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
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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
No text entered.

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) ]

Measure Type Primary
Measure Title Knowledge of Breast Cancer Risk Factors
Measure Description 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
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  
Number of Participants Analyzed  
[units: participants]
  655     580  
Knowledge of Breast Cancer Risk Factors  
[units: units on a scale]
Mean ± Standard Deviation
  48.9  ± 24.3     56.4  ± 24.3  

No statistical analysis provided for Knowledge of Breast Cancer Risk Factors



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

Measure Type Primary
Measure Title Percentage of Participants With Correct Perception of Risk
Measure Description 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.
Time Frame baseline, 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  
Number of Participants Analyzed  
[units: participants]
  655     580  
Percentage of Participants With Correct Perception of Risk  
[units: percentage of participants]
   
Baseline     69.9     65.9  
Final (one week post-intial visit)     73.3     71.1  

No statistical analysis provided for Percentage of Participants With Correct Perception of Risk



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

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  
Number of 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 ]

Measure Type Primary
Measure Title Percentage of Participants Who Reported Discussion of Mammography Screening
Measure Description Self reported discussion of mammography with physician.
Time Frame up to 14 months  
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  
Number of Participants Analyzed  
[units: participants]
  655     580  
Percentage of Participants Who Reported Discussion of Mammography Screening  
[units: percentage of participants]
  51.6     61.5  

No statistical analysis provided for Percentage of Participants Who Reported Discussion of Mammography Screening




  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
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