Finding Predictors of Side Effects to Chemoradiation Treatment in Elderly Patients With Head and Neck Cancer

Study Overview
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Brief Summary
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To look at what types of measures can be used to predict how an older person will tolerate chemoradiation treatment for head and neck cancer. This study uses surveys and a blood draw to look at the different measures.

Detailed Description
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Purpose: To identify baseline predictors of change in function over the course of treatment with chemoradiotherapy in patients with head and neck cancer. Participants: Patients 65 or older who have an appointment at the North Carolina Cancer Hospital (NCCH) or other participating sites, have planned chemoradiotherapy for head and neck cancer Procedures (methods): Consenting subjects will complete a Geriatric Assessment, Functional Assessment of Cancer Therapy - Head and Neck and give a blood sample for CBC and p16INK4a at the start of their chemoradiotherapy, at week four, at the end and 90 days post therapy. They will also complete a health behavior questionnaire at baseline.

Official Title
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Identification of Predictors of Tolerance to Chemoradiotherapy in Elderly Patients With Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Other: Collect Blood and Survey Instruments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients will be eligible for this protocol provided they have an appointment at the North Carolina Cancer Hospital (NCCH), have planned chemoradiotherapy for head and neck cancer (any histology) and consent to complete the Geriatric Assessment. No exclusions will be made based on gender, ethnicity, performance status or race. Patient must be able to read and speak English. Signed, IRB approved written informed consent. Age of at least 65 years. Enrollment in other studies, both therapeutic and observational, will not result in exclusion. Exclusion Criteria Inability to read and speak English. Inability to comply with study for any other reason than language

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elderly Chemorads<br>Elderly patients with Head and Neck Cancer who are Undergoing Chemotherapy | Other: Collect Blood and Survey Instruments<br>* Each subject will be administered the appropriate surveys and blood draws over the course of the study.<br>* Other names: Health Behavior Questionnaire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant Change in Function from Baseline to Post-Treatment | To determine if there is a significant change in the Instrumental Activities of Daily Living (IADL) subscore of the Geriatric Assessment (GA) from baseline to 90 days post-treatment. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore Association between Baseline Measures and Decline in Living Status | To explore the association of baseline measures with time to decline in living status. (For example, completely independent to requiring home help, or requiring home help to moving to a nursing home, etc.) | 2 years | 
| Explore Association of Baseline Measures with Grade 3 or Higher Toxicity | To explore the association of baseline measures with the occurrence of any grade 3 or higher toxicity as a consequence of chemoradiotherapy. | 2 years | 
| Explore Association of Baseline p16 with Baseline GA Measures | To explore the association of baseline p16 expression with baseline subscores of the Geriatric Assessment. | 2 years | 
| Explore Changes in p16 Expression, GA Subscales and FACT-HN Scores Over Time. | To explore changes in p16 expression, GA subscales, and FACT-HN scores over the course of treatment | 2 years | 
| Explore Association between Baseline Measures and Changes in IADL Subscore | To explore the association of baseline measures with change in IADL subscore. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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p16, Geriatrics, Oncology, Biological Markers, Survey Instruments, Geriatric Oncology, Biological Markers of Aging, Symptom Assessment, Cancer, Older Persons, Head and Neck Cancer