Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-30 @ 3:02 AM
Study NCT ID:
NCT04066868
Status:
COMPLETED
Last Update Posted:
2025-04-20
First Post:
2019-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1013}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2019-08-19', 'studyFirstSubmitQcDate': '2019-08-21', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EORTC Quality of Life Questionnaire C30 and additional questions from the EORTC Item Library', 'timeFrame': 'single assessment of quality of life before the medical consultation', 'description': 'patient-reported quality of life'}, {'measure': 'CTCAE V5.0', 'timeFrame': 'single assessment during the medical consultation with physician 1 on the same day of PRO assessment', 'description': 'physician 1 rates patient symptoms (17 CTCAE domains matching the EORTC C30 and additional questions)'}, {'measure': 'CTCAE V5.0', 'timeFrame': 'single assessment during the medical consultation with physician 2 on the same day of PRO assessment', 'description': 'physician 2 rates patient symptoms (17 CTCAE domains matching the EORTC C30 and additional questions)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['patient-reported outcomes (PRO)', 'common terminology criteria for adverse events (CTCAE)', 'quality of life', 'electronic data assessment'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '33050917', 'type': 'DERIVED', 'citation': 'Wintner LM, Giesinger JM, Sztankay M, Bottomley A, Holzner B; EORTC Quality of Life Group. Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial. Trials. 2020 Oct 13;21(1):849. doi: 10.1186/s13063-020-04745-w.'}], 'seeAlsoLinks': [{'url': 'https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04745-w', 'label': 'Study protocol publication'}]}, 'descriptionModule': {'briefSummary': "This open randomized trial investigates, if clinicians complete CTCAE ratings differently when receiving patients' patient-reported outcome (PRO) data prior to their CTCAE completion. The primary objective is to demonstrate superior inter-rater reliability of CTCAE ratings from physicians relying on EORTC PRO data as additional data source over traditional CTCAE ratings not including PRO information.", 'detailedDescription': 'In oncology, detection and tracking of adverse events (AEs) are a top priority in both clinical trials and routine care. The classification of AEs mostly relies on the Common Toxicity Terminology for Adverse Events (CTCAE) developed by the US-American National Institutes of Health and the National Cancer Institute.\n\nIt is known, however, that the assessment of AEs can greatly vary depending on whether they are assessed by patients or by clinicians.\n\nProcedure: The patients (any oncological diagnosis, day clinic or inpatient for treatment with chemotherapy or immunotherapy; open 1:1 randomized) fill out an EORTC quality of life questionnaire electronically (C30 + further questions). These PRO data are immediately available for the clinicians. Independently of each other, two different clinicians conduct a medical consultation with the patient and electronically a CTCAE rating. For the intervention Group, clinicians see the PRO values directly next to the input options for the CTCAE rating. For the control Group, clinicians see the input options for the CTCAE rating. The similarity of the assessments is checked using intra-class correlation.\n\nThe combined use of PROs and CTCAE data makes particular sense for AEs/aspects that are directly experienced by the patient (fatigue, pain, cognitive problems, emotional functioning, ...) and can only be adequately recorded by the clinician through communication with the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any Cancer diagnosis\n* current treatment with chemotherapy or immunotherapy\n* symptom burden equal or greater score 3 of the screening question "On a scale of 0 to 10, to what degree did you experience physical or emotional symptoms/problems during the last week?"\n* ability to understand the questions linguistically and cognitively\n* written informed consent\n\nExclusion Criterion:\n\n* psychiatric diagnosis or mental health problems'}, 'identificationModule': {'nctId': 'NCT04066868', 'briefTitle': 'Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Evaluating the Use of Patient-Reported Outcome Measures for Improving the Inter-Rater Reliability of Common Terminology Criteria for Adverse Event Ratings', 'orgStudyIdInfo': {'id': '1020/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRO active', 'interventionNames': ['Other: Patient-reported outcomes assessment', 'Other: CTCAE rating', 'Other: PRO data is displayed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PRO not active', 'interventionNames': ['Other: Patient-reported outcomes assessment', 'Other: CTCAE rating']}], 'interventions': [{'name': 'Patient-reported outcomes assessment', 'type': 'OTHER', 'description': 'Patient-reported outcomes are electronically assessed using EORTC QOL measures', 'armGroupLabels': ['PRO active', 'PRO not active']}, {'name': 'CTCAE rating', 'type': 'OTHER', 'description': 'CTCAE Ratings are conducted by clinicians', 'armGroupLabels': ['PRO active', 'PRO not active']}, {'name': 'PRO data is displayed', 'type': 'OTHER', 'description': 'PRO data is displayed right next to the CTCAE rating', 'armGroupLabels': ['PRO active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6330', 'city': 'Kufstein', 'country': 'Austria', 'facility': 'Bezirkskrankenhaus Kufstein', 'geoPoint': {'lat': 47.58333, 'lon': 12.16667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bezirkskrankenhaus Kufstein', 'class': 'UNKNOWN'}, {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, {'name': 'Martin-Luther-Universität Halle-Wittenberg', 'class': 'OTHER'}, {'name': 'Università di Cagliari', 'class': 'UNKNOWN'}, {'name': 'Kansai Medical University', 'class': 'OTHER'}, {'name': 'King Hussein Cancer Center', 'class': 'OTHER'}, {'name': 'Tata Memorial Hospital', 'class': 'OTHER_GOV'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Clinical Hospital Center Rijeka', 'class': 'OTHER'}, {'name': 'N.N. Blokhin National Medical Research Center of Oncology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}