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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Contraception Fertility Menopausal Symptoms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pioneers Medical Health District, Brawley, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-component oncofertility care intervention

Behavioral

The intervention includes:

Young breast cancer patients presenting to oncology visits will complete a clinic-based oncofertility needs screen with a member of the clinical team. This needs screen assesses i) desire to have a child in the future, ii) need for contraception, and iii) sexual health/menopause symptoms.
A women's health survivorship care plan (SCP) in Spanish and English encompasses content on screening and management strategies for a) fertility concerns/pregnancy health; b) contraception; c) hot flashes and d) sexual health.
Oncofertility navigation consists of one telehealth or in-person session with a social worker to: i) assess the patient's oncofertility needs, ii) review the women's health SCP, iii) provide support with the goal of engaging in oncofertility care.
Oncofertility consultation as indicated via telehealth or in person will occur between the patient and reproductive specialist. Each consultation is estimated to be 1 hour.

Primary outcomes

Medical record review of engagement in goal-concordant oncofertility care

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

Cancer Resource Center of the Desert
El Centro Regional Medical Center
Pioneers Memorial Healthcare District

Registry information

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Jun 10, 2022
Registry last updated: Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed