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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
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


  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 
Overall Participants Analyzed 
[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) ]

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) ]
  Hide Outcome Measure 3

Measure Type Primary
Measure Title Percentage of Participants Who Had a Discussion of Breast Cancer Risk
Measure Description Self-reported discussion of breast cancer risk with physicians.
Time Frame one week post-initial visit (approximately one week)  
Safety Issue No  

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.
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.


Measured Values
   Usual Care   BreastCARE Intervention 
Participants Analyzed 
[Units: Participants]
 655   580 
Percentage of Participants Who Had a Discussion of Breast Cancer Risk 
[Units: Percentage of participants]
 15   41 

No statistical analysis provided for Percentage of Participants Who Had a Discussion of Breast Cancer Risk



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


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information