship between the study procedures and event onset, or an alternate etiology 
has been established. 
 
Expectedness: All AEs and SAEs are assessed by the principal investigator, and if necessary, another 
professional with clinical experience in the study population to determine their expectedness. 
Expectedness is assessed based on the awareness of AEs and/or SAEs previously observed, not on the 
basis of what might be anticipated from the properties of the study intervention.  
 
Expectedness of the event is assessed using the categories below: 
• Expected: An event is considered expected if the nature, severity, or frequency of the event is 
consistent with the risk information previously described for the study procedures. 
• Unexpected: An event is considered unexpected if the nature, severity, or frequency of the event is 
not consistent with the risk information previously described for the study procedures. 
 
Time Period and Frequency for Event Follow-up: Research staff record events with occurring after 
informed consent is given up until the end of the intervention. The occurrence of AEs and/or SAEs may 
come to the attention of study personnel during study visits, interviews, and questionnaires; or when a 
study participant presents for medical care. 
 
AEs and SAEs are captured on the appropriate case report form (CRF). Information collected includes 
event description; time of onset; clinician assessment of severity, relationship to study procedures 
(assessed only by those with the training and authority to make a diagnosis), expectedness; and time of 
resolution/stabilization of the event. All AEs and SAEs occurring during the above-mentioned timeframe 
are documented appropriately regardless of relationship to the intervention. Events are followed for 
outcome information until resolution or stabilization. 
 
Reporting: AEs are reported to the NCH IRB at least annually. AEs are reported to the DSMB at each 
meeting. AEs are reported to NCI according to their recommended timelines.  Per NCH HRP-103 (updated 
12/10/18), SAEs determined to be related to the intervention and unexpected are reported to the NCH IRB 
within 5 business days of discovery; other SAEs are reported to the NCH IRB annually. SAEs are reported 
to the DSMB and to NCI according to their recommended timelines.  
 
 Unanticipated Problems 
Definition: This protocol uses the definition of Unanticipated Problems as defined by the Office for 
Human Research Protections (OHRP). OHRP considers unanticipated problems involving risks to 
participants or others to include, in general, any incident, experience, or outcome that meets all the 
following criteria: 
• Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research ("possibly related" means there is a reasonable 
possibility that the incident, experience, or outcome may have been caused by the procedures involved in 
the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
 

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Reporting: Unanticipated problems (UPs) are reported by the PI to the Institutional Review Board (IRB) 
and the DSMB within 5 business days of discovery. SAEs are initially reported to NCI within five 
calendar days, with a full report filed within 10 calendar days. 
 
 Provisions to Protect the Privacy Interests of Subjects 
Plan to Protect Participant Privacy: Participant confidentiality and privacy is strictly held in trust by the 
participating investigators, their staff, the safety and oversight monitor(s), and the funding agency. This 
confidentiality is extended to the data being collected as part of this study. Data that could be used to 
identify a specific study participant will be held in strict confidence within the research team. No 
personally-identifiable information from the study will be released to any unauthorized third party without 
prior written approval of the funding agency. 
 
All research activities will be conducted in as private a setting, as much as possible. 
 
Authorized representatives of the sponsor, study monitors, representatives of the Institutional Review 
Board (IRB), or regulatory agencies may inspect all documents and records required to be maintained by 
the investigator. The clinical study site will permit access to such records. 
 
The study participant’s contact information will be securely stored for internal use during the study. At 
the end of the study, all records will continue to be kept in a secure location for as long a period as dictated 
by the reviewing IRB, Institutional policies, or other requirements. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be collected and maintained in REDCap, a secure electronic data capture system on the NCH research 
internet server. Individual participants and their research data will be identified by a unique study 
identification number. Other types of data (e.g., audio recordings from the interviews and intervention, 
paper surveys) may be kept in a locked cabinet within a locked office at the hospital or on an NCH 
computer. Interviews will be audio recorded and transcribed verbatim. Both the audio files and 
transcriptions will be stored on a secured intranet server only accessible by research staff. All identifying 
information will be removed from the transcripts and audio files will be deleted after data collection is 
completed. Only direct study personnel will have access to this information. The study data entry, study 
management systems, and related study files will be secured and password protected. 
 
To help participants feel at ease and able to speak openly, study staff will be trained in active interviewing 
techniques (e.g. active listening, empathizing, proper body language). After interviews, staff will debrief 
with the principal investigators and address any issues that may have arisen during the interview. 
 
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), has 
issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, clinical 
or other human subjects research funded wholly or in part by the federal government. Recipients of NIH 
funding for human subjects research are required to protect identifiable research information from forced 
disclosure per the terms of the NIH Policy (see https://humansubjects.nih.gov/coc/index). As set forth in 
45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH-supported research covered 
by this Policy are required to establish and maintain effective internal controls (e.g., policies and 
procedures) that provide reasonable assurance that the award is managed in compliance with Federal 
statutes, regulations, and the terms and conditions of award. It is the NIH policy that investigators and 
others who have access to research records will not disclose identifying information except when the 
participant consents or in certain instances when federal, state, or local law or regulation requires 

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disclosure. NIH expects investigators to inform research participants of the protections and the limits to 
protections provided by a Certificate issued by this Policy. 
 
 Compensation for Research-Related Injury 
N/A 
 
 Economic Burden to Subjects 
N/A 
 
 Consent Process 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
participant and written documentation of informed consent is required prior to starting any data collection 
procedures or randomizing the family. Families will be given a copy of the signed consent form for their 
records.  
 
Caregivers will provide informed consent for their children aged 12-17 years, as well as themselves. 
Child participants who are 18 years old or older will provide consent for themselves. Children, aged 12-
17, will additionally provide assent. Informed consent and assent (if applicable) will be obtained, prior 
to any study procedures taking place. During the process, the study will be described to participants and 
families will have the opportunity to discuss participation, before enrolling. Throughout the study, 
participants will be reminded of the voluntary nature of their involvement. 
 
Consent will take place either in-person or via remote connection. In-person participants will each receive 
a copy of the consent form to follow along as the study staff reviews its content. The study staff will then 
collect all participants’ signatures on a single form. Consent will be obtained from remote participant(s) 
by sending an electronic REDCap link via email. During the process, participants will be connected in 
via phone or Webex and will have the opportunity to discuss participation. Participants will be provided 
with an electronic copy of the consent form after submitting the REDCap version. 
 
Trained study staff will obtain consent according to IRB policy, SOP: Informed Consent Process for 
Research (HRP-090) to ensure participants understand and do not feel coerced into consenting. 
 
Waiver of Written Documentation of Consent (verbal) 
N/A 
 
 Process to Document Consent in Writing 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
participant and written documentation of informed consent is required prior to starting any data collection 
procedures or randomizing the family. Families will be given a copy of the signed consent form for their 
records. 
 
 Setting 
Research will be conducted at a single-site, Nationwide Children’s Hospital (Columbus, OH). After an 
initial and new cancer diagnosis, an automatic referral is placed for a fertility consult and Dr. Nahata is 
immediately notified of the age and sex of the patient. The patient and family then consult with a fertility 
navigator to discuss fertility options, per standard of care. During the fertility consult the fertility 
navigator will assess pubertal status/eligibility for sperm banking, provide verbal and written information 
about infertility risk and FP options (masturbation/sperm extraction), and then introduce the study. The 

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patient’s eligibility is communicated to study staff who then approach the family for recruitment 
purposes. 
 
All study procedures except interviews will take place in the patient’s hospital room (or clinic room), or 
other private location at Nationwide Children’s Hospital. Interviews will be carried in private 
consultation rooms on the treatment floors, or other private location at Nationwide Children’s Hospital. 
In the event that a parent (or the entire family) is not present, surveys or interviews may be administered 
over the phone or via Webex. 
 
 Resources Available 
Feasibility: There are approximately 30 males newly diagnosed with cancer in our target age range each 
year. Taking into account our inclusion/exclusion criteria, infrastructure of the fertility consult service, 
and recruitment rates in our pilot (>90%), we anticipate completing our recruitment goals within the 
allocated timeframe.  
 
Time Devoted to the Research: Dr. Nahata assembled a multidisciplinary team with expertise in mixed 
methods research; family systems and communication; and the design, implementation, and analysis of 
clinical trials to support and carry out this project.   
 
As the Principal Investigator of the project, Dr. Nahata will assume overall responsibility for the 
administrative and scientific conduct of the study. Dr. Nahata will maintain the consistency and integrity 
of study materials and training related to data collection. She will submit and gain IRB approval for the 
RCT and will coordinate, conduct and/or supervise all aspects of the recruitment process, data collection, 
data management, statistical and qualitative analysis, and dissemination of results. As the medical director 
of the NCH Fertility and Reproductive Health team, Dr. Nahata is immediately notified about every new 
fertility consult that is placed, which has led to >90% recruitment rates in the pilot. 
 
Dr. Gerhardt will provide focused guidance on 1) designing the facilitated conversation prompts, 2) 
conducting the intervention, 3) coding and thematic analysis, 4) using qualitative data to enhance 
quantitative data, and 5) integrating quantitative and qualitative data from multiple informants into a 
statistical model.  
 
Dr. O’Brien will provide guidance on how to sensitively approach AYA newly diagnosed with cancer and 
their families to optimize recruitment and retention, as well as direct mentorship in RCT design and 
implementation.  
 
Dr. Quinn will provide mentorship in adapting this tool to our study population. She will assist with the 
qualitative analyses and provide input in developing the family-centered psychoeducational intervention. 
Dr. Rausch will oversee data management and analyses.  
 
Dr. Klosky will provide guidance on the content of the intervention. 
 
Research assistants will assist with recruitment and data collection, and an individual with 
ENRICH/ECHO (oncofertility communication) training will deliver the intervention. 
 
Facilities: All study procedures except interviews will take place in the patient’s hospital room (or clinic 
room), or other private location at Nationwide Children’s Hospital. Private consultation rooms are 
available on the treatment floors, or other private location at Nationwide Children’s Hospital. 
 

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Availability of Medical or Psychological Resources: As part of their cancer treatment, patients are 
assigned a psychosocial provider who can be called as needed. Additionally, participants are being treated 
by an interdisciplinary medical team.  
 
Process to ensure that all persons assisting with the research are adequately informed about the protocol, 
the research procedures, and their duties and functions: All study personnel who will be working with 
data or protected health information will be properly trained, which includes completing the online 
Collaborative Institutional Training Initiative (CITI) certification and undergoing a day-long instructional 
seminar at the hospital for protecting human subjects and engaging in best practices for responsible 
conduct of research. Additionally, per NIH policy, clinical trial staff who are involved in the design, 
conduct, oversight, or management of the trial will be trained in Good Clinical Practice (GCP).  
Additionally, staff will receive extensive training in administration of all questionnaires as well as 
professional behavior with families. The interventionist will have additional training in ENRICH/ECHO, 
an oncofertility communication training program. Finally, Staff will be trained to contact the PI 
immediately if an adverse event occurs, and corrective action, including IRB notification, will occur, if 
necessary. 
 
 Multi-Site Research* 
N/A 
 
 
Protected Health Information Recording 
29.1 
  Indicate which subject identifiers will be recorded for this research. 
☐  Name 
☒  Complete Address 
☒  Telephone or Fax Number 
☐  Social Security Number (do not check if only used for ClinCard) 
☒  Dates (treatment dates, birth date, date of death) 
☒  Email address, IP address or URL 
☒  Medical Record Number or other account number 
☐  Health Plan Beneficiary Identification Number 
☒  Full face photographic images and/or any comparable images (x-rays) 
☐  Account Numbers 
☐  Certificate/License Numbers 
☐  Vehicle Identifiers and Serial Numbers (e.g. VINs, License Plate Numbers) 
☐  Device Identifiers and Serial Numbers 
☒  Biometric identifiers, including finger and voice prints 
☐  Other number, characteristic or code that could be used to identify an individual 
☐  None (Complete De-identification Certification Form) 
 
29.2 
Check the appropriate category and attach the required form* on the Local Site 
Documents, #3. Other Documents, page of the application.  (Choose one.) 
☒  Patient Authorization will be obtained. (Include the appropriate HIPAA language (see 
Section 14 of consent template) in the consent form OR attach the HRP-900, HIPAA 
AUTHORIZATION form.) 
☐  Protocol meets the criteria for waiver of authorization. (Attach the HRP-901, WAIVER OF 
HIPAA AUTHORIZATION REQUEST form.) 

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☐  Protocol is using de-identified information. (Attach the HRP-902, DE-IDENTIFICATION 
CERTIFICATION form.) (Checked "None" in 1.0 above) 
☐  Protocol involves research on decedents. (Attach the HRP-903, RESEARCH ON 
DECEDENTS REQUEST form.) 
☐  Protocol is using a limited data set and data use agreement. (Contact the Office of 
Technology Commercialization to initiate a Limited Data Use Agreement. 
 
29.3 
How long will identifying information on each participant be maintained? 
The PHI collected or created under this research study will be used or shared as needed until the 
end of the study. The records of this study will be kept for an indefinite period of time and your 
authorization to use or share your PHI will not expire. 
 
29.4 
Describe any plans to code identifiable information collected about each participant. 
Once enrolled in the study, participants (patients and parent(s)) will receive a study ID number. 
This number will be entered on their survey, be it paper or online (i.e., using REDCap, an online 
survey system that is housed securely on the NCH research drive). The only link between the 
participant’s name and study ID will be an electronic tracking sheet, which will be password 
protected and stored on the secured research network drive of the hospital. The tracking sheet will 
contain the following protected health information: name, medical record number, date of birth, 
address, phone number, diagnosis, and dates of study visits. Only direct study personnel will have 
access to this file. Participants will be identified in all datasets by their study ID. 
 
29.5 
Check each box that describes steps that will be taken to safeguard the confidentiality of 
information collected for this research: 
☒ Research records will be stored in a locked cabinet in a secure location 
☒ Research records will be stored in a password-protected computer file 
☒ The list linking the assigned code number to the individual subject will be maintained 
separately from the other research data 
☒ Only certified research personnel will be given access to identifiable subject information 
 
29.6 
Describe the provisions included in the protocol to protect the privacy interests of subjects, 
where "privacy interests" refer to the interest of individuals in being left alone, limiting 
access to them, and limiting access to their information. (This is not the same provision to 
maintain the confidentiality of data.) 
Participants may opt out of participating in this study at any time. If a participant or family 
requests to be removed from the study, study staff will cease further contact with the family. If a 
patient declines to participate in the study, no further information will be gathered. 
 
 Confidential Health Information 
 
30.1 
Please mark all categories that reflect the nature of health information to be accessed and 
used as part of this research. 
☒  Demographics (age, gender, educational level) 
☒  Diagnosis 
☒  Laboratory reports 
☐  Radiology reports 
☐  Discharge summaries 

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☒  Procedures/Treatments received 
☒  Dates related to course of treatment (admission, surgery, discharge) 
☐  Billing information 
☒  Names of drugs and/or devices used as part of treatment 
☐  Location of treatment 
☒  Name of treatment provider 
☒  Surgical reports 
☒  Other information related to course of treatment 
☐  None 
 
30.2 
Please discuss why it is necessary to access and review the health information noted in your 
response above. 
Medical information for each patient will be accessed to ensure eligibility and to provide data for 
analysis on factors that impact FP decisions and decision satisfaction.  
 
30.3 
Is the health information to be accessed and reviewed the minimal necessary to achieve the 
goals of this research?  ☒ Yes    ☐ No 
 
30.4 
Will it be necessary to record information of a sensitive nature?  ☒ Yes   ☐ No 
 
30.5 
Do you plan to obtain a federally-issued Certificate of Confidentiality as a means of 
protecting the confidentiality of the information collected?  ☒ Yes   ☐ No 
 
 
 
 

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