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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05414812
Other study ID # 800646
Secondary ID B27BB4247
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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