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

NCT03824145 | Recruiting DMC

• 1 other identifier: 27600
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 2

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).

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (8)

• Serum Biomarker Inflammation - C-Reactive Protein

  Change from baseline to 4 month

• Serum Biomarker Insulin Resistance - Insulin

  Change from baseline to 4 month

• Serum Biomarker Insulin Resistance- Glucose

  Change from baseline to 4 month

• Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha

  Change from baseline to 4 month

• Serum Biomarker Insulin Resistance- C-Peptide

  Change from baseline to 4 month

Other Outcomes (1)

• nRNA and Metabolomics - exploratory

  Baseline to 3 months

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

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

Attention Control

OTHER

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.

Behavioral: Attention Control

Interventions

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.

Immediate Intervention

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.

Attention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Does not meet the above criteria.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Loyola University Chicago: collaborator

Study Sites (2)

Loyola University

Maywood, Illinois, 60153, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Melinda Stolley, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen OConnell, MSW

CONTACT

414-955-2114; kaoconnell@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Attention Control

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: January 31, 2019
• Study Start: November 1, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (2)