Metastatic Breast CancerEDCNCT03824145
Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
A study testing Lifestyle Intervention in people with Metastatic Breast Cancer, run by Medical College of Wisconsin at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- -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.
Who cannot join
- Does not meet the above criteria.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loyola University
Maywood, Illinois, 60153
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
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).
Read the detailed 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 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Lifestyle Intervention, Attention Control
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
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 ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | The experimental arm will receive a 16-week lifestyle intervention that promotes nutritional and physical activity changes concordant with those contained in the ACS nutrition and physical activity guidelines for cancer survivors. The 16-week intervention includes:
1) a curriculum binder covering weekly topics and including self-monitoring tools to support adherence; 2) lifestyle coaching for 16-weeks, with in-person or virtual supervised exercise sessions and telephone-based sessions; 3) exercise supplies (Fitbit, resistance bands), 4) twice weekly text messaging targeting self-efficacy and social support; and 5) attendance to cooking classes emphasizing plant-based eating. Receives: Behavioral: Lifestyle Intervention |
| Attention Control | Other | The attention control participants will receive a home/work organization intervention:
* Participants will receive a book with overview of home/work organization program with 16 weekly topics with an overview of each chapter.
* Virtual or weekly phone calls- with a home organization coach with standard prompts.
* Text messages supporting home/work organization.
Following completion of the attention control home/work organization program and 16-week assessment, women will receive the lifestyle program. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention adherence
Number of lifestyle coaching sessions completed out of a possible total of 16 sessions
Measured: 4 months
Intervention retention
Number of women who complete the 4-month data collection
Measured: 4 months
Intervention retention
Number of women who complete the 8-month data collection
Measured: 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.
Measured: Change from baseline to 4 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.
Measured: 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.
Measured: change from baseline to 4 months
Body composition
Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.
Measured: change from baseline to 8 months
Secondary outcomes (8)
Serum Biomarker Inflammation - C-Reactive Protein
Analyzed by EVE technologies using standard ELISA kits
Measured: Change from baseline to 4 month
Serum Biomarker Insulin Resistance - Insulin
Analyzed by EVE technologies using standard ELISA kits
Measured: Change from baseline to 4 month
Serum Biomarker Insulin Resistance- Glucose
Analyzed by EVE technologies using standard ELISA kits
Measured: Change from baseline to 4 month
Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha
Analyzed by EVE technologies using standard ELISA kits
Measured: Change from baseline to 4 month
Serum Biomarker Insulin Resistance- C-Peptide
Analyzed by EVE technologies using standard ELISA kits
Measured: Change from baseline to 4 month
Serum Biomarker Adipokine Dysregulation - Adiponectin
Analyzed by EVE technologies using standard ELISA kits
Measured: Change from baseline to 4 month
Serum Biomarker Adipokine Dysregulation - Leptin
Analyzed by EVE technologies using standard ELISA kits
Measured: Change from baseline to 4 month
Serum Biomarker Inflammation - Interleukin 6
Analyzed by EVE technologies using standard ELISA kits
Measured: Change from baseline to 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Nov 2022
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Attention Control
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola University Chicago
- Responsible party
- Principal investigator, Melinda Stolley, Medical College of Wisconsin
- Investigators
- Melinda Stolley, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824145
- Sponsor's protocol ID
- 27600
- Acronym
- EDC
- Status last verified
- Apr 2025
- First submitted
- 19 Feb 2018
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03824145
- Acronym / sponsor ID
- EDC / 27600
- Conditions
- Metastatic Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Loyola University Chicago
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Attention Control
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Lifestyle InterventionThe experimental arm will receive a 16-week lifestyle intervention that promotes nutritional and physical activity changes concordant with those contained in the ACS nutrition and physical activity guidelines for cancer survivors. The 16-week intervention includes: 1) a curriculum binder covering weekly topics and including self-monitoring tools to support adherence; 2) lifestyle coaching for 16-weeks, with in-person or virtual supervised exercise sessions and telephone-based sessions; 3) exercise supplies (Fitbit, resistance bands), 4) twice weekly text messaging targeting self-efficacy and social support; and 5) attendance to cooking classes emphasizing plant-based eating. |
| Attention Control | Other | Behavioral: Attention ControlThe attention control participants will receive a home/work organization intervention: * Participants will receive a book with overview of home/work organization program with 16 weekly topics with an overview of each chapter. * Virtual or weekly phone calls- with a home organization coach with standard prompts. * Text messages supporting home/work organization. Following completion of the attention control home/work organization program and 16-week assessment, women will receive the lifestyle program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (1 listed)
- Does not meet the above criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle InterventionThe lifestyle intervention is a 16-week cognitive-behavioral intervention that addresses key changes in diet and PA behaviors to promote positive body composition changes. | Behavioural | Immediate Intervention |
| Attention ControlThe 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. | Behavioural | Attention Control |
Primary outcome
Intervention adherence
Time frame: 4 months
Number of lifestyle coaching sessions completed out of a possible total of 16 sessions
Intervention retention
Time frame: 4 months
Number of women who complete the 4-month data collection
Intervention retention
Time frame: 8 months
Number of women who complete the 8-month data collection
Change in Quality of Life
Time frame: Change 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 Life
Time frame: change 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 composition
Time frame: change 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 composition
Time frame: change 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.
8 secondary outcomes
Serum Biomarker Inflammation - C-Reactive Protein
Time frame: Change from baseline to 4 month
Serum Biomarker Insulin Resistance - Insulin
Time frame: Change from baseline to 4 month
Serum Biomarker Insulin Resistance- Glucose
Time frame: Change from baseline to 4 month
Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha
Time frame: Change from baseline to 4 month
Serum Biomarker Insulin Resistance- C-Peptide
Time frame: Change from baseline to 4 month
Serum Biomarker Adipokine Dysregulation - Adiponectin
Time frame: Change from baseline to 4 month
Serum Biomarker Adipokine Dysregulation - Leptin
Time frame: Change from baseline to 4 month
Serum Biomarker Inflammation - Interleukin 6
Time frame: Change from baseline to 4 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melinda Stolley, PhD principal investigator
Principal Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Metastatic Breast Cancer, run by Medical College of Wisconsin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention adherence (time frame: 4 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.