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

Memorial Sloan Kettering Cancer Center6 sites in 1 country112 target enrollmentSeptember 2011

ConditionsCancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 112
Locations: 6
Primary Endpoint: the ability for the PRO-CTCAE system to be used in Spanish-speaking populations in the U.S.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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".

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

May 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

the ability for the PRO-CTCAE system to be used in Spanish-speaking populations in the U.S.

Time Frame: 2 years

Patient Questionnaire (either via paper or read to them verbatim), and undergo a subsequent cognitive interview, as described in this protocol. Interviews will be conducted either by bilingual site staff who have been trained to conduct these interviews, or by trained bilingual interviewers from FACITtrans