Improving Well-Being for Breast Cancer Patients

Adjuvant endocrine therapy (AET) is a crucial component of treatment used to prevent
recurrence and reduce breast cancer-related mortality for breast cancer patients with hormone
receptor positive disease. Studies report low rates of adherence to AET (38% to 86%) and in
our preliminary work, 65% of breast cancer patients taking AET reported one or more
non-adherent medication taking behaviors (e.g., skipped dose, forgot, adjusted dose) in the
past month. Symptoms (e.g., arthralgia, vasomotor symptoms) associated with AET are strongly
related to non-adherence and early discontinuation of treatment. Poor adherence to AET due to
symptoms may compromise the effectiveness of AET. Prior to conducting a clinical trial, we
will conduct user testing of the self-management intervention protocol with 20 women. In the
proposed randomized clinical trial, 400 women who are taking AET for breast cancer will be
randomly assigned to one of two conditions: 1) a self-management intervention for improving
adherence and symptom management, or 2) a general health education control condition. The
self-management intervention integrates three key theory-based strategies for improving
adherence to AET: coping skills training for managing symptoms (e.g., arthralgia, vasomotor
symptoms), behavioral strategies for improving medication adherence, and symptom and
medication education. The intervention addresses the specific symptoms a woman is
experiencing and is designed to meet the needs of women who are at high risk for
non-adherence to AET (e.g., low socioeconomic status, low literacy). The self-management
intervention is administered by a nurse via the telephone, and combines the use of phone
calls and tailored interactive voice messaging based on information exchanged during phone
sessions and real-time adherence data obtained from smart medication bottles. Women randomly
assigned to the control condition will receive a general health education intervention that
is delivered by a nurse via the telephone. This study will take place in the Duke Cancer
Institute breast clinic and in community hospitals that are members of the Duke Cancer
Network, which will allow access to women receiving care outside the medical center setting
and increase generalizability of findings to a variety of settings. Adherence to AET will be
assessed over the 18 month period following study enrollment using wireless smart medication
bottles that provide real-time adherence data. Patient-reported outcome measures assessing
symptoms, perceived necessity of AET, concerns about AET, and self-efficacy will be obtained
at baseline and 3, 6, 12, and 18 months. To increase the likelihood of later implementation
of the self-management intervention, the cost effectiveness of the intervention will be
evaluated.