Digital Rehabilitation for Gastric Cancer Surgery After Neoadjuvant Therapy

NCT07441850 | Recruiting

• 1 other identifier: 2026-P2-011-01
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the effects of a perioperative multimodal rehabilitation program on the incidence of postoperative complications and perioperative clinical indexes including functional capacity, nutritional and psychological status in patients with gastric cancer undergoing neoadjuvant therapy. Besides the investigators also develop a smart phone based digital platform aiming to evaluate its effectiveness in improving patient adherence, compared with the conventional telephone supervision approach. The main questions it aims to answer are:

• Can the perioperative multimodal rehabilitation program reduce postoperative complications in patients with gastric cancer undergoing neoadjuvant therapy?
• Can the smart phone based digital platform improve patients' adherence compared to traditional telephone supervision?
• Can the perioperative multimodal rehabilitation program improve the perioperative clinical indicators of patients with gastric cancer undergoing neoadjuvant therapy, including functional capacity, nutritional status and psychological condition? The investigators will compare the perioperative multimodal rehabilitation program with the standard treatment alone to determine whether this program has the effects mentioned above. Participants will follow the perioperative multimodal rehabilitation program from neoadjuvant therapy through to four weeks after discharge.

Conditions

Gastric Cancer

Keywords

Gastric cancer; Neoadjuvant therapy; Digital health; Randomized control trial; Perioperative rehabilitation; Multimodal intervention

Outcome Measures

Primary Outcomes (1)

• Complications at 90 days after surgery

  The primary outcome of the study is the postoperative morbidity rate by the Clavien-Dindo classification at 90 days postoperatively. All postoperative complications will be documented at discharge and the surgeon will record any events after discharge at the outpatient appointment 90 days postoperatively. All complications will be classified by the Clavien-Dindo classification.

  From the time of the surgery to 90 days postoperatively

Secondary Outcomes (41)

• Adherence--(1)Assessment completion rate

  From enrollment to 4 weeks after discharge

• Adherence--(2)The mean number of training sessions attended

  From enrollment to 4 weeks after discharge

• Adherence--(3)The number of patients requiring exercise intensity adjustment

  From enrollment to 4 weeks after discharge

• Adherence--(4)The number of patients requiring early termination of the intervention

  From enrollment to 4 weeks after discharge

• Adherence--(5)The number of patients who permanently discontinued the training

  From enrollment to 4 weeks after discharge

Study Arms (3)

Control group

ACTIVE COMPARATOR

Patients in control group receive usual care throughout their cancer pathway. Besides, we will provide verbal exercise, dietary, and psychological advice to patients but did not provide written advice and supervision

Procedure: Usual Care

Telephone therapeutic group

EXPERIMENTAL

Patients in telephone therapeutic group receive the perioperative multimodal rehabilitation programme, with supervision delivered via conventional telephone calls.

Behavioral: perioperative multimodal rehabilitation program with telephone supervision

Digital therapeutic group

EXPERIMENTAL

Patients in digital therapeutic group receive the same perioperative multimodal rehabilitation programme but with all supervision conducted through a smart phone based digital platform. The mode of supervision is thus the key variable that distinguishes the telephone therapeutic group.

Behavioral: perioperative multimodal rehabilitation program with digital supervision

Interventions

perioperative multimodal rehabilitation program with telephone supervision BEHAVIORAL

The perioperative rehabilitation program in this study constitutes a multimodal intervention that integrates exercise, nutrition, and psychological support. The exercise component consists of aerobic training five times per week, elastic band-based resistance training twice per week, daily respiratory muscle exercises, and post-exercise stretching routines. For nutrition, daily targets are set at 25-30 kcal/kg for energy and 1.5 g/kg for protein intake based on ideal body weight, supported by standardized meal plans and nutritional reference materials. The psychological intervention includes weekly motivational videos and psychoeducational content, supplemented by regular assessment of emotional and cognitive status using validated scales. Patients independently follow the program, and record all activities in a rehabilitation diary, which will be returned post-trial.Additionally, patients will receive a weekly telephone call, to assess adherence to the program.

Telephone therapeutic group

Usual Care PROCEDURE

Patients receive usual care throughout their cancer pathway. Besides, we will provide verbal exercise, dietary, and psychological advice to patients but did not provide written advice and supervision.

Control group

perioperative multimodal rehabilitation program with digital supervision BEHAVIORAL

The perioperative rehabilitation program in this study constitutes a multimodal intervention that integrates exercise, nutrition, and psychological support. The exercise component consists of aerobic training five times per week, elastic band-based resistance training twice per week, daily respiratory muscle exercises, and post-exercise stretching routines. For nutrition, daily targets are set at 25-30 kcal/kg for energy and 1.5 g/kg for protein intake based on ideal body weight, supported by standardized meal plans and nutritional reference materials. The psychological intervention includes weekly motivational videos and psychoeducational content, supplemented by regular assessment of emotional and cognitive status using validated scales. The digital platform provides personalized exercise videos, nutritional logging tools, and psychological modules. Researchers monitor engagement metrics weekly to guide adjustments.

Digital therapeutic group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged between 18 and 70 years;
• patients with histologically confirmed resectable adenocarcinoma of the oesophago gastric junction or stomach;
• patients referred by a multidisciplinary team (MDT) for neoadjuvant therapy;
• patients able to use a smartphone and the digital follow up platform, and willing to comply with regular follow up assessments;
• patients who provide written informed consent.

You may not qualify if:

• presence of distant metastasis;
• severe cardiopulmonary disease or other contraindications precluding completion of the 6MWT or participation in exercise training;
• concurrent other malignant tumours;
• suspected recurrent gastric cancer;
• cognitive impairment, communication barriers, or psychiatric conditions that would prevent compliance with the study procedures;
• women who are pregnant, lactating, or planning a pregnancy.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Zhi Zheng, Attending surgon

CONTACT

+86-13811132175; zhengzhi@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Surgeon

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: March 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)