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

April 10, 2013
August 14, 2014
June 2011
August 2012   (final data collection date for primary outcome measure)
  • 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.
  • Breast Cancer Risk Knowledge [ Time Frame: up to 14 months ] [ Designated as safety issue: No ]

    06/01/2011-08/01/2012

    This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey.

  • Mammography Screening [ Time Frame: up to 14 months ] [ Designated as safety issue: No ]

    06/01/2011-08/01/2012

    Current status of mammography screenings were confirmed with chart reviews through the UCSF and SFGH electronic records systems.

  • Perception of Risk [ Time Frame: up to 14 months ] [ Designated as safety issue: No ]

    06/01/2011-08/01/2012

    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.

  • Breast Cancer Risk Discussion [ Time Frame: up to 14 months ] [ Designated as safety issue: No ]

    06/01/2011-08/01/2012

    Receipt of appropriate recommended risk reduction actions based on risk based on survey responses. To estimate objective risk for breast cancer we used three measures: the Referral Screening Tool (RST)5, the Gail Model26, and the Breast Cancer Surveillance Consortium Model (BCSC).

Complete list of historical versions of study NCT01830933 on ClinicalTrials.gov Archive Site
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Breast Cancer Risk Reduction: A Patient Doctor Intervention
Breast Cancer Risk Reduction: A Patient Doctor Intervention

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Breast Cancer
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.
  • 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.

    Intervention: Other: BreastCARE
  • 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.

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1235
December 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
40 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01830933
150B-0158
Yes
University of California, San Francisco
University of California, San Francisco
  • Susan G. Komen Breast Cancer Foundation
  • California Breast Cancer Research Program
Principal Investigator: Celia P Kaplan, DrPH, MA University of California, San Francisco
University of California, San Francisco
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP