Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT01356251
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2011-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychosocial Needs and Exploration of Online Support for Patients With Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008654', 'term': 'Mesothelioma'}], 'ancestors': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2011-05-17', 'studyFirstSubmitQcDate': '2011-05-18', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe the psychological needs of patients with mesothelioma.', 'timeFrame': '1 year', 'description': "Patients'psychological symptom burden will be assessed by the set of questionnaires administered in part 1 of the study. scores of the assessments of coping (28-item Brief Cope), social support (6-item SSQ-SF), depressive symptoms (20-item Zung), and quality of life (36-item FACT-Lung)."}], 'secondaryOutcomes': [{'measure': 'the aim is to explore the acceptability and promise of an Internet-based discussion group for patients with mesothelioma.', 'timeFrame': '1 year', 'description': 'The investigators will summarize acceptability and gather pilot data on the promise of the intervention. Acceptability in this study will be assessed through the enrollment rate (percentage of eligible individuals consented and recruited into the Internet-based discussion group). The adherence rate will be the percentage of enrolled patients who complete all virtual group sessions.'}]}, 'conditionsModule': {'keywords': ['Quality of life', 'support group', 'questionnaires', 'Internet-based support group', '11-066'], 'conditions': ['Mesothelioma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan-Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to learn about how mesothelioma affects patients' emotional and physical well-being. Also, the investigators would like to learn more about what patients need and how they deal with this illness. This information can help us find ways to lessen physical and emotional strains. Part of the study tests an alternate way of giving emotional support through the Internet. By providing support online, patients can participate in the comfort of their home."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of pleural mesothelioma and receiving care at MSKCC\n* At least 18 years of age or older\n* Able to read and speak English\n* Patients who choose to participate in the Internet-based discussion groups, need a telephone, a computer, Internet access, and an e-mail account.\n\nExclusion Criteria:\n\n* Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in a group-format intervention (i.e., acute psychiatric symptoms which require individual treatment)."}, 'identificationModule': {'nctId': 'NCT01356251', 'briefTitle': 'Psychosocial Needs and Exploration of Online Support for Patients With Mesothelioma', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Mesothelioma From a Patient Perspective: A Survey of Psychosocial Needs and Exploration of Online Support for Patients', 'orgStudyIdInfo': {'id': '11-066'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgical group with mesothelioma', 'description': "The study proposed here has two parts: part 1 surveys mesothelioma patients' psychological and physical symptom burden and quality of life through a set of questionnaires that covers topics including coping, interpersonal support, mood, anxiety, and overall quality of life. In part 2, patients are invited to participate in an Internet-based discussion group.", 'interventionNames': ['Behavioral: Questionnaires & online virtual support group']}, {'type': 'EXPERIMENTAL', 'label': 'Non Surgical group with mesothelioma', 'description': "The study proposed here has two parts: part 1 surveys mesothelioma patients' psychological and physical symptom burden and quality of life through a set of questionnaires that covers topics including coping, interpersonal support, mood, anxiety, and overall quality of life. In part 2, patients are invited to participate in an Internet-based discussion group", 'interventionNames': ['Behavioral: Questionnaires & online virtual support group']}], 'interventions': [{'name': 'Questionnaires & online virtual support group', 'type': 'BEHAVIORAL', 'description': "Part 1 surveys mesothelioma patients' psychological and physical symptom burden and quality of life by administering a set of questionnaires that covers topics including coping, interpersonal support, mood, anxiety, and overall quality of life. All mesothelioma patients who complete the questionnaires in part 1 will be offered an opportunity to participate in a trial of a therapeutic Internet-based discussion group. The groups will consist of either approximately 3-5 surgical patients or approximately 3-5 non-surgical patients. The groups will run for approximately 60 minutes once a week for six consecutive weeks.", 'armGroupLabels': ['Surgical group with mesothelioma']}, {'name': 'Questionnaires & online virtual support group', 'type': 'BEHAVIORAL', 'description': "Part 1 surveys mesothelioma patients' psychological and physical symptom burden and quality of life by administering a set of questionnaires that covers topics including coping, interpersonal support, mood, anxiety, and overall quality of life. All mesothelioma patients who complete the questionnaires in part 1 will be offered an opportunity to participate in a trial of a therapeutic Internet-based discussion group. The groups will consist of either 3-5 surgical patients or 3-5 non-surgical patients. The groups will run for approximately 60 minutes once a week for six consecutive weeks.", 'armGroupLabels': ['Non Surgical group with mesothelioma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Christian Nelson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}