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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Contraception; Menopausal Symptoms; Fertility
• Intervention / Treatment: Behavioral: Multi-component oncofertility care intervention

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sally Romero, PhD, MPH; Phone Number: 858-822-1371; Email: saromero@health.ucsd.edu
• Study Contact Backup: Name: H. Irene Su, MD, MSCE; Phone Number: 858-822-5986; Email: hisu@health.ucsd.edu

Study Locations

• United States
  • California
    • Brawley, California, United States, 92227
      • Recruiting
      • Pioneers Medical Health District
      • Contact: H. Irene Su, MD, MSCE; Phone Number: 858-822-5986; Email: hisu@health.ucsd.edu
    • El Centro, California, United States, 92243
      • Active, not recruiting
      • Cancer Resource Center of the Desert
    • El Centro, California, United States, 92243
      • Recruiting
      • El Centro Regional Medical Center
      • Contact: H. Irene Su, MD, MSCE; Phone Number: 858-822-5986; Email: hisu@health.ucsd.edu
    • La Jolla, California, United States, 92093
      • Active, not recruiting
      • University of California San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Usual Care; Prior to the intervention implementation, all breast cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Cancer Resource Center of the Desert; El Centro Regional Medical Center; Pioneers Memorial Healthcare District
• Investigators: Principal Investigator: H. Irene Su, MD, MSCE, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 14, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Oncofertility
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 800646; B27BB4247 (Other Grant/Funding Number: California Breast Cancer Research Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.
• IPD Sharing Time Frame: Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
• IPD Sharing Access Criteria: Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to the principal investigator (H. Irene Su).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No