Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-30 @ 1:23 AM
Study NCT ID:
NCT04884204
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2021-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-26', 'studyFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Diagnose', 'timeFrame': 'At baseline', 'description': 'Diagnose at baseline'}, {'measure': 'Medication', 'timeFrame': 'At baseline', 'description': 'Medication at baseline'}, {'measure': 'Immunosuppresive drugs', 'timeFrame': '12 months of follow up from date of transplantation', 'description': 'Immunosuppresive drugs the participants receive after transplantation (within the study period)'}, {'measure': 'Hospitalization', 'timeFrame': '12 months of follow up from date of transplantation', 'description': 'Periods with hospitalizations within the study period'}, {'measure': 'Referrals to other hospital departments', 'timeFrame': '12 months of follow up from date of transplantation', 'description': 'Number of referrals to other hospital departments within the study period'}, {'measure': 'Referrals to general practitioner', 'timeFrame': '12 months of follow up from date of transplantation', 'description': 'Number referrals to general practitioner within the study period'}, {'measure': 'Referrals to municipality', 'timeFrame': '12 months of follow up from date of transplantation', 'description': 'Number of referrals to rehabilitation in the municipality within the study period'}, {'measure': 'Infections treated with antibiotics', 'timeFrame': '12 months of follow up from date of transplantation', 'description': 'Number of infections treated with antibiotics within the study period'}, {'measure': 'Number of telephone contacts to Dept. of Hematology', 'timeFrame': '12 months of follow up from date of transplantation', 'description': 'Number of telephone contacts to Dept. of Hematology within the study period'}], 'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': 'Recruiment time frame: 12 months', 'description': 'Number of participants included from eligible participants'}, {'measure': 'Adherence to intervention', 'timeFrame': 'Intervention time frame: 12 months of follow up', 'description': 'Number of visits completed out of planned visits during intervention'}], 'secondaryOutcomes': [{'measure': 'Quality of life measured by the European Organization for Research and Treatment of Cancer - quality of life questionnaire C30 (EORTC-QLQ-C30)', 'timeFrame': '12 months; at baseline (0 months), 6 and 12 months', 'description': 'Change in quality of life measured by the European Organization for Research and Treatment of Cancer - quality of life questionnaire C30'}, {'measure': 'Depression and Anxiety measured with the Hospital Anxiety and Depression Scale', 'timeFrame': '12 months; at baseline (0 months), 6 and 12 months', 'description': 'Change in symptoms of depression and anxiety measured by the Hospital Anxiety Depression Scale'}, {'measure': 'MD Andersons Symptom Inventory (MDASI)', 'timeFrame': '12 months; at baseline (0 months), 6 and 12 months', 'description': 'Change in symptom burden measured by the scale M.D. Andersons Symptom Inventory'}, {'measure': "HM-PRO questionaire developed by the 'Scientific Working Group for QoL and Symptoms,' within the European Hematology Association", 'timeFrame': '12 months; at baseline (0 months), 3, 6, 9 and 12 months', 'description': "Change in HM-PRO developed by The 'Scientific Working Group for QoL and Symptoms,' within the European Hematology Association"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lee Symptom Scale', 'Symptom management', 'Patient reported outcome'], 'conditions': ['GVHD, Chronic', 'Hematological Malignancy']}, 'descriptionModule': {'briefSummary': 'A two sited feasibility study to test the feasibility of systematic symptom identification with disease specific and clinically developed PROM (Lee Symptom Scale) longitudinally with a 12 month follow up in outpatient care in patients post HSCT to assess symptoms of chronic GVHD (n= 30).', 'detailedDescription': 'A prospective, non-randomized, feasibility study examining a systematic approach to symptom management using PROMs with 12 months of follow up in hematological outpatient clinic'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\> 18 years old\n* Approximately 3 months post HSCT (they will be included before HSCT, but the intervention will begin at 3 moths).\n* Patients included needs to be able to manage a computer to receive and respond to collect PRO data.\n\nExclusion Criteria:\n\n* Patients who do not understand, read and speak Danish and/or have cognitive/psychiatric disorders not compatible with inclusion in a clinical study.'}, 'identificationModule': {'nctId': 'NCT04884204', 'acronym': 'SIMPly-CARE', 'briefTitle': 'Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT - a Two Site Feasibility Study', 'orgStudyIdInfo': {'id': 'Copenhagen, Rigshospitalet'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Symptom management with Lee Symptom Scale', 'description': 'Participants will receive disease specific questionnaires electronically, cGVHD-PRO (Lee Symtpom Scale), one week prior to their scheduled visit in the outpatient clinic. The participants will be asked to answer the questionnaire from home without any involvement from clinicians. Afterwards the PRO data will be used during the scheduled clinical consultations as an instrument to discover symptoms on chronic GVHD and systematically to monitoring symptoms developing over time.', 'interventionNames': ['Behavioral: Lee Symptom Scala']}], 'interventions': [{'name': 'Lee Symptom Scala', 'type': 'BEHAVIORAL', 'description': 'Symptom identification and management with Lee Symptom Scale in follow up care', 'armGroupLabels': ['Symptom management with Lee Symptom Scale']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Mary Jarden', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mary Jarden', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}