Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01830933
Recruitment Status : Completed
First Posted : April 12, 2013
Results First Posted : May 16, 2013
Last Update Posted : August 19, 2014
Sponsor:
Collaborators:
Susan G. Komen Breast Cancer Foundation
California Breast Cancer Research Program
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Breast Cancer
Intervention Other: BreastCARE
Enrollment 1235
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Usual Care BreastCARE Intervention
Hide Arm/Group Description Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.

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.

Period Title: Overall Study
Started 823 812
Completed Meet-up 675 603
Completed 655 580
Not Completed 168 232
Arm/Group Title Usual Care BreastCARE Intervention Total
Hide Arm/Group Description Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.

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 of all reporting groups
Overall Number of Baseline Participants 655 580 1235
Hide Baseline Analysis Population Description
Number of participants who completed follow-up.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 655 participants 580 participants 1235 participants
<50 years 183 182 365
51-65 years 362 300 662
>65 years 110 98 208
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 655 participants 580 participants 1235 participants
Female
655
 100.0%
580
 100.0%
1235
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 655 participants 580 participants 1235 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 655 participants 580 participants 1235 participants
655 580 1235
1.Primary Outcome
Title Knowledge of Breast Cancer Risk Factors
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care BreastCARE Intervention
Hide Arm/Group Description:
Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.

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.

Overall Number of Participants Analyzed 655 580
Mean (Standard Deviation)
Unit of Measure: units on a scale
48.9  (24.3) 56.4  (24.3)
2.Primary Outcome
Title Percentage of Participants With Correct Perception of Risk
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care BreastCARE Intervention
Hide Arm/Group Description:
Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.

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.

Overall Number of Participants Analyzed 655 580
Measure Type: Number
Unit of Measure: percentage of participants
Baseline 69.9 65.9
Final (one week post-intial visit) 73.3 71.1
3.Primary Outcome
Title Percentage of Participants Who Had a Discussion of Breast Cancer Risk
Hide Description Self-reported discussion of breast cancer risk with physicians.
Time Frame one week post-initial visit (approximately one week)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care BreastCARE Intervention
Hide Arm/Group Description:
Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.

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.

Overall Number of Participants Analyzed 655 580
Measure Type: Number
Unit of Measure: percentage of participants
15 41
4.Primary Outcome
Title Percentage of Participants Who Reported Discussion of Mammography Screening
Hide Description Self reported discussion of mammography with physician.
Time Frame up to 14 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care BreastCARE Intervention
Hide Arm/Group Description:
Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.

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.

Overall Number of Participants Analyzed 655 580
Measure Type: Number
Unit of Measure: percentage of participants
51.6 61.5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care BreastCARE Intervention
Hide Arm/Group Description Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.

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.

All-Cause Mortality
Usual Care BreastCARE Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care BreastCARE Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/655 (0.00%)   0/580 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care BreastCARE Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/655 (0.00%)   0/580 (0.00%) 
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
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01830933     History of Changes
Obsolete Identifiers: NCT01836250
Other Study ID Numbers: 150B-0158
First Submitted: April 10, 2013
First Posted: April 12, 2013
Results First Submitted: May 15, 2013
Results First Posted: May 16, 2013
Last Update Posted: August 19, 2014