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

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).

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Self-Report Survey; Behavioral: Qualitative Interviews

• Study Type: Observational
• Enrollment (Actual): 265

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown Lombardi Comprehensive Cancer Center
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Women will be recruited from mammography and primary care clinics, community-based outreach events, or via Facebook

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reporting Receipt of MRI Breast Screening at Any Time	Participant-reported receipt of screening breast MRI at any time in the past.	Baseline
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reporting Receipt of Mammogram	Participant-reported receipt of breast cancer screening mammogram in the last 24 months	Baseline
Reporting Receipt of Ultrasound	Participant-reported receipt of breast cancer screening ultrasound in the last 24 months	Baseline
Reporting Receipt of Chemoprevention	Participant-reported receipt of chemoprevention at any point in time (including currently receiving).	Baseline
Reporting Receipt of Genetic Testing	Participant-reported receipt of genetic testing at any time in the past	Baseline
Reporting Receipt of Genetic Counseling	Participant-reported receipt of genetic counseling at any time in the past	Baseline

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Susan Vadaparampil, PhD, MPH, Moffitt Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Actual): January 19, 2022
• Study Completion (Actual): January 19, 2022

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Pathogenic BRCA 1/2 Mutation
• Other Study ID Numbers: MCC-20257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No