Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 11:36 PM
Study NCT ID:
NCT07441850
Status:
RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Rehabilitation for Gastric Cancer Surgery After Neoadjuvant Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 186}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications at 90 days after surgery', 'timeFrame': 'From the time of the surgery to 90 days postoperatively', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Adherence--(1)Assessment completion rate', 'timeFrame': 'From enrollment to 4 weeks after discharge', 'description': '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.'}, {'measure': 'Adherence--(2)The mean number of training sessions attended', 'timeFrame': 'From enrollment to 4 weeks after discharge'}, {'measure': 'Adherence--(3)The number of patients requiring exercise intensity adjustment', 'timeFrame': 'From enrollment to 4 weeks after discharge'}, {'measure': 'Adherence--(4)The number of patients requiring early termination of the intervention', 'timeFrame': 'From enrollment to 4 weeks after discharge'}, {'measure': 'Adherence--(5)The number of patients who permanently discontinued the training', 'timeFrame': 'From enrollment to 4 weeks after discharge'}, {'measure': 'Adherence--(6)The number of patients lost to follow-up', 'timeFrame': 'From enrollment to 4 weeks after discharge'}, {'measure': 'Short-term safety--(1)Incidence of adverse events during the study', 'timeFrame': 'From enrollment to 4 weeks after discharge'}, {'measure': 'Short-term safety--(2) Postoperative in-hospital mortality rate', 'timeFrame': 'From date of surgery until date of hospital discharge, assessed up to 2 weeks'}, {'measure': 'Short-term safety--(3) 90-day postoperative mortality rate', 'timeFrame': 'From the time of surgery to 90-day postoperative'}, {'measure': 'Short-term safety--(4)Postoperative in-hospital morbidity rate', 'timeFrame': 'From date of surgery until date of hospital discharge, assessed up to 2 weeks'}, {'measure': 'Short-term safety--(5) 30-day postoperative morbidity rate', 'timeFrame': 'From the time of surgery to 30-day postoperative'}, {'measure': 'Short-term safety--(6) Morbidity rate during neoadjuvant therapy', 'timeFrame': 'From start of neoadjuvant treatment to end of neoadjuvant treatment, assessed up to 100 days'}, {'measure': 'The quality of life--(1) EORTC-QLQ-C30', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': '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.'}, {'measure': 'The quality of life--(2) EORTC-QLQ-STO22', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': '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.'}, {'measure': 'The quality of life--(3)PGSAS-45', 'timeFrame': 'From the time of surgery to 1 year postoperatively', 'description': '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.'}, {'measure': 'Functional capacity--(1) The sit to stand test', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': '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.'}, {'measure': 'Functional capacity--(2) The handgrip strength', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': '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.'}, {'measure': 'Functional capacity--(3) Peak oxygen consumption (VO₂ peak)', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': 'The indicator will be assessed by cardiopulmonary exercise test (CPET)'}, {'measure': 'Functional capacity--(4) anaerobic threshold (AT)', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': 'The indicator will be assessed by cardiopulmonary exercise test (CPET)'}, {'measure': 'Functional capacity--(5) 6-minute walk test(6MWT)', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': '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.'}, {'measure': 'Functional capacity--(6) Frailty', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': '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".'}, {'measure': 'Nutritional status--(1) BMI', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': 'It is calculated in the standard manner as weight in kilograms divided by height in meters squared (kg/m²).'}, {'measure': 'Nutritional status--(2)skeletal muscle index(SMI)', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': '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.'}, {'measure': 'Nutritional status--(3)mid-upper arm circumference(MUAC)', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': "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."}, {'measure': 'Nutritional status--(4)triceps skinfold thickness(TSF)', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': '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.'}, {'measure': 'Nutritional status--(5)insulin resistance(IR)', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': 'IR will be measured using the homeostasis model assessment(HOMA) calculation. HOMA-IR = (fasting glucose × fasting insulin) / 22.5.'}, {'measure': 'Nutritional status--(6)Hemoglobin level', 'timeFrame': 'From enrollment to 1 year postoperatively'}, {'measure': 'Nutritional status--(7)Prealbumin level', 'timeFrame': 'From enrollment to 1 year postoperatively'}, {'measure': 'Nutritional status--(8)Total cholesterol level', 'timeFrame': 'From enrollment to 1 year postoperatively'}, {'measure': 'Nutritional status--(9)Serum albumin level', 'timeFrame': 'From enrollment to 1 year postoperatively'}, {'measure': 'Nutritional status--(10)Total lymphocyte count', 'timeFrame': 'From enrollment to 1 year postoperatively'}, {'measure': 'Nutritional status--(11)Inflammatory marker', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': 'It will be measured by serum C reactive protein (CRP) level.'}, {'measure': 'Nutritional status--(12)Glasgow Prognostic Score (GPS)', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': '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.'}, {'measure': 'Nutritional status--(13)prognostic nutritional index(PNI)', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': '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.'}, {'measure': 'Psychological scale scores--(1)Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': '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.'}, {'measure': 'Psychological scale scores--(2)Life Orientation Test Revised (LOT-R)', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': "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."}, {'measure': 'Psychological scale scores--(3)General Self Efficacy Scale (GSE)', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': "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."}, {'measure': 'Psychological scale scores--(4)EuroQol 5 Dimension 5 Level (EQ-5D-5L)', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': '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.'}, {'measure': 'Psychological scale scores--(5)Pearlin Mastery Scale (PMS)', 'timeFrame': 'From enrollment to 1 year postoperatively', 'description': "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."}, {'measure': 'Psychological scale scores--(6)Surgical Fear Questionnaire (SFQ)', 'timeFrame': 'From enrollment to the day before surgery, assessed up to 100 days', 'description': '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.'}, {'measure': 'Gastric emptying function', 'timeFrame': 'From the time of surgery to 90-day postoperative', 'description': 'It is evaluated by gastric emptying half-time (GET₁/₂) measured via radionuclide scintigraphy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric cancer', 'Neoadjuvant therapy', 'Digital health', 'Randomized control trial', 'Perioperative rehabilitation', 'Multimodal intervention'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': "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:\n\n* Can the perioperative multimodal rehabilitation program reduce postoperative complications in patients with gastric cancer undergoing neoadjuvant therapy?\n* Can the smart phone based digital platform improve patients' adherence compared to traditional telephone supervision?\n* 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.\n\nParticipants will follow the perioperative multimodal rehabilitation program from neoadjuvant therapy through to four weeks after discharge."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged between 18 and 70 years;\n* patients with histologically confirmed resectable adenocarcinoma of the oesophago gastric junction or stomach;\n* patients referred by a multidisciplinary team (MDT) for neoadjuvant therapy;\n* patients able to use a smartphone and the digital follow up platform, and willing to comply with regular follow up assessments;\n* patients who provide written informed consent.\n\nExclusion Criteria:\n\n* presence of distant metastasis;\n* severe cardiopulmonary disease or other contraindications precluding completion of the 6MWT or participation in exercise training;\n* concurrent other malignant tumours;\n* suspected recurrent gastric cancer;\n* cognitive impairment, communication barriers, or psychiatric conditions that would prevent compliance with the study procedures;\n* women who are pregnant, lactating, or planning a pregnancy.'}, 'identificationModule': {'nctId': 'NCT07441850', 'briefTitle': 'Digital Rehabilitation for Gastric Cancer Surgery After Neoadjuvant Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2026-P2-011-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': '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', 'interventionNames': ['Procedure: Usual Care']}, {'type': 'EXPERIMENTAL', 'label': 'Telephone therapeutic group', 'description': 'Patients in telephone therapeutic group receive the perioperative multimodal rehabilitation programme, with supervision delivered via conventional telephone calls.', 'interventionNames': ['Behavioral: perioperative multimodal rehabilitation program with telephone supervision']}, {'type': 'EXPERIMENTAL', 'label': 'Digital therapeutic group', 'description': '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.', 'interventionNames': ['Behavioral: perioperative multimodal rehabilitation program with digital supervision']}], 'interventions': [{'name': 'perioperative multimodal rehabilitation program with telephone supervision', 'type': 'BEHAVIORAL', 'description': '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.\n\nPatients 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.', 'armGroupLabels': ['Telephone therapeutic group']}, {'name': 'Usual Care', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Control group']}, {'name': 'perioperative multimodal rehabilitation program with digital supervision', 'type': 'BEHAVIORAL', 'description': '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.\n\nThe digital platform provides personalized exercise videos, nutritional logging tools, and psychological modules. Researchers monitor engagement metrics weekly to guide adjustments.', 'armGroupLabels': ['Digital therapeutic group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhi Zheng, Attending surgon', 'role': 'CONTACT', 'email': 'zhengzhi@ccmu.edu.cn', 'phone': '13811132175'}], 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhi Zheng, Attending surgon', 'role': 'CONTACT', 'email': 'zhengzhi@ccmu.edu.cn', 'phone': '+86-13811132175'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Surgeon', 'investigatorFullName': 'JunZhang', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}