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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention plus 12 months maintenance | Experimental | 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. |
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| Intervention plus 10 months maintenance | Experimental | 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. |
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| Intervention plus 8 months maintenance | Experimental | 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. |
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| Intervention plus 6 months maintenance | Experimental | 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. |
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| Intervention plus 4 months maintenance | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention plus 12 months maintenance | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (2-months prior to intervention) to 9 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Designated female at birth.
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| Name | Affiliation | Role |
|---|---|---|
| Lucy B Spalluto, MD MPH | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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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.
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).
| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2023 |
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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.
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| Intervention plus 10 months maintenance | Other | 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. |
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| Intervention plus 8 months maintenance | Other | 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. |
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| Intervention plus 6 months maintenance | Other | 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. |
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| Intervention plus 4 months maintenance | Other | 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. |
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| Baseline (2-months prior to intervention) to 9 months post-intervention |
| 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. | Baseline (2-months prior to intervention) to 9 months post-intervention |
| 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. | Baseline (2-months prior to intervention) to 9 months post-intervention |
| Control Group |
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| Intervention Group |
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| Maintenance Group |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | 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). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Baseline (2-months prior to intervention) to 9 months post-intervention |
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| 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. | For this measure, the denominator includes women who had risk assessment completed and documented. | Posted | Count of Participants | Participants | Baseline (2-months prior to intervention) to 9 months post-intervention |
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| 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. | For this measure, the denominator includes only those who were identified as high risk. | Posted | Count of Participants | Participants | Baseline (2-months prior to intervention) to 9 months post-intervention |
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| 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. | For this measure, the denominator includes only those who were identified as high risk. | Posted | Count of Participants | Participants | Baseline (2-months prior to intervention) to 9 months post-intervention |
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Baseline (2-months prior to intervention) to 9 months post-intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Participants in the control group are those meeting eligibility criteria seen at the enrolled clinic during the control time period. | 0 | 299 | 0 | 299 | 0 | 299 |
| EG001 | Intervention Group | Participants in the intervention group are those meeting eligibility criteria seen at the enrolled clinic during the intervention time period. | 0 | 362 | 0 | 362 | 0 | 362 |
| EG002 | Maintenance Group | Participants in the maintenance group are those meeting eligibility criteria seen at the enrolled clinic during the maintenance time period. | 0 | 410 | 0 | 410 | 0 | 410 |
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We had significant difficulty enrolling community clinics during this trial due to the impacts of the COVID 19 pandemic and resulting limitations in clinic resources.
We enrolled a single clinic. This clinic was in Arm 1 - (2 months control, 4 months intervention,12 months maintenance). Due to clinic limited resources, we were also limited to 9 months of data collection in the maintenance time period, rather than the full 12 months.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lucy Spalluto | Vanderbilt University Medical Center | 615-875-5649 | lucy.b.spalluto@vumc.org |
| Jul 30, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D008283 | Maintenance |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D005159 | Health Care Facilities Workforce and Services |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| American Indian or Alaska Native |
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| White |
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| Unknown/Not Reported |
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| Native Hawaiian/Pacific Islander |
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| More than once race |
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| OG002 | Maintenance Group | 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). For this measure, the denominator includes only those who had risk assessment completed. |
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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). For this measure, the denominator includes only those who were identified as high risk.
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