Breast Cancer Risk Reduction: A Patient Doctor Intervention (BreastCARE)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Breast Cancer

Treatments: Other: BreastCARE

Study type: Interventional

Funder types: Other

Identifiers

NCT01830933

150B-0158

Details and patient eligibility

About

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.

Enrollment: 1,235 patients

Sex: All

Ages: 40 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.

2. Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF

Exclusion criteria

1. Patient component: Women whose physicians object to their participation in the study
2. Physician component: No exclusion criteria for physicians

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,235 participants in 2 patient groups

BreastCARE Intervention

Experimental group

Description:

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.

Treatment:

Other: BreastCARE

BreastCARE Comparison

No Intervention group

Description:

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.