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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
History of Changes
Results First Received: May 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of participants who completed follow-up.

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.
Total Total of all reporting groups

Baseline Measures
    Usual Care     BreastCARE Intervention     Total  
Number of Participants  
[units: participants]
 		  655     580     1235  
Age, Customized  
[units: participants]
 		     
<50 years     183     182     365  
51-65 years     362     300     662  
>65 years     110     98     208  
Gender  
[units: participants]
 		     
Female     655     580     1235  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
 		     
Non-Latina White     229     202     431  
Latina     144     141     285  
Black/ African American     150     125     275  
Asian or Pacific Islander     123     105     228  
Native American or Other     9     7     16  
Region of Enrollment  
[units: participants]
 		     
United States     655     580     1235  



  Outcome Measures
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1.  Primary:   Knowledge of Breast Cancer Risk Factors   [ Time Frame: one week post-initial visit (approximately one week) ]
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2.  Primary:   Percentage of Participants With Correct Perception of Risk   [ Time Frame: baseline, one week post-initial visit (approximately one week) ]
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3.  Primary:   Percentage of Participants Who Had a Discussion of Breast Cancer Risk   [ Time Frame: one week post-initial visit (approximately one week) ]
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4.  Primary:   Percentage of Participants Who Reported Discussion of Mammography Screening   [ Time Frame: up to 14 months ]
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  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

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.

Serious Adverse Events
    Usual Care     BreastCARE Intervention  
Total, serious adverse events      
# participants affected / at risk     0/655 (0.00%)     0/580 (0.00%)  




  Other Adverse Events
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  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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Celia P. Kaplan, Professor
Organization: University of California, San Francisco
phone: 415-502-5601
e-mail: celia.kaplan@ucsf.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


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