A Population-Based Randomized Trial to Assess the Effects of Short-Term Cessation of HRT on Mammography Assessments and Breast Density
Abstract
This randomized controlled trial is 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 by duration of HRT cessation. The study is being conducted at Group Health Cooperative, a managed health care organization with an organized breast cancer screening program. The authors are projecting that they will recruit between 630 to 785 women to randomize to one of three HRT arms: (1) cessation 2 months before the screening mammogram, (2) cessation 1 month before the mammogram, and (3) continued HRT use. They are measuring breast density using a computer-assisted method, and obtaining mammography recall rates from an expert radiologist's review of the mammogram. Both readers will be blinded to HRT status. They recruited women from November 2004 through May 2005 and contacted 1,119 potentially eligible subjects. Among the women contacted, 30% agreed to participate, 40% refused, and 30% were deemed ineligible. Of the women who agreed to participate, 23% have withdrawn from the study. There are several modifications to the study materials that were reviewed and approved by the HSRRB. The authors have some proposed changes to their materials to increase recruitment that will be submitted in June 2005.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jun 01, 2005
- Accession Number
- ADA444247
Entities
People
- Diana S. Buist
Organizations
- Group Health Cooperative