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
- 2
- 主要终点
- Intervention adherence
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.
研究组 & 干预措施
Immediate Intervention
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.
干预措施: Lifestyle Intervention (Behavioral)
Attention Control
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.
干预措施: Attention Control (Behavioral)
结局指标
主要结局
Intervention adherence
时间窗: 4 months
Number of lifestyle coaching sessions completed out of a possible total of 16 sessions
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.
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.
Intervention retention
时间窗: 4 months
Number of women who complete the 4-month data collection
Change in Quality of Life
时间窗: 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.
Body composition
时间窗: 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.
次要结局
- Serum Biomarker Adipokine Dysregulation - Adiponectin(Change from baseline to 4 month)
- Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha(Change from baseline to 4 month)
- Serum Biomarker Insulin Resistance- C-Peptide(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