Oral Endocrine Therapy Nonadherence, Adverse Effects, Decisional Support, and Decisional Needs in Women With Breast Cancer.

BACKGROUND: Oral endocrine therapy (OET) such as tamoxifen or aromatase inhibitors reduces recurrence and mortality for the 75% of breast cancer survivors (BCSs) with a diagnosis of estrogen receptor-positive breast cancer. Because many BCSs decide not take OET as recommended because of adverse effects, understanding BCSs' decisional supports and needs is foundational to supporting quality OET decision making about whether to adhere to OET. OBJECTIVE: The aim of this study was to examine literature pertaining to OET nonadherence and adverse effects using the Ottawa Decision Support Framework categories of decisional supports and decisional needs because these factors potentially influence OET use. METHODS: A systematic literature search was performed in PubMed and CINAHL using combined search terms "aromatase inhibitors and adherence" and "tamoxifen and adherence." Studies that did not meet criteria were excluded. Relevant data from 25 publications were extracted into tables and reviewed by 2 authors. RESULTS: Findings identified the impact of adverse effects on OET nonadherence, an absence of decisional supports provided to or available for BCSs who are experiencing OET adverse effects, and the likelihood of unmet decisional needs related to OET. CONCLUSIONS: Adverse effects contribute to BCSs decisions to stop OET, yet there has been little investigation of the process through which that occurs. This review serves as a call to action for providers to provide support to BCSs experiencing OET adverse effects and facing decisions related to nonadherence. IMPLICATIONS FOR PRACTICE: Findings suggest BCSs prescribed OET have unmet decisional needs, and more decisional supports are needed for BCSs experiencing OET adverse effects.

Laboratory and ambulatory evaluation of vasomotor symptom monitors from the Menopause Strategies Finding Lasting Answers for Symptoms and Health network.

OBJECTIVE: The aim of this study was to evaluate monitors for assessing vasomotor symptoms (VMS) in laboratory and ambulatory settings before use in the Menopause Strategies Finding Lasting Answers for Symptoms and Health network clinical trials testing VMS therapies. METHODS: This was a three-phase study. Phase 1 included laboratory testing of the Freedman and prototype Bahr Monitor, phase 2 included laboratory testing of the commercial Bahr Monitor and Biolog, and phase 3 included ambulatory testing of the commercial Bahr Monitor and Biolog. All phases enrolled midlife women with VMS, midlife women without VMS, and young women without VMS. The participants self-reported VMS by pressing event marker buttons. Questionnaires assessed demographics (all phases) and monitor acceptability (phases 2 and 3). RESULTS: Phase I testing was stopped because of sensitivity of the Freedman device to ambient humidity changes and lack of analytic software for the prototype Bahr Monitor. In phases 2 and 3, agreement between event-marked and commercial Bahr Monitor or Biolog-recorded VMS was higher in the laboratory than in the ambulatory setting; however, agreement between monitors was poor in two of three laboratory groups (midlife no VMS and young no VMS) and in all ambulatory groups. During ambulatory monitoring, the mean number of Bahr Monitor VMS was 16.33 in midlife women with VMS, 9.61 in midlife women without VMS, and 14.63 in young women without VMS (software version, March 2011). The Bahr Monitor was more acceptable than the larger Biolog, but feedback reflected annoyance at having to wear a device that itched and was visible under clothing. CONCLUSIONS: The Bahr Monitor and Biolog seem suitable for use in controlled laboratory conditions during short periods of time. However, the current versions of these monitors may not be suitable for ambulatory clinical trials at this time.