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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Geriatric Assessment and Quality of Life in Older Adults Undergoing Definitive Treatment for Head and Neck or Lung Cancer and Their Informal Caregivers

Conditions
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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

Intervention / Treatment
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* Other: Comprehensive Geriatric Assessment
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PATIENT: Diagnosed with non-metastatic or metastatic head and neck cancer or lung cancer PATIENT: Scheduled to undergo either upfront surgery or definitive radiation treatment (including CRT) PATIENT: Age >= 65 years PATIENT: Able to read and understand English FAMILY CAREGIVER: Family member/friend identified by the patient as the primary caregiver before and after surgery and/or radiation (including CRT) FAMILY CAREGIVER: Age >= 21 years FAMILY CAREGIVER: Able to read and understand English ALL SUBJECTS: Must have the ability to understand and the willingness to sign a written informed consent Exclusion Criteria: Patients should not have any uncontrolled illness including ongoing or active infection Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I (geriatric and quality of life assessments)<br>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. | Other: Comprehensive Geriatric Assessment<br>* Complete comprehensive geriatric assessment<br>Other: Quality-of-Life Assessment<br>* Complete quality of life assessment<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Complete questionnaires<br>|
| Group II (quality of life assessment)<br>Family caregivers complete quality of life assessment at baseline, and at 1, 3, and 6 months following patient radiation or CRT completion. | Other: Quality-of-Life Assessment<br>* Complete quality of life assessment<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |