Combination of an aromatase inhibitor and ovarian suppression is more effective than tamoxifen alone in premenopausal women with high risk ER or PR positive BC. However, combination therapy has been associated with more adverse effects, poor treatment adherence, and decline in QOL. Various behavioral interventions can be effective to reduce treatment-related side effects and thereby to improve treatment tolerance and QOL. Nevertheless, there is a paucity of evidence about effect of individualized behavioral and complementary interventions in younger women who are treated with combination endocrine therapy. The study aims to evaluate if younger women with early stage BC treated with combination endocrine therapy could benefit from individualized behavioral and complementary intervention (s) during their treatment. This benefit will be assessed primarily by change in QOL and cognitive function from the baseline measurement and secondarily by adherence to adjuvant endocrine treatment.
In this phase 2 multicenter study 40 premenopausal women with stage I, II and III ER/PR positive BC treated with combination endocrine therapy are being recruited. All participants will be provided a list of behavioral interventions such as exercise, yoga, acupuncture, and massage therapy. A participant will be able to select one or more intervention based on her preferences. Assessments of patients reported outcomes will be performed at baseline, at 3, and every 6 months, thereafter for up to 3 years. The QOL and cognitive function will be assessed using Functional Assessment of Cancer Therapy – Breast Symptom Index (FACT-B), FACT – Endocrine System (FACT-ES), and FACT-Cognitive Function scales. Linear mixed models will be used to assess changes over time for overall QOL and for separate components of QOL. Treatment adherence will be monitored monthly basis. Individually-tailored behavioral and complementary interventions could promote self-management and empower the women with early stage BC to manage treatment related side effects.
NCT03407768.
Shahid Ahmed.
College of Medicine, University of Saskatchewan.
All authors have declared no conflicts of interest.