A Randomized Controlled Trial (RCT) to assess the effect of nurse-led nutrition and exercise intervention on nutritional status, activities of daily living and quality of life among patients with gastro-intestinal cancer at IRCH, AIIMS, New Delhi.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- nutritional status
研究概览
简要总结
The thesis research protocol focuses on a randomized controlled trial (RCT) to assess the impact of a nurse-led nutrition and exercise intervention on the nutritional status, activities of daily living, and quality of life among patients with gastrointestinal cancer at IRCH, AIIMS New Delhi. The study aims to evaluate how such an intervention can improve patient outcomes compared to standard care. The primary objectives include assessing changes in nutritional status, activities of daily living, and quality of life, while the secondary objectives explore the relationships between demographic factors and outcomes, along with patient satisfaction. A total of 300 patients will participate, randomized into intervention and control groups, with the intervention group receiving structured dietary advice and supervised exercise plans for 8 weeks. Data collection will include tools like biophysiological assessments and validated questionnaires. The study aims to address gaps in low-resource settings, providing a model for cost-effective, sustainable care to enhance patient recovery and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are 18 years Able to understand English or Hindi language Diagnosed with Gastro intestinal cancer 1-2 cycle of Neo Adjuvant therapy Eastern Cooperative Oncology Group Performance Status Score from 1 to 4 Having at least one caregiver of age more than 18 years Patients who are physically and mentally stable.
排除标准
- •Patients who were unwilling to participate will be excluded from the study Patients who cannot read and write Hindi & English language Patients with advanced cancer.
结局指标
主要结局
nutritional status
时间窗: at base line at 1 month at 2 month at 3 month
次要结局
- activities of daily living(at base line at 1 month at 2 month at 3 month)
- quality of life(at base line at 1 month at 2 month at 3 month)
研究者
Ms Akansha
College of Nursing AIIMS New Delhi