Table 2 BWEL (A011401) study measures and time points
Baseline | Month 6 | Month 12 and 18 | Month 24 | Month 30 and 36 | Annual follow-up | |
|---|---|---|---|---|---|---|
Site collected measures | ||||||
History and physical | X | X | X | X | X | X |
Height | X | |||||
Weight | X | X | X | X | X | X |
Waist and hip circumference | X | X | X | X | X | X |
Co-morbidity assessment | X | X | X | X | X | X |
Adverse event assessment | X | X | X | X | ||
Outcome assessment | X | X | X | X | X | |
Bilateral mammogram | X | (performed yearly while on study as applicable) | ||||
Laboratory | ||||||
Fasting glucose (performed at site) | X | X | X | |||
Fasting serum and plasma (collected and sent to biobank) | X | X | X | |||
Tissue-based and genomic biomarkers A011401-ST1: for patients who consent to participate | ||||||
Fasting whole blood | X | X | X | |||
Sample of tumor and benign (if available) breast tissue from primary surgery | X | |||||
Centrally collected measures: health behaviors and PRO (A011401-HO1) | ||||||
(First 514 patients who enroll on A011401) | ||||||
24-h dietary recall, 7-day physical activity recall and accelerometer | X | X | X | X | ||
(all administered centrally) | ||||||
PRO questionnaire booklet | X | X | X | X | ||
