NCT06205394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

October 31, 2023

Last Update Submit

January 10, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

GROUP 1 (focus group)

Cancer survivors participate in a focus group on study.

Other: Non-Interventional Study

GROUP 2 (interview)

Breast cancer clinicians undergo a semi-structured interview on study.

Other: Non-Interventional Study

Interventions

Non-interventional study

GROUP 1 (focus group)GROUP 2 (interview)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Elizabeth K Arthur, PhD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2023

First Posted

January 16, 2024

Study Start

August 24, 2022

Primary Completion

October 15, 2023

Study Completion

October 15, 2023

Last Updated

January 16, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations