Development and Pilot Testing of a Family Building Decision Support Intervention for Female Adolescent and Young Adult Cancer Survivors
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.
Arms & interventions
- BehavioralNurse 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 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.
- BehavioralSurvivorship Education
NCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed.
Outcome measures
Primary
Feasibility as measured by number of adolescents and young adults (AYAs) enrolled
Feasibility will be assessed by study enrollment. The intervention will be considered feasible if N=48 AYAs enroll during the 10-month study period.
Time frame: up to 10 months
Feasibility as measured by the number of participants who complete all four sessions
The intervention will be considered feasible if \>80% of participants complete all four sessions.
Time frame: Post-treatment (4-6 weeks)
Feasibility as measured by frequency of program skills use
Feasibility will be assessed by a novel questionnaire designed to assess use of program skills (intervention strategies). Participants will be asked to evaluate the frequency with which they used skills or ideas presented in the intervention program, on a scale from 1 (not at all) to 6 (every day), since their last study session.
Time frame: Post-treatment (4-6 weeks), follow-up (8-10 weeks)
Feasibility as measured by frequency of specific program skills use
Feasibility will be assessed by a novel questionnaire designed to assess use of program skills (intervention strategies). Participants will be asked to evaluate use of 16 specific program skills or strategies since their last study session, on a scale of 1 (not at all) to 5 (6 or more days per week).
Time frame: Post-treatment (4-6 weeks), follow-up (8-10 weeks)
Acceptability as measured by the Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire is an 8-item scale assessing participants' views of an intervention as acceptable and satisfactory. Items are rated on a 4-point scale (e.g., 1 "very dissatisfied" to 4 "very satisfied") and averaged. The intervention will be considered acceptable if \>80% of intervention arm participants rate it as \>3 out of 4.
Time frame: Post-treatment (4-6 weeks)
Acceptability as measured by the Treatment Acceptability Questionnaire
The Treatment Acceptability Questionnaire is a six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable") and averaged. The intervention will be acceptable if \>80% of intervention arm participants rate it as \>5 out of 7 on the TAQ.
Time frame: Post-treatment (4-6 weeks)
Acceptability as measured by the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)
Participants will complete the 13-item Satisfaction with Therapy and Therapist Scale-Revised specific to the program they received. The first 12 items ask participants to rate their agreement with statements related to intervention satisfaction on a 5-point scale ranging from "strongly disagree" (1) to "strongly agree" (5). The 13th item asks "How much did the intervention help with your symptoms?" with 5 answer choices ranging from "made things a lot better" to "made things a lot worse."
Time frame: Post-treatment (4-6 weeks)
Secondary
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
Study locations (1)
Duke Cancer Institute
Durham, North Carolina, 27710