Back to resultsBRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity (BRAVE)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention plus 12 months maintenance
Intervention plus 10 months maintenance
Intervention plus 8 months maintenance
Intervention plus 6 months maintenance
Intervention plus 4 months maintenance
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer focused on measuring breast cancer, mammogram, screening, risk assessment
Eligibility Criteria
Inclusion Criteria:
- ages 25-49
Exclusion Criteria:
- personal history of breast cancer
Sites / Locations
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Intervention plus 12 months maintenance
Intervention plus 10 months maintenance
Intervention plus 8 months maintenance
Intervention plus 6 months maintenance
Intervention plus 4 months maintenance
Arm Description
Clinics in this group will be in the control phase for 2 months, receive the 4 month intervention, and be in the maintenance phase for 12 months.
Clinics in this group will be in the control phase for 4 months, receive the 4 month intervention, and be in the maintenance phase for 10 months.
Clinics in this group will be in the control phase for 6 months, receive the 4 month intervention, and be in the maintenance phase for 8 months.
Clinics in this group will be in the control phase for 8 months, receive the 4 month intervention, and be in the maintenance phase for 6 months.
Clinics in this group will be in the control phase for 10 months, receive the 4 month intervention, and be in the maintenance phase for 4 months.
Outcomes
Primary Outcome Measures
Proportion of eligible women who receive breast cancer risk assessment
Proportion will be measured as a binary outcome (yes/no received risk assessment)
Secondary Outcome Measures
Number of women identified as high risk for breast cancer
Women with a 20% or greater lifetime risk of breast cancer using the Tyrer Cuzick risk assessment tool will be considered high risk. The Tyrer Cuzick risk assessment tool is an 11 question electronic risk assessment tool about a woman's family history of cancer and personal history to immediately calculate a lifetime risk percentage.
Number of high risk women who received screening
Screening is defined as screening mammography or breast MRI. The number of women who received screening will be calculated from electronic health records.
Number of cancers detected in high risk women
Cancers will include invasive cancers and cancer in situ. Cancers will be identified from electronic health records.
Full Information
NCT ID
NCT05051631
First Posted
September 10, 2021
Last Updated
July 28, 2023
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05051631
Brief Title
BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity
Acronym
BRAVE
Official Title
BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The central goal of this study is to test strategies to implement evidence-based breast cancer risk assessment in healthcare clinics in Tennessee. The BRAVE Strategy (Breast cancer Risk Assessment - achieVing Equity) study aims to assess the feasibility, reach, acceptability, and appropriateness of select customized strategies to increase uptake of breast cancer risk assessment. The investigators will achieve these aims through a conducting a stepped-wedge trial conducted in 10 healthcare clinics in the state of Tennessee. The primary outcome is the proportion of women age 25-49 having risk assessment. Secondary outcomes include the numbers of 1) women identified as high-risk; 2) pursuing risk-adherent screening; and 3) diagnosed with breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, mammogram, screening, risk assessment
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stepped-Wedge Trial. 10 clinics will be assigned to 5 arms to receive the intervention at sequential times. The time at which each arm receives the intervention will be randomized.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention plus 12 months maintenance
Arm Type
Experimental
Arm Description
Clinics in this group will be in the control phase for 2 months, receive the 4 month intervention, and be in the maintenance phase for 12 months.
Arm Title
Intervention plus 10 months maintenance
Arm Type
Experimental
Arm Description
Clinics in this group will be in the control phase for 4 months, receive the 4 month intervention, and be in the maintenance phase for 10 months.
Arm Title
Intervention plus 8 months maintenance
Arm Type
Experimental
Arm Description
Clinics in this group will be in the control phase for 6 months, receive the 4 month intervention, and be in the maintenance phase for 8 months.
Arm Title
Intervention plus 6 months maintenance
Arm Type
Experimental
Arm Description
Clinics in this group will be in the control phase for 8 months, receive the 4 month intervention, and be in the maintenance phase for 6 months.
Arm Title
Intervention plus 4 months maintenance
Arm Type
Experimental
Arm Description
Clinics in this group will be in the control phase for 10 months, receive the 4 month intervention, and be in the maintenance phase for 4 months.
Intervention Type
Other
Intervention Name(s)
Intervention plus 12 months maintenance
Intervention Description
The intervention will include 2 months of data collection in the control period, 4 months of education and awareness training, and 12 months of data collection in the maintenance time period.
Intervention Type
Other
Intervention Name(s)
Intervention plus 10 months maintenance
Intervention Description
The intervention will include 4 months of data collection in the control period, 4 months of education and awareness training, and 10 months of data collection in the maintenance time period.
Intervention Type
Other
Intervention Name(s)
Intervention plus 8 months maintenance
Intervention Description
The intervention will include 6 months of data collection in the control period, 4 months of education and awareness training, and 8 months of data collection in the maintenance time period.
Intervention Type
Other
Intervention Name(s)
Intervention plus 6 months maintenance
Intervention Description
The intervention will include 8 months of data collection in the control period, 4 months of education and awareness training, and 6 months of data collection in the maintenance time period.
Intervention Type
Other
Intervention Name(s)
Intervention plus 4 months maintenance
Intervention Description
The intervention will include 10 months of data collection in the control period, 4 months of education and awareness training, and 4 months of data collection in the maintenance time period.
Primary Outcome Measure Information:
Title
Proportion of eligible women who receive breast cancer risk assessment
Description
Proportion will be measured as a binary outcome (yes/no received risk assessment)
Time Frame
baseline to 18 months
Secondary Outcome Measure Information:
Title
Number of women identified as high risk for breast cancer
Description
Women with a 20% or greater lifetime risk of breast cancer using the Tyrer Cuzick risk assessment tool will be considered high risk. The Tyrer Cuzick risk assessment tool is an 11 question electronic risk assessment tool about a woman's family history of cancer and personal history to immediately calculate a lifetime risk percentage.
Time Frame
baseline to 18 months
Title
Number of high risk women who received screening
Description
Screening is defined as screening mammography or breast MRI. The number of women who received screening will be calculated from electronic health records.
Time Frame
baseline to 24 months
Title
Number of cancers detected in high risk women
Description
Cancers will include invasive cancers and cancer in situ. Cancers will be identified from electronic health records.
Time Frame
baseline to 24 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Designated female at birth.
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ages 25-49
Exclusion Criteria:
personal history of breast cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucy B Spalluto, MD MPH
Phone
615-322-1585
Email
lucy.b.spalluto@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy B Spalluto, MD MPH
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy B Spalluto, MD MPH
Phone
615-322-1585
Email
lucy.b.spalluto@vumc.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity
We'll reach out to this number within 24 hrs