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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05414812
• Other study ID #: 800646
• Secondary ID: B27BB4247
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: October 2023
• Source: University of California, San Diego
• Contact: Sally Romero, PhD, MPH
• Phone: 858-822-1371
• Email: saromero[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Contraception
• Fertility
• Menopausal Symptoms

Intervention

Behavioral:
• Multi-component oncofertility care intervention
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.

Locations

Country	Name	City	State
United States	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

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Diego	Cancer Resource Center of the Desert, El Centro Regional Medical Center, Pioneers Memorial Healthcare District

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical record review of engagement in goal-concordant oncofertility care	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.	12 weeks after oncology visit