Family Building Decision Support for Female Adolescent and Young Adult Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-39
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Visual, hearing, or cognitive impairment or severe mental illness that would interfere with participation as determined by study staff.
Trial design
Design model
Parallel
Treatments tested in this trial
Nurse Navigator-Delivered Family Building Decision Support
BehavioralFour \~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
BehavioralNCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Nurse Navigator-Delivered Family Building Decision SupportExperimental treatment 1 intervention
Group B: Survivorship Educational MaterialsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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)3
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)4
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)Secondary outcomes
1
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.
Time frame
Baseline, follow-up (8-10 weeks)2
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.
Time frame
Baseline, follow-up (8-10 weeks)3
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.
Time frame
Baseline, follow-up (8-10 weeks)4
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.
Time frame
Baseline, follow-up (8-10 weeks)Other outcomes
1
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.
Time frame
Baseline, follow-up (8-10 weeks)2
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).
Time frame
Baseline, follow-up (8-10 weeks)3
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).
Time frame
Post-treatment (4-6 weeks), follow-up (8-10 weeks)Sponsors and contacts
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Source ClinicalTrials.gov