Trial Outcomes & Findings for Breast Cancer Risk Reduction: A Patient Doctor Intervention (NCT NCT01830933)
NCT ID: NCT01830933
Last Updated: 2014-08-19
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1235 participants
Primary outcome timeframe
one week post-initial visit (approximately one week)
Results posted on
2014-08-19
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
823
|
812
|
|
Overall Study
Completed Meet-up
|
675
|
603
|
|
Overall Study
COMPLETED
|
655
|
580
|
|
Overall Study
NOT COMPLETED
|
168
|
232
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Breast Cancer Risk Reduction: A Patient Doctor Intervention
Baseline characteristics by cohort
| Measure |
Usual Care
n=655 Participants
Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
|
BreastCARE Intervention
n=580 Participants
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
n=1235 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<50 years
|
183 participants
n=5 Participants
|
182 participants
n=7 Participants
|
365 participants
n=5 Participants
|
|
Age, Customized
51-65 years
|
362 participants
n=5 Participants
|
300 participants
n=7 Participants
|
662 participants
n=5 Participants
|
|
Age, Customized
>65 years
|
110 participants
n=5 Participants
|
98 participants
n=7 Participants
|
208 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
655 Participants
n=5 Participants
|
580 Participants
n=7 Participants
|
1235 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Latina White
|
229 participants
n=5 Participants
|
202 participants
n=7 Participants
|
431 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latina
|
144 participants
n=5 Participants
|
141 participants
n=7 Participants
|
285 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/ African American
|
150 participants
n=5 Participants
|
125 participants
n=7 Participants
|
275 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
123 participants
n=5 Participants
|
105 participants
n=7 Participants
|
228 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American or Other
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
655 participants
n=5 Participants
|
580 participants
n=7 Participants
|
1235 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one week post-initial visit (approximately one week)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
Outcome measures
| Measure |
Usual Care
n=655 Participants
Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
|
BreastCARE Intervention
n=580 Participants
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.
|
|---|---|---|
|
Knowledge of Breast Cancer Risk Factors
|
48.9 units on a scale
Standard Deviation 24.3
|
56.4 units on a scale
Standard Deviation 24.3
|
PRIMARY outcome
Timeframe: baseline, one week post-initial visit (approximately one week)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.
Outcome measures
| Measure |
Usual Care
n=655 Participants
Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
|
BreastCARE Intervention
n=580 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Correct Perception of Risk
Baseline
|
69.9 percentage of participants
|
65.9 percentage of participants
|
|
Percentage of Participants With Correct Perception of Risk
Final (one week post-intial visit)
|
73.3 percentage of participants
|
71.1 percentage of participants
|
PRIMARY outcome
Timeframe: one week post-initial visit (approximately one week)Self-reported discussion of breast cancer risk with physicians.
Outcome measures
| Measure |
Usual Care
n=655 Participants
Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
|
BreastCARE Intervention
n=580 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Had a Discussion of Breast Cancer Risk
|
15 percentage of participants
|
41 percentage of participants
|
PRIMARY outcome
Timeframe: up to 14 monthsSelf reported discussion of mammography with physician.
Outcome measures
| Measure |
Usual Care
n=655 Participants
Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
|
BreastCARE Intervention
n=580 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Reported Discussion of Mammography Screening
|
51.6 percentage of participants
|
61.5 percentage of participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BreastCARE Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Celia P. Kaplan, Professor
University of California, San Francisco
Phone: 415-502-5601
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place