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

Status:	Completed
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	5/24/2017
Start Date:	September 2011
End Date:	May 2017

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

The purpose of this study is to see if questions in English about symptoms that patients may
have during cancer treatment are understandable when translated into Spanish. These
questions will later be used in future studies to give a better understanding of patient
symptoms".

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 (chemotherapy or radiation therapy) 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.

Exclusion Criteria:

- Cognitive impairment as determined by the patient's Physician or Nurse which or study
coordinators renders them unable to understand the items or report on his/her
symptoms from the last 7 days.

- Participants who have only received surgery are not eligible

- If participants request to have the consent form in English, they will not be
eligible for participation in this study.

We found this trial at

sites

University of Miami

Miami, Florida 33124

(305) 284-2211