Clinical trial NCT03824145: Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
Official title: Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Breast Cancer
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Loyola University Chicago
First posted: 2019-01-31
Enrollment: 176
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Attention Control
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Intervention adherence
timeFrame: 4 months
measure: Intervention retention
timeFrame: 4 months
measure: Intervention retention
timeFrame: 8 months
measure: Change in Quality of Life
timeFrame: Change from baseline to 4 months
measure: Change in Quality of Life
timeFrame: change from baseline to 8 months
measure: Body composition
timeFrame: change from baseline to 4 months
measure: Body composition
timeFrame: change from baseline to 8 months
Secondary outcomes:
measure: Serum Biomarker Inflammation - C-Reactive Protein
timeFrame: Change from baseline to 4 month
measure: Serum Biomarker Insulin Resistance - Insulin
timeFrame: Change from baseline to 4 month
measure: Serum Biomarker Insulin Resistance- Glucose
timeFrame: Change from baseline to 4 month
measure: Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha
timeFrame: Change from baseline to 4 month
measure: Serum Biomarker Insulin Resistance- C-Peptide
timeFrame: Change from baseline to 4 month
measure: Serum Biomarker Adipokine Dysregulation - Adiponectin
timeFrame: Change from baseline to 4 month
measure: Serum Biomarker Adipokine Dysregulation - Leptin
timeFrame: Change from baseline to 4 month
measure: Serum Biomarker Inflammation - Interleukin 6
timeFrame: Change from baseline to 4 month
Other outcomes:
measure: nRNA and Metabolomics - exploratory
timeFrame: Baseline to 3 months
Locations:
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Principal Investigator
name: Melinda Stolley, PhD
role: PRINCIPAL_INVESTIGATOR
References: