Trials / Recruiting
RecruitingNCT07471685
Family Building Decision Support for Female Adolescent and Young Adult Cancer Survivors
Development and Pilot Testing of a Family Building Decision Support Intervention for Female Adolescent and Young Adult Cancer Survivors
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Duke University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 39 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to develop and pilot-test a nurse navigator-delivered behavioral program to support female adolescent and young adult (AYA) cancer survivors in making informed, values-driven family-building decisions after completion of cancer treatment. Female AYA survivors often face fertility impairments, uncertainty about reproductive potential, elevated obstetric risks during pregnancy, and significant emotional distress related to parenthood planning. Currently, few interventions address these post-treatment decision-making needs. The intervention consists of four videoconference sessions that combine personalized, risk-based reproductive health education with coping strategies derived from Acceptance and Commitment Therapy and Patient Activation Theory. A pilot randomized controlled trial will evaluate feasibility, acceptability, and preliminary changes in knowledge, decisional conflict, self-efficacy, and reproductive-health-related distress among 48 participants randomized to the intervention or a survivorship-education control condition. Findings will inform future testing of the intervention's efficacy in a larger clinical trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Nurse Navigator-Delivered Family Building Decision Support | Four \~60-minute, weekly or biweekly videoconference sessions over 4-6 weeks. Components include: Personalized, risk-based reproductive health education based on cancer type and treatment exposures (e.g., gonadotoxic chemotherapy, chest or uterine radiation, anthracyclines); review of fertility potential evaluation, assisted reproductive technologies, adoption pathways, and pregnancy health considerations (maternal/fetal risks, surveillance, co-management). ACT-derived coping skills (values clarification, cognitive defusion, acceptance, committed action) to align decisions with personal values and reduce avoidance. Patient activation strategies to promote engagement in risk-based reproductive care and informed decision-making. Includes between-session practice and brief home exercises. |
| BEHAVIORAL | Survivorship Education | NCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2026-03-13
- Last updated
- 2026-03-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07471685. Inclusion in this directory is not an endorsement.