Functional Assessment and Radiation Adherence/Toxicity in Older and Younger Patients With Non-Ovarian Gynecological Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pre-treatment I-ADL dependency
研究概览
简要总结
The purpose of this study is to investigate the association between the Independent Activities of Daily Living (I-ADL) component of the Comprehensive Geriatric Assessment (CGA) and poor tolerance to radiation treatment in older and younger patients with non-ovarian gynecological cancers.
详细描述
There are little data regarding the impact of functional age on tolerance to radiotherapy for gynecologic cancers. A comprehensive geriatric assessment (CGA) tool which measures functional status (including the Instrumental Activities of Daily Living (I-ADL)), among many other important geriatric related conditions, was developed by Hurria and colleagues. Geriatric assessment variables including functional status predicted for toxicity in older patients receiving chemotherapy and surgery for multiple cancer types., 2 We hypothesize that I-ADL can be used to predict treatment tolerance in patients of all ages receiving pelvic and/or paraaortic region radiation therapy for gynecologic malignancies.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥Age 18 years (no upper age limit)
- •Diagnosis of cervical, vaginal, vulvar, or endometrial cancer with either pelvic radiotherapy or chemoradiotherapy planned as part of standard treatment.
- •Consented for receipt of External Beam Radiation Therapy (EBRT) at the University of North Carolina Chapel Hill
- •Ability to read English (required for CGA)
- •Curative treatment intent as defined by their radiation oncologist
- •Negative serum pregnancy test in women of childbearing potential
排除标准
- •< Age 18 years
- •Incurable cancer as defined by their radiation oncologist
- •Planned radiation for palliative intent only
- •Inability to complete the I-ADL section of the CGA
- •Prior radiation to areas targeted by radiotherapy within this study
- •Other active, invasive malignancy requiring active ongoing therapy during their radiotherapy with the exception of:
- •Localized squamous cell carcinoma of the skin
- •Basal-cell carcinoma of the skin
- •Other malignancies requiring locally ablative therapy only
结局指标
主要结局
Pre-treatment I-ADL dependency
时间窗: Pre-treatment
Pre-treatment I-ADL dependency is defined as scoring less than 14 on the I-ADL scale of the CGA.
次要结局
- Poor adherence to treatment(During or 4-8 weeks post-treatment)