Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT02521194
Status:
TERMINATED
Last Update Posted:
2020-01-13
First Post:
2015-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Occupational Therapy in Palliative Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 86}}, 'statusModule': {'whyStopped': 'PI requested', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-08', 'studyFirstSubmitDate': '2015-08-10', 'studyFirstSubmitQcDate': '2015-08-10', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction Rate of Inpatient Occupational Therapy Session', 'timeFrame': '1 day', 'description': 'Satisfaction rate defined as the percentage of patients that "strongly agree" or "agree" after inpatient occupational session as being beneficial.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Cancers', 'Inpatient occupational therapy', 'Questionnaire', 'Survey'], 'conditions': ['Advanced Cancers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to learn if inpatient occupational therapy can help patients in the Palliative Care Unit (PCU).', 'detailedDescription': 'Caregivers Consent:\n\nIf you agree to take part in this study, you will complete a questionnaire about your opinion on the inpatient occupational therapy session the patient (person you are caring for) received. It should take about 10 minutes to complete the questionnaire. You will be left alone in a room to complete the questionnaire.\n\nLength of Study:\n\nYour participation on this study will be over after you complete the questionnaire.\n\nThis is an investigational study.\n\n50 patients and up to 50 caregivers will take part in this study. All will be enrolled at MD Anderson.\n\nPatients Consent:\n\nIf you agree to take part in this study, you will complete a questionnaire about your opinion of the inpatient occupational therapy session you just had. The questionnaire should take about 10 minutes to complete. You will be left alone in the room to complete the questionnaire.\n\nLength of Study:\n\nYou participation on this study will be over after you complete the questionnaire.\n\nThis is an investigational study.\n\n50 patients and up to 50 caregivers will take part in this study. All will be enrolled at MD Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must have an inpatient occupational therapy (OT) order and be able to tolerate an OT session as judged by the attending physician\n2. Patients with cancer admitted to inpatient acute palliative care unit\n3. Caregiver participation is optional, but must be identified as the primary caregiver in order to complete the Caregiver Satisfaction Survey.\n4. Caregiver (if participating) must be present during the session.\n5. Patient (and caregiver (if participating) must be 18 years of age or older.\n6. Both patient (and caregiver if participating) must be able to understand, read, write and speak English.\n7. Both patient and caregiver (if participating) must sign an Informed Consent Form.\n\nExclusion Criteria:\n\n1. Patients or caregivers with physical limitations (visual or motor impairment) causing inability to read, complete or sign the consent form and survey.\n2. Patients or caregivers who the attending physician deems unable to participate due to poor cognitive capacity or acute physical distress.'}, 'identificationModule': {'nctId': 'NCT02521194', 'briefTitle': 'Occupational Therapy in Palliative Care', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Is Inpatient Occupational Therapy Perceived to be Beneficial by the Palliative Patient and Caregiver?', 'orgStudyIdInfo': {'id': '2015-0350'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caregiver Questionnaire', 'description': 'Questionnaire completion regarding opinion on the inpatient occupational therapy session person being cared for received.', 'interventionNames': ['Behavioral: Questionnaire']}, {'type': 'EXPERIMENTAL', 'label': 'Patient Questionnaire', 'description': 'Questionnaire completion regarding opinion of the inpatient occupational therapy session patient received.', 'interventionNames': ['Behavioral: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'otherNames': ['Survey'], 'description': 'Questionnaire completion regarding opinion of the inpatient occupational therapy session patient received.', 'armGroupLabels': ['Caregiver Questionnaire', 'Patient Questionnaire']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Paul W. Walker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}