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OpenTrials
Completed

NCT Number: NCT04257474

Barriers to Screening Breast MRI Utilization Among Patients at Elevated Risk

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

Georgetown Lombardi Comprehensive Cancer Center, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Report Survey

Behavioral

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

Qualitative interviews

Behavioral

Researchers will randomly select 30 participants from group 1 and will use semi structured qualitive interviews exploring factors impacting utilization of screening breast MRI

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Reporting Receipt of Mammogram

    Time frame: Baseline

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

  2. Reporting Receipt of Ultrasound

    Time frame: Baseline

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

  3. Reporting Receipt of Chemoprevention

    Time frame: Baseline

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

  4. Reporting Receipt of Genetic Testing

    Time frame: Baseline

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

  5. Reporting Receipt of Genetic Counseling

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Acronym: B-SUPER

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2020
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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