Breast Cancer
Conditions
Keywords
breast cancer, mammogram, screening, risk assessment
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.
Interventions
OTHERIntervention plus 12 months maintenance
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.
OTHERIntervention plus 10 months maintenance
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.
OTHERIntervention plus 8 months maintenance
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.
OTHERIntervention plus 6 months maintenance
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.
OTHERIntervention plus 4 months maintenance
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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* ages 25-49
Exclusion criteria
* personal history of breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eligible Women Who Received Breast Cancer Risk Assessment | Baseline (2-months prior to intervention) to 9 months post-intervention | The number of women eligible for risk assessment who received documented breast cancer risk assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women Who Received Risk Assessment Who Were Identified as High Risk for Breast Cancer. | Baseline (2-months prior to intervention) to 9 months post-intervention | 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. |
| Number of Women Identified as High Risk Women Who Received Breast Cancer Screening. | Baseline (2-months prior to intervention) to 9 months post-intervention | 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. |
| Number of Cancers Detected in Women Identified at High Risk. | Baseline (2-months prior to intervention) to 9 months post-intervention | 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. |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 299 |
| Intervention 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). | 362 |
| Maintenance 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). | 410 |
| Total | 1,071 |
Baseline characteristics
| Characteristic | Control | Total | Maintenance | Intervention |
|---|---|---|---|---|
| Age, Continuous | 39.1 years STANDARD_DEVIATION 7.31 | 37.7 years STANDARD_DEVIATION 7.43 | 36.6 years STANDARD_DEVIATION 7.25 | 37.8 years STANDARD_DEVIATION 7.55 |
| Ethnicity (NIH/OMB) Ethnicity Hispanic or Latino | 113 Participants | 437 Participants | 192 Participants | 132 Participants |
| Ethnicity (NIH/OMB) Ethnicity Not Hispanic or Latino | 79 Participants | 246 Participants | 75 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Ethnicity Unknown or Not Reported | 107 Participants | 388 Participants | 143 Participants | 138 Participants |
| Race/Ethnicity, Customized African American/Black | 22 Participants | 86 Participants | 33 Participants | 31 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 21 Participants | 17 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 11 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized More than once race | 0 Participants | 4 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown/Not Reported | 176 Participants | 653 Participants | 270 Participants | 207 Participants |
| Race/Ethnicity, Customized White | 96 Participants | 295 Participants | 82 Participants | 117 Participants |
| Region of Enrollment United States | 299 participants | 1071 participants | 410 participants | 362 participants |
| Sex: Female, Male Female | 299 Participants | 1071 Participants | 410 Participants | 362 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 299 | 0 / 362 | 0 / 410 |
| other Total, other adverse events | 0 / 299 | 0 / 362 | 0 / 410 |
| serious Total, serious adverse events | 0 / 299 | 0 / 362 | 0 / 410 |
Outcome results
Primary
Number of Eligible Women Who Received Breast Cancer Risk Assessment
The number of women eligible for risk assessment who received documented breast cancer risk assessment.
Time frame: Baseline (2-months prior to intervention) to 9 months post-intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Eligible Women Who Received Breast Cancer Risk Assessment | 8 Participants |
| Intervention | Number of Eligible Women Who Received Breast Cancer Risk Assessment | 56 Participants |
| Maintenance | Number of Eligible Women Who Received Breast Cancer Risk Assessment | 29 Participants |
Secondary
Number of Cancers Detected in Women Identified at 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.
Time frame: Baseline (2-months prior to intervention) to 9 months post-intervention
Population: For this measure, the denominator includes only those who were identified as high risk.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Cancers Detected in Women Identified at High Risk. | 0 Participants |
| Intervention | Number of Cancers Detected in Women Identified at High Risk. | 1 Participants |
| Maintenance | Number of Cancers Detected in Women Identified at High Risk. | 0 Participants |
Secondary
Number of Women Identified as High Risk Women Who Received Breast Cancer Screening.
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.
Time frame: Baseline (2-months prior to intervention) to 9 months post-intervention
Population: For this measure, the denominator includes only those who were identified as high risk.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Women Identified as High Risk Women Who Received Breast Cancer Screening. | 0 Participants |
| Intervention | Number of Women Identified as High Risk Women Who Received Breast Cancer Screening. | 2 Participants |
| Maintenance | Number of Women Identified as High Risk Women Who Received Breast Cancer Screening. | 2 Participants |
Secondary
Number of Women Who Received Risk Assessment Who Were Identified as High Risk for Breast Cancer.
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.
Time frame: Baseline (2-months prior to intervention) to 9 months post-intervention
Population: For this measure, the denominator includes women who had risk assessment completed and documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Women Who Received Risk Assessment Who Were Identified as High Risk for Breast Cancer. | 0 Participants |
| Intervention | Number of Women Who Received Risk Assessment Who Were Identified as High Risk for Breast Cancer. | 3 Participants |
| Maintenance | Number of Women Who Received Risk Assessment Who Were Identified as High Risk for Breast Cancer. | 4 Participants |