Intervening on Women's Health for Rural Young Breast Cancer Survivors
2 other identifiers
interventional
81
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Oct 2021
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2021
CompletedFirst Submitted
Initial submission to the registry
May 25, 2022
CompletedFirst Posted
Study publicly available on registry
June 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedJanuary 10, 2025
November 1, 2024
2.5 years
May 25, 2022
January 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Multi-component oncofertility care intervention
EXPERIMENTALAfter the intervention implementation, all breast cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive the multi-component oncofertility care intervention.
Usual Care
NO INTERVENTIONPrior to the intervention implementation, all breast cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive usual care.
Interventions
The intervention includes: 1. 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. 2. 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. 3. 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. 4. 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.
Eligibility Criteria
You may qualify if:
- Breast cancer (Stages 0-IV) diagnosis
- Primary language English or Spanish
- Receiving oncology care at participating clinical sites
- Living in Imperial County, California
You may not qualify if:
- \- Women who are pregnant at recruitment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Diegolead
- Cancer Resource Center of the Desertcollaborator
- El Centro Regional Medical Centercollaborator
- Pioneers Memorial Healthcare Districtcollaborator
Study Sites (4)
Pioneers Medical Health District
Brawley, California, 92227, United States
Cancer Resource Center of the Desert
El Centro, California, 92243, United States
El Centro Regional Medical Center
El Centro, California, 92243, United States
University of California San Diego
La Jolla, California, 92093, United States
Related Publications (1)
Romero SAD, Palomino H, Ahmed SH, Peacher D, Urias A, Ramirez L, Yocupicio J, Gutierrez P, Flores Ortega RE, Reyes B, Kaiser BN, Hoyt H, Su HI. Intervening on women's health for rural young breast cancer survivors: A study protocol. Contemp Clin Trials. 2023 Jul;130:107215. doi: 10.1016/j.cct.2023.107215. Epub 2023 May 8.
PMID: 37164298DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
H. Irene Su, MD, MSCE
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 25, 2022
First Posted
June 10, 2022
Study Start
October 15, 2021
Primary Completion
April 30, 2024
Study Completion
April 30, 2024
Last Updated
January 10, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
- 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).
Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.