Patricia Sheean1, Lauren Matthews2, Alexis Visotcky3, Anjishnu Banerjee3, Andrea Moosreiner4, Kimberly Kelley5, Christopher R Chitambar6, Paula E Papanek7, Melinda Stolley8. 1. Loyola University Chicago, 2160 South First Avenue, Building 115, Room 344, Maywood, IL, 60153, USA. psheean1@luc.edu. 2. Center for Gastrointestinal Biology and Disease, University of North Carolina at Chapel Hill, 130 Mason Farm Road, Chapel Hill, NC, 27599, USA. 3. Division of Biostatistics, Institute for Health and Society, Medical College of Wisconsin, 8701 Watertown Plank Rd., Wauwatosa, WI, 53226, USA. 4. Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI, 53226, USA. 5. , 2071 S. 91st St., West Allis, WI, 53227, USA. 6. Medical College of Wisconsin and Froedtert Clincial Cancer Center, 9200 W. Wisconsin Ave, Milwaukee, WI, 53226, USA. 7. Department of Physical Therapy, Marquette University, 604 N. 16th St., Milwaukee, WI, 53233, USA. 8. Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI, 53226, USA.
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.
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.
Entities:
Keywords:
Exercise; Lifestyle intervention; Metastatic breast cancer; Nutrition; Quality of life
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