Family Building Decision Support for Female Adolescent and Young Adult Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nurse Navigator-Delivered Family Building Decision Support, Survivorship Education.
- Who it may be relevant to
- Registry conditions: Cancer Survivorship, Family Planning, Adolescent and Young Adult Cancer. Basic parameters: 18 years — 39 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Pilot Testing of a Family Building Decision Support Intervention for Female Adolescent and Young Adult Cancer Survivors
Overview
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.
Interventions
- 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 cl - Behavioral Survivorship Education
NCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed.
Primary outcome measures
- Feasibility as measured by number of adolescents and young adults (AYAs) enrolled [Time frame: up to 10 months]
- Feasibility as measured by the number of participants who complete all four sessions [Time frame: Post-treatment (4-6 weeks)]
- Feasibility as measured by frequency of program skills use [Time frame: Post-treatment (4-6 weeks), follow-up (8-10 weeks)]
- Feasibility as measured by frequency of specific program skills use [Time frame: Post-treatment (4-6 weeks), follow-up (8-10 weeks)]
- Acceptability as measured by the Client Satisfaction Questionnaire [Time frame: Post-treatment (4-6 weeks)]
- Acceptability as measured by the Treatment Acceptability Questionnaire [Time frame: Post-treatment (4-6 weeks)]
- Acceptability as measured by the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R) [Time frame: Post-treatment (4-6 weeks)]
Secondary outcome measures (5)
- Decisional conflict as measured by the Decisional Conflict Scale [Time frame: Baseline, follow-up (8-10 weeks)]
- Self-efficacy as measured by the Decision Self-Efficacy Scale [Time frame: Baseline, follow-up (8-10 weeks)]
- Distress as measured by the Reproductive Concerns after Cancer Scale [Time frame: Baseline, follow-up (8-10 weeks)]
- Distress as measured by the Fertility Problem Inventory [Time frame: Baseline, follow-up (8-10 weeks)]
- Family building knowledge as measured by knowledge item pool [Time frame: Baseline, follow-up (8-10 weeks)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Duke Cancer Institute — Durham
Identifiers
NCT: NCT07471685 · Pro00113254