Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-25 @ 2:59 PM
Study NCT ID:
NCT04493450
Status:
UNKNOWN
Last Update Posted:
2020-08-03
First Post:
2020-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NEMO - an App for Side Effect Management in Oncology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2020-07-23', 'studyFirstSubmitQcDate': '2020-07-28', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase I: Patient acceptance of a new medium of communication', 'timeFrame': '6 months', 'description': 'Acceptance of documentation of occurring side effects of oncological therapies with new communication media'}, {'measure': 'Phase II: Change of occurred adverse events', 'timeFrame': '6 months', 'description': 'Changes of side effects by at least 1 degree according to CTCAE scoring in comparison to the study start'}], 'secondaryOutcomes': [{'measure': 'Phase II: Doses of chemotherapy', 'timeFrame': '6 months', 'description': 'Maintenance of chemotherapy doses through better adverse event management'}, {'measure': 'Phase II: Incidence of adverse events', 'timeFrame': '6 months', 'description': 'Incidence of treatment-emergent adverse events as assessed by the CTCAE scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer Patients']}, 'referencesModule': {'references': [{'pmid': '34086740', 'type': 'DERIVED', 'citation': 'Kestler AMR, Kuhlwein SD, Kraus JM, Schwab JD, Szekely R, Thiam P, Huhne R, Jahn N, Furstberger A, Ikonomi N, Balig J, Schuler R, Kuhn P, Steger F, Seufferlein T, Kestler HA. Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. PLoS One. 2021 Jun 4;16(6):e0252493. doi: 10.1371/journal.pone.0252493. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the use of digital and standardized documentation by patients of frequently occurring adverse events in oncological therapies.', 'detailedDescription': 'This research study is structured as a Phase I and II clinical trial. In phase I, the feasibility of using a smartphone application to document adverse events that have occurred during oncological therapies by the patient will be investigated. In phase II we will investigate whether the use of the smartphone app allows an improvement of patient care by reducing occurred adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Phase I:\n\n\\- 30 participants in total non-randomly divided into three age groups (\\< 55 years, 55-75 years, \\> 75 years) of 10 people each.\n\nPhase II:\n\n\\- 36 participants randomly assigned a group of 18 persons (smartphone users, non-smartphone users)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infusional combination therapy with at least two chemotherapy substances with or without further targeted therapies\n* combination of at least two immune-checkpoint inhibitors\n* able to read and understand German\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded:\n\n* severe neurological disorders\n* severe psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT04493450', 'acronym': 'NEMO', 'briefTitle': 'NEMO - an App for Side Effect Management in Oncology', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'NEMO - an App for Side Effect Management in Oncology', 'orgStudyIdInfo': {'id': 'NEMO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smartphone-users', 'description': 'Cancer patients who use smartphones', 'interventionNames': ['Other: Documentation of cancer treatment side effects']}], 'interventions': [{'name': 'Documentation of cancer treatment side effects', 'type': 'OTHER', 'description': 'Standardized documentation of occurred side effects', 'armGroupLabels': ['Smartphone-users']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'centralContacts': [{'name': 'Thomas Seufferlein, Prof. Dr.', 'role': 'CONTACT', 'email': 'thomas.seufferlein@uniklinik-ulm.de', 'phone': '+4973150044501'}], 'overallOfficials': [{'name': 'Seufferlein', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Ulm'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Seufferlein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Head of Department', 'investigatorFullName': 'Thomas Seufferlein', 'investigatorAffiliation': 'University of Ulm'}}}}