Breast CarcinomaNCT06205394
Improving The Breast Cancer Care Delivery Model for Sex and Gender Minority Survivors, Intended for SGM Study
An observational study of Breast Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2022to 15 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Breast Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 (focus group) | Cancer survivors participate in a focus group on study. Receives: Other: Non-Interventional Study | |
| GROUP 2 (interview) | Breast cancer clinicians undergo a semi-structured interview on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivor participant feedback, opinions, and preferences for breast cancer care
Data is verbally reported and collected in focus groups
Measured: 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
Measured: At completion of study up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start24 Aug 2022
- Primary completion15 Oct 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Arthur, Ohio State University Comprehensive Cancer Center
- Investigators
- Elizabeth K Arthur, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205394
- Sponsor's protocol ID
- OSU-22123
- Other IDs
- NCI-2023-00667, OSU-22123
- Status last verified
- Jan 2024
- First submitted
- 31 Oct 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Breast Cancer Care Delivery Model for Sex and Gender Minority Survivors (Intended for SGM)
- ClinicalTrials.gov ID
- NCT06205394
- Acronym / sponsor ID
- OSU-22123
- Conditions
- Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 (focus group) | – | Other: Non-Interventional StudyCancer survivors participate in a focus group on study. |
| GROUP 2 (interview) | – | Other: Non-Interventional StudyBreast cancer clinicians undergo a semi-structured interview on study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- SURVIVORS:
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | GROUP 1 (focus group), GROUP 2 (interview) |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth K Arthur, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivor participant feedback, opinions, and preferences for breast cancer care (time frame: At completion of study up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.