Breast Cancer Risk Reduction: A Patient Doctor Intervention (BreastCARE)
|ClinicalTrials.gov Identifier: NCT01830933|
Recruitment Status : Completed
First Posted : April 12, 2013
Results First Posted : May 16, 2013
Last Update Posted : August 19, 2014
|Study Design:||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Prevention|
|Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations|
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|Significant events and approaches for the overall study following participant enrollment, but prior to group assignment|
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|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.
Participant Flow: Overall Study
|Usual Care||BreastCARE Intervention|
|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