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

Memorial Sloan Kettering Cancer Center112 enrolled

Overview

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".

Study Type

OBSERVATIONAL

Enrollment

112

Conditions

Cancer

Interventions

questionnaire administration followed by cognitive interviewsBEHAVIORAL

Each cognitive interviewing procedure will include two parts. Participants will first be asked to independently complete a series of PRO-CTCAE symptom items in a Patient Questionnaire. Following completion by the participant of the Patient Questionnaire containing PRO-CTCAE items, the bilingual interviewer will query participants regarding item comprehension, relevance, inclusiveness, cultural appropriateness, and cognitive processes used to generate responses, via a semi-scripted cognitive debriefing interview developed to assure consistency across interviews.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

St Joseph'S Hospital

Los Angeles, California, United States

University of Miami

Miami, Florida, United States

Hektoen /Stroger Hospital

Chicago, Illinois, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

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

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

Time frame: 2 years

Data from ClinicalTrials.gov

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