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

Sponsor

University of California, San Diego (Other)

Overall Status

Recruiting

CT.gov ID

NCT05414812

Collaborator

Cancer Resource Center of the Desert (Other), El Centro Regional Medical Center (Other), Pioneers Memorial Healthcare District (Other)

135

Enrollment

Locations

Arms

30.5

Anticipated Duration (Months)

33.8

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Fertility Contraception Menopausal Symptoms	Behavioral: Multi-component oncofertility care intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

135 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Interrupted time series designInterrupted time series design

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 15, 2021

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pioneers Medical Health District	Brawley	California	United States	92227
2	Cancer Resource Center of the Desert	El Centro	California	United States	92243
3	El Centro Regional Medical Center	El Centro	California	United States	92243
4	University of California San Diego	La Jolla	California	United States	92093

Sponsors and Collaborators

University of California, San Diego
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hui-Chun Irene Su, Professor, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT05414812

Other Study ID Numbers:

800646
B27BB4247

First Posted:

Jun 10, 2022

Last Update Posted:

Jun 10, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hui-Chun Irene Su, Professor, University of California, San Diego

Oncofertility

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Jun 10, 2022