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

Completed

• Conditions: Breast Carcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06205394
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-08-24
• Primary Completion: 2023-10-15
• Study Completion: 2023-10-15
• Study First Submitted: 2023-10-31
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-16
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GROUP 1 (focus group)	Non-Interventional Study	Cancer survivors participate in a focus group on study.
GROUP 2 (interview)	Non-Interventional Study	Breast cancer clinicians undergo a semi-structured interview on study.

Primary Outcome Measures

Name	Time	Method
Survivor participant feedback, opinions, and preferences for breast cancer care	At completion of study up to 2 years	Data is verbally reported and collected in focus groups
Clinician participant reports of experiences, opinions, and knowledge of caring for LGBTQ+ people	At completion of study up to 2 years	Data is verbally reported and collected in interviews

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States