Actively Recruiting
Development and Pilot Testing of a Family Building Decision Support Intervention for Female Adolescent and Young Adult Cancer Survivors
Led by Duke University · Updated on 2026-05-14
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a behavioral program designed to support female adolescent and young adult cancer survivors in making informed family-building decisions after completing cancer treatment. These survivors often face challenges such as fertility impairments, uncertain reproductive potential, increased pregnancy risks, and emotional distress related to parenthood planning. The study aims to pilot-test the program's feasibility and acceptability and to observe preliminary impacts on knowledge, decision-making confidence, and reproductive health distress. The intervention includes four approximately 60-minute videoconference sessions over 4 to 6 weeks, led by a nurse navigator. The sessions cover personalized, risk-based reproductive health education tailored to the participant's cancer type and treatment exposures, coping strategies based on Acceptance and Commitment Therapy, and patient activation techniques to encourage engagement in reproductive health care. Participants receive between-session practice exercises. The control group receives survivorship educational materials, including an NCI booklet and supportive service referrals as needed. Participants will complete surveys and assessments at baseline, post-treatment (4 to 6 weeks), and follow-up (8 to 10 weeks). Researchers will measure feasibility by enrollment numbers, session completion rates, and use of program skills. Acceptability will be assessed through satisfaction questionnaires. Secondary outcomes include decisional conflict, self-efficacy, distress related to reproductive concerns, and family-building knowledge. The total participation period extends up to 10 weeks, with ongoing monitoring of participant experiences.
CONDITIONS
Brief Title
Family Building Decision Support for Female Adolescent and Young Adult Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female (biological sex) adolescent and young adult cancer survivor aged 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) or treatments increasing obstetric risk (e.g., chest radiation, radiation to uterus, anthracycline exposure)
- Has not completed family building
- Able to speak and read English
- Willing and able to complete videoconference sessions and REDCap surveys
You will not qualify if you...
- Visual, hearing, or cognitive impairment or severe mental illness that would interfere with participation as determined by study staff
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) for eligibility assessment
Duration - 4 to 6 weeks
Participants receive either four approximately 60-minute videoconference sessions of nurse navigator-delivered family building decision support over 4 to 6 weeks or survivorship educational materials at baseline with possible referrals to supportive services.
4 weekly or biweekly videoconference sessions for the decision support arm; 1 baseline visit for the education arm
Duration - 2 to 4 weeks after treatment
Participants complete follow-up assessments to measure program skill use, decisional conflict, self-efficacy, distress, and family building knowledge.
1 to 2 follow-up visits or surveys conducted 8 to 10 weeks after baseline
Trial Site Locations
Total: 1 location
1
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
S
Smrithi Divakaran, MBBS, MSPH
M
Michael W Willis, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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