Spanish Translation and Linguistic Validation of the Patient- Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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.
- INCLUSION CRITERIA:
- Participants must be 18 years or older and be able to provide informed consent.
- Participants must be patients being followed for clinical care at one of the
collaborating sites, and must be either currently undergoing or having completed
treatment for cancer in the previous 6 months.
- Participants must be native Spanish-speakers.
- Participants must be able either to read and understand the items in Spanish or to
hear and understand and respond to the items when read to them verbatim in Spanish.
- Cognitive impairment as determined by the patient's Physician or Nurse which renders
them unable to understand the items or report on his/her symptoms from the last 7
- If participants request to have the consent form in English, they will not be
eligible for participation in this study.
Type of Study:
Time Perspective: Prospective
Linguistically validate a Spanish-language version of PRO-CTCAE symptom in the native Spanish-speaking population.
Sandra A Mitchell, C.R.N.P.
National Cancer Institute (NCI)
United States: Federal Government
- Cognitive Testing
- Adverse Events
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