NCT04257474

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 31, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2022

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

March 18, 2024

Completed
Last Updated

March 18, 2024

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

January 31, 2020

Results QC Date

October 17, 2022

Last Update Submit

August 31, 2023

Conditions

Breast Cancer

Keywords

Pathogenic BRCA 1/2 Mutation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Reporting Receipt of Mammogram

    Baseline

  • Reporting Receipt of Ultrasound

    Baseline

  • Reporting Receipt of Chemoprevention

    Baseline

  • Reporting Receipt of Genetic Testing

    Baseline

  • Reporting Receipt of Genetic Counseling

    Baseline

Study Arms (2)

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

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

Interventions

Self-Report SurveyBEHAVIORAL

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

Assessing Health Services Utilization Model (HSUM)
Qualitative InterviewsBEHAVIORAL

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

Qualitative Interviews

Eligibility Criteria

Age25 Years - 85 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe lifetime risk for breast cancer in men is very low (1.2% for male BRCA1 mutation carriers and 6.8% for male BRCA2 mutation carriers).
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • Women who have received a prior diagnosis of breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Susan T. Vadaparampil, PhD, MPH
Organization
Moffitt Cancer Center
Susan.Vadaparampil@moffitt.org
813-745-1997

Study Officials

  • Susan Vadaparampil, PhD, MPH

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 6, 2020

Study Start

January 30, 2020

Primary Completion

January 19, 2022

Study Completion

January 19, 2022

Last Updated

March 18, 2024

Results First Posted

March 18, 2024

Record last verified: 2023-08

Locations

US(2)