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

Study Overview
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Brief Summary
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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
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Aims/Objectives 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.

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

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Behavioral: Lifestyle Intervention
* Behavioral: Attention Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Attention Control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention<br>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. | Behavioral: Lifestyle Intervention<br>* The lifestyle intervention is a 16-week cognitive-behavioral intervention that addresses key changes in diet and PA behaviors to promote positive body composition changes.<br>|
| Other: Attention Control<br>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. | Behavioral: Attention Control<br>* The attention control participants will receive a home/work organization intervention:<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention adherence | Number of lifestyle coaching sessions completed out of a possible total of 16 sessions | 4 months | 
| Intervention retention | Number of women who complete the 4-month data collection | 4 months | 
| Intervention retention | Number of women who complete the 8-month data collection | 8 months | 
| Change in Quality of Life | 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. | Change from baseline to 4 months | 
| Change in Quality of Life | 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. | change from baseline to 8 months | 
| Body composition | Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable. | change from baseline to 4 months | 
| Body composition | Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable. | change from baseline to 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Biomarker Inflammation - C-Reactive Protein | Analyzed by EVE technologies using standard ELISA kits | Change from baseline to 4 month | 
| Serum Biomarker Insulin Resistance - Insulin | Analyzed by EVE technologies using standard ELISA kits | Change from baseline to 4 month | 
| Serum Biomarker Insulin Resistance- Glucose | Analyzed by EVE technologies using standard ELISA kits | Change from baseline to 4 month | 
| Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha | Analyzed by EVE technologies using standard ELISA kits | Change from baseline to 4 month | 
| Serum Biomarker Insulin Resistance- C-Peptide | Analyzed by EVE technologies using standard ELISA kits | Change from baseline to 4 month | 
| Serum Biomarker Adipokine Dysregulation - Adiponectin | Analyzed by EVE technologies using standard ELISA kits | Change from baseline to 4 month | 
| Serum Biomarker Adipokine Dysregulation - Leptin | Analyzed by EVE technologies using standard ELISA kits | Change from baseline to 4 month | 
| Serum Biomarker Inflammation - Interleukin 6 | Analyzed by EVE technologies using standard ELISA kits | Change from baseline to 4 month |