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
1. 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.
3) 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.
研究组 & 干预措施
Enhanced Follow-up Group
Participants in this group will receive comprehensive follow-up care starting from the 4th week post-surgery. Every 3 weeks, they will undergo a thorough assessment that includes:
Symptom Assessment: Comprehensive evaluation of symptoms. Nutritional Assessment: Using internationally recognized tools such as NRS 2002 and PG-SGA.
Psychological Assessment: Utilizing 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).
干预措施: Enhanced Follow-up (Other)
Standard Follow-up Group
Participants in this group will receive standard postoperative follow-up care, which includes medical examinations and treatments as necessary. Nutritional and psychological assessments will only be conducted if deemed necessary by the patient or the healthcare provider. This group will serve as the control group for comparison with the enhanced follow-up group.
干预措施: Enhanced Follow-up (Other)
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.)