Family-building support for young women after cancer
Development and Pilot Testing of a Family Building Decision Support Intervention for Female Adolescent and Young Adult Cancer Survivors
This pilot tests whether a nurse-delivered four-session videoconference program helps young female cancer survivors make informed, values-based decisions about having children.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | Female |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT07471685 on ClinicalTrials.gov |
What this trial studies
This pilot randomized trial tests a nurse navigator–delivered behavioral program that combines personalized, risk-based reproductive health education with coping strategies from Acceptance and Commitment Therapy and Patient Activation Theory. The intervention is delivered in four videoconference sessions and is compared to survivorship education among 48 female adolescent and young adult (AYA) cancer survivors. Outcomes include feasibility, acceptability, knowledge, decisional conflict, self-efficacy, and reproductive-health–related distress measured by REDCap surveys. Enrollment targets survivors who completed curative cancer treatment and had prior gonadotoxic or obstetric-risk exposures.
Who should consider this trial
Good fit: Ideal candidates are English-speaking female AYA cancer survivors (diagnosed age 15–39, currently 18–39) who completed cancer treatment with curative intent, had treatments posing gonadotoxic or obstetric risk, have not completed family building, and can join videoconference sessions.
Not a fit: Patients unlikely to benefit include non-English speakers, those with severe sensory or cognitive impairment or active severe mental illness that precludes participation, people without videoconference access, and survivors who have already completed family building or lack relevant treatment exposures.
Why it matters
Potential benefit: If effective, the program could help survivors better understand fertility risks, reduce decisional conflict, increase confidence in family-building choices, and lower reproductive-health-related distress.
How similar studies have performed: Decision aids and counseling interventions in fertility and survivorship settings have improved knowledge and reduced decisional conflict and ACT-based approaches have reduced distress, but nurse-delivered videoconference family-building programs for AYA survivors are novel and largely untested in randomized trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Durham, North Carolina
- Duke Cancer Institute — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Caroline S Dorfman, PhD — Duke University
- Study coordinator: Smrithi Divakaran, MBBS, MSPH
- Email: smrithi.divakaran@duke.edu
- Phone: 919-681-7695
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.