Recruiting

Behavioral Program

Sponsor:

Duke University

Code:

NCT07471685

Conditions

Cancer Survivorship

Family Planning

Adolescent and Young Adult Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

Nurse Navigator-Delivered Family Building Decision Support

Survivorship Education

Study Details

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

Study ID

NCT07471685

Start date

May 11, 2026

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 39

Healthy Volunteers: Not accepted

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 Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Nurse Navigator-Delivered Family Building Decision Support

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.

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.

Interventions

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.

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

Smrithi Divakaran, MBBS, MSPH

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

Michael W Willis, BA

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

Locations

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Smrithi Divakaran, MBBS, MSPH

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

Michael W Willis, BA

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

Principal Investigator:

Caroline S Dorfman, PhD

More Information

Sponsor

Duke University

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • AYA
  • oncofertility
  • fertility after cancer
  • survivorship

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-14.