Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT06038604
Status:
COMPLETED
Last Update Posted:
2024-07-31
First Post:
2023-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glioblastoma Psychosocial Support Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2023-09-08', 'studyFirstSubmitQcDate': '2023-09-08', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who complete study participation', 'timeFrame': 'End of study (4-months)', 'description': 'Completion of sessions by 70% of participants across a four-month period'}, {'measure': 'Number of participants who complete post-intervention assessment', 'timeFrame': 'End of study (4-months)', 'description': 'Completion of assessments by 70% of participants across a four-month period'}, {'measure': "Participants' satisfaction with treatment", 'timeFrame': 'End of study (4-months)', 'description': 'Overall satisfaction rating for the psychosocial intervention with 70% of patients and caregivers reporting satisfaction. The Evaluation of Services measure will take the average of the item scores (0-4), with a mean of 3.0/4.0 as an indication of satisfaction'}], 'secondaryOutcomes': [{'measure': 'Anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Baseline; Post-intervention follow up (up to 4 months)', 'description': 'The HADS will measure symptoms of anxiety and depression. The measure has 14 items (higher scores indicate higher distress).'}, {'measure': 'General distress as measured by the Distress Thermometer', 'timeFrame': 'Baseline; Post-intervention follow up (up to 4 months)', 'description': 'The Distress Thermometer will be used to measure general distress (higher scores indicate higher distress).'}, {'measure': 'Functional well-being as measured by the Functional Assessment of Cancer Therapy - General (FACT-G)', 'timeFrame': 'Baseline; Post-intervention follow up (up to 4 months)', 'description': 'The functional well-being subscale of the FACT-G will be used to measure functional well-being (higher scores indicate higher functional well-being).'}, {'measure': 'Caregiving efficacy as measured by the caregiver inventory', 'timeFrame': 'Baseline; Post-intervention follow up (up to 4 months)', 'description': 'The caregiver inventory will be used to measure caregiving efficacy. The measure has 21 items (higher scores indicate higher levels of efficacy).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioblastoma']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to conduct a pilot test of the psychosocial support intervention with family caregivers and/or patients coping with glioblastoma.', 'detailedDescription': 'The specific aims of this study is to pilot test the psychosocial support program for patients with glioblastoma and/or their family caregivers. The investigators will recruit patient-caregiver dyads for the psychosocial support intervention; participants will have the choice whether to take part in the intervention as a dyad or individually given the variability of symptoms and progression of glioblastoma. The investigators will examine acceptability and feasibility of the intervention and examine whether participation in the program can help reduce distress and improve quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For patients:\n\nInclusion Criteria:\n\n* Patients who self-report a diagnosis of glioblastoma\n* Age \\>18 years\n* English Speaking\n\nExclusion Criteria:\n\n* Lacks capacity for interview or is unable to provide informed consent\n* Visual or hearing impairments or severe behavioral problems that preclude participation\n* Too sick to participate\n\nFor caregivers:\n\nInclusion Criteria:\n\n* Age \\>18 years\n* English Speaking\n\nExclusion Criteria:\n\n* Lacks capacity for interview or is unable to provide informed consent\n* Visual or hearing impairments or severe behavioral problems that preclude participation\n* Too sick to participate'}, 'identificationModule': {'nctId': 'NCT06038604', 'briefTitle': 'Glioblastoma Psychosocial Support Program', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Psychosocial Support Program for Patients With Glioblastoma and Their Family Caregivers', 'orgStudyIdInfo': {'id': 'Pro00110738'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psychosocial Support Intervention', 'description': 'The psychosocial support intervention includes components such as logistical and practical support and self-care, strategies to manage cognitive changes, as well as strategies for effective communication when coping with glioblastoma.', 'interventionNames': ['Behavioral: Psychosocial Support Intervention']}], 'interventions': [{'name': 'Psychosocial Support Intervention', 'type': 'BEHAVIORAL', 'description': 'Participants will receive six weekly 60-minute sessions conducted by videoconference.', 'armGroupLabels': ['Psychosocial Support Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Laura S. Porter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Glioblastoma Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}