Early Postoperative Intervention in Gastric Cancer Patients

February 25, 2026 updated by: Qu Hui, Qilu Hospital of Shandong University

Early Postoperative Structured Intervention for Quality of Life and Prognosis in Gastric Cancer Patients After Neoadjuvant Therapy：: A Multicenter,Open Label Randomized Controlled Trial

This study was conducted by Qilu Hospital and five other renowned medical centers, aiming to evaluate the impact of early structured postoperative intervention on quality of life and prognosis in patients with gastric cancer after neoadjuvant therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Investigators are conducting a two-arm, multicenter, interventional study at Qilu Hospital of Shandong University and five other renowned hospitals in China. A total of 264 gastric cancer patients who have completed preoperative neoadjuvant therapy will be randomly assigned to either the control group or the experimental group.For control group,patients will receive standard ERAS discharge management, including routine discharge education; outpatient follow-up visits on postoperative day 7 and postoperative day 30; and emergency contact via hospital telephone or emergency department visits for urgent situations.For experimental group,in addition to standard ERAS discharge management, patients will receive multimodal structured interventions during follow-up visits targeting nutritional status, psychological status, and exercise status. Nutritional intervention: Routine postoperative oral nutritional supplements (ONS) will be provided, and patients with metabolic diseases such as diabetes will undergo strict glycemic control. Psychological intervention: Patients with a Hospital Anxiety and Depression Scale (HADS) score ≥ 8 will receive cognitive behavioral therapy (CBT), and those with a HADS score ≥ 11 will be referred for psychological consultation. Exercise intervention: Postoperative rehabilitation training will be guided according to different postoperative periods.During the study period, the incidence of complications within 30 days postoperatively and quality of postoperative recovery were statistically analyzed, among other outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
264

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-80 years;
  • Histologically confirmed adenocarcinoma by preoperative pathology;
  • Completed preoperative neoadjuvant therapy without obvious immune-related adverse events (irAEs);
  • Patients with ycT3-4N+Mx disease deemed surgically resectable based on evaluation by gastroscopy, CT, PET-CT, and other imaging modalities;
  • Signed informed consent and voluntary participation in this study;
  • Standard ERAS (Enhanced Recovery After Surgery) management during the - perioperative period, with postoperative hospital stay ≤7 days.

Exclusion Criteria:

  • Patients with central nervous system diseases or psychiatric disorders;
  • Patients with severe diseases of other organ systems;
  • Patients with recurrent infectious diseases or severe comorbidities;
  • Patients requiring synchronous surgery for other diseases;
  • Patients undergoing emergency surgery;
  • Patients who developed any complication during hospitalization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with early structured postoperative intervention
Combination product: Early structured postoperative intervention encompassing nutrition, psychology, and exercise
Nutritional intervention: Routine postoperative oral nutritional supplements (ONS) will be provided, and patients with metabolic diseases such as diabetes will undergo strict glycemic control. Psychological intervention: Patients with a Hospital Anxiety and Depression Scale (HADS) score ≥ 8 will receive cognitive behavioral therapy (CBT), and those with a HADS score ≥ 11 will be referred for psychological consultation. Exercise intervention: Postoperative rehabilitation training will be guided according to different postoperative periods.
No Intervention: Patients without early structured postoperative intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
incidence of complications within 30 days postoperatively
Time Frame: 30 days after operation
The incidence of complications within 30 days postoperatively was calculated as the number of patients who developed complications within 30 days after surgery divided by the total number of patients in that group.
30 days after operation
Postoperative recovery quality
Time Frame: Baseline (Day of Discharge) and POD 30（30 days after surgery）
Postoperative recovery quality was assessed using The 15-item Quality of Recovery Score scale, with a maximum score of 150 points and a minimum score of 0 points, where higher scores indicate better postoperative recovery quality
Baseline (Day of Discharge) and POD 30（30 days after surgery）

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Readmission or emergency department visit rate within 30 days postoperatively
Time Frame: 30 days after surgery
The rate of Readmission or emergency department visit within 30 days postoperatively was calculated as the number of patients who was readmitted or visited emergency department within 30 days after surgery divided by the total number of patients in that group.
30 days after surgery
Time interval between surgery and initiation of adjuvant chemotherapy
Time Frame: 6 month after surgery
The time interval was calculated as the number of days from postoperative day 1 to the start of adjuvant chemotherapy.
6 month after surgery
Completion rate of postoperative chemotherapy / Adherence to adjuvant chemotherapy
Time Frame: 6 month after surgery
The completion rate of postoperative chemotherapy was calculated as the number of chemotherapy cycles actually completed divided by the number of chemotherapy cycles planned.
6 month after surgery
Grading of chemotherapy-related adverse events
Time Frame: 6 month after surgery
It was evaluated by CTCAE version 5.0，with severity classified from Grade 1 (mild) to Grade 5 (death).
6 month after surgery
Postoperative quality of life score
Time Frame: Baseline (Day of Discharge) and POD 30（30 days after surgery）
The EORTC Quality of Life Questionnaire for Gastric Cancer (C30 + STO22) questionaire was used to evaluate quality of postoperative recovery, all scales range from 0 to 100. For global health status, higher scores indicate better outcomes; for all functioning and symptom scales in both questionnaires, higher scores indicate worse outcomes.
Baseline (Day of Discharge) and POD 30（30 days after surgery）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Hospital of Shandong University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Yantai Yuhuangding Hospital
Liaocheng People's Hospital
Linyi People's Hospital
Weifang People's Hospital
Central Hospital of Zibo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KYLL-202501-049-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data (IPD) underlying the published results

IPD Sharing Time Frame

Beginning 6 months and ending 36 months following publication

IPD Sharing Access Criteria

Data will be made available to researchers who provide a methodologically sound proposal, subject to approval by an independent review committee and execution of a data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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