Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 4
- 主要终点
- Intervention retention
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Does not meet the above criteria.
结局指标
主要结局
Intervention retention
时间窗: 8 months
Number of women who complete the 8-month data collection
Body composition
时间窗: 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.
Intervention adherence
时间窗: 4 months
Number of lifestyle coaching sessions completed out of a possible total of 16 sessions
Change in Quality of Life
时间窗: 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.
次要结局
- Serum Biomarker Adipokine Dysregulation - Adiponectin(Change from baseline to 4 month)
- Serum Biomarker Insulin Resistance- C-Peptide(Change from baseline to 4 month)
- Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha(Change from baseline to 4 month)
- Serum Biomarker Inflammation - C-Reactive Protein(Change from baseline to 4 month)
- Serum Biomarker Insulin Resistance- Glucose(Change from baseline to 4 month)
- Serum Biomarker Adipokine Dysregulation - Leptin(Change from baseline to 4 month)
- Serum Biomarker Insulin Resistance - Insulin(Change from baseline to 4 month)
- Serum Biomarker Inflammation - Interleukin 6(Change from baseline to 4 month)
研究者
Melinda Stolley
Professor
Medical College of Wisconsin