Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-22 @ 7:08 AM
Study NCT ID:
NCT01632969
Status:
TERMINATED
Last Update Posted:
2015-03-06
First Post:
2012-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving End of Life Care in Head and Neck Cancer
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': 'RETROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Lack of accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2012-06-29', 'studyFirstSubmitQcDate': '2012-07-03', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of care received by patients', 'timeFrame': '1 year', 'description': 'To determine the perception of the family members of the quality of care received by patients with aerodigestive mucosal squamous cell carcinoma of the head and neck at the end of their lives. A survey will be administered to the families and next-of-kin of deceased patients. A recently validated survey instrument, the Family Assessment of Treatment at the End of life (FATE), is designed to assess treatment at the end of life based upon the responses of family members of the deceased (Finlay, Shreve et al. 2008).'}], 'secondaryOutcomes': [{'measure': 'quality of death outcomes', 'timeFrame': '1 year', 'description': 'To identify specific risk factors or interventions that might predict certain quality of death outcomes. A survey will be administered to the families and next-of-kin of deceased patients.A recently validated survey instrument, the Family Assessment of Treatment at the End of life (FATE), is designed to assess treatment at the end of life based upon the responses of family members of the deceased (Finlay, Shreve et al. 2008).'}, {'measure': 'awareness among caregivers', 'timeFrame': '1 year', 'description': 'To raise awareness among caregivers of the perspectives of family members of deceased patients, and of risk factors that might predict patient quality of death. This survey will be administered to the families and next-of-kin of deceased patients. A recently validated survey instrument, the Family Assessment of Treatment at the End of life (FATE), is designed to assess treatment at the end of life based upon the responses of family members of the deceased (Finlay, Shreve et al. 2008).'}]}, 'conditionsModule': {'keywords': ['12-136'], 'conditions': ['The Families or Next of Kin of Patients Treated at MSKCC for Non-cutaneous Squamous Cell Carcinomas of the', 'Upper Aerodigestive Tract']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to improve the quality of care provided for head and neck cancer patients. By better understanding the end of life experiences of dying patients and their families, the investigators hope to better anticipate and improve upon the experiences of future patients and their families.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Deceased Head and Neck Surgery patients will be queried from Dataline and screened for eligibility. Interviews with family members and next of kin of deceased patients treated at MSKCC for noncutaneous squamous cell carcinomas of the upper aerodigestive tract will be conducted via telephone, employing the survey instruments.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Head and neck cancer patients who received their treatment at MSKCC who have died of noncutaneous squamous cell carcinomas of the upper aerodigestive tract and for whom family / next of kin contact information is available.\n* Time of patient death must have been at least 6 months ago and no more than 4 years ago\n* Patient age at time of death must be over 21 years of age.\n* Those interviewed must be English-fluent.\n\nExclusion Criteria:\n\n* Non-English speaking interviewees\n* Next-of-kin who reported being unfamiliar with care received during the last month of life\n* Next-of-kin who did not identify themselves as one of the patient's primary social supports during the last month of life\n* Next-of-kin who were not physically present with the deceased at least once during the last week of his/her life\n* Next-of-kin under age 21"}, 'identificationModule': {'nctId': 'NCT01632969', 'briefTitle': 'Improving End of Life Care in Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Improving End of Life Care in Head and Neck Cancer', 'orgStudyIdInfo': {'id': '12-136'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'families or next-of-kin of deceased patients', 'description': 'The families of deceased patients treated at MSKCC for non-cutaneous squamous cell carcinomas of the upper aerodigestive tract for whom contact information is available will be recruited by mail and by phone.', 'interventionNames': ['Behavioral: The The Family Assessment of Treatment at the End of life (FATE ) survey']}], 'interventions': [{'name': 'The The Family Assessment of Treatment at the End of life (FATE ) survey', 'type': 'BEHAVIORAL', 'description': 'Study candidates will be contacted by mail with an initial contact letter with information explaining the study, and then will receive a follow-up phone call to discuss their participation in the study no later than 1 month following the posting of the initial contact letter. If a family member or next-of-kin chooses to participate, verbal informed consent will be obtained over the phone and a one-time telephone interview will be conducted.', 'armGroupLabels': ['families or next-of-kin of deceased patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065-0009', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Snehal Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}