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

Primary Purpose

Breast Cancer, Fertility, Contraception

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-component oncofertility care intervention
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Oncofertility

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Pioneers Medical Health DistrictRecruiting
  • Cancer Resource Center of the Desert
  • El Centro Regional Medical CenterRecruiting
  • University of California San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multi-component oncofertility care intervention

Usual Care

Arm Description

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.

Prior to the intervention implementation, all breast cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive usual care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 25, 2022
Last Updated
October 14, 2023
Sponsor
University of California, San Diego
Collaborators
Cancer Resource Center of the Desert, El Centro Regional Medical Center, Pioneers Memorial Healthcare District
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1. Study Identification

Unique Protocol Identification Number
NCT05414812
Brief Title
Intervening on Women's Health for Rural Young Breast Cancer Survivors
Official Title
Intervening on Women's Health for Rural Young Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Cancer Resource Center of the Desert, El Centro Regional Medical Center, Pioneers Memorial Healthcare District

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Fertility, Contraception, Menopausal Symptoms
Keywords
Oncofertility

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Interrupted time series design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multi-component oncofertility care intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Prior to the intervention implementation, all breast cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Multi-component oncofertility care intervention
Intervention Description
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 Outcome Measure Information:
Title
Medical record review of engagement in goal-concordant oncofertility care
Description
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.
Time Frame
12 weeks after oncology visit

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sally Romero, PhD, MPH
Phone
858-822-1371
Email
saromero@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
H. Irene Su, MD, MSCE
Phone
858-822-5986
Email
hisu@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Irene Su, MD, MSCE
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pioneers Medical Health District
City
Brawley
State/Province
California
ZIP/Postal Code
92227
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H. Irene Su, MD, MSCE
Phone
858-822-5986
Email
hisu@health.ucsd.edu
Facility Name
Cancer Resource Center of the Desert
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
El Centro Regional Medical Center
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H. Irene Su, MD, MSCE
Phone
858-822-5986
Email
hisu@health.ucsd.edu
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

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

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