Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:14 AM
Study NCT ID:
NCT07307404
Status:
RECRUITING
Last Update Posted:
2025-12-29
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Web-based Platform for Nutrition Management in Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-14', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-12-14', 'lastUpdatePostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'EORTC QLQ C30', 'timeFrame': 'baseline, pre-intervention；every 4 weeks after randomization until 6 moths.', 'description': 'using Quality-of-Life Questionnaire Core 30'}, {'measure': 'caregiver burden', 'timeFrame': 'baseline, pre-intervention；every 4 weeks after randomization until 6 moths.', 'description': 'using the 12-Item Zarit Burden Interview \\[ZBI\\]'}, {'measure': 'psychology characteristics', 'timeFrame': 'baseline, pre-intervention；every 4 weeks after randomization until 6 moths.', 'description': 'Hospital Anxiety and Depression Scale \\[HADS\\]'}], 'primaryOutcomes': [{'measure': 'body weight change', 'timeFrame': 'baseline, pre-intervention；every 2 weeks after randomization until 6 moths.', 'description': 'change of body weight during the trail'}], 'secondaryOutcomes': [{'measure': 'PG-SGA', 'timeFrame': 'baseline, pre-intervention；every 2 weeks after randomization until 6 moths.', 'description': 'assessed using the PG-SGA score'}, {'measure': 'NRS2002', 'timeFrame': 'baseline, pre-intervention；every 2 weeks after randomization until 6 moths.', 'description': 'using nutrition risk screening \\[NRS 2002\\]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer'], 'conditions': ['Nutrition']}, 'descriptionModule': {'briefSummary': "It is crucial to promptly identify nutritional issues in these patients within the community and provide them with dietary guidance, nutritional counseling, and support. This study will be conducted in communities in Chengdu, Sichuan. Community management teams will register oncology patients, collecting information such as demographic data, tumor type, stage, specific treatment plan, treatment hospital, regularity of hospital admissions, and frequency of independent smartphone use. Registered patients will be screened based on inclusion and exclusion criteria. For those who meet the criteria, the community management team will contact them and recommend the use of a dedicated app developed by the research team. An initial nutritional assessment will also be conducted. Patients identified with nutritional risks will be directly referred to the research team's clinical nutritionists for face-to-face consultations. After additional tests, such as body composition analysis, necessary nutritional education and stepwise nutritional interventions will be provided. These patients will also use the app for dietary monitoring and nutritional guidance. For patients without nutritional risks, the app will be recommended for daily questionnaire completion and activity tracking."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed malignant tumor;\n* PG-SGA score of 4-9 points;\n* Age: ≥18 years, with an expected survival time of more than 1 year;\n* Possesses adequate cognitive and reading abilities to complete questionnaires and use the APP.\n\nExclusion Criteria:\n\n* Presence of neurological or psychiatric disorders affecting cognitive function, including central nervous system metastasis of tumors;\n* Suffering from conditions severely impacting digestion, metabolism, or food intake;\n* Patients in the cachexia stage or refractory cachexia phase.'}, 'identificationModule': {'nctId': 'NCT07307404', 'briefTitle': 'Web-based Platform for Nutrition Management in Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Web-based Platform for Nutrition Management in Patients With Cancer: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2024-2316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'Self-Intervention: During the period of staying at home, patients use the app developed by the team for self-intervention, including dietary monitoring and check-ins, nutritional risk assessment, learning of educational knowledge, and online expert consultations.\n\nCommunity Intervention: When nutritional risks are detected, pop-up alerts will notify patients to communicate with the community management team. Patients can seek basic nutritional consultations and receive advice from the community management team. If necessary, the management team will refer patients to relevant higher-level hospital outpatient clinics for further care. If patients experience other issues related to their primary condition, the community management team will refer them to community healthcare providers for consultation and treatment.\n\nThe community will also organize thematic lectures on nutritional management for cancer patients, with oncologists and nutritionists providing regular voluntary consultatio', 'interventionNames': ['Other: nutrtion care based on app']}, {'type': 'NO_INTERVENTION', 'label': 'standard care', 'description': 'standard nutrtion care'}], 'interventions': [{'name': 'nutrtion care based on app', 'type': 'OTHER', 'description': 'Self-Intervention: During the period of staying at home, patients use the app developed by the team for self-intervention, including dietary monitoring and check-ins, nutritional risk assessment, learning of educational knowledge, and online expert consultations.\n\nCommunity Intervention: When nutritional risks are detected, pop-up alerts will notify patients to communicate with the community management team. Patients can seek basic nutritional consultations and receive advice from the community management team. If necessary, the management team will refer patients to relevant higher-level hospital outpatient clinics for further care. If patients experience other issues related to their primary condition, the community management team will refer them to community healthcare providers for consultation and treatment.\n\nThe community will also organize thematic lectures on nutritional management for cancer patients, with oncologists and nutritionists providing regular voluntary consultation', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingchen Peng', 'role': 'CONTACT', 'email': 'pxx2014@163.com', 'phone': '18980606753'}], 'facility': 'West China hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Xingchen Peng', 'role': 'CONTACT', 'email': 'pxx2014@163.com', 'phone': '18980606753'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xingchen Peng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD, Professor', 'investigatorFullName': 'Xingchen Peng', 'investigatorAffiliation': 'West China Hospital'}}}}