Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Interventions
- Behavioral: Lifestyle InterventionBehavioral: Attention Control
- Registration Number
- NCT03824145
- Lead Sponsor
- Medical College of Wisconsin
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 176
-
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.
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Non-adherence to ACS nutritional or PA guidelines for cancer survivors as documented by questionnaire.
- Does not meet the above criteria.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Immediate Intervention Lifestyle Intervention The experimental arm will receive a 16-week lifestyle intervention that promotes nutritional and physical activity changes concordant with those contained in the ACS nutrition and physical activity guidelines for cancer survivors. The 16-week intervention includes: 1) a curriculum binder covering weekly topics and including self-monitoring tools to support adherence; 2) lifestyle coaching for 16-weeks, with in-person or virtual supervised exercise sessions and telephone-based sessions; 3) exercise supplies (Fitbit, resistance bands), 4) twice weekly text messaging targeting self-efficacy and social support; and 5) attendance to cooking classes emphasizing plant-based eating. Attention Control Attention Control The attention control participants will receive a home/work organization intervention: * Participants will receive a book with overview of home/work organization program with 16 weekly topics with an overview of each chapter. * Virtual or weekly phone calls- with a home organization coach with standard prompts. * Text messages supporting home/work organization.
- Primary Outcome Measures
Name Time Method Intervention retention 8 months Number of women who complete the 8-month data collection
Body composition change from baseline to 8 months Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.
Intervention adherence 4 months Number of lifestyle coaching sessions completed out of a possible total of 16 sessions
Change in Quality of Life change from baseline to 8 months Patient reported outcomes as measured by Functional Assessment of Cancer Therapy-Measured by the Functional Assessment of Cancer Therapies Breast, Fatigue and Endocrine Symptoms (FACT-B, F and ES). The FACT-G is the overarching measure with a score range of 0-108; FACT-B (breast) subscale score range is 0-40; FACT-ES (endocrine symptoms) subscale score range is 0-76; FACT-F (fatigue) subscale is 0-52. Higher scores are better.
- Secondary Outcome Measures
Name Time Method Serum Biomarker Adipokine Dysregulation - Adiponectin Change from baseline to 4 month Analyzed by EVE technologies using standard ELISA kits
Serum Biomarker Insulin Resistance- C-Peptide Change from baseline to 4 month Analyzed by EVE technologies using standard ELISA kits
Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha Change from baseline to 4 month Analyzed by EVE technologies using standard ELISA kits
Serum Biomarker Inflammation - C-Reactive Protein Change from baseline to 4 month Analyzed by EVE technologies using standard ELISA kits
Serum Biomarker Insulin Resistance- Glucose Change from baseline to 4 month Analyzed by EVE technologies using standard ELISA kits
Serum Biomarker Adipokine Dysregulation - Leptin Change from baseline to 4 month Analyzed by EVE technologies using standard ELISA kits
Serum Biomarker Insulin Resistance - Insulin Change from baseline to 4 month Analyzed by EVE technologies using standard ELISA kits
Serum Biomarker Inflammation - Interleukin 6 Change from baseline to 4 month Analyzed by EVE technologies using standard ELISA kits
Trial Locations
- Locations (2)
Loyola University
🇺🇸Maywood, Illinois, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States