Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-31 @ 6:02 PM
Study NCT ID:
NCT04013828
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2019-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Decision-making in Patients With Recurrent High-grade Glioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2019-07-08', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Experiences of patients and relatives', 'timeFrame': 'Interviews are performed 2-6 weeks after the decision-making', 'description': 'How patients and their close relatives experience the decision-making process'}, {'measure': 'Involvement preferences', 'timeFrame': 'Interviews are performed 2-6 weeks after the decision-making', 'description': 'The preferences of patients and relatives for being involved in the decision-making.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High-grade glioma', 'Patient experiences', 'Decision-making', 'Patient involvement'], 'conditions': ['Malignant Glioma', 'Life Experiences']}, 'descriptionModule': {'briefSummary': 'This qualitative study explores the lived experience of high-grade glioma patients and their close relatives at time of recurrence. With focus on the decision-making about treatment and care..', 'detailedDescription': 'High-Grade Glioma is a life-threatening disease that can cause the patient substantial physical, mentally and psychosocially impairment. The life expectancy is short, and a majority of patients experience recurrence of tumour growth. At time of recurrence, the treatment possibilities can include surgery, oncological treatment and/or palliative care.\n\nIn this situation the patients and their close relatives need to make a difficult balancing between benefits and trade offs.\n\nLittle is known about how the patients and their close relatives experience the recurrence and the decision-making process.\n\nThe objective of this study is therefore to explore the perspectives, experiences and needs in patients and their close relatives in relation to the decision-making process at time of recurrence.\n\nData will be generated through semi-structured interviews. Interviews will be analysed and interpreted using a Ricoeur inspired method of qualitative analysis.\n\nThe study is part of a larger PhD-study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Two study populations:\n\n1. \\- Adult patients with recurrence of high-grade glioma who are offered surgical treatment as one of the treatment possibilities.\n2. \\- The adult relative most involved in the decision-making. The relative is apointed by the patient and the patient gives written concent to the relative' participation.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient is offered surgical treatment (after an assesment done by the multidisciplinary team)\n* Able to speak and understand danish\n* Able to participate in an interview\n* Able to give informed concent for participation\n\nExclusion Criteria:\n\n* Patients with severe cognitive impairment which prohibits them from either giving informed concent or participating in interview.\n* Relatives are excluded if the patient do not give concent for the participation of relatives'}, 'identificationModule': {'nctId': 'NCT04013828', 'briefTitle': 'Treatment Decision-making in Patients With Recurrent High-grade Glioma', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Recurrent High-grade Glioma: Experiences of Patients and Their Close Relatives During the Treatment Decision-making Process.', 'orgStudyIdInfo': {'id': 'OP870'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with recurrent high-grade glioma'}, {'label': 'Relatives', 'description': 'Close relatives of patients with recurrent high-grade glioma'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital; Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Frantz Rom Poulsen, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Neurosurgery Odense University Hospital DK-5000 Odense C DENMARK'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Region of Southern Denmark', 'class': 'OTHER'}, {'name': 'Danish Cancer Society', 'class': 'OTHER'}, {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Helle Sørensen von Essen', 'investigatorAffiliation': 'Odense University Hospital'}}}}