Web-based Platform for Nutrition Management in Patients With Cancer: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- body weight change
研究概览
简要总结
It is crucial to promptly identify nutritional issues in these patients within the community and provide them with dietary guidance, nutritional counseling, and support. This study will be conducted in communities in Chengdu, Sichuan. Community management teams will register oncology patients, collecting information such as demographic data, tumor type, stage, specific treatment plan, treatment hospital, regularity of hospital admissions, and frequency of independent smartphone use. Registered patients will be screened based on inclusion and exclusion criteria. For those who meet the criteria, the community management team will contact them and recommend the use of a dedicated app developed by the research team. An initial nutritional assessment will also be conducted. Patients identified with nutritional risks will be directly referred to the research team's clinical nutritionists for face-to-face consultations. After additional tests, such as body composition analysis, necessary nutritional education and stepwise nutritional interventions will be provided. These patients will also use the app for dietary monitoring and nutritional guidance. For patients without nutritional risks, the app will be recommended for daily questionnaire completion and activity tracking.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed malignant tumor;
- •PG-SGA score of 4-9 points;
- •Age: ≥18 years, with an expected survival time of more than 1 year;
- •Possesses adequate cognitive and reading abilities to complete questionnaires and use the APP.
排除标准
- •Presence of neurological or psychiatric disorders affecting cognitive function, including central nervous system metastasis of tumors;
- •Suffering from conditions severely impacting digestion, metabolism, or food intake;
- •Patients in the cachexia stage or refractory cachexia phase.
结局指标
主要结局
body weight change
时间窗: baseline, pre-intervention；every 2 weeks after randomization until 6 moths.
change of body weight during the trail
次要结局
- PG-SGA(baseline, pre-intervention；every 2 weeks after randomization until 6 moths.)
- NRS2002(baseline, pre-intervention；every 2 weeks after randomization until 6 moths.)
研究者
Xingchen Peng
PhD, Professor
West China Hospital