CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
FP Decision Tool and Discussionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04268004
NCT04268004N/ACompleted

Optimizing Fertility Preservation and Decision Quality in Male AYA With Cancer: A Family-centered Intervention

Leena Nahata·interventional·Posted Feb 13, 2020·Updated Jul 29, 2025

In Brief

A clinical study evaluating FP Decision Tool and Discussion for Infertility, Male. Completed, enrolled 53 participants across 1 site.

Detailed Summary

Very little is known about how medical providers can help adolescent and young adults (AYAs) and their caregivers make decisions about fertility preservation (sperm banking) before beginning cancer treatment. The purpose of this study is to see if having a guided conversation about fertility preservation increases preservation rates and/or satisfaction with the decision among AYA males with cancer. 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) will have higher rates of FP uptake. The secondary hypothesis is that families in the intervention group will report better FP decision quality compared to those in the control arm.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 13, 2020
Enrollment StartFeb 8, 2021
Primary CompletionJan 4, 2024
Study CompletionJun 1, 2025
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.4 years ago

Interventions

FP Decision Tool and Discussionbehavioral

The intervention will be administered by a trained interventionist. The interventionist will administer the digital FP Decision Tool to families in the intervention arm. The tool asks questions examining each AYA's thoughts or feelings regarding parenthood and fertility preservation. The parent version asks the same questions, plus additional 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 Health Belief Model (perceived benefits, perceived barriers, perceived threats, self-efficacy, and cues to action). Items are scored and the trained interventionist will facilitate a guided discussion based on the family's responses and discrepancies.