Breast Cancer Risk Reduction: A Patient Doctor Intervention (BreastCARE)
|Study Design:||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Prevention|
|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.|
|Usual Care||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||Total of all reporting groups|
|Usual Care||BreastCARE Intervention||Total|
Number of Participants
|Black/ African American||150||125||275|
|Asian or Pacific Islander||123||105||228|
|Native American or Other||9||7||16|
Region of Enrollment
|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 ]|
Limitations and Caveats