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

Metastatic Breast Cancer Clinical Trial

— EDC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03824145
• Other study ID #: 27600
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: February 1, 2027

Study information

• Verified date: March 2024
• Source: Medical College of Wisconsin
• Contact: Kathleen OConnell, MSW
• Phone: 414-955-2114
• Email: kaoconnell[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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.
• Attention Control
The attention control participants will receive a home/work organization intervention:

Locations

Country	Name	City	State
United States	Loyola University	Maywood	Illinois
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Loyola University Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Intervention adherence	Number of lifestyle coaching sessions completed out of a possible total of 16 sessions	4 months
Primary	Intervention retention	Number of women who complete the 4-month data collection	4 months
Primary	Intervention retention	Number of women who complete the 8-month data collection	8 months
Primary	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
Primary	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
Primary	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
Primary	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	Serum Biomarker Inflammation - C-Reactive Protein	Analyzed by EVE technologies using standard ELISA kits	Change from baseline to 4 month
Secondary	Serum Biomarker Insulin Resistance - Insulin	Analyzed by EVE technologies using standard ELISA kits	Change from baseline to 4 month
Secondary	Serum Biomarker Insulin Resistance- Glucose	Analyzed by EVE technologies using standard ELISA kits	Change from baseline to 4 month
Secondary	Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha	Analyzed by EVE technologies using standard ELISA kits	Change from baseline to 4 month
Secondary	Serum Biomarker Insulin Resistance- C-Peptide	Analyzed by EVE technologies using standard ELISA kits	Change from baseline to 4 month
Secondary	Serum Biomarker Adipokine Dysregulation - Adiponectin	Analyzed by EVE technologies using standard ELISA kits	Change from baseline to 4 month
Secondary	Serum Biomarker Adipokine Dysregulation - Leptin	Analyzed by EVE technologies using standard ELISA kits	Change from baseline to 4 month
Secondary	Serum Biomarker Inflammation - Interleukin 6	Analyzed by EVE technologies using standard ELISA kits	Change from baseline to 4 month