Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-02 @ 4:11 AM
Study NCT ID:
NCT03902535
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2019-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Geriatric and Quality of Life Assessments in Older Patients With Non-metastatic or Metastatic Head and Neck or Lung Cancer Undergoing Surgery or Chemoradiation and Their Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015577', 'term': 'Geriatric Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'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': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2019-04-02', 'lastUpdatePostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comprehensive geriatric assessment (CGA) scores and domains', 'timeFrame': 'Up to 6 months post therapy', 'description': 'Descriptive statistics will be used to summarize all CGA measure scores/domains.'}, {'measure': 'Physical activity levels', 'timeFrame': 'Up to 6 months post therapy', 'description': 'Descriptive statistics will be used to summarize all physical activity levels.'}, {'measure': 'Quality of life (QOL) measures', 'timeFrame': 'Up to 6 months post therapy', 'description': 'Descriptive statistics will be used to summarize all QOL measures.'}, {'measure': 'Incidence and type of grade 2-5 toxicities', 'timeFrame': 'Up to week 4', 'description': 'Types of grade 2-5 toxicities will be summarized and proportions of patients with grade 2-5 toxicities will be tabulated and reported according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.'}, {'measure': 'Family caregiver (FCG)-reported caregiving burden level and QOL scores', 'timeFrame': 'Up to 6 months post therapy', 'description': 'Descriptive statistics will be used to summarize all FCG-reported measure scores/domains.'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with vulnerability using the geriatric assessment', 'timeFrame': 'Up to 6 months post therapy', 'description': 'Percentage of patients with vulnerability will be calculated as the number of patients with vulnerability divided by 30 (target sample).'}, {'measure': 'Percentage of patients who receive and accept referrals', 'timeFrame': 'Up to 6 months post therapy', 'description': 'The percentage of patients who receive and accept referrals will be calculated as the number of patients with referral divided by the number of patients with vulnerability.'}, {'measure': 'Treatment modification and healthcare utilization in patients', 'timeFrame': 'Up to week 12', 'description': 'Frequency and reasons for healthcare resource use and treatment modifications will be tabulated.'}, {'measure': 'Change in CGA scores and domains', 'timeFrame': 'Baseline up to 6 months post therapy', 'description': 'Changes will be calculated as post-treatment scores minus pre-treatment scores. The pattern of changes in CGA assessment will be summarized.'}, {'measure': 'Change in physical activity levels', 'timeFrame': 'Baseline up to 6 months post therapy', 'description': 'Will utilize the pedometer to assess physical activity level during and after treatment and record changes. The pattern of changes in physical activity levels will be summarized.'}, {'measure': 'Change in QOL measures', 'timeFrame': 'Baseline up to 6 months post therapy', 'description': 'Changes will be calculated as post-treatment scores minus pre-treatment scores. The pattern of changes in QOL measures will be summarized.'}, {'measure': 'Change in FCG-reported caregiving burden level and QOL scores', 'timeFrame': 'Baseline up to 6 months post therapy', 'description': 'Changes will be calculated as post-treatment scores minus pre-treatment scores.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caregiver', 'Head and Neck Carcinoma', 'Lung Carcinoma', 'Metastatic Head and Neck Carcinoma', 'Metastatic Lung Carcinoma', 'Stage 0 Lung Cancer AJCC v8', 'Stage I Lung Cancer AJCC v8', 'Stage IA1 Lung Cancer AJCC v8', 'Stage IA2 Lung Cancer AJCC v8', 'Stage IA3 Lung Cancer AJCC v8', 'Stage IB Lung Cancer AJCC v8', 'Stage II Lung Cancer AJCC v8', 'Stage IIA Lung Cancer AJCC v8', 'Stage IIB Lung Cancer AJCC v8', 'Stage III Lung Cancer AJCC v8', 'Stage IIIA Lung Cancer AJCC v8', 'Stage IIIB Lung Cancer AJCC v8', 'Stage IIIC Lung Cancer AJCC v8', 'Stage IV Lung Cancer AJCC v8', 'Stage IVA Lung Cancer AJCC v8', 'Stage IVB Lung Cancer AJCC v8']}, 'descriptionModule': {'briefSummary': 'This trial studies comprehensive geriatric and quality of life assessments in older patients with head and neck or lung cancer that has or has not spread to other parts of the body who are undergoing standard surgery or chemoradiation, and their caregivers. Comprehensive geriatric assessment may improve the quality of life of patients with head and neck or lung cancer and their caregivers.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To describe the patterns and distribution of comprehensive geriatric assessment (CGA) scores and physical activity levels and quality of life measures in older (\\>= 65) patients with non-metastatic or metastatic head and neck or lung cancer undergoing upfront surgery followed (may be followed by adjuvant therapy) or upfront definitive radiation (with or without chemotherapy at the same time) to cure the disease.\n\nII. To describe the incidence and type of grade 2-5 toxicities in this patient population.\n\nIII. To describe the family caregiver (FCG)-reported caregiving burden level and quality of life (QOL) scores.\n\nSECONDARY OBJECTIVES:\n\nI. To identify areas of vulnerability in this patient population using the geriatric assessment.\n\nII. To identify potential referrals based on geriatric assessment results. III. To describe other healthcare resource use and potential treatment modifications (unplanned hospitalization, emergency room (ER) visits, readmission rates, breaks in radiation and/or chemoradiation (CRT), dose modifications).\n\nIV. To explore changes in geriatric assessment and patient-reported symptoms, QOL, weight, and functional status from pre-treatment to 3-months, 6 months post-treatment.\n\nV. To explore changes in family caregiver (FCG)-reported caregiving burden and QOL from pre-treatment to 3-months, 6 months post-treatment.\n\nVI. To explore the relationship between geriatric assessment results and patient-reported symptoms and QOL.\n\nOUTLINE: Participants are assigned to 1 of 2 groups.\n\nGROUP I: Patients complete comprehensive geriatric and quality of life assessments within 1-4 weeks of treatment (either upfront surgery which may be followed by radiation with or without chemotherapy or upfront radiation which may include CRT) initiation (baseline), and at 1, 3, and 6 months following CRT completion.\n\nGROUP II: Family caregivers complete quality of life assessment at baseline, and at 1, 3, and 6 months following patient radiation or CRT completion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are scheduled to undergo upfront surgery or concurrent CRT for non-metastatic head and neck cancer and family caregivers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PATIENT: Diagnosed with non-metastatic or metastatic head and neck cancer or lung cancer\n* PATIENT: Scheduled to undergo either upfront surgery or definitive radiation treatment (including CRT)\n* PATIENT: Age \\>= 65 years\n* PATIENT: Able to read and understand English\n* FAMILY CAREGIVER: Family member/friend identified by the patient as the primary caregiver before and after surgery and/or radiation (including CRT)\n* FAMILY CAREGIVER: Age \\>= 21 years\n* FAMILY CAREGIVER: Able to read and understand English\n* ALL SUBJECTS: Must have the ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Patients should not have any uncontrolled illness including ongoing or active infection\n* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study'}, 'identificationModule': {'nctId': 'NCT03902535', 'briefTitle': 'Geriatric and Quality of Life Assessments in Older Patients With Non-metastatic or Metastatic Head and Neck or Lung Cancer Undergoing Surgery or Chemoradiation and Their Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Geriatric Assessment and Quality of Life in Older Adults Undergoing Definitive Treatment for Head and Neck or Lung Cancer and Their Informal Caregivers', 'orgStudyIdInfo': {'id': '18294'}, 'secondaryIdInfos': [{'id': 'NCI-2018-02024', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '18294', 'type': 'OTHER', 'domain': 'City of Hope Comprehensive Cancer Center'}, {'id': 'P30CA033572', 'link': 'https://reporter.nih.gov/quickSearch/P30CA033572', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I (geriatric and quality of life assessments)', 'description': 'Patients complete comprehensive geriatric and quality of life assessments within 1-4 weeks of treatment (either upfront surgery which may be followed by radiation with or without chemotherapy or upfront radiation which may include CRT) initiation (baseline), and at 1, 3, and 6 months following CRT completion.', 'interventionNames': ['Other: Comprehensive Geriatric Assessment', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'label': 'Group II (quality of life assessment)', 'description': 'Family caregivers complete quality of life assessment at baseline, and at 1, 3, and 6 months following patient radiation or CRT completion.', 'interventionNames': ['Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Comprehensive Geriatric Assessment', 'type': 'OTHER', 'description': 'Complete comprehensive geriatric assessment', 'armGroupLabels': ['Group I (geriatric and quality of life assessments)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Complete quality of life assessment', 'armGroupLabels': ['Group I (geriatric and quality of life assessments)', 'Group II (quality of life assessment)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Group I (geriatric and quality of life assessments)', 'Group II (quality of life assessment)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Arya Amini', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}