Predicting Tolerance to Radiation Therapy in Older Adults With Cancer: A Prospective Blinded Study of the Comprehensive Geriatric Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and poor tolerance to radiation therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥Age 65 years (no upper age limit)
- •Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment.
- •Consented for receipt of External Beam Radiation Therapy (EBRT) at UNC Chapel Hill
- •Able to read English (required for CGA)
- •Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent
- •Patients enrolled in other CGA studies will not be excluded (see LCCC 0916, 1208)
排除标准
- •≥Age 65 years (no upper age limit)
- •Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment.
- •Consented for receipt of EBRT at UNC Chapel Hill
- •Able to read English (required for CGA)
- •Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent
- •Patients enrolled in other CGA studies will not be excluded (see LCCC 0916, 1208)
结局指标
主要结局
Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and poor tolerance to radiation therapy
时间窗: 4-8 weeks post-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
次要结局
- Comparison of physician and patient-reported acute grade 3-5 toxicities(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(4-8 weeks post-radiation therapy)
- Association between pre-treatment loss of at least one independent activity of daily living and changes in Quality of Life measures(4-8 weeks post radiation therapy)
- 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(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(4-8 weeks post-radiation therapy)