Breast CancerB-SUPERNCT04257474
Barriers to Screening Breast MRI Utilization Among Patients at Elevated Risk
An observational study of Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
Trial summary
This study seeks to develop an explanatory framework for breast MRI utilization to inform future interventions. The Health Services Utilization Model (HSUM) will guide the selection of specific participant-level factors for examination, including predisposing characteristics (knowledge, health/cultural beliefs)… Read more about this study
- Who is it for?
- Ages 25 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Self-Report Survey and Qualitative Interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 265 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jan 2020to 19 Jan 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 85 years
- Women only
- Adult, Older adult
Study population: Women will be recruited from mammography and primary care clinics, community-based outreach events, or via Facebook
Who may be able to join
- Ability to speak/read English
- Within 2 years of last screening mammogram
- Pathogenic BRCA1/2 mutations OR estimated lifetime risk ≥20% per the National Cancer Institute (NCI) Breast Cancer Risk Assessment Tool (BCRAT)
Who cannot join
- Women who have received a prior diagnosis of breast cancer
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Moffitt Cancer Center
Tampa, Florida, 33612
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Barriers to Screening Breast MRI Utilization Among Patients at Elevated Risk (B-SUPER)
This study seeks to develop an explanatory framework for breast MRI utilization to inform future interventions. The Health Services Utilization Model (HSUM) will guide the selection of specific participant-level factors for examination, including predisposing characteristics (knowledge, health/cultural beliefs), enabling resources (social support, cost/insurance coverage), and perceived need (perceived susceptibility, provider recommendation).
- Conditions
- Breast Cancer
- Being tested
- Self-Report Survey, Qualitative Interviews
- Keywords
- Pathogenic BRCA 1/2 Mutation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Report SurveyBehavioural
The self-report survey will be created using the Health Services Utilization Model (HSUM)
Qualitative InterviewsBehavioural
Researchers will randomly select 30 participants from group 1 and will use semi structured qualitive interviews exploring factors impacting utilization of screening breast MRI
| Study group | Role | What they receive |
|---|---|---|
| Assessing Health Services Utilization Model (HSUM) | 150 women with a high lifetime breast cancer risk will be recruited from mammography and primary care clinics. Researchers will assess HSUM factors influencing screening breast MRI utilization. Results will identify participant-level HSUM factors significantly associated with screening outcomes. Receives: Behavioral: Self-Report Survey | |
| Qualitative Interviews | Researchers will randomly select 30 participants from group 1 and will use semi-structured qualitive interviews exploring factors impacting utilization of screening breast MRI Receives: Behavioral: Qualitative Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reporting Receipt of MRI Breast Screening at Any Time
Participant-reported receipt of screening breast MRI at any time in the past.
Measured: Baseline
Reporting Receipt of MRI Breast Screening in the Last 24 Months
Participant-reported receipt of screening breast MRI in the last 24 months
Measured: Baseline
Secondary outcomes (5)
Reporting Receipt of Mammogram
Participant-reported receipt of breast cancer screening mammogram in the last 24 months
Measured: Baseline
Reporting Receipt of Ultrasound
Participant-reported receipt of breast cancer screening ultrasound in the last 24 months
Measured: Baseline
Reporting Receipt of Chemoprevention
Participant-reported receipt of chemoprevention at any point in time (including currently receiving).
Measured: Baseline
Reporting Receipt of Genetic Testing
Participant-reported receipt of genetic testing at any time in the past
Measured: Baseline
Reporting Receipt of Genetic Counseling
Participant-reported receipt of genetic counseling at any time in the past
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start30 Jan 2020
- Primary completion19 Jan 2022
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Vadaparampil, PhD, MPH, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257474
- Sponsor's protocol ID
- MCC-20257
- Acronym
- B-SUPER
- Status last verified
- Aug 2023
- First submitted
- 31 Jan 2020
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers to Screening Breast MRI Utilization Among Patients at Elevated Risk (B-SUPER)
- ClinicalTrials.gov ID
- NCT04257474
- Acronym / sponsor ID
- B-SUPER / MCC-20257
- Conditions
- Breast Cancer
- Keywords
- Pathogenic BRCA 1/2 Mutation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Posted 18 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to develop an explanatory framework for breast MRI utilization to inform future interventions. The Health Services Utilization Model (HSUM) will guide the selection of specific participant-level factors for examination, including predisposing characteristics (knowledge, health/cultural beliefs), enabling resources (social support, cost/insurance coverage), and perceived need (perceived susceptibility, provider recommendation).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assessing Health Services Utilization Model (HSUM) | – | Behavioral: Self-Report Survey150 women with a high lifetime breast cancer risk will be recruited from mammography and primary care clinics. Researchers will assess HSUM factors influencing screening breast MRI utilization. Results will identify participant-level HSUM factors significantly associated with screening outcomes. |
| Qualitative Interviews | – | Behavioral: Qualitative InterviewsResearchers will randomly select 30 participants from group 1 and will use semi-structured qualitive interviews exploring factors impacting utilization of screening breast MRI |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women will be recruited from mammography and primary care clinics, community-based outreach events, or via Facebook
Key inclusion criteria (3 listed)
- Ability to speak/read English
- Within 2 years of last screening mammogram
- Pathogenic BRCA1/2 mutations OR estimated lifetime risk ≥20% per the National Cancer Institute (NCI) Breast Cancer Risk Assessment Tool (BCRAT)
Key exclusion criteria (1 listed)
- Women who have received a prior diagnosis of breast cancer
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 |
|---|---|---|
| Self-Report SurveyThe self-report survey will be created using the Health Services Utilization Model (HSUM) | Behavioural | Assessing Health Services Utilization Model (HSUM) |
| Qualitative InterviewsResearchers will randomly select 30 participants from group 1 and will use semi structured qualitive interviews exploring factors impacting utilization of screening breast MRI | Behavioural | Qualitative Interviews |
Primary outcome
Reporting Receipt of MRI Breast Screening at Any Time
Time frame: Baseline
Participant-reported receipt of screening breast MRI at any time in the past.
Reporting Receipt of MRI Breast Screening in the Last 24 Months
Time frame: Baseline
Participant-reported receipt of screening breast MRI in the last 24 months
5 secondary outcomes
Reporting Receipt of Mammogram
Time frame: Baseline
Reporting Receipt of Ultrasound
Time frame: Baseline
Reporting Receipt of Chemoprevention
Time frame: Baseline
Reporting Receipt of Genetic Testing
Time frame: Baseline
Reporting Receipt of Genetic Counseling
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Susan Vadaparampil, PhD, MPH principal investigator
Moffitt Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites 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 3 inclusion and 1 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 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 18 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reporting Receipt of MRI Breast Screening at Any Time (time frame: Baseline). 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 18 Mar 2024.