Barriers to Screening Breast MRI Utilization Among Patients at Elevated Risk

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Qualitative Interviews; Behavioral: Self-Report Survey

• Registration Number: NCT04257474
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-30
• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-06
• Primary Completion: 2022-01-19
• Study Completion: 2022-01-19
• Results First Submitted: 2022-10-17
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-31
• Last Update Submitted: 2023-08-31
• Results First Posted: 2024-03-18
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 265

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Qualitative Interviews	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
Assessing Health Services Utilization Model (HSUM)	Self-Report Survey	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.

Primary Outcome Measures

Name	Time	Method
Reporting Receipt of MRI Breast Screening at Any Time	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	Baseline	Participant-reported receipt of screening breast MRI in the last 24 months

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Georgetown Lombardi Comprehensive Cancer Center; 🇺🇸 Washington, District of Columbia, United States