A Prospective, Single-Center, Randomized Controlled Trial Comparing Enhanced Follow-up With Standard Follow-up in Post-Gastrectomy Patients With Advanced Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 158
- 主要终点
- Quality of Life Improvement
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of enhanced follow-up with standard follow-up in postoperative patients with advanced gastric cancer who have undergone radical gastrectomy. The main questions it aims to answer are:
Can enhanced follow-up alleviate symptom burden and improve quality of life? What is the impact of enhanced follow-up on overall survival rates at 3 and 5 years post-surgery?
Participants will:
Be randomly assigned to either the enhanced follow-up group or the standard follow-up group.
Undergo comprehensive symptom, nutritional, and psychological assessments every 3 weeks (enhanced follow-up group).
Receive routine postoperative follow-up including medical examinations and treatments as needed, with additional assessments only when necessary (standard follow-up group).
Researchers will compare the enhanced follow-up group with the standard follow-up group to see if enhanced follow-up can improve quality of life and increase overall survival rates at 3 and 5 years post-surgery.
Outcomes will be measured using the EORTC QLQ-C30 quality of life questionnaire and overall survival rates. This prospective, single-center, randomized controlled clinical trial will span 5 years from the approval by the institutional ethics committee and will include 158 patients.
详细描述
- Study Design and Methods 1.1 Study Design: This study is designed as a randomized controlled trial, with randomization implemented through an online clinical database. In this study, "enhanced follow-up" refers to comprehensive assessments every 3 weeks post-surgery, including symptom, nutritional, and psychological evaluations. "Standard follow-up" follows routine clinical practice, providing assessments only when necessary.
Experimental Group (Enhanced Follow-up Group) 1) Patients will undergo comprehensive assessments every 3 weeks post-surgery. 2) Nutritional Assessment: Using internationally recognized tools such as NRS 2002 and PG-SGA.
- Psychological Assessment: Using tools such as the Distress Thermometer (DT), Generalized Anxiety Disorder 7-item scale (GAD-7), Fear of Cancer Recurrence 7-item scale (FCR-7), Insomnia Severity Index (ISI), and the Patient Health Questionnaire 9-item depression scale (PHQ-9).
Control Group (Standard Follow-up Group)
- Patients will receive standard postoperative follow-up, including medical examinations and treatments as needed.
- Nutritional and psychological assessments will be conducted only when deemed necessary by the patient or the healthcare provider.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 72 years at the time of informed consent.
- •Underwent radical total gastrectomy.
- •Postoperative pathology confirmed advanced adenocarcinoma of the stomach or gastroesophageal junction.
- •Estimated survival time ≥3 months.
- •Good cognitive and reading abilities, capable of completing questionnaires.
- •Willing and able to provide written informed consent for the study.
排除标准
- •Participation in another clinical trial within 4 weeks prior to enrollment.
- •Patients with other malignancies.
- •Clinically significant cardiovascular disease, such as heart failure (NYHA III-IV), uncontrolled coronary artery disease, cardiomyopathy, arrhythmia, or hypertension.
- •Neurological or psychiatric disorders affecting cognitive function, including central nervous system metastasis.
- •Active infectious diseases, such as active hepatitis or tuberculosis.
- •Uncontrolled systemic diseases, such as poorly controlled diabetes.
- •Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease on baseline chest X-ray/CT.
- •Pregnant or breastfeeding.
结局指标
主要结局
Quality of Life Improvement
时间窗: Assessed every 6 weeks from the 4th week post-surgery until 6 months post-chemotherapy completion.
Measurement of quality of life improvement in postoperative advanced gastric cancer patients using the EORTC QLQ-C30 questionnaire. The assessment will include various dimensions such as physical functioning, emotional well-being, social functioning, and overall health status.
次要结局
- 3-Year Overall Survival Rate(3 years post-surgery.)
- 5-Year Overall Survival Rate(5 years post-surgery.)