A lifestyle program for women with metastatic breast cancer
Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
This study is testing a lifestyle program to see if it can improve the quality of life for women with metastatic breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 2 sites (Maywood, Illinois and 1 other locations) |
| Trial ID | NCT03824145 on ClinicalTrials.gov |
What this trial studies
This multi-site intervention aims to evaluate the effects of the Every Day Counts program on quality of life, body composition, and biomarkers in women with metastatic breast cancer. The study will recruit 176 participants from Milwaukee and Chicago, randomly assigning them to either the lifestyle intervention or an attention control group. The primary goal is to determine if the intervention leads to significant improvements in quality of life and to explore the underlying biological mechanisms involved. Additionally, the study will investigate changes in microRNA signatures related to inflammation and metabolic processes.
Who should consider this trial
Good fit: Ideal candidates are adult women with confirmed metastatic breast cancer who are clinically stable and have a life expectancy of more than six months.
Not a fit: Patients who do not meet the eligibility criteria or have uncontrolled disease progression may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance the quality of life for women living with metastatic breast cancer.
How similar studies have performed: Other studies have shown promising results with lifestyle interventions in cancer care, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Maywood, Illinois and 1 other locations
- Loyola University — Maywood, Illinois, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Melinda Stolley, PhD — Principal Investigator
- Study coordinator: Kathleen OConnell, MSW
- Email: kaoconnell@mcw.edu
- Phone: 414-955-2114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.