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

ConditionMetastatic Breast Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorMedical College of Wisconsin

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Does not meet the above criteria.

Trial design

Design model

Crossover

Treatments tested in this trial

Lifestyle Intervention
Behavioral
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 Control
Behavioral
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.

Treatment groups

176 Participants

are divided into 2 treatment groups

Group A: Immediate InterventionExperimental treatment 1 intervention

Group B: Attention ControlOther 1 intervention

Trial outcomes

Primary outcomes

Intervention adherence

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

Time frame

4 months

Intervention retention

Number of women who complete the 4-month data collection

Time frame

4 months

Intervention retention

Number of women who complete the 8-month data collection

Time frame

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.

Time frame

Change from baseline to 4 months

Secondary outcomes

Serum Biomarker Inflammation - C-Reactive Protein

Analyzed by EVE technologies using standard ELISA kits

Time frame

Change from baseline to 4 month

Serum Biomarker Insulin Resistance - Insulin

Analyzed by EVE technologies using standard ELISA kits

Time frame

Change from baseline to 4 month

Serum Biomarker Insulin Resistance- Glucose

Analyzed by EVE technologies using standard ELISA kits

Time frame

Change from baseline to 4 month

Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha

Analyzed by EVE technologies using standard ELISA kits

Time frame

Change from baseline to 4 month

Other outcomes

nRNA and Metabolomics - exploratory

MTo explore if microRNA (miRNA) signatures associated with inflammation and/or Metabolomics are altered with the EDC intervention. analyzed using a Seahorse Bioscience extracellular flux analyzer.

Time frame

Baseline to 3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

Loyola University Chicago

Collaborator

Source ClinicalTrials.gov

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