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| ID | Type | Description | Link |
|---|---|---|---|
| 1224 | Other Grant/Funding Number | Lineberger Cancer Center | |
| 121731 | Other Identifier | UNC IRB |
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| Name | Class |
|---|---|
| Alpha Omega Alpha Honor Medical Society | UNKNOWN |
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A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict how older adults tolerate cancer treatments. The investigators think this same tool (referred to as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance.
A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict for toxicity in older patients during cancer treatments.1 The investigators hypothesize that the same tool (referred to throughout this document as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance. The primary objective of this study is to assess the association between pre-treatment functional status (as measured by the Independent Activities of Daily Living (I-ADL) components of the CGA) and poor tolerance to radiation therapy (as defined in section 2.3.1). Secondary objectives include exploration of associations between pre-treatment I-ADL status on the CGA and the occurrence of any acute grade 3-5 toxicity from radiation therapy, or any decrease in Quality of Life (QoL) measures throughout radiation therapy as assessed by the EORTC QLQ-C30 questionnaire. The investigators also want to compare the rate of physician reported acute toxicities to patient reported acute toxicities in an older cancer patient population, assess any association between elevated p16Ink4α expression in peripheral T lymphocytes and poor tolerance to or acute grade 3-5 toxicity from radiation therapy, and explore any association between other baseline components of the CGA and poor tolerance to or acute grade 3-5 toxicity from radiation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer Patients Age 65 or above | Cancer patients age 65 years or above with a diagnosis of head and neck cancer or lung cancer with radiotherapy or chemoradiotherapy planned as part of curative standard treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and poor tolerance to radiation therapy | To assess the association between pre-treatment loss of at least one independent activity of daily living (I-ADL) on the CGA and poor tolerance to radiation therapy | 4-8 weeks post-radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and the occurrence of any patient-reported toxicity from radiation therapy | To assess the association between pre-treatment loss of at least one I-ADL on the CGA and the occurrence of any patient-reported acute grade 3-5 toxicity from radiation therapy | 4-8 weeks post-radiation therapy |
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Inclusion Criteria:
Exclusion Criteria:
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Patients age ≥ 65 years of age, with one of the inclusion diagnoses, and an appointment for CT simulation for planning of radiation therapy at UNCH department of radiation oncology will be assessed for inclusion for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Bhishamjit Chera, MD | Radiation Oncology UNC Cancer Hospital | Principal Investigator |
| Noam VanderWalde, MD | Radiation Oncology UNC Cancer Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiation Oncology Clinic - UNC Cancer Hospital | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28258889 | Background | VanderWalde NA, Deal AM, Comitz E, Stravers L, Muss H, Reeve BB, Basch E, Tepper J, Chera B. Geriatric Assessment as a Predictor of Tolerance, Quality of Life, and Outcomes in Older Patients With Head and Neck Cancers and Lung Cancers Receiving Radiation Therapy. Int J Radiat Oncol Biol Phys. 2017 Jul 15;98(4):850-857. doi: 10.1016/j.ijrobp.2016.11.048. Epub 2016 Dec 2. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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Whole blood
| Association between pre-treatment loss of at least one independent activity of daily living and changes in Quality of Life measures | To assess the association between pre-treatment loss of at least one I-ADL on the CGA and changes in QoL measures, as evaluated by the EORTC-QLQ-C30 throughout radiation therapy | 4-8 weeks post radiation therapy |
| Comparison of physician and patient-reported acute grade 3-5 toxicities | To compare physician-reported acute grade 3-5 toxicities to patient-reported grade 3-5 acute toxicities in this older adult population. | 4-8 weeks post-radiation therapy |
| Association between elevated p16Ink4α gene expression and poor tolerance to and/or physician/patient-reported toxicity from radiation therapy | To assess the association between elevated p16Ink4α expression in peripheral T lymphocytes and poor tolerance to and/or patient reported and physician reported acute grade 3-5 toxicity from radiation therapy | 4-8 weeks post-radiation therapy |
| Association between baseline components of the Comprehensive Geriatric Assessment and poor tolerance to or occurrence of patient-reported toxicity from radiation treatment | To explore the association between baseline components of the CGA (other than I-ADL) and poor tolerance to or occurrence of any patient-reported acute grade 3-5 toxicity from radiation treatment. | 4-8 weeks post-radiation therapy |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |