Recruiting
Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
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).
ClinicalTrials.gov IDNCT03824145
PhaseNA
Enrollment176
SponsorMedical College of Wisconsin
Age18 Years
SexFEMALE
Conditions studied
Metastatic Breast Cancer
About this study
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).
Interventions
- 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.
- Behavioral: 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.
Primary outcomes
- Intervention adherence (4 months)
- Intervention retention (4 months)
- Intervention retention (8 months)
- Change in Quality of Life (Change from baseline to 4 months)
- Change in Quality of Life (change from baseline to 8 months)
- Body composition (change from baseline to 4 months)
- Body composition (change from baseline to 8 months)
Eligibility information
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.
Study locations
- Loyola University, Maywood, Illinois 60153 United States
- Medical College of Wisconsin, Milwaukee, Wisconsin 53226 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.