Abstract
Purpose
To explore the feasibility, adherence, safety and potential efficacy of Every Day Counts; a randomized pilot trial designed for women with metastatic breast cancer (MBC) framed by the American Cancer Society nutrition and physical activity (PA) guidelines
Methods
Women with clinically stable MBC were recruited to complete an interview, dual energy X-ray absorptiometry imaging and phlebotomy at baseline and post-intervention. Multidimensional quality of life, symptom burden, lifestyle behaviors (nutrition and PA) and biomarkers of prognosis were procured and quantified. Women were randomized to the immediate intervention or a waitlist control arm. The 12-week intervention included a curriculum binder, lifestyle coaching (in-person and telephone-based sessions) and intervention support (activity monitor, text messaging, cooking classes.) Women in the waitlist control were provided monthly text messaging.
Results
Forty women were recruited within 9 months (feasibility). Women in the immediate intervention attended 86% of all 12 weekly coaching sessions (adherence) and showed significant improvements in general QOL (p = 0.001), and QOL related to breast cancer (p = 0.001), endocrine symptoms (p = 0.002) and fatigue (p = 0.037), whereas the waitlist control did not (all p values ≥ 0.05) (efficacy). PA significantly increased for women in the intervention compared to control (p < 0.0001), while dietary changes were less evident across groups due to high baseline adherence. No significant changes in biomarkers or lean mass were noted, yet visceral adipose tissue declined (p = 0.001). No intervention-related injuries were reported (safety). Qualitative feedback strongly supports the desire for a longer intervention with additional support.
Conclusions
Lifestyle interventions are of interest, safe and potentially beneficial for women with MBC. A larger trial is warranted.
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Acknowledgements
We acknowledge the efforts, enthusiasm and feedback of the ladies who participated in our EDC study, and the assistance of the Clinical and Translational Science Institute of Southeastern Wisconsin through the NIH Clinical and Translational Science Award (UL1TR001436.) Additionally, we want to thank Dr. Zora Djuric for generously sharing her dietary assessment tools and trackers.
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This study was funded by the National Cancer Institute R21CA218888.
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P Sheean has no conflict of interest. L Williams has no conflict of interest. A Visotcky has no conflict of interest. A Banerjee has no conflict of interest. A Moosreiner has no conflict of interest. K Kelley owns and operates the Kelley Kinetics. C Chitambar has no conflict of interest. P Papanek has no conflict of interest. M Stolley has no conflict of interest.
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Sheean, P., Matthews, L., Visotcky, A. et al. Every Day Counts: a randomized pilot lifestyle intervention for women with metastatic breast cancer. Breast Cancer Res Treat 187, 729–741 (2021). https://doi.org/10.1007/s10549-021-06163-1
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DOI: https://doi.org/10.1007/s10549-021-06163-1