Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
Medical College of Wisconsin
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…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 NC…
Interventions
- BehavioralLifestyle 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.
- BehavioralAttention 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.
Locations (2)
- Loyola UniversityMaywood, Illinois
- Medical College of WisconsinMilwaukee, Wisconsin