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| ID | Type | Description | Link |
|---|---|---|---|
| 12-0805 | Other Identifier | UNC IRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly Chemorads | Elderly patients with Head and Neck Cancer who are Undergoing Chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collect Blood and Survey Instruments | Other | Each subject will be administered the appropriate surveys and blood draws over the course of the study. |
|
| 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 |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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Elderly (65 and older) patients with Head and Neck Cancer
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| Name | Affiliation | Role |
|---|---|---|
| Jared Weiss, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27514 | United States |
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| Label | URL |
|---|---|
| UNC Geriatric Oncology Program | View source |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D015577 | Geriatric Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Whole Blood
|
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 |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D015991 | Epidemiologic Measurements |