Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
NCT ID: NCT03824145
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
176 participants
INTERVENTIONAL
2022-11-01
2027-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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:
* 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.
Following completion of the attention control home/work organization program and 16-week assessment, women will receive the lifestyle program.
Attention Control
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.
Interventions
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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:
Following completion of the attention control home/work organization program and 16-week assessment, women will receive the lifestyle program.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Loyola University Chicago
OTHER
Medical College of Wisconsin
OTHER
Responsible Party
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Melinda Stolley
Professor
Principal Investigators
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Melinda Stolley, PhD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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Loyola University
Maywood, Illinois, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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27600
Identifier Type: -
Identifier Source: org_study_id
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