Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer

Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer

This multi-site study is being conducted to examine dietary and activity patterns, body composition, blood and quality of life in breast cancer patients. The study will recruit 176 women with MBC in Milwaukee (n=88) and Chicago (n=88).

Aims/Objectives

Aim 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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Does not meet the above criteria.