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

NCT06468969 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2024-06-21

No results posted yet for this study

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.

Conditions

  • Gastric Cancer
  • Total Gastrectomy
  • Postoperative Care
  • Quality of Life
  • Follow-up

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)

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Dazhi Xu, MD, PHD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-07-01
Completion
2029-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06468969 on ClinicalTrials.gov