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

This study has been completed.
Sponsor:
Collaborators:
Susan G. Komen Breast Cancer Foundation
California Breast Cancer Research Program
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01830933
First received: April 10, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Other: BreastCARE

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Breast Cancer Risk Reduction: A Patient Doctor Intervention

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Knowledge of Breast Cancer Risk Factors [ Time Frame: one week post-initial visit (approximately one week) ] [ Designated as safety issue: No ]
    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

  • Percentage of Participants With Correct Perception of Risk [ Time Frame: baseline, one week post-initial visit (approximately one week) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Had a Discussion of Breast Cancer Risk [ Time Frame: one week post-initial visit (approximately one week) ] [ Designated as safety issue: No ]
    Self-reported discussion of breast cancer risk with physicians.

  • Percentage of Participants Who Reported Discussion of Mammography Screening [ Time Frame: up to 14 months ] [ Designated as safety issue: No ]
    Self reported discussion of mammography with physician.


Enrollment: 1235
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01830933

Locations
United States, California
University of California, San Francisco Mt. Zion campus
San Francisco, California, United States, 94143
San Francisco General Hospital (SFGH)
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Susan G. Komen Breast Cancer Foundation
California Breast Cancer Research Program
Investigators
Principal Investigator: Celia P Kaplan, DrPH, MA University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01830933     History of Changes
Obsolete Identifiers: NCT01836250
Other Study ID Numbers: 150B-0158
Study First Received: April 10, 2013
Results First Received: May 15, 2013
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Breast cancer concern, breast cancer risk perception, breast cancer risk

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014