Breast Cancer Clinical Trial
Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
The Study will examine the feasibility and acceptability of a randomized trial in 40 women with clinically stable MBC to participate in a cognitive behavioral lifestyle intervention based on the American Cancer Society's (ACS) cancer survivorship guidelines for nutrition and physical activity. The Investigator will use dual-energy x-ray absorptiometry or DXA to document intervention effects on body composition; and the Investigator will also examine patient reported outcomes, mitochondrial function and biomarkers of prognosis/survival.
AAim 1. To examine the efficacy of the Every Day Counts intervention in producing significant post-intervention changes in multidimensional QOL in women with MBC.
Hypothesis 1: Women randomized to the immediate EDC intervention (n=88) will exhibit greater improvements in multidimensional QOL compared to women randomized to the attention control (n=88).
Aim 2. To investigate the mechanistic effects of the Every Day Counts intervention on body composition, adipokines, serum biomarkers of inflammation and insulin sensitivity.
Hypothesis 2: The EDC intervention leads to improved QOL through mediating factors including body composition, prognostic serum biomarkers of inflammation and/or insulin resistance.
Exploratory Aim 3: To explore if microRNA (miRNA) signatures associated with inflammation and/or Metabolomics are altered with the EDC intervention.
Hypothesis: miRNAs identified in our pilot study (miR-10a-5p, miR-205-5p, and miR-211-5p) that regulate inflammation and/or Metabolomics will be related to QOL improvements and can identify women more likely to respond to lifestyle changes.
Adult (≥ 18 years), female
Confirmed Metastatic Breast Cancer
Patients clinically stable with treated brain metastases are eligible
Written documentation from their oncologist permitting study participation
Determined to be "clinically stable" by their medical oncologist (i.e., no unintentional weight loss, no new symptoms or change in performance status for the past 4 weeks, no clinical [including laboratory] or radiologic evidence of disease progression, no recent or planned change in anti-neoplastic therapies, no reports of severe pain [≥ Grade 3 per the NCI CTCAE)
Life expectancy >6 months
-Written documentation from their oncologist permitting study participation
Access to a mobile phone
Understand/speak English fluently.
Non-adherence to ACS nutritional or PA guidelines for cancer survivors as documented by questionnaire.
Does not meet the above criteria.
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There is 1 Location for this study
Milwaukee Wisconsin, 53226, United States More Info
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