Breast Cancer Risk Reduction: A Patient Doctor Intervention (BreastCARE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01830933|
Recruitment Status : Completed
First Posted : April 12, 2013
Results First Posted : May 16, 2013
Last Update Posted : August 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: BreastCARE||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1235 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Breast Cancer Risk Reduction: A Patient Doctor Intervention|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||December 2012|
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.
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.
- Knowledge of Breast Cancer Risk Factors [ Time Frame: one week post-initial visit (approximately one week) ]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) ]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) ]Self-reported discussion of breast cancer risk with physicians.
- Percentage of Participants Who Reported Discussion of Mammography Screening [ Time Frame: up to 14 months ]Self reported discussion of mammography with physician.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830933
|United States, California|
|San Francisco General Hospital (SFGH)|
|San Francisco, California, United States, 94110|
|University of California, San Francisco Mt. Zion campus|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Celia P Kaplan, DrPH, MA||University of California, San Francisco|