Digital Rehabilitation for Gastric Cancer Surgery After Neoadjuvant Therapy

The Effect of Perioperative Rehabilitation Programme Delivered Via a Smart Phone Based Digital Platform in Patients Undergoing Neoadjuvant Therapy for Gastric Cancer Surgery: Study Protocol for a Randomised Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: Usual Care; Behavioral: perioperative multimodal rehabilitation program with telephone supervision; Behavioral: perioperative multimodal rehabilitation program with digital supervision

• Study Type: Interventional
• Enrollment (Estimated): 186
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhi Zheng, Attending surgon; Phone Number: +86-13811132175; Email: zhengzhi@ccmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Friendship Hospital, Capital Medical University
    • Contact: Zhi Zheng, Attending surgon; Phone Number: 13811132175; Email: zhengzhi@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 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; 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.
Experimental: Telephone therapeutic group; 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; 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.
Experimental: Digital therapeutic group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence--(1)Assessment completion rate	In the telephone therapeutic group , patients use a rehabilitation diary to report their progress throughout the perioperative multimodal rehabilitation program. Besides, adherence is additionally assessed by researchers through a structured adherence assessment form during the scheduled weekly calls. In the digital therapeutic group, all completion data are recorded directly by the digital platform. It is measured by the completion status of the adherence assessment form or the completion data recorded by the digital platform.	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
Adherence--(6)The number of patients lost to follow-up		From enrollment to 4 weeks after discharge
Short-term safety--(1)Incidence of adverse events during the study		From enrollment to 4 weeks after discharge
Short-term safety--(2) Postoperative in-hospital mortality rate		From date of surgery until date of hospital discharge, assessed up to 2 weeks
Short-term safety--(3) 90-day postoperative mortality rate		From the time of surgery to 90-day postoperative
Short-term safety--(4)Postoperative in-hospital morbidity rate		From date of surgery until date of hospital discharge, assessed up to 2 weeks
Short-term safety--(5) 30-day postoperative morbidity rate		From the time of surgery to 30-day postoperative
Short-term safety--(6) Morbidity rate during neoadjuvant therapy		From start of neoadjuvant treatment to end of neoadjuvant treatment, assessed up to 100 days
The quality of life--(1) EORTC-QLQ-C30	The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC-QLQ-C30) includes 30 items measuring functional, symptomatic, and global quality-of-life domains.Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.	From enrollment to 1 year postoperatively
The quality of life--(2) EORTC-QLQ-STO22	The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Module 22(EORTC-QLQ-STO22) supplement contains 22 items assessing symptoms and concerns specific to gastric cancer. Scores are transformed to a 0-100 scale, with higher scores indicating greater symptom burden.	From enrollment to 1 year postoperatively
The quality of life--(3)PGSAS-45	The Postgastrectomy Syndrome Assessment Scale 45(PGSAS-45), consisting of 45 items, will be used to comprehensively evaluate postgastrectomy symptoms, digestive status, and daily life functions.All subscale scores are linearly transformed to a 0-100 range. For symptom-related subscales, higher scores indicate greater symptom burden; for functional and quality of life subscales, higher scores indicate better functioning or quality of life.	From the time of surgery to 1 year postoperatively
Functional capacity--(1) The sit to stand test	Participants will sit on a standard-height chair (43-45 cm) with arms crossed over the chest, feet flat on the floor placed shoulder-width apart and parallel. They will then complete 10 repetitions of standing up and sitting down as quickly as possible, ensuring full knee extension upon each stand. The time to complete 10 repetitions will be recorded. Each participant will perform two trials, and the best time will be recorded.	From enrollment to 1 year postoperatively
Functional capacity--(2) The handgrip strength	The handgrip strength test will be administered using a digital hand dynamometer. Participants will stand with the dominant upper arm held firmly against the trunk and the forearm positioned at a 90-degree angle. The gripping handle will be adjusted to a comfortable width, allowing the fat pads of the four fingers to rest securely on the handle. Participants will be instructed to squeeze the handle with maximum effort for 3 seconds. Each participant will perform three trials with adequate rest between attempts, and the average value will be recorded.	From enrollment to 1 year postoperatively
Functional capacity--(3) Peak oxygen consumption (VO₂ peak)	The indicator will be assessed by cardiopulmonary exercise test (CPET)	From enrollment to 1 year postoperatively
Functional capacity--(4) anaerobic threshold (AT)	The indicator will be assessed by cardiopulmonary exercise test (CPET)	From enrollment to 1 year postoperatively
Functional capacity--(5) 6-minute walk test(6MWT)	The 6MWT is conducted along a 20 meter course marked by cones. Participants are instructed to walk back and forth as far as possible within 6 minutes, and the total distance walked (calculated from the number of laps) is recorded. The test is administered following the standardized instructions recommended by the European Respiratory Society.	From enrollment to 1 year postoperatively
Functional capacity--(6) Frailty	Frailty will be assessed according to the Fried Frailty Phenotype, which comprises five components: shrinking, exhaustion, weakness, slowness, and low physical activity. Participants meeting three or more criteria will be classified as "frail"; those meeting one or two criteria will be classified as "pre frail"; and those meeting none will be classified as "robust/non frail".	From enrollment to 1 year postoperatively
Nutritional status--(1) BMI	It is calculated in the standard manner as weight in kilograms divided by height in meters squared (kg/m²).	From enrollment to 1 year postoperatively
Nutritional status--(2)skeletal muscle index(SMI)	As part of standard care, patients undergo CT imaging at baseline, following neoadjuvant therapy, and during postoperative follow-up. Sarcopenia is measured at these time points using ImageJ software. At the L3 level, total skeletal muscle, subcutaneous fat and visceral fat will be measured. SMI will be calculated as follows: skeletal muscle /height(m)2. Measurements will be recorded by two individuals, one of whom will be external to the trial group.	From enrollment to 1 year postoperatively
Nutritional status--(3)mid-upper arm circumference(MUAC)	Patients stand upright with shoulders relaxed and the right arm hanging naturally. The assessor, positions to the participant's right, wraps a measuring tape around the midpoint between the acromion and olecranon processes, ensuring it remains perpendicular to the long axis of the arm. The tape is held snug but without compressing the underlying soft tissue. The measurement is taken on the lateral aspect of the arm, with the zero end of the tape aligned under the measurement mark.	From enrollment to 1 year postoperatively
Nutritional status--(4)triceps skinfold thickness(TSF)	TSF is measured at the same marked midpoint on the right upper arm as MUAC. With the patients standing, a vertical skinfold parallel to the arm is gently grasped above the mark. A caliper is applied perpendicular to the fold, and the thickness is recorded to the nearest 0.1 mm before release.	From enrollment to 1 year postoperatively
Nutritional status--(5)insulin resistance(IR)	IR will be measured using the homeostasis model assessment(HOMA) calculation. HOMA-IR = (fasting glucose × fasting insulin) / 22.5.	From enrollment to 1 year postoperatively
Nutritional status--(6)Hemoglobin level		From enrollment to 1 year postoperatively
Nutritional status--(7)Prealbumin level		From enrollment to 1 year postoperatively
Nutritional status--(8)Total cholesterol level		From enrollment to 1 year postoperatively
Nutritional status--(9)Serum albumin level		From enrollment to 1 year postoperatively
Nutritional status--(10)Total lymphocyte count		From enrollment to 1 year postoperatively
Nutritional status--(11)Inflammatory marker	It will be measured by serum C reactive protein (CRP) level.	From enrollment to 1 year postoperatively
Nutritional status--(12)Glasgow Prognostic Score (GPS)	It is a combined score based on CRP and serum albumin level. Scores range from 0 to 2, with higher scores indicating greater systemic inflammation and poorer prognosis.	From enrollment to 1 year postoperatively
Nutritional status--(13)prognostic nutritional index(PNI)	It is a combined score based on serum albumin level and total lymphocyte count. It is calculated as 10 × serum albumin (g/dL) + 0.005 × total lymphocyte count (cells/μL). Higher scores indicate better nutritional and immunological status.	From enrollment to 1 year postoperatively
Psychological scale scores--(1)Hospital Anxiety and Depression Scale (HADS)	It is a 14 item self report instrument comprising two 7 item subscales designed to screen for symptoms of anxiety and depression in non psychiatric medical settings. Each subscale is scored separately, providing independent measures of anxiety and depressive symptomatology while minimizing confounding from physical illness. Each item is scored from 0 to 3, with subscale scores ranging from 0 to 21. Higher scores indicate greater levels of anxiety or depression. The scale has been validated and demonstrates good reliability in clinical populations.	From enrollment to 1 year postoperatively
Psychological scale scores--(2)Life Orientation Test Revised (LOT-R)	It comprises 10 items evaluating an individual's expectancies for positive versus negative future experiences. Each item is scored on a 5-point scale (0-4). After reverse-scoring pessimism items, total scores range from 0 to 24, with higher scores indicating greater optimism.	From enrollment to 1 year postoperatively
Psychological scale scores--(3)General Self Efficacy Scale (GSE)	It is a 10-item psychometric instrument designed to assess optimistic self-beliefs in one's ability to cope with a wide range of difficult life demands. It is a well-validated and highly reliable measure of generalized self-efficacy. Each item is scored on a 4-point scale (1-4). Total scores range from 10 to 40, with higher scores indicating greater self-efficacy.	From enrollment to 1 year postoperatively
Psychological scale scores--(4)EuroQol 5 Dimension 5 Level (EQ-5D-5L)	It is a standardized, generic instrument developed by the EuroQoL Group to measure health status. It provides a concise profile of health outcomes designed for use in both clinical studies and health economic evaluations. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises five levels of perceived problems, ranging from no problems to extreme problems. Responses are summarized as a five-digit health profile, which can be converted into a utility index score, typically ranging from 0 to 1, with higher scores indicating better health status.	From enrollment to 1 year postoperatively
Psychological scale scores--(5)Pearlin Mastery Scale (PMS)	It is a 7-item scale developed to measure psychological coping resources, specifically an individual's sense of mastery or perceived control over life circumstances. It is also a validated and reliable tool. Each item is scored on a 4-point scale (1-4). Total scores range from 7 to 28, with higher scores indicating greater perceived mastery or sense of control.	From enrollment to 1 year postoperatively
Psychological scale scores--(6)Surgical Fear Questionnaire (SFQ)	It is an eight-item instrument designed to assess fear related to surgery. It consists of two subscales measuring fear of short-term and long-term surgical consequences, and has been validated as a reliable index of surgical fear. Each item is scored on an 11-point scale (0-10). Subscale scores range from 0 to 40, and total scores range from 0 to 80. Higher scores indicate greater surgical fear.	From enrollment to the day before surgery, assessed up to 100 days
Gastric emptying function	It is evaluated by gastric emptying half-time (GET₁/₂) measured via radionuclide scintigraphy.	From the time of surgery to 90-day postoperative

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Gastric cancer; Neoadjuvant therapy; Randomized control trial; Digital health; Multimodal intervention; Perioperative rehabilitation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2026-P2-011-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No