FindTrial
Sign In

Barriers to Screening Breast MRI Utilization Among Patients at Elevated Risk

Barriers to Screening Breast MRI Utilization Among Patients at Elevated Risk (B-SUPER)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04257474
Acronym
B-SUPER
Enrollment
265
Registered
2020-02-06
Start date
2020-01-30
Completion date
2022-01-19
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Pathogenic BRCA 1/2 Mutation

Brief 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), enabling resources (social support, cost/insurance coverage), and perceived need (perceived susceptibility, provider recommendation).

Interventions

BEHAVIORALSelf-Report Survey

The self-report survey will be created using the Health Services Utilization Model (HSUM)

BEHAVIORALQualitative 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

Sponsors

H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 85 Years

Inclusion criteria

* 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)

Exclusion criteria

* Women who have received a prior diagnosis of breast cancer

Design outcomes

Primary

MeasureTime frameDescription
Reporting Receipt of MRI Breast Screening in the Last 24 MonthsBaselineParticipant-reported receipt of screening breast MRI in the last 24 months
Reporting Receipt of MRI Breast Screening at Any TimeBaselineParticipant-reported receipt of screening breast MRI at any time in the past.

Secondary

MeasureTime frameDescription
Reporting Receipt of ChemopreventionBaselineParticipant-reported receipt of chemoprevention at any point in time (including currently receiving).
Reporting Receipt of MammogramBaselineParticipant-reported receipt of breast cancer screening mammogram in the last 24 months
Reporting Receipt of Genetic CounselingBaselineParticipant-reported receipt of genetic counseling at any time in the past
Reporting Receipt of Genetic TestingBaselineParticipant-reported receipt of genetic testing at any time in the past
Reporting Receipt of UltrasoundBaselineParticipant-reported receipt of breast cancer screening ultrasound in the last 24 months

Countries

United States

Participant flow

Participants by arm

ArmCount
Group 1: Self-Report Surveys Only
Women with a high lifetime breast cancer risk were recruited from mammography and primary care clinics. Group 1 took a self-report survey that was created using the Health Services Utilization Model (HSUM)
172
Group 2: Self-Report Survey and Qualitative Interviews
Women with a high lifetime breast cancer risk were recruited from mammography and primary care clinics. Self-Report Survey: The self-report survey was created using the Health Services Utilization Model (HSUM) Researchers randomly selected participants from group 1 who took self-report Survey and held semi-structured qualitive interviews exploring factors impacting utilization of screening breast MRI
63
Total235

Baseline characteristics

CharacteristicGroup 1: Self-Report Surveys OnlyGroup 2: Self-Report Survey and Qualitative InterviewsTotal
Age, Customized
25-29
20 Participants3 Participants23 Participants
Age, Customized
30-39
62 Participants18 Participants80 Participants
Age, Customized
40-49
38 Participants12 Participants50 Participants
Age, Customized
50-59
28 Participants19 Participants47 Participants
Age, Customized
60-69
17 Participants10 Participants27 Participants
Age, Customized
70-79
5 Participants1 Participants6 Participants
Age, Customized
80-85
2 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants3 Participants11 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
164 Participants60 Participants224 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Asian
3 Participants1 Participants4 Participants
Race (NIH/OMB)
Black or African American
10 Participants5 Participants15 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants1 Participants9 Participants
Race (NIH/OMB)
White
149 Participants54 Participants203 Participants
Region of Enrollment
United States
172 participants63 participants235 participants
Sex: Female, Male
Female
172 Participants63 Participants235 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Reporting Receipt of MRI Breast Screening at Any Time

Participant-reported receipt of screening breast MRI at any time in the past.

Time frame: Baseline

Population: This study uses a mixed-methods design. All data from participants who completed self-report surveys were analyzed as one group. Semi-structured interviews were done to understand more about the patients decisions, not to compare any group against another.

ArmMeasureValue (NUMBER)
All ParticipantsReporting Receipt of MRI Breast Screening at Any Time32.34 percentage of participants
Primary

Reporting Receipt of MRI Breast Screening in the Last 24 Months

Participant-reported receipt of screening breast MRI in the last 24 months

Time frame: Baseline

Population: This study uses a mixed-methods design. All data from participants who completed self-report surveys were analyzed as one group. Semi-structured interviews were done to understand more about the patients decisions, not to compare any group against another.

ArmMeasureValue (NUMBER)
All ParticipantsReporting Receipt of MRI Breast Screening in the Last 24 Months25.11 percentage of participants
Secondary

Reporting Receipt of Chemoprevention

Participant-reported receipt of chemoprevention at any point in time (including currently receiving).

Time frame: Baseline

Population: This study uses a mixed-methods design. All data from participants who completed self-report surveys were analyzed as one group. Semi-structured interviews were done to understand more about the patients decisions, not to compare any group against another.

ArmMeasureValue (NUMBER)
All ParticipantsReporting Receipt of Chemoprevention18.30 percentage of participants
Secondary

Reporting Receipt of Genetic Counseling

Participant-reported receipt of genetic counseling at any time in the past

Time frame: Baseline

Population: This study uses a mixed-methods design. All data from participants who completed self-report surveys were analyzed as one group. Semi-structured interviews were done to understand more about the patients decisions, not to compare any group against another.

ArmMeasureValue (NUMBER)
All ParticipantsReporting Receipt of Genetic Counseling39.57 percentage of participants
Secondary

Reporting Receipt of Genetic Testing

Participant-reported receipt of genetic testing at any time in the past

Time frame: Baseline

Population: This study uses a mixed-methods design. All data from participants who completed self-report surveys were analyzed as one group. Semi-structured interviews were done to understand more about the patients decisions, not to compare any group against another.

ArmMeasureValue (NUMBER)
All ParticipantsReporting Receipt of Genetic Testing42.99 percentage of participants
Secondary

Reporting Receipt of Mammogram

Participant-reported receipt of breast cancer screening mammogram in the last 24 months

Time frame: Baseline

Population: This study uses a mixed-methods design. All data from participants who completed self-report surveys were analyzed as one group. Semi-structured interviews were done to understand more about the patients decisions, not to compare any group against another.

ArmMeasureValue (NUMBER)
All ParticipantsReporting Receipt of Mammogram71.06 percentage of participants
Secondary

Reporting Receipt of Ultrasound

Participant-reported receipt of breast cancer screening ultrasound in the last 24 months

Time frame: Baseline

Population: This study uses a mixed-methods design. All data from participants who completed self-report surveys were analyzed as one group. Semi-structured interviews were done to understand more about the patients decisions, not to compare any group against another.

ArmMeasureValue (NUMBER)
All ParticipantsReporting Receipt of Ultrasound34.04 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026