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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01830933
First Posted: April 12, 2013
Last Update Posted: August 19, 2014
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.
Collaborators:
Susan G. Komen Breast Cancer Foundation
California Breast Cancer Research Program
Information provided by (Responsible Party):
University of California, San Francisco
Results First Submitted: May 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition: Breast Cancer
Intervention: Other: BreastCARE

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Usual Care Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
BreastCARE Intervention

Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.

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 patients before she meets with her doctor.

BreastCARE : The physician will receive a physician report that contains information similar to the patient report.


Participant Flow:   Overall Study
    Usual Care   BreastCARE Intervention
STARTED   823   812 
Completed Meet-up   675   603 
COMPLETED   655   580 
NOT COMPLETED   168   232 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Knowledge of Breast Cancer Risk Factors   [ Time Frame: one week post-initial visit (approximately one week) ]

2.  Primary:   Percentage of Participants With Correct Perception of Risk   [ Time Frame: baseline, one week post-initial visit (approximately one week) ]

3.  Primary:   Percentage of Participants Who Had a Discussion of Breast Cancer Risk   [ Time Frame: one week post-initial visit (approximately one week) ]

4.  Primary:   Percentage of Participants Who Reported Discussion of Mammography Screening   [ Time Frame: up to 14 months ]


  Serious Adverse Events


  Other Adverse Events
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Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Usual Care Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
BreastCARE Intervention

Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.

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 patients before she meets with her doctor.

BreastCARE : The physician will receive a physician report that contains information similar to the patient report.


Other Adverse Events
    Usual Care   BreastCARE Intervention
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   0/655 (0.00%)   0/580 (0.00%) 



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information