Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-26 @ 6:34 PM
Study NCT ID:
NCT05724966
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2023-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-neoplastic Treatment, Based on PRO Data Reported Through a MHealth App Solution in Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2023-01-09', 'studyFirstSubmitQcDate': '2023-02-10', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time registrations of side effects using an app', 'timeFrame': '18 months', 'description': 'PRO data (time registrations of side effects using an app)'}, {'measure': 'patient registration of side effects using an app', 'timeFrame': '18 months', 'description': 'PRO data'}], 'secondaryOutcomes': [{'measure': 'Qualitative perspectives interview', 'timeFrame': '16 months', 'description': 'Through semi-structured interview'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'Pirmary endpoint: to examine the feasibility of using an mHealth app for reporting of side effects instead of a telephone call from the hospital staff together with examining the perspectives of patients with multiple myeloma and healthcare professionals of this new method for reporting side effects, and to assess organizational aspects. Usual procedure to assess side effect prior to cancer treatment with Bortezomib is a telephone call the day before. With this innovative method investigator aimed to give the patient more independence in their daily life and in that way improve their quality of life.', 'detailedDescription': 'It is a prospective, clinical, parallel mixed-method design with a quantitative core and a qulitative supplementary component. There will be used a Mhealth app called "My Hospital".\n\nQuantitative data will be acquired from time registrations performed by patients and nurses and will be descriptively analyzed applying a micro-costing approach, using cost data per individual. Qualitative data will be obtained from individual, semi-structured interviews with patients and one focus group interview with healthcare professionals and will be analyzed applying a hermeneutic approach.\n\nEligible for inclusion were patients with MM scheduled for Bortezomib. Moreover, patients should have access to a smartphone, be able to self-report side effects of Bortezomib using a smartphone app, and be willing to participate in a semi-structured interview.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Multiple Myeloma planned treatment with Bortezomib.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with MM scheduled for Bortezomib\n* patients should have access to a smartphone\n* patients should be able to self-report side effects of Bortezomib using a smartphone app, and be willing to participate in a semi-structured interview.\n\nExclusion Criteria:\n\n* patients had to talk and read danish'}, 'identificationModule': {'nctId': 'NCT05724966', 'briefTitle': 'Anti-neoplastic Treatment, Based on PRO Data Reported Through a MHealth App Solution in Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Anti-neoplastic Treatment, Based on PRO Data Reported Through a MHealth App Solution in Multiple Myeloma - a Mixed Method Study', 'orgStudyIdInfo': {'id': 'Fit for treatment'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Registration of side effects', 'description': 'patients are to registrer side effects prior to treatment with Bortezomib through an app.', 'interventionNames': ['Device: mHealth app']}], 'interventions': [{'name': 'mHealth app', 'type': 'DEVICE', 'description': 'We wish to examine the perspectives of patients with multiple myeloma and healthcare professionals of this new method for reporting side effects, and to assess organizational aspects. Usual procedure to assess side effect prior to cancer treatment with Bortezomib is a telephone call the day before.', 'armGroupLabels': ['Registration of side effects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Jannie Kirkegaard, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense Universitetshospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Lund', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Thomas Lund', 'investigatorAffiliation': 'Odense University Hospital'}}}}