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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BreastCARE
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast cancer concern, breast cancer risk perception, breast cancer risk

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BreastCARE Intervention

BreastCARE Comparison

Arm 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.

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.

Outcomes

Primary Outcome Measures

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
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.
Percentage of Participants Who Had a Discussion of Breast Cancer Risk
Self-reported discussion of breast cancer risk with physicians.
Percentage of Participants Who Reported Discussion of Mammography Screening
Self reported discussion of mammography with physician.

Secondary Outcome Measures

Full Information

First Posted
April 10, 2013
Last Updated
August 14, 2014
Sponsor
University of California, San Francisco
Collaborators
Susan G. Komen Breast Cancer Foundation, California Breast Cancer Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT01830933
Brief Title
Breast Cancer Risk Reduction: A Patient Doctor Intervention
Acronym
BreastCARE
Official Title
Breast Cancer Risk Reduction: A Patient Doctor Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Susan G. Komen Breast Cancer Foundation, California Breast Cancer Research Program

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer concern, breast cancer risk perception, breast cancer risk

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BreastCARE Intervention
Arm Type
Experimental
Arm 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.
Arm Title
BreastCARE Comparison
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
BreastCARE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knowledge of Breast Cancer Risk Factors
Description
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
Time Frame
one week post-initial visit (approximately one week)
Title
Percentage of Participants With Correct Perception of Risk
Description
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.
Time Frame
baseline, one week post-initial visit (approximately one week)
Title
Percentage of Participants Who Had a Discussion of Breast Cancer Risk
Description
Self-reported discussion of breast cancer risk with physicians.
Time Frame
one week post-initial visit (approximately one week)
Title
Percentage of Participants Who Reported Discussion of Mammography Screening
Description
Self reported discussion of mammography with physician.
Time Frame
up to 14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF Exclusion Criteria: Patient component: Women whose physicians object to their participation in the study Physician component: No exclusion criteria for physicians
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celia P Kaplan, DrPH, MA
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital (SFGH)
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
University of California, San Francisco Mt. Zion campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26476466
Citation
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.
Results Reference
derived

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Breast Cancer Risk Reduction: A Patient Doctor Intervention

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