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

This study is ongoing, but not recruiting participants.
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: May 15, 2013
Last verified: May 2013
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
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.


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
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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


  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.


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.  


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


No publications provided


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: May 15, 2013
Health Authority: United States: Institutional Review Board