Testing a Spanish Version of a Patient Toxicity Questionnaire
- 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.
- To test a Spanish version of the PRO-CTCAE questionnaire.
- Latinos at least 18 years of age who are having or have recently finished cancer treatments and whose main language is Spanish
- 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Spanish Translation and Linguistic Validation of the Patient- Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)|
- Perceptions of the clarity and ease of response to a series of questions [ Time Frame: At enrollment ]
|Study Start Date:||January 2, 2012|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517152
|United States, Maryland|
|National Cancer Institute (NCI), 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Sandra A Mitchell, C.R.N.P.||National Cancer Institute (NCI)|