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NOT YET RECRUITING
NCT06468969
NA

Enhanced vs. Routine Follow-Up After Total Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective, Single-Center, Randomized Controlled Trial Comparing Enhanced Follow-up With Standard Follow-up in Post-Gastrectomy Patients With Advanced Gastric Cancer

Key Details

Gender

All

Age Range

18 Years - 72 Years

Study Type

INTERVENTIONAL

Enrollment

158

Start Date

2024-07-01

Completion Date

2029-07-01

Last Updated

2024-06-21

Healthy Volunteers

No

Interventions

OTHER

Enhanced Follow-up

Participants 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 Nutritional Assessment (using NRS 2002 and PG-SGA) Psychological Assessment (using DT, GAD-7, FCR-7, ISI, PHQ-9)