Family Building Decision Support for Female Adolescent and Young Adult Cancer Survivors

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07471685
Status
Recruiting
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Conditions

  • Adolescent and Young Adult Cancer
  • Cancer Survivorship
  • Family Planning

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Nurse Navigator-Delivered Family Building Decision Support — BEHAVIORAL
    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.
  • Survivorship Education — BEHAVIORAL
    NCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed.

Study Details

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.

Key Dates

Start date
May 11, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Nurse Navigator-Delivered Family Building Decision Support
    Four \~60-minute, weekly or biweekly videoconference sessions over 4-6 weeks. Components include: 1. 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). 2. ACT-derived coping skills (values clarification, cognitive defusion, acceptance, committed action) to align decisions with personal values and reduce avoidance. 3. Patient activation strategies to promote engagement in risk-based reproductive care and informed decision-making. Includes between-session practice and brief home exercises.
  • Active Comparator: Survivorship Educational Materials
    NCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed.

Primary Outcome Measure

Feasibility as measured by number of adolescents and young adults (AYAs) enrolled [ Time Frame: up to 10 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Cancer InstituteDurhamNorth Carolina27710
Smrithi Divakaran, MBBS, MSPH
[email protected]
919-681-7695
Michael W Willis, BA
[email protected]
919-681-8437
Caroline S Dorfman, PhD (PRINCIPAL_INVESTIGATOR)

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