Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-01-01 @ 11:43 AM
Study NCT ID:
NCT02558257
Status:
COMPLETED
Last Update Posted:
2021-04-14
First Post:
2015-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perception of Palliative Care Encounter
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-13', 'studyFirstSubmitDate': '2015-09-22', 'studyFirstSubmitQcDate': '2015-09-22', 'lastUpdatePostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Participants' Perceptions of Timeliness of Referral to an Outpatient Palliative Care Clinic", 'timeFrame': '1 day', 'description': 'Percentage of respondents who report that their referral to supportive care was late (including "late" and "too late") estimated with a standard error not larger than 0.04.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Cancers', 'Survey', 'Questionnaire'], 'conditions': ['Advanced Cancers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': "Objectives:\n\nPrimary Objective The primary objective is to determine patients' perceptions of the timeliness of their referral to an outpatient palliative care clinic.\n\nThe secondary objectives are to determine:\n\n1. The factors and variables associated with perception of timeliness such as age, gender, and symptom distress\n2. The patients' perceptions of the physical environment of the outpatient clinic at UT MD Anderson Cancer Center (UTMDACC) such as lighting, music, and lack of a waiting room; and\n3. If there is an association between level of distress (physical, psychological, and spiritual distress as measured by Edmonton Symptom Assessment Scale (ESAS) and the usefulness of the referral to palliative care center.", 'detailedDescription': "If participant agrees to take part, they will complete 1 questionnaire over the phone, in person, or via e-mail about their first consultation experience, within 1 month after their visit. It should take about 15 minutes to complete. Health information about participant (such as their name, medical record number, telephone number, e-mail address, IP address, age, gender, race/ethnicity and cancer type) will also be collected but will not be shared with anyone outside of MD Anderson, except when required for regulatory purposes, or when required to be shared with study sponsors or study monitors. Participant's survey answers will not be shared with the Supportive Care staff.\n\nDistress Plan:\n\nTelephone - If participant experiences any distress while answering the survey questions, the research assistant will immediately contact our nurse in the Supportive Care Center. Participant will be contacted immediately to provide telephone counseling or address any other issue that may be causing distress. Our phone care nurse will offer participant to schedule a face-to-face visit with one of the Supportive Care physicians or to see a nurse in the Supportive Care Center.\n\nIn-person - If participant experiences significant and high levels of distress while participating in the study, we will refer participant to their primary care physician, physician in the Supportive Care Center or one of the supportive care counselors.\n\nOnline - If participant experiences significant and high levels of distress while completing the online survey, they may stop the survey and call the Supportive Care Center (during office hours) or the Supportive Care Mobile Team (after office hours or weekends). The contact information will be displayed on each page of the online survey.\n\nPatient's participation on the study will be over after they have completed the questionnaire. Participant's de-identified study information will be kept by the Principal Investigator in a locked file cabinet and password protected electronic study database for 5 years after publication of the research and then destroyed. Online survey responses, demographics, e-mail address, and IP address will be stored indefinitely in a secured database by the Qualtrics team."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who have undergone a consultation with a supportive Care doctor in the Supportive Care Center at The University of Texas MD Anderson Cancer Center in Houston, Texas.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have advanced cancer, defined as locally advanced, metastatic or incurable disease\n2. \\>/=18 years of age\n3. Seen at UTMDACC outpatient Supportive Care Center for consultation\n4. Provided informed consent\n\nExclusion Criteria:\n\n1. Memorial Delirium Assessment Scale (MDAS) \\>/= 13.\n2. Inability to read and speak English'}, 'identificationModule': {'nctId': 'NCT02558257', 'briefTitle': 'Perception of Palliative Care Encounter', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Perception of the Palliative Care Encounter by Patients Who Are Referred to Outpatient Supportive/ Palliative Care', 'orgStudyIdInfo': {'id': '2015-0578'}, 'secondaryIdInfos': [{'id': 'NCI-2017-01598', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Palliative Care Survey', 'description': 'Initial consultation visit followed by phone survey within 1 week +/- 4 days of initial consultation.', 'interventionNames': ['Behavioral: Survey']}], 'interventions': [{'name': 'Survey', 'type': 'BEHAVIORAL', 'otherNames': ['Questionnaire'], 'description': 'Participants complete palliative care survey within 1 week +/- 4 days of initial consultation via phone survey conducted by Research nurse/assistant.', 'armGroupLabels': ['Palliative Care Survey']}]}, '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': 'Angelique N. Wong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}