Food as Medicine: A Phase III Randomized Controlled Trial of Home Delivered, Medically Tailored Meals (HDMTM) on Quality of Life in Metastatic Lung and Non-colorectal GI Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Quality of life measurement
研究概览
简要总结
The purpose of this study is to determine whether medically tailored meals (HDTM) can improve quality of life for patients with metastatic cancer.
详细描述
The current standard of care at the cancer center is for all patients receiving cytotoxic therapy to undergo a nutritional consultation and evaluation with a registered oncology dietitian. The goal of this consultation is to prevent nutritional deficiencies, promote optimal nutritional intake, hydration, and weight maintenance, as well as maintain lean body mass.
All patients on this study will receive standard of care nutritional services including nutrition consult, evaluation, and as needed follow-ups. However, patients randomized to arm 2 will receive home delivered, medically tailored meals in addition to the standard nutritional care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of pathologically confirmed metastatic pancreatic, hepatobiliary, esophageal, or lung cancer, either newly metastatic or metastatic at presentation (M1+) and enrollment within 6 weeks of diagnosis; measurable disease need not be present.
- •Pain Score (PS) 0-3
- •Both male and female subjects eligible
- •All ethnicities eligible
- •Access to refrigerator or freezer
排除标准
- •Diagnosis of metastatic cancer no greater than 6 weeks prior to expected study enrollment
- •Currently receiving home delivered meals from other sources
- •Evidence of any alimentary tract obstruction or other condition preventing oral alimentation
- •Requirement for enteral or parenteral nutrition at time of diagnosis
- •Incarcerated individuals
结局指标
主要结局
Quality of life measurement
时间窗: At 12 weeks follow up
Quality of life will be assessed using the Functional Assessment in Cancer Therapy - General (FACT-G). Developed by Cella et al. the FACT-G is a well validated and widely used multi-dimensional health related quality of life measure for cancer patients. It consists of 28 self-assessment items on a 5 point Likert scale that address four domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. Scores are calculated for each sub-scale per FACT scoring instructions and summed for a total score ranging between 0 and 108 with higher scores indicating a higher quality of life.
次要结局
- Change in mood assessment(From baseline to 12 weeks)
- Nutritional status assessment(From baseline to 12 weeks)
- Financial toxicity assessment(From baseline to 12 weeks)
- Patient weight assessment(From baseline to 12 weeks)
- Food security assessment plus HDMTM from baseline to 12 weeks(From baseline to 12 weeks)