Intervening on Women's Health for Rural Young Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Contraception; Breast Cancer; Menopausal Symptoms; Fertility
• Interventions: Behavioral: Multi-component oncofertility care intervention

• Registration Number: NCT05414812
• Lead Sponsor: University of California, San Diego

Brief Summary

The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young breast cancer survivors' engagement in goal-concordant oncofertility care, concurrently with observing and gathering information on how the intervention is implemented. The investigators hypothesize that implementation of the intervention will result in increased young breast cancer survivors' engagement in goal-concordant oncofertility care.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-15
• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-10
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-11
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

Inclusion Criteria

• Breast cancer (Stages 0-IV) diagnosis
• Primary language English or Spanish
• Receiving oncology care at participating clinical sites
• Living in Imperial County, California

Exclusion Criteria

• Women who are pregnant at recruitment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Multi-component oncofertility care intervention	Multi-component oncofertility care intervention	After the intervention implementation, all breast cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive the multi-component oncofertility care intervention.

Primary Outcome Measures

Name	Time	Method
Medical record review of engagement in goal-concordant oncofertility care	12 weeks after oncology visit	Study staff will be trained to abstract the primary outcome of engagement in goal-concordant oncofertility care from the patient's medical records using standardized case report forms. Engagement in goal-concordant oncofertility care will be assigned to young breast cancer survivors who undergo: 1) oncofertility needs screen, complete a navigation session, receive the women's health survivorship care plan (SCP), and thereafter have no oncofertility needs; OR 2) oncofertility needs screen, complete a navigation session, receive the SCP, have an oncofertility need, undergo telehealth oncofertility consultation, and thereafter have no oncofertility services needs; OR 3) oncofertility needs screen, complete a navigation session, receive the SCP, have an oncofertility need, undergo telehealth oncofertility consultation, have an oncofertility services need, and thereafter uptake appropriate services.

Trial Locations

Locations (4)

Pioneers Medical Health District; 🇺🇸 Brawley, California, United States

Cancer Resource Center of the Desert; 🇺🇸 El Centro, California, United States

El Centro Regional Medical Center; 🇺🇸 El Centro, California, United States

University of California San Diego; 🇺🇸 La Jolla, California, United States