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

This study is testing a 16-week lifestyle program called "Every Day Counts" for women with metastatic breast cancer (cancer that has spread to other parts of the body). The program focuses on diet and physical activity to improve body composition (the amount of fat, bone, muscle, and water in your body). Some participants will first receive an "Attention Control" program about home/work organization, and then get the lifestyle program later. Researchers want to see if the Every Day Counts program improves quality of life, body composition, and certain blood markers. You can join if you are an adult woman (18 or older) with confirmed metastatic breast cancer, are clinically stable, and your oncologist (cancer doctor) approves your participation. The study aims to enroll 176 women.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 176 women and compares a lifestyle intervention to an attention control group.
What's involved
The lifestyle intervention lasts for 16 weeks. Participants will have assessments at 4 months and 8 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for intervention adherence and retention at 4 months and 8 months.

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NCT03824145

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

Recruiting
NAAges 18+InterventionalSupportive care
Medical College of Wisconsin
~176 participants
Updated 2025-04-27 on ClinicalTrials.gov
What's tested:Lifestyle InterventionAttention Control

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intervention adherence
Measured over 4 months
+6 more outcomes measured
Metastatic Breast Cancer
2 sites across 2 states
Illinois1
Wisconsin1
  • Melinda Stolley, PhD · PRINCIPAL_INVESTIGATOR · Principal Investigator

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Eligibility criteria

Inclusion

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

Does not meet the above criteria.
  • Intervention adherence4 months

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

  • Intervention retention4 months

    Number of women who complete the 4-month data collection

  • Intervention retention8 months

    Number of women who complete the 8-month data collection

  • Change in Quality of LifeChange from baseline to 4 months

    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 in Quality of Lifechange from baseline to 8 months

    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.

  • Body compositionchange from baseline to 4 months

    Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.

  • Body compositionchange from baseline to 8 months

    Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.