Translation, Cross-Cultural Adaptation and Validation of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for Italian-speaking Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 233
- 试验地点
- 16
- 主要终点
- cultural and linguistic validity of Italian language version of the PRO-CTCAE
研究概览
简要总结
The purpose of this study is to see if the Italian language version of a questionnaire about symptoms that patients may have during cancer treatment is understandable to Italian speaking patients. The questionnaire is called the PRO-CTCAE, and was originally developed at the U.S. National Cancer Institute to help get information about patients' symptoms directly from the patients themselves. The Italian version of the questionnaire will be used in future studies to gain a better understanding of patient symptoms.
详细描述
This study will be conducted in two steps. The first is the Italian translation and cross cultural adaptation of the original US NCI's version of the PRO-CTCAE questionnaire. The questionnaire will be translated and administered to a sample of 96 Italian patients. After protocol amendment in November 2016, the second step was modified and consists of test-retest reliability assessment of the Italian language version of the PRO-CTCAE questionnaire that was developed in the first step, with a minimum of 59 Italian speaking patients to be enrolled. A validation study is planned and will be the subject of a separate protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age.
- •Patient is able to complete PRO-CTCAE on two consecutive days.
- •Patient is actively receivingmedical treatment for cancer or has completed treatment not more than 4 weeks before Visit 1
- •Any type of cancer
- •Able to complete questionnaire by themselves or with assistance.
- •Providing informed written consent.
- •Able to speak and understand Italian
排除标准
- •Clinically significant cognitive or memory impairment in the opinion of clinical or research staff.
- •Other important acute medical conditions that, in the opinion of the Investigator, may prevent compliance..
结局指标
主要结局
cultural and linguistic validity of Italian language version of the PRO-CTCAE
时间窗: 2 years
次要结局
未报告次要终点