Nutritional Psychological Intervention and Vomit-free Management on Survival and Quality of Life in Advanced Gastrointestinal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Median progression-free survival time
研究概览
简要总结
Aims to observe and evaluate the impact of survival and quality of life of patients with gastrointestinal tumors such as advanced esophageal, gastric, liver, pancreatic, and colorectal cancers through nutritional-psychological interventions versus no-vomit management compared to standard antitumor therapy alone
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75, male or female;
- •Patients with advanced esophageal cancer, gastric cancer, liver cancer and colorectal cancer and other gastrointestinal tumors diagnosed by pathological histology or cytology;
- •Expected survival ³ 8 weeks and able to receive long-term follow-up;
- •Eastern Cooperative Oncology Group(ECOG)-Performance Status(PS) score of 0-2;
- •First-line treatment receiving standard oncology treatment and nutritional psychological intervention and vomit-free management group (study group); first-line treatment receiving only standard oncology treatment group (control group);
- •Voluntarily signing an informed consent form.
排除标准
- •Other malignant tumors diagnosed within the previous 5 years, except for effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or effectively resected in situ cervical cancer or breast cancer;
- •history of psychiatric illness prior to the diagnosis of the tumor
- •patients who resist treatment
- •patients with poorly controlled severe heart disease, liver or kidney insufficiency, severe anemia, multiple lymph node enlargement, leukopenia, etc;
- •patients who are pregnant or have a pregnancy plan;
- •patients who, in the judgment of the investigator, are not suitable for inclusion in this study.
结局指标
主要结局
Median progression-free survival time
时间窗: Approximately 40 months from date of the first participant randomization
Progression-free survival is defined as the period from the date of treatment to the date of the first occurrence of disease progression or death from any cause, whichever occurs first. Median progression-free survival is the time to progression-free survival that corresponds to when the cumulative progression-free survival rate is 0.5, indicating that 50% of individuals will live through this time without disease progression.
次要结局
- completion rate(Approximately 40 months from date of the first participant randomization)
- median Overall Survival(Approximately 40 months from date of the first participant randomization)
- Quality of Life(QoL)(Approximately 40 months from date of the first participant randomization)
- Duration of Response(Approximately 40 months from date of the first participant randomization)
- Disease Control Rate(Approximately 40 months from date of the first participant randomization)
- Objective Response Rate(Approximately 40 months from date of the first participant randomization)
研究者
Yongshun Chen
Professor
Renmin Hospital of Wuhan University