Barriers to Screening Breast MRI Utilization Among Patients at Elevated Risk

Breast Cancer Clinical Trial

— B-SUPER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04257474
• Other study ID #: MCC-20257
• Status: Completed
• Start date: January 30, 2020
• Est. completion date: January 19, 2022

Study information

• Verified date: August 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: January 19, 2022
• Est. primary completion date: January 19, 2022
• Gender: Female
• Age group: 25 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Self-Report Survey
The self-report survey will be created using the Health Services Utilization Model (HSUM)
• 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

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida
United States	Georgetown Lombardi Comprehensive Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reporting Receipt of MRI Breast Screening at Any Time	Participant-reported receipt of screening breast MRI at any time in the past.	Baseline
Primary	Reporting Receipt of MRI Breast Screening in the Last 24 Months	Participant-reported receipt of screening breast MRI in the last 24 months	Baseline
Secondary	Reporting Receipt of Mammogram	Participant-reported receipt of breast cancer screening mammogram in the last 24 months	Baseline
Secondary	Reporting Receipt of Ultrasound	Participant-reported receipt of breast cancer screening ultrasound in the last 24 months	Baseline
Secondary	Reporting Receipt of Chemoprevention	Participant-reported receipt of chemoprevention at any point in time (including currently receiving).	Baseline
Secondary	Reporting Receipt of Genetic Testing	Participant-reported receipt of genetic testing at any time in the past	Baseline
Secondary	Reporting Receipt of Genetic Counseling	Participant-reported receipt of genetic counseling at any time in the past	Baseline