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

Medical College of Wisconsin176 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

176

Conditions

Metastatic Breast Cancer

Interventions

Lifestyle InterventionBEHAVIORAL

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 ControlBEHAVIORAL

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

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Loyola University

Maywood, Illinois, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

RECRUITING

Outcomes

Primary Outcomes

Intervention adherence

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

Time frame: 4 months

Intervention retention

Number of women who complete the 4-month data collection

Time frame: 4 months

Intervention retention

Number of women who complete the 8-month data collection

Time frame: 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.

Time frame: Change from baseline to 4 months

Change in Quality of Life

Time frame: 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.

Time frame: change from baseline to 4 months

Body composition

Central Contacts

Kathleen OConnell, MSW

CONTACT

414-955-2114 kaoconnell@mcw.edu

Data from ClinicalTrials.gov

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