Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Hide Baseline Characteristics

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
  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
  Hide Other Adverse Events

Time Frame No text entered.
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
  Hide Limitations and Caveats

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