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

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).

Study Overview

• Status: Recruiting
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Behavioral: Lifestyle Intervention; Behavioral: Attention Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathleen OConnell, MSW; Phone Number: 414-955-2114; Email: kaoconnell@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin
      • Contact: Kathleen O'Connell, MSW; Phone Number: 414-955-2114; Email: kaoconnell@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate 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.	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.
Other: 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.	Behavioral: Attention Control; The attention control participants will receive a home/work organization intervention:

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
nRNA and Metabolomics - exploratory	MTo explore if microRNA (miRNA) signatures associated with inflammation and/or Metabolomics are altered with the EDC intervention. analyzed using a Seahorse Bioscience extracellular flux analyzer.	Baseline to 3 months

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Loyola University Chicago
• Investigators: Principal Investigator: Melinda Stolley, PhD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): February 1, 2027
• Study Completion (Anticipated): February 1, 2027

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 27600

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No