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

Not Applicable

Recruiting

• Conditions: Metastatic Breast Cancer

• 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.

Study Timeline

• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-31
• Study Start: 2022-11-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Serum Biomarker Inflammation - Interleukin 6	Change from baseline to 4 month	Analyzed by EVE technologies using standard ELISA kits
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

Trial Locations

Locations (2)

Loyola University; 🇺🇸 Maywood, Illinois, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States