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临床试验/NCT01517152
NCT01517152已完成不适用

Spanish Translation and Linguistic Validation of the Patient- Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2012年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
1
主要终点
Perceptions of the clarity and ease of response to a series of questions

研究概览

简要总结

Background:

  • The Common Terminology Criteria for Adverse Events (CTCAE) is a list of toxicities and side effects that may occur when people are having cancer treatment. Doctors and nurses use this list to describe the side effects patients experience from cancer treatment. We have developed a questionnaire to ask people having cancer treatment directly about common symptoms and side effects and to supply this information to their doctors and nurses. This questionnaire is known as PRO-CTCAE and is completed by a patient.
  • PRO-CTCAE was originally developed in English. Researchers want to develop a Spanish version of the patient questionnaire. To test whether the questions are well understood and whether it is easy to complete the questionnaire, the researchers will interview individuals whose primary language is Spanish and who are being treated for different types of cancer.

Objectives:

  • To test a Spanish version of the PRO-CTCAE questionnaire.

Eligibility:

  • Latinos at least 18 years of age who are having or have recently finished cancer treatments and whose main language is Spanish

Design:

  • Participants will complete a questionnaire in Spanish with selected questions from the translated PRO-CTCAE. They will discuss their answers and any difficulties they might have had in understanding or answer the questions with an interviewer, who will take notes and record comments and suggestions.
  • Literacy is not required for this study. Participants may opt to have the questions read aloud to them by an interviewer.

详细描述

This study describes a study to assess a newly created Spanish version of the National Cancer Institute s (NCI s) patient toxicity questionnaire, the Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), via semi-structured interviews among Spanish-speaking patients with cancer in the United States.

Background:

The NCI s PRO-CTCAE initiative has developed and preliminarily validated a library of items in English intended for patient self-reporting of treatment toxicity and symptoms during participation in cancer clinical trials. These items have also been translated into Spanish, using a methodology consistent with internationally agreed-upon guidelines for developing global translations.

Objective:

To linguistically validate a Spanish-language version of PRO-CTCAE symptom items to assure that they are culturally, semantically, and linguistically proficient to the native Spanish-speaking population with cancer in the United States.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Perceptions of the clarity and ease of response to a series of questions

时间窗: At enrollment

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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