Every Day Counts: A lifestyle program for women metastatic breast cancer

The community of women with metastatic breast cancer (MBC) is growing due to greater disease incidence and treatment advances, with over 30% of women now surviving over 5 years (vs. just 4% in 2000). Managing symptoms to maintain the highest quality of life (QOL) is the major goal of care in the metastatic setting. Thus, research that addresses QOL, prognosis and survivorship in this burgeoning and underserved survivor group is critically needed. BC treatment is associated with adverse body composition changes, specifically gains in adipose tissue and reductions in strength and lean mass (LM; also known as skeletal muscle). Excess adiposity contributes to inflammation and insulin-resistance, which are theorized to promote tumor progression and loss of LM. Low levels of LM are associated with chemotherapy toxicity, increased symptom burden and compromised survival in women with MBC. Lifestyle interventions with early stage BC survivors result in reduced symptoms, improved biomarkers of BC prognosis and enhanced quality of life (QOL). To date, women with MBC have been largely excluded from these trials. Our pilot work in women with MBC supports they are interested, cabable, adherent and benefit from participation in a lifestyle intervention. Our results show improvements in QOL, physical activity, strength, biomarkers of prognosis and mitochondrial function for women in the immediate intervention vs. waitlist control.group. Further, our work shows that inflammation-associated microRNAs are differentially expressed following participation in our pilot trial, providing highly novel potential targets that explain the mechanisms by which lifestyle interventions improve QOL for these women. We propose a randomized waitlist control trial in women with MBC (n=176) to test the short and longer-term effects of “Every Day Counts,” a 16-week lifestyle intervention grounded in social cognitive theory and based on current lifestyle recommendations for cancer survivors. In this larger trial, we will be adequately powered to examine changes in: 1) QOL – the primary determinant of care in the metastatic setting; (2) body composition, serum biomarkers of prognosis/survival, and other patient reported outcomes; and (3) we will explore mitochondrial function and novel microRNA signatures associated with inflammatory biomarkers and mitochondrial function. Every Day Counts incorporates critical feedback and experiences from our pilot study with women with MBC. Our robust, multidisciplinary study team applies an innovative, highly integrated physiologic model to examine the mechanistic effects of the intervention on decidedly relevant outcomes of interest. The present study challenges the current clinical assumptions regarding the presumed ineffectiveness of lifestyle behaviors in the metastatic setting, providing evidence that may inform a paradigm shift expanding the application and relevance of the nutrition and PA guidelines to women with MBC. Importantly, this study will provide clinicians with updated evidence and strategies to help make every day count for women with MBC representing high impact for a currently underserved group of survivors.