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

NCT07471685 | Recruiting

• 1 other identifier: Pro00113254
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer Survivorship; Family Planning; Adolescent and Young Adult Cancer

Keywords

AYA; oncofertility; fertility after cancer; survivorship

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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).

  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.

  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.

  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."

  Post-treatment (4-6 weeks)

Secondary Outcomes (5)

• Decisional conflict as measured by the Decisional Conflict Scale

  Baseline, follow-up (8-10 weeks)

• Self-efficacy as measured by the Decision Self-Efficacy Scale

  Baseline, follow-up (8-10 weeks)

• Distress as measured by the Reproductive Concerns after Cancer Scale

  Baseline, follow-up (8-10 weeks)

• Distress as measured by the Fertility Problem Inventory

  Baseline, follow-up (8-10 weeks)

• Family building knowledge as measured by knowledge item pool

  Baseline, follow-up (8-10 weeks)

Other Outcomes (3)

• Unmet Fertility Information Needs

  Baseline, follow-up (8-10 weeks)

• Family building priorities as measured by the Family Building Priorities Tool

  Baseline, follow-up (8-10 weeks)

• Family Building Action Steps

  Post-treatment (4-6 weeks), follow-up (8-10 weeks)

Study Arms (2)

Nurse Navigator-Delivered Family Building Decision Support

EXPERIMENTAL

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.

Behavioral: Nurse Navigator-Delivered Family Building Decision Support

Survivorship Educational Materials

ACTIVE COMPARATOR

NCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed.

Behavioral: Survivorship Education

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.

Nurse Navigator-Delivered Family Building Decision Support

Survivorship Education BEHAVIORAL

NCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed.

Survivorship Educational Materials

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Visual, hearing, or cognitive impairment or severe mental illness that would interfere with participation as determined by study staff.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27710, United States

RECRUITING

Study Officials

• Caroline S Dorfman, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Smrithi Divakaran, MBBS, MSPH

CONTACT

919-681-7695; smrithi.divakaran@duke.edu

Michael W Willis, BA

CONTACT

919-681-8437; michael.w.willis@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)