Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lifestyle Intervention, Attention Control.
- Who it may be relevant to
- Registry conditions: Metastatic Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Lifestyle Intervention
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. - Behavioral Attention Control
The attention control participants will receive a home/work organization intervention: Following completion of the attention control home/work organization program and 16-week assessment, women will receive the lifestyle program.
Primary outcome measures
- Intervention adherence [Time frame: 4 months]
- Intervention retention [Time frame: 4 months]
- Intervention retention [Time frame: 8 months]
- Change in Quality of Life [Time frame: Change from baseline to 4 months]
- Change in Quality of Life [Time frame: change from baseline to 8 months]
- Body composition [Time frame: change from baseline to 4 months]
- Body composition [Time frame: change from baseline to 8 months]
Secondary outcome measures (8)
- Serum Biomarker Inflammation - C-Reactive Protein [Time frame: Change from baseline to 4 month]
- Serum Biomarker Insulin Resistance - Insulin [Time frame: Change from baseline to 4 month]
- Serum Biomarker Insulin Resistance- Glucose [Time frame: Change from baseline to 4 month]
- Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha [Time frame: Change from baseline to 4 month]
- Serum Biomarker Insulin Resistance- C-Peptide [Time frame: Change from baseline to 4 month]
- Serum Biomarker Adipokine Dysregulation - Adiponectin [Time frame: Change from baseline to 4 month]
- Serum Biomarker Adipokine Dysregulation - Leptin [Time frame: Change from baseline to 4 month]
- Serum Biomarker Inflammation - Interleukin 6 [Time frame: Change from baseline to 4 month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Loyola University — Maywood
- Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT03824145 · 27600