Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Breast Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Wait List controlMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
Aims/Objectives Aim 1. To examine the feasibility and acceptability of a 12 week cognitive-behavioral lifestyle intervention, assessing rates of study eligibility, accrual, adherence, and attrition. Aim 2. To examine the impact of a 12-week lifestyle intervention on body composition, the association...
Aims/Objectives Aim 1. To examine the feasibility and acceptability of a 12 week cognitive-behavioral lifestyle intervention, assessing rates of study eligibility, accrual, adherence, and attrition. Aim 2. To examine the impact of a 12-week lifestyle intervention on body composition, the associations with serum biomarkers of prognosis and survival, and patient reported outcomes. Hypothesis 1: Increases in LST with or without decreases in adipose tissue [measured by dual energy x-ray absorptiometry (DXA)] will be associated with improvements in the serum biomarkers of BC prognosis and survival [inflammatory markers (e.g., C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-?), interleukin-6 (IL-6)]; cytokines (e.g., leptin, adiponectin); insulin resistance (e.g., insulin, glucose)]. Hypothesis 2: Increases in LST with or without decreases in adipose tissue will be associated with improvements in symptom burden and quality of life. Exploratory Aim Aim 3. To explore the effect of a 12-week lifestyle intervention on mitochondrial function and its association with symptom burden.
Tracking Information
- NCT #
- NCT03824145
- Collaborators
- Loyola University Chicago
- Investigators
- Principal Investigator: Melinda Stolley, PhD Principal Investigator