NCT06834945

Addressing Fertility Information Needs and Distress

Addressing Fertility Information Needs and Fertility-related Distress Among Female Adult Survivors of Childhood Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to develop and refine a behavioral intervention to address fertility-related information needs and fertility-related distress among female adult survivors of childhood cancer.

Detailed description

Adult survivors of childhood cancer are a growing population who face a number of long-term and late effects secondary to their cancer treatment, which have the potential to profoundly impact their future health, quality of life, and achievement of life goals. This project will examine the feasibility, acceptability of a novel behavioral intervention aiming to address fertility-related information needs and fertility-related distress among adult survivors of childhood cancer. Following the Obesity-Related Behavioral Intervention Trials (ORBIT) Model of intervention development, the proposed study seeks to design and refine a behavioral intervention to address unmet fertility-related information needs and fertility-related distress among female adult survivors of childhood cancer (aged 18-44). The intervention is organized into six remotely delivered sessions integrating patient activation theory and Acceptance and Commitment Therapy (ACT) strategies, and evidence-based reproductive health information and help to empower empower survivors to make informed decisions that align with their personal values. Intervention content will be delivered to a small sample of the target population (N=30). Feasibility and acceptability, as well as examination of pre- to post-intervention patterns of change in intervention targets (primary: fertility health knowledge, fertility-related distress; secondary: psychological flexibility, patient activation, and self-efficacy), will be assessed and utilized to further refine the intervention (e.g., intervention strategies, intervention length, and delivery modality). Although this project is focused on the late effect of impaired fertility, the intervention developed through this study has the potential to produce significant public health benefits: it could be applied to address other late effects in this population, which if left untreated, may lead to greater health complications in this growing population later in life.

Conditions

• Childhood Cancer
• Fertility Issues

Interventions

Type	Name	Description
BEHAVIORAL	AYA SPARK	Intervention includes video conferencing based sessions to cover topics related to fertility-related information needs and concerns among female adult survivors of childhood cancer over a 6-8 week period.

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-05-28
• Completion: 2025-05-28
• First posted: 2025-02-19
• Last updated: 2025-07-20

Locations

1 site across 1 country: United States