Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT03040102
Status:
COMPLETED
Last Update Posted:
2022-08-30
First Post:
2017-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study of a Hospice Video Educational Tool for Patients With Advanced Cancer and Their Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-28', 'studyFirstSubmitDate': '2017-01-28', 'studyFirstSubmitQcDate': '2017-01-30', 'lastUpdatePostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Perception of Hospice Care Questionnaire', 'timeFrame': 'immediately after the video intervention or verbal narrative', 'description': 'we will assess perception of hospice using the Hospice Perception Questionnaire'}, {'measure': 'Patient Hospice Utilization', 'timeFrame': '1 year after study completion', 'description': 'We will assess patient hospice utilization and length of stay in hospice'}, {'measure': 'Caregiver Preference for Hospice Question', 'timeFrame': 'immediately after the video intervention or verbal narrative', 'description': "we will assess caregiver's preference for their loved one using hospice (yes vs. no)"}, {'measure': 'Caregiver Knowledge about Hospice Questionnaire', 'timeFrame': 'immediately after the video intervention or verbal narrative', 'description': 'we will assess knowledge about hospice using 10 knowledge questions'}, {'measure': 'Caregiver Perception of Hospice Care Questionnaire', 'timeFrame': 'immediately after the video intervention or verbal narrative', 'description': 'we will assess perception of hospice using the Hospice Perception Questionnaire'}, {'measure': 'Caregiver satisfaction with end-of-life care (FAMCARE)', 'timeFrame': '1 year after study completion', 'description': "We will use 9 items from the FAMCARE to assess caregivers' satisfaction with patient's end of life care"}], 'primaryOutcomes': [{'measure': 'Patient Preference for Hospice Question', 'timeFrame': 'immediately after the video intervention or verbal narrative', 'description': 'We will ask patients whether they would prefer to receive hospice care at the end of life (yes vs. no)'}], 'secondaryOutcomes': [{'measure': 'Patient knowledge about hospice Questionnaire', 'timeFrame': 'immediately after the video intervention or verbal narrative', 'description': 'we will assess knowledge about hospice using 10 knowledge questions'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Cancer'], 'conditions': ['Advanced Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to compare two ways to educate patients with cancer and their caregivers about hospice care services', 'detailedDescription': "The purpose of this research study is to compare two ways to educate patients with cancer and their caregivers about hospice care services - a video educational tool or a verbal narrative. The study will assess the effect of these methods on patients' and caregivers' knowledge about hospice care, as well as their perceptions and preferences for this service.\n\nUsing this research, the investigators hope to find out the best way to help patients and their loved ones better understand hospice care. The educational methods used in this study (the video educational tool or verbal narrative) are meant to serve as an introduction to hospice care. Further details about hospice should be discussed directly with your care team.\n\nThis study will enroll 150 patients with advanced cancer and up to 150 of their caregivers in this randomized clinical trial. The study will use questionnaires to measure the participant and the caregivers' knowledge of hospice care, as well as your perceptions and preferences for these services. Study assessments will be completed before and after watching the video or hearing the verbal narrative in the hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients Eligibility Criteria:\n\n* Adult patients (≥18 years) with a diagnosis of metastatic solid cancer.\n* A prognosis of 12 months or less based on the treating oncologist's assessment.\n* The ability to provide informed consent.\n* Ability to comprehend and speak English.\n\nCaregivers Eligibility Criteria:\n\n* Adult caregivers (\\>18 years) of patients who have agreed to participate in study.\n* A relative or a friend upon whom the patient relies for help and who will be likely to be present during hospitalization, or willing to participate by phone.\n* Ability to comprehend and speak English.\n\nExclusion Criteria:\n\nPatients Exclusion Criteria:\n\n-Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures"}, 'identificationModule': {'nctId': 'NCT03040102', 'briefTitle': 'Randomized Study of a Hospice Video Educational Tool for Patients With Advanced Cancer and Their Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Randomized Study of a Hospice Video Educational Tool for Patients With Advanced Cancer and Their Caregivers', 'orgStudyIdInfo': {'id': '17-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hospice Video Educational Tool', 'description': '* The hospice video educational tool is a 6 minute video\n* Participants will watch an approximately 6-minute digital video regarding hospice on an iPad', 'interventionNames': ['Other: Hospice Video Educational Tool']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hospice Verbal Narrative', 'description': '* The RA will read a verbal narrative that is identical to the narrative of the video to participants\n* Standard of Care practice is used', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'Hospice Video Educational Tool', 'type': 'OTHER', 'description': "it's a 6 minute video regarding hospice care", 'armGroupLabels': ['Hospice Video Educational Tool']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Standard of Care practice is used', 'armGroupLabels': ['Hospice Verbal Narrative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts general Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Areej El-Jawahri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gordon and Betty Moore Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Areej El-Jawahri, MD', 'investigatorFullName': 'El-Jawahri, Areej,M.D.', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}