Metastatic Breast Cancer
Conditions
Brief 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).
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.
Interventions
BEHAVIORALLifestyle 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.
BEHAVIORALAttention 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.
Sponsors
Loyola University Chicago
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Attention Control
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | 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. |
| Intervention adherence | 4 months | Number of lifestyle coaching sessions completed out of a possible total of 16 sessions |
| Intervention retention | 4 months | Number of women who complete the 4-month data collection |
| Change in Quality of Life | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha | Change from baseline to 4 month | Analyzed by EVE technologies using standard ELISA kits |
| Serum Biomarker Insulin Resistance- C-Peptide | Change from baseline to 4 month | Analyzed by EVE technologies using standard ELISA kits |
| Serum Biomarker Adipokine Dysregulation - Leptin | Change from baseline to 4 month | Analyzed by EVE technologies using standard ELISA kits |
| Serum Biomarker Inflammation - Interleukin 6 | Change from baseline to 4 month | Analyzed by EVE technologies using standard ELISA kits |
| Serum Biomarker Adipokine Dysregulation - Adiponectin | Change from baseline to 4 month | Analyzed by EVE technologies using standard ELISA kits |
| Serum Biomarker Inflammation - C-Reactive Protein | Change from baseline to 4 month | Analyzed by EVE technologies using standard ELISA kits |
| Serum Biomarker Insulin Resistance - Insulin | Change from baseline to 4 month | Analyzed by EVE technologies using standard ELISA kits |
| Serum Biomarker Insulin Resistance- Glucose | Change from baseline to 4 month | Analyzed by EVE technologies using standard ELISA kits |
Other
| Measure | Time frame | Description |
|---|---|---|
| nRNA and Metabolomics - exploratory | Baseline to 3 months | 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. |
Countries
United States
Contacts
Primary ContactKathleen OConnell, MSW
Outcome results
None listed