Improving The Breast Cancer Care Delivery Model for Sex and Gender Minority Survivors, Intended for SGM Study
January 10, 2024 updated by: Elizabeth Arthur, Ohio State University Comprehensive Cancer Center
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
GROUP 1 (focus group)
Cancer survivors participate in a focus group on study.
|
Non-interventional study
|
|
GROUP 2 (interview)
Breast cancer clinicians undergo a semi-structured interview on 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
Time Frame: At completion of study up to 2 years
|
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
Time Frame: At completion of study up to 2 years
|
Data is verbally reported and collected in interviews
|
At completion of study up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Elizabeth K Arthur, PhD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.