A Population-Based Randomized Trial to Assess the Effects of Short-Term Cessation of Hormone Replacement Therapy on Mammography Assessments and Breast Density
Abstract
This randomized controlled trial was designed to test whether short-term (1-2 months) hormone replacement therapy (HRT) cessation will sufficiently lower breast density to decrease the proportion of women who receive a recommendation for additional evaluation following a screening mammogram, and to examine whether there is a trend in decreased recall by duration of HRT cessation. The study was conducted at Group Health, a managed health care organization with an organized breast cancer screening program. We sought to recruit 1,500 women to be randomized to one of three HRT arms: 1) cessation two months before the screening mammogram, 2) cessation one month before, and 3) continued HRT use. We measured breast density using a computer-assisted method and mammography recall rates from an expert radiologist review of the mammograms; both readers were blinded to HRT status. Recruitment started 11/2004 and ran through 9/30/2007, we contacted 5,861 potentially eligible women. Among those, we consented, enrolled and randomized 1704 (29.1%) women. Of the remaining 4,157 (70.9%); 977 (16.7%) were ineligible, we were unable to contact 179 (3.1%) and 2 (<0.1%) have an unknown reason.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jun 01, 2008
- Accession Number
- ADA489927
Entities
People
- Diana S. Buist
- Katherine Newton
- Susan Reed
Organizations
- Group Health Cooperative