Trial Outcomes & Findings for BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity (NCT NCT05051631)
NCT ID: NCT05051631
Last Updated: 2025-08-28
Results Overview
The number of women eligible for risk assessment who received documented breast cancer risk assessment.
COMPLETED
NA
1071 participants
Baseline (2-months prior to intervention) to 9 months post-intervention
2025-08-28
Participant Flow
Control: Patients meeting eligibility criteria presenting for visit at an enrolled clinic during the time period prior to intervention (during the control time period). Intervention: Patients meeting eligibility criteria presenting for visit at an enrolled clinic during the time period of intervention (during the intervention time period). Maintenance: Patients meeting eligibility criteria presenting for visit at an enrolled clinic after intervention (during the maintenance time period).
Only a single clinic was enrolled. This clinic was in Arm 1 - (2 months control, 4 months intervention,12 months maintenance). Due to lack of clinic resources, the clinic was limited to 9 months of data collection in the maintenance time period.
Unit of analysis: Clinics
Participant milestones
| Measure |
Arm 1
Arm 1 - 2 months control, 4 months intervention, 12 months maintenance (maintenance limited due to 9 months due to lack of clinic resources)
|
|---|---|
|
Overall Study
STARTED
|
1071 1
|
|
Overall Study
Control Group
|
299 1
|
|
Overall Study
Intervention Group
|
362 1
|
|
Overall Study
Maintenance Group
|
410 1
|
|
Overall Study
COMPLETED
|
1071 1
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity
Baseline characteristics by cohort
| Measure |
Control
n=299 Participants
Participants in the control group are those meeting eligibility criteria seen at the enrolled clinic during the control time period (the 2 month baseline time period prior to delivery of the intervention).
|
Intervention
n=362 Participants
Participants in the intervention group are those meeting eligibility criteria seen at the enrolled clinic during the intervention time period (the 4 month time period over which the intervention was delivered).
|
Maintenance
n=410 Participants
Participants in the maintenance group are those meeting eligibility criteria seen at the enrolled clinic during the maintenance time period (the 9 month time period after the delivery of the intervention).
|
Total
n=1071 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 7.31 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 7.55 • n=7 Participants
|
36.6 years
STANDARD_DEVIATION 7.25 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 7.43 • n=4 Participants
|
|
Sex: Female, Male
Female
|
299 Participants
n=5 Participants
|
362 Participants
n=7 Participants
|
410 Participants
n=5 Participants
|
1071 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Hispanic or Latino
|
113 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
437 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
246 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Unknown or Not Reported
|
107 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
388 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
22 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
96 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
295 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not Reported
|
176 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
653 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than once race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
299 participants
n=5 Participants
|
362 participants
n=7 Participants
|
410 participants
n=5 Participants
|
1071 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (2-months prior to intervention) to 9 months post-interventionThe number of women eligible for risk assessment who received documented breast cancer risk assessment.
Outcome measures
| Measure |
Control
n=299 Participants
Participants in the control group are those meeting eligibility criteria seen at the enrolled clinic during the control time period (the 2 month baseline time period prior to delivery of the intervention).
|
Intervention
n=362 Participants
Participants in the intervention group are those meeting eligibility criteria seen at the enrolled clinic during the intervention time period (the 4 month time period over which the intervention was delivered).
|
Maintenance
n=410 Participants
Participants in the maintenance group are those meeting eligibility criteria seen at the enrolled clinic during the maintenance time period (the 9 month time period after the delivery of the intervention).
|
|---|---|---|---|
|
Number of Eligible Women Who Received Breast Cancer Risk Assessment
|
8 Participants
|
56 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Baseline (2-months prior to intervention) to 9 months post-interventionPopulation: For this measure, the denominator includes women who had risk assessment completed and documented.
Number of women who received risk assessment who were identified as high risk for breast cancer. Women are considered high risk if they have 20% or greater lifetime risk of breast cancer using the Tyrer Cuzick risk assessment tool. 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.
Outcome measures
| Measure |
Control
n=8 Participants
Participants in the control group are those meeting eligibility criteria seen at the enrolled clinic during the control time period (the 2 month baseline time period prior to delivery of the intervention).
|
Intervention
n=56 Participants
Participants in the intervention group are those meeting eligibility criteria seen at the enrolled clinic during the intervention time period (the 4 month time period over which the intervention was delivered).
|
Maintenance
n=29 Participants
Participants in the maintenance group are those meeting eligibility criteria seen at the enrolled clinic during the maintenance time period (the 9 month time period after the delivery of the intervention).
|
|---|---|---|---|
|
Number of Women Who Received Risk Assessment Who Were Identified as High Risk for Breast Cancer.
|
0 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline (2-months prior to intervention) to 9 months post-interventionPopulation: For this measure, the denominator includes only those who were identified as high risk.
Screening is defined as screening mammography or breast MRI. The number of women who received screening will be identified through from electronic health record review. For this measure, the denominator includes only those who were identified as high risk.
Outcome measures
| Measure |
Control
Participants in the control group are those meeting eligibility criteria seen at the enrolled clinic during the control time period (the 2 month baseline time period prior to delivery of the intervention).
|
Intervention
n=3 Participants
Participants in the intervention group are those meeting eligibility criteria seen at the enrolled clinic during the intervention time period (the 4 month time period over which the intervention was delivered).
|
Maintenance
n=4 Participants
Participants in the maintenance group are those meeting eligibility criteria seen at the enrolled clinic during the maintenance time period (the 9 month time period after the delivery of the intervention).
|
|---|---|---|---|
|
Number of Women Identified as High Risk Women Who Received Breast Cancer Screening.
|
0 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (2-months prior to intervention) to 9 months post-interventionPopulation: For this measure, the denominator includes only those who were identified as high risk.
Cancers will include invasive cancers and cancer in situ. Cancers will be identified from electronic health records. For this measure, the denominator includes only those who were identified as high risk.
Outcome measures
| Measure |
Control
Participants in the control group are those meeting eligibility criteria seen at the enrolled clinic during the control time period (the 2 month baseline time period prior to delivery of the intervention).
|
Intervention
n=3 Participants
Participants in the intervention group are those meeting eligibility criteria seen at the enrolled clinic during the intervention time period (the 4 month time period over which the intervention was delivered).
|
Maintenance
n=4 Participants
Participants in the maintenance group are those meeting eligibility criteria seen at the enrolled clinic during the maintenance time period (the 9 month time period after the delivery of the intervention).
|
|---|---|---|---|
|
Number of Cancers Detected in Women Identified at High Risk.
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Control Group
Intervention Group
Maintenance Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place