Factors associated with non-compliance with hormone therapy cessation before screening mammography

Abstract

Objectives To evaluate factors associated with non-compliance with discontinuation of hormone therapy (HT) within a study on the effect of HT cessation on mammography performance.

Methods This randomized, controlled trial was conducted at Group Health, a health plan in Washington State, USA. Eligibility included: age 45–80 years; due for screening (‘study’) mammogram; and prior screening mammogram while using HT. We randomized 1704 women to no cessation (n = 567), 1-month (n = 570), or 2-month cessation (n = 567), and called participants before cessation to review instructions. We collected self-reported data at randomization (baseline) and before the study mammogram, including symptoms and compliance. This analysis includes women randomized to 1-month or 2-month cessation with complete baseline and follow-up questionnaires (n = 883).

Results  Most participants were using unopposed estrogen (63.3%) and intended to continue HT (90%); 9.6% were non-compliant with HT cessation. Comparing 2-month vs. 1-month cessation, the age and body mass index (BMI)-adjusted relative risk (RR) for non-compliance was 1.72 (95% confidence interval (CI) 1.12–2.60). Baseline variables associated with non-compliance included: age ≤55 vs. >55 years (RR 2.34; 95% CI 1.34–4.41); BMI < 25 vs. BMI ≥30 kg/m (RR 1.63; 95% CI 1.01–2.63); unopposed estrogen vs. estrogen plus progestin (RR 1.59; 95% CI 1.01–2.51); using HT to manage sleep (RR 1.80; 95% CI 1.20–2.71); severe vs. no night sweats (RR 1.68; 95% CI 1.03–2.74); and night sweats that interfered with sleep (RR 1.78; 95% CI 1.02–3.11).

Conclusions Non-compliance with HT cessation before screening mammogram was associated with younger age, lower BMI, symptom severity and use of unopposed estrogen. Alternatives for menopause symptom management are needed to assist women with HT cessation.

Key words:

• HORMONE THERAPY CESSATION
• ESTROGEN THERAPY
• RANDOMIZED CLINICAL TRIAL
• BREAST CANCER SCREENING
• MENOPAUSE

Acknowledgements

The study team had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. This study could not have been completed without the assistance of Dawn Fitzgibbons, Juleann Gandara, MD, Tammy Dodd, Linda Palmer, and Melissa Rabelhofer. We would further like to thank members of our advisory board: Hermien Watkins, Paula Hoffman, Deb Schiro, and Margrit Schubiger; members of the Data Safety and Monitoring Board: Susan Heckbert, MD, PhD, Chair, University of Washington Department of Epidemiology; Ben Anderson, MD, University of Washington; Mary Anne Rossing, DVM, PhD, Fred Hutchinson Cancer Research Center; Robert D. Rosenberg, MD, University of New Mexico; Thomas Lumley, PhD, University of Washington Department of Biostatistics; and Elizabeth Lin, MD, Group Health Permanente medical monitor. We also acknowledge Stephen Taplin, MD, MPH for his collaboration in getting this study funded when he was an investigator at Group Health.

Conflict of interest  The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.

Source of funding  A population-based trial to assess the effects of short-term hormone therapy (HT) suspension on mammography assessments and breast density, the READ study. Funded by the Department of Defense (PI: D Buist; DAMD17-03-1-0447). Registered clinical trial number: NCT00117663. Study participants were recruited from the Group Health Breast Cancer Screening Program funded by the National Cancer Institute (PI: D Buist, U01CA63731).