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

Development and Pilot Testing of a Family Building Decision Support Intervention for Female Adolescent and Young Adult Cancer Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Family Planning; Cancer Survivorship; Adolescent and Young Adult Cancer
• Intervention / Treatment: Behavioral: Nurse Navigator-Delivered Family Building Decision Support; Behavioral: Survivorship Education

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Smrithi Divakaran, MBBS, MSPH; Phone Number: 919-681-7695; Email: smrithi.divakaran@duke.edu
• Study Contact Backup: Name: Michael W Willis, BA; Phone Number: 919-681-8437; Email: michael.w.willis@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke Cancer Institute
      • Principal Investigator: Caroline S Dorfman, PhD
      • Contact: Smrithi Divakaran, MBBS, MSPH; Phone Number: 919-681-7695; Email: smrithi.divakaran@duke.edu
      • Contact: Michael W Willis, BA; Phone Number: 919-681-8437; Email: michael.w.willis@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 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.	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 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.
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.	Behavioral: Survivorship Education; NCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional conflict as measured by the Decisional Conflict Scale	Decisional conflict related to family building options will be assessed using the Decisional Conflict Scale. Participants will respond to 16 questions about decisional conflict related to family building from 0 (strongly agree) to 4 (strongly disagree). The total scores ranges from 0 to 64, with higher scores indicating greater conflict.	Baseline, follow-up (8-10 weeks)
Self-efficacy as measured by the Decision Self-Efficacy Scale	Self-efficacy will be assessed using the Decision Self-Efficacy Scale; items will be worded to assess self-efficacy for family building decision-making. Participants will respond to 11 items assessing decision self-efficacy from 0 (not at all confident) to 4 (very confident). The total score ranges from 0 to 44, with higher scores indicating greater self-efficacy.	Baseline, follow-up (8-10 weeks)
Distress as measured by the Reproductive Concerns after Cancer Scale	Distress will be assessed using the 18-item Reproductive Concerns after Cancer Scale. Participants will respond to statements with ratings from 1 (strongly disagree) to 5 (strongly agree) about concerns related to having (more) biological children. The total score ranges from 18 to 90, with higher scores indicating greater reproductive-related concerns.	Baseline, follow-up (8-10 weeks)
Distress as measured by the Fertility Problem Inventory	Distress will be assessed using the Fertility Problem Inventory, which asks participants to rate their agreement with 38 statements across 4 domains (social concerns, relationship concerns, rejection of childfree lifestyle, need for parenthood). Participants will rate each statement from 1 (strongly disagree) to 6 (strongly agree). The total score ranges from 38 to 228, with higher scores indicating greater fertility-related distress.	Baseline, follow-up (8-10 weeks)
Family building knowledge as measured by knowledge item pool	Knowledge will be assessed using an item pool developed for the study. Each participant will respond true (1) or false (0) to 10 items, with the specific items being dependent on the risk-based education provided and associated family building options discussed during the intervention sessions. Knowledge will be calculated as the percent of correct items.	Baseline, follow-up (8-10 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unmet Fertility Information Needs	Participants will respond to a novel 8-item questionnaire assessing unmet fertility information needs. Participants will respond yes (1) or no (0) to questions asking if they have as much information as they would like about different fertility-related topics. The total score ranges from 0 to 8, with higher scores indicating a greater number of unmet fertility information needs.	Baseline, follow-up (8-10 weeks)
Family building priorities as measured by the Family Building Priorities Tool	Family building priorities will be assessed by the Family Building Priorities Tool, a measure that presents 10 topics that people may consider when deciding which family building options to pursue. Participants are asked to rank each item from 10 (most important) to 1 (least important).	Baseline, follow-up (8-10 weeks)
Family Building Action Steps	Participants will be asked to indicate yes (1) or no (0) to questions asking if they have spoken with anyone about family building goals, and if they have taken any action steps toward family building goals. Participants will also be asked who they spoke with about their family building goals (if anyone), what specific steps they have taken toward family building (if they have taken any steps)), and what barriers they have faced to working toward family building goals (if they have taken no steps).	Post-treatment (4-6 weeks), follow-up (8-10 weeks)

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Caroline S Dorfman, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: survivorship; oncofertility; AYA; fertility after cancer
• Other Study ID Numbers: Pro00113254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No