Enhanced vs. Routine Follow-Up After Total Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-72
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced Follow-up
Other interventionParticipants 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)
Treatment groups
158 Participants
are divided into 2 treatment groupsGroup A: Enhanced Follow-up GroupExperimental treatment 1 intervention
Group B: Standard Follow-up GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quality of Life Improvement
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.
Time frame
Assessed every 6 weeks from the 4th week post-surgery until 6 months post-chemotherapy completion.Secondary outcomes
1
3-Year Overall Survival Rate
The proportion of patients who are still alive 3 years after surgery.
Time frame
3 years post-surgery.2
5-Year Overall Survival Rate
The proportion of patients who are still alive 5 years after surgery.
Time frame
5 years post-surgery.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: