Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT04649320
Status:
UNKNOWN
Last Update Posted:
2020-12-02
First Post:
2020-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perception of the COVID-19 Pandemic in Patients With Haematological or Solid Neoplasias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-30', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Influence of the COVID-19 pandemic on cancer patient's daily life", 'timeFrame': 'single time', 'description': 'evaluation via questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'COVID19 pandemic', 'cancer patients', 'distress', 'HRQOL'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Cancer patients are among the most vulnerable individuals, whose health-related quality of life (HRQOL) may be substantially impacted by the COVID19 pandemic. We want to study how the COVID-19 pandemic influences the life of cancer patients and how these patients cope with the additional distress with the aim to facilitate the development of improved future interventional strategies to maintain resilience and HRQOL', 'detailedDescription': 'In December 2019, the novel human pathogenic virus "SARS-CoV2" from the coronavirus family was identified, causing a respiratory disease known as "COVID19" (coronavirus disease 2019). COVID19 manifests itself primarily with influenza-like symptoms, but in special cases it can lead to severe conditions such as ARDS (acute respiratory distress syndrome). Compared to other pulmotropic viruses such as the influenza virus, SARS-CoV-2 is associated with a higher contagiousness and mortality.\n\nHaematological and oncological patients are particularly vulnerable due to their advanced age, immunological restrictions in the context of the underlying disease and the treatment modalities (chemotherapy, radiation therapy, ...).\n\nTo evaluate the effects of the COVID19 pandemic on the perception of patients with malignant diseases, we aim to record so-called "patient-reported outcomes" (PROs) from patients at the University Hospital of Innsbruck at the Department of Internal Medicine V (Hematology and Oncology) and at the Department for Radiotherapy and Radiation Oncology. We use the validated EORT QLQ-C30 and a specially developed questionnaire for COVID19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult cancer patients, with solid or hematologic malignancies, neither tested positive nor having COVID19 symptoms, with an age over 18 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* validated hematological or oncological disease\n* informed consent\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Insufficient discernment'}, 'identificationModule': {'nctId': 'NCT04649320', 'briefTitle': 'Perception of the COVID-19 Pandemic in Patients With Haematological or Solid Neoplasias', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Investigation of the Perception of the COVID-19 Pandemic in Patients With Haematological or Solid Neoplasias Using Patient-reported Outcome Measures (PROMs)', 'orgStudyIdInfo': {'id': '1264/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cancer patients', 'description': 'adult cancer patients, with solid or hematologic malignancies, neither tested positive nor having COVID19 symptoms', 'interventionNames': ['Other: questionnaire']}], 'interventions': [{'name': 'questionnaire', 'type': 'OTHER', 'description': "1. 13-item questionnaire about cancer patient's distress and everyday life,\n2. EORTC-QLQ-C30", 'armGroupLabels': ['cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Reinhard Stauder, M.D.', 'role': 'CONTACT', 'email': 'reinhard.stauder@i-med.ac.at', 'phone': '+43 512 504 81387'}], 'facility': 'Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'centralContacts': [{'name': 'Reinhard Stauder, M.D.', 'role': 'CONTACT', 'email': 'reinhard.stauder@i-med.ac.at', 'phone': '+43 512 504 81387'}], 'overallOfficials': [{'name': 'Reinhard Stauder, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Innsbruck, Anichstraße 35, A-6020 Innsbruck, Austria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}