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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Carcinoma
• Intervention / Treatment: Other: Non-Interventional Study

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 Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer survivors that self-identify as a member of the sex and gender minority community or partner with an individual of the same sex or gender and breast oncology clinicians recruited through Ohio State University Comprehensive Cancer Center.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GROUP 1 (focus group); Cancer survivors participate in a focus group on study.	Other: Non-Interventional Study; Non-interventional study
GROUP 2 (interview); Breast cancer clinicians undergo a semi-structured interview on study.	Other: Non-Interventional Study; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Elizabeth K Arthur, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Actual): October 15, 2023
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Estimated): January 15, 2024

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: OSU-22123 (Other Identifier: Ohio State University Comprehensive Cancer Center); NCI-2023-00667 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No