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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02024 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 18294 | Other Identifier | City of Hope Comprehensive Cancer Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
I. 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.
II. To describe the incidence and type of grade 2-5 toxicities in this patient population.
III. To describe the family caregiver (FCG)-reported caregiving burden level and quality of life (QOL) scores.
SECONDARY OBJECTIVES:
I. To identify areas of vulnerability in this patient population using the geriatric assessment.
II. 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).
IV. 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.
V. To explore changes in family caregiver (FCG)-reported caregiving burden and QOL from pre-treatment to 3-months, 6 months post-treatment.
VI. To explore the relationship between geriatric assessment results and patient-reported symptoms and QOL.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP 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.
GROUP II: Family caregivers complete quality of life assessment at baseline, and at 1, 3, and 6 months following patient radiation or CRT completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (geriatric and quality of life assessments) | 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. |
| |
| Group II (quality of life assessment) | Family caregivers complete quality of life assessment at baseline, and at 1, 3, and 6 months following patient radiation or CRT completion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Geriatric Assessment | Other | Complete comprehensive geriatric assessment |
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| Measure | Description | Time Frame |
|---|---|---|
| Comprehensive geriatric assessment (CGA) scores and domains | Descriptive statistics will be used to summarize all CGA measure scores/domains. | Up to 6 months post therapy |
| Physical activity levels | Descriptive statistics will be used to summarize all physical activity levels. | Up to 6 months post therapy |
| Quality of life (QOL) measures | Descriptive statistics will be used to summarize all QOL measures. | Up to 6 months post therapy |
| Incidence and type of grade 2-5 toxicities | 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. | Up to week 4 |
| Family caregiver (FCG)-reported caregiving burden level and QOL scores | Descriptive statistics will be used to summarize all FCG-reported measure scores/domains. | Up to 6 months post therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with vulnerability using the geriatric assessment | Percentage of patients with vulnerability will be calculated as the number of patients with vulnerability divided by 30 (target sample). | Up to 6 months post therapy |
| Percentage of patients who receive and accept referrals |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are scheduled to undergo upfront surgery or concurrent CRT for non-metastatic head and neck cancer and family caregivers
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| Name | Affiliation | Role |
|---|---|---|
| Arya Amini | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| Quality-of-Life Assessment | Other | Complete quality of life assessment |
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| Questionnaire Administration | Other | Complete questionnaires |
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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. |
| Up to 6 months post therapy |
| Treatment modification and healthcare utilization in patients | Frequency and reasons for healthcare resource use and treatment modifications will be tabulated. | Up to week 12 |
| Change in CGA scores and domains | Changes will be calculated as post-treatment scores minus pre-treatment scores. The pattern of changes in CGA assessment will be summarized. | Baseline up to 6 months post therapy |
| Change in physical activity levels | 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. | Baseline up to 6 months post therapy |
| Change in QOL measures | Changes will be calculated as post-treatment scores minus pre-treatment scores. The pattern of changes in QOL measures will be summarized. | Baseline up to 6 months post therapy |
| Change in FCG-reported caregiving burden level and QOL scores | Changes will be calculated as post-treatment scores minus pre-treatment scores. | Baseline up to 6 months post therapy |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015577 | Geriatric Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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