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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: BreastCARE

• Study Type: Interventional
• Enrollment (Actual): 1235
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • San Francisco General Hospital (SFGH)
    • San Francisco, California, United States, 94143
      • University of California, San Francisco Mt. Zion campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BreastCARE Intervention; 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; 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: BreastCARE Comparison; 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?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Susan G. Komen Breast Cancer Foundation; California Breast Cancer Research Program
• Investigators: Principal Investigator: Celia P Kaplan, DrPH, MA, University of California, San Francisco

Publications and helpful links

General Publications

• Livaudais-Toman J, Karliner LS, Tice JA, Kerlikowske K, Gregorich S, Perez-Stable EJ, Pasick RJ, Chen A, Quinn J, Kaplan CP. Impact of a primary care based intervention on breast cancer knowledge, risk perception and concern: A randomized, controlled trial. Breast. 2015 Dec;24(6):758-66. doi: 10.1016/j.breast.2015.09.009. Epub 2015 Oct 21.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 10, 2013
• First Posted (Estimate): April 12, 2013

Study Record Updates

• Last Update Posted (Estimate): August 19, 2014
• Last Update Submitted That Met QC Criteria: August 14, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Breast cancer concern, breast cancer risk perception, breast cancer risk
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 150B-0158