Breast Cancer Risk Reduction: A Patient Doctor Intervention

Study Overview
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Brief Summary
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The proposed research combines the scientific advances in breast cancer research with health information technology (IT) to design a personalized intervention that assesses breast cancer risk for women, disseminates important breast health information, and facilitates discussion of breast cancer risk reduction practices. Our goal is to implement a tablet-PC (personal computer) based breast cancer risk education (BreastCare) intervention in the primary care setting that estimates a woman's individual risk for breast cancer and provides her and her physician with personalized breast cancer risk information and recommendations for action.

Official Title
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Breast Cancer Risk Reduction: A Patient Doctor Intervention

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: BreastCARE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient component: Women who visit the General Internal Medicine (GIM) practices at SFGH and UCSF during the study period Between the ages of 40 and 74 Self-identify as Asian American, Spanish- and English-speaking Latinas, African American, or White Have no history of breast cancer are eligible to participate. Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF Exclusion Criteria: Patient component: Women whose physicians object to their participation in the study Physician component: No exclusion criteria for physicians

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BreastCARE Intervention<br>Intervention Clinic Patients: The RA will welcome the patient upon arrival at the clinic and again explain study procedures and field any questions. The RA will have the patient sign the HIPAA authorization form and then demonstrate how to enter information and answer questions on the tablet-PC and the patient will indicate their consent electronically before beginning the assessment. Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patietns before she meets with her doctor. | Other: BreastCARE<br>* Physician Report. At the time of an individual participant's visit to her primary care physician and her completion of the assessment tool, her physician will receive a physician report. The physician report is designed to facilitate communication about breast cancer risk during the primary care visit and to provide tailored risk reduction recommendations.<br>|
| No Intervention: BreastCARE Comparison<br>Patients will be randomized into the intervention or comparison groups at the time of recruitment. Block-randomization will be used to assign patients to intervention or comparison groups. Comparison Clinic Patients. Contact and baseline interview procedures will be the same for patients from the comparison clinics, however there will be no computer assessment at the time of their clinic visit. An RA will meet the patient 10 minutes prior to her appointment time to obtain written HIPAA authorization. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of Breast Cancer Risk Factors | Risk knowledge was assessed using a post-survey. Participants could have scored 0-100 (with 0 meaning no correct answers, and 100 is all correct answers). This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey. O | one week post-initial visit (approximately one week) | 
| Percentage of Participants With Correct Perception of Risk | This outcome was measured through a survey. Women were asked what they thought about their risk of getting breast cancer was compared to other women of the same age. | baseline, one week post-initial visit (approximately one week) | 
| Percentage of Participants Who Had a Discussion of Breast Cancer Risk | Self-reported discussion of breast cancer risk with physicians. | one week post-initial visit (approximately one week) | 
| Percentage of Participants Who Reported Discussion of Mammography Screening | Self reported discussion of mammography with physician. | up to 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer concern, breast cancer risk perception, breast cancer risk