NCT07471685 Family Building Decision Support for Female Adolescent and Young Adult Cancer Survivors
| NCT ID | NCT07471685 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Cancer Survivorship |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-05-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2026-05-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Female (biological sex) AYA cancer survivor age 15-39 at original diagnosis and 18-39 at enrollment. * Completed cancer treatment with curative intent. * Prior exposure to treatments posing gonadotoxic risk (e.g., alkylating agents, total body irradiation) and/or treatments increasing obstetric risk (e.g., chest radiation, radiation to uterus, anthracycline exposure). * Has not completed family building. * Able to speak/read English. * Willing and able to complete videoconference sessions and REDCap surveys. Exclusion Criteria: * Visual, hearing, or cognitive impairment or severe mental illness that would interfere with participation as determined by study staff.
Contact & Investigator
Caroline S Dorfman, PhD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT07471685 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 39 Years, studying Cancer Survivorship. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07471685 currently recruiting?
Yes, NCT07471685 is actively recruiting participants. Contact the research team at smrithi.divakaran@duke.edu for enrollment information.
Where is the NCT07471685 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT07471685 clinical trial?
NCT07471685 is sponsored by Duke University. The principal investigator is Caroline S Dorfman, PhD at Duke University. The trial plans to enroll 48 participants.
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