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NCT Number: NCT03824145

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

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).

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loyola University, Maywood, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle Intervention

Behavioral

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.

Attention Control

Behavioral

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 outcomes

  1. Intervention adherence

    Time frame: 4 months

    Number of lifestyle coaching sessions completed out of a possible total of 16 sessions

  2. Intervention retention

    Time frame: 4 months

    Number of women who complete the 4-month data collection

  3. Intervention retention

    Time frame: 8 months

    Number of women who complete the 8-month data collection

  4. Change in Quality of Life

    Time frame: Change from baseline to 4 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.

  5. Change in Quality of Life

    Time frame: 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.

  6. Body composition

    Time frame: change from baseline to 4 months

    Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.

  7. Body composition

    Time frame: 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 outcomes

  1. Serum Biomarker Inflammation - C-Reactive Protein

    Time frame: Change from baseline to 4 month

    Analyzed by EVE technologies using standard ELISA kits

  2. Serum Biomarker Insulin Resistance - Insulin

    Time frame: Change from baseline to 4 month

    Analyzed by EVE technologies using standard ELISA kits

  3. Serum Biomarker Insulin Resistance- Glucose

    Time frame: Change from baseline to 4 month

    Analyzed by EVE technologies using standard ELISA kits

  4. Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha

    Time frame: Change from baseline to 4 month

    Analyzed by EVE technologies using standard ELISA kits

  5. Serum Biomarker Insulin Resistance- C-Peptide

    Time frame: Change from baseline to 4 month

    Analyzed by EVE technologies using standard ELISA kits

  6. Serum Biomarker Adipokine Dysregulation - Adiponectin

    Time frame: Change from baseline to 4 month

    Analyzed by EVE technologies using standard ELISA kits

  7. Serum Biomarker Adipokine Dysregulation - Leptin

    Time frame: Change from baseline to 4 month

    Analyzed by EVE technologies using standard ELISA kits

  8. Serum Biomarker Inflammation - Interleukin 6

    Time frame: Change from baseline to 4 month

    Analyzed by EVE technologies using standard ELISA kits

Other outcomes

  1. nRNA and Metabolomics - exploratory

    Time frame: Baseline to 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen OConnell, MSW

CONTACT

[email protected]

414-955-2114

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Loyola University Chicago

Registry information

Acronym: EDC

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 31, 2019
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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