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CompletedNCT06205394Updated Jan 16, 2024

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

An observational study in Breast Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-01-16.

Sponsored by Ohio State University Comprehensive Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
28
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Breast Carcinoma

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 28 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Eligibility criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
28 participants (actual)

Groups and cohorts

  • 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

  • OtherNon-Interventional Study

    Non-interventional study

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What researchers measure

Primary outcomes

  1. Survivor participant feedback, opinions, and preferences for breast cancer care

    Data is verbally reported and collected in focus groups

    Time frame: At completion of study up to 2 years

  2. Clinician participant reports of experiences, opinions, and knowledge of caring for LGBTQ+ people

    Data is verbally reported and collected in interviews

    Time frame: At completion of study up to 2 years

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Study locations

1 site
  • Ohio State University Comprehensive Cancer Center
    Columbus, Ohio 43210, United States
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References and documents

Related links

Study documents

  • Informed consent form · Apr 14, 2023
  • Informed consent form · Apr 14, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06205394
Lead sponsor
Ohio State University Comprehensive Cancer Center
Responsible party
Elizabeth Arthur (Principal Investigator, Ohio State University Comprehensive Cancer Center) — Principal investigator
First posted
Jan 16, 2024
Start date
Aug 24, 2022
Primary completion
Oct 15, 2023
Completion
Oct 15, 2023
Last update
Jan 16, 2024

Study contacts

Elizabeth K Arthur, PhD
principal investigator · Ohio State University Comprehensive Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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