This trial is active, not recruiting.

Condition breast cancer
Treatment breastcare
Sponsor University of California, San Francisco
Collaborator Susan G. Komen Breast Cancer Foundation
Start date June 2011
End date August 2012
Trial size 1235 participants
Trial identifier NCT01830933, 150B-0158, NCT01836250


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
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.
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.
(No Intervention)
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.

Primary Outcomes

Knowledge of Breast Cancer Risk Factors
time frame: one week post-initial visit (approximately one week)
Percentage of Participants With Correct Perception of Risk
time frame: baseline, one week post-initial visit (approximately one week)
Percentage of Participants Who Had a Discussion of Breast Cancer Risk
time frame: one week post-initial visit (approximately one week)
Percentage of Participants Who Reported Discussion of Mammography Screening
time frame: up to 14 months

Eligibility Criteria

Male or female participants from 40 years up to 74 years old.

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

Additional Information

Official title Breast Cancer Risk Reduction: A Patient Doctor Intervention
Principal investigator Celia P Kaplan, DrPH, MA
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by University of California, San Francisco.