Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 2:35 AM
Study NCT ID:
NCT04280133
Status:
UNKNOWN
Last Update Posted:
2023-01-26
First Post:
2020-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAR T-CELL Therapy Educational Video Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-08-09', 'releaseDate': '2024-03-12'}], 'estimatedResultsFirstSubmitDate': '2024-03-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-02-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2020-02-19', 'studyFirstSubmitQcDate': '2020-02-19', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility (enrollment and retention rates)', 'timeFrame': 'Up to 1 year', 'description': 'The primary endpoint is feasibility. The proposed video intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study.'}], 'secondaryOutcomes': [{'measure': 'Knowledge about CAR-T cell therapy (CAR-T cell Knowledge Questionnaire)', 'timeFrame': 'up to 1 month', 'description': "To compare patient's knowledge about CAR-T cell therapy between groups as measured by the CAR-T cell therapy Knowledge Questionnaire (Score range 0-10). Higher scores indicating higher knowledge."}, {'measure': 'Psychological distress (Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'up to 1 month', 'description': "To compare patient's psychological distress between groups as measured by the HADS. HADS Anxiety and Depression subscales range from 0-21, with higher scores indicating worse psychological distress."}, {'measure': "Patient's self-efficacy (modified version of CASE-cancer)", 'timeFrame': 'up to 1 month', 'description': "To compare patient's self-efficacy between the groups as measured by a modified version of the Communication and Attitudinal Self-Efficacy Scale-Cancer (CASE-cancer) for patients receiving CAR-T cell therapy. The modified CASE ranges from 0-170 with higher scores indicating higher self-efficacy"}, {'measure': 'Preferences for CAR T-cell therapy (single-item preference for CAR-T cell therapy)', 'timeFrame': 'up to 1 week', 'description': 'To compare patient\'s preferences for CAR-T cell therapy between groups as measured by a single-item "Do you prefer to receive CAR-T cell therapy". We will compare proportion of patients stating "yes" to receiving CAR-T cell therapy between groups.'}, {'measure': 'Decision Satisfaction around receipt of CAR-T cell therapy', 'timeFrame': 'up to 1 month', 'description': 'To compare patient\'s satisfaction around the decision to receive CAR-T cell therapy between groups as measured by a five-item Likert scale ranging from "Strongly Disagree" to "Strongly Agree" with statements about satisfaction regarding the decision to receive CAR-T cell therapy, with "Strongly Agree" indicating the highest decision satisfaction. We will compare the proportion of patients stating "Agree" or "Strongly Agree" to the six items between groups.'}, {'measure': 'Acceptability of the video (intervention arm only)', 'timeFrame': 'up to 1 month', 'description': 'To assess, in the intervention group only, patients\' comfort with watching the video, whether they find the video helpful in their understanding of CAR T-cell therapy, and whether they would recommend it to others as measured by a 3-item survey. Each of the three items is a four-point Likert scale. Acceptability is defined as at least 80% of patients intervention reporting they felt "very comfortable" or "somewhat comfortable" on a four-point Likert scale when asked about their comfort watching the video.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hematologic Malignancy', 'CAR-T cell therapy'], 'conditions': ['Hematologic Malignancy', 'CAR-T Cell Therapy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test a new educational video to help patients and doctors talk about CAR-T cell therapy, a treatment being used in cancer.\n\n\\- Educational video tool for patients receiving CAR-T cell therapy.', 'detailedDescription': 'This research study is a Feasibility Study, which is the first-time investigators are examining this educational video tool for patients receiving CAR-T cell therapy.\n\nThe research study procedures include screening for eligibility, randomization and a series of questionnaires\n\nParticipants will be randomized to one of 2 groups:\n\n* Group A: Educational video tool\n* Group B: Standard care\n\nParticipants will be in the research study for a month after consent\n\nIt is expected that about 80 participants will take part in this research study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or age or older\n* Established diagnosis of a hematologic malignancy\n* Under consideration for CAR T-cell therapy at Massachusetts General Hospital\n\nExclusion Criteria:\n\n* Significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary oncologist believes prohibits informed consent or participation in the study\n* Undergoing CAR T-cell therapy for solid tumor malignancy\n* Inability to comprehend English, as the video is currently only available in English at this time'}, 'identificationModule': {'nctId': 'NCT04280133', 'briefTitle': 'CAR T-CELL Therapy Educational Video Trial', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Randomized Controlled Trial of an Educational Video Tool for Patients Receiving CAR T-Cell Therapy', 'orgStudyIdInfo': {'id': '19-790'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational Video Tool', 'description': 'Patients randomized to the intervention arm will watch a 3-minute video educational tool about CAR-T cell therapy prior to admission for CAR-T cell therapy.', 'interventionNames': ['Behavioral: Educational Video Tool']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': "Patients randomized to the control arm will receive usual care per the treating team. Any questions regarding CAR-T cell therapy will be directed to the patient's medical team"}], 'interventions': [{'name': 'Educational Video Tool', 'type': 'BEHAVIORAL', 'description': 'The video educational tool was written by the investigators in collaboration with a panel of experts on CAR T-cell therapy, medical ethicists, palliative care clinicians, and oncologists.', 'armGroupLabels': ['Educational Video Tool']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Patrick C Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Contact the Partners Innovations team at http://www.partners.org/innovation'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Patrick C. Johnson, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-03-12', 'type': 'RELEASE'}, {'date': '2024-08-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Patrick C. Johnson, MD, Principal Investigator, Massachusetts General Hospital'}}}}