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NCT06205394 Clinical Trial

Improving The Breast Cancer Care Delivery Model for Sex and Gender Minority Survivors, Intended for SGM Study

Breast Carcinoma Clinical Trial

Official title:
Improving the Breast Cancer Care Delivery Model for Sex and Gender Minority Survivors (Intended for SGM)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06205394
Other study ID # OSU-22123
Secondary ID NCI-2023-00667OS
Status Completed
Phase
First received
Last updated
Start date August 24, 2022
Est. completion date October 15, 2023

Study information
Verified date January 2024
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates Improving the Breast Cancer Care Delivery Model for Sex and Gender Minority (INTENDED for SGM) in identifying the patient, support person and provider barriers to quality care in SGM breast/chest cancer survivors.

Description:

PRIMARY OBJECTIVE: I. To determine the important ways the iCanDecide breast cancer decision aid needs revised for SGM people, and how best to integrate a culturally-relevant tool into clinical practice. OUTLINE: This is an observational study. AIM 1: Interview transcripts from SANGRIA study utilized to explore the values, preferences and key considerations for breast cancer treatment decision making in SGM individuals. AIM 2: Patients are assigned to 1 of 2 groups. GROUP 1: Cancer survivors participate in a focus group on study. GROUP 2: Breast cancer clinicians undergo a semi-structured interview on study.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date October 15, 2023
Est. primary completion date October 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - SURVIVORS: - Self-identify as a member of the sex and gender minority community or partner with an individual of the same sex or gender - Must be a breast cancer survivor, in active treatment or completed active treatment in the last 10 years (not including hormone therapy) - Be over age 18 - English-speaking - Received care in the US BREAST ONCOLOGY CLINICIANS: Physicians, advanced practice providers, nurses, psychologists and social workers will be eligible if they: - Provide care and/or surgical decision support to individuals diagnosed with early stage breast cancer in the US - Are English-speaking

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations
Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survivor participant feedback, opinions, and preferences for breast cancer care Data is verbally reported and collected in focus groups At completion of study up to 2 years
Primary Clinician participant reports of experiences, opinions, and knowledge of caring for LGBTQ+ people Data is verbally reported and collected in interviews At completion of study up to 2 years
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