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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: questionnaire administration followed by cognitive interviews


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spanish-speaking Latino participants<br>The investigators will conduct up to two rounds of PRO-CTCAE (patient-reported outcome- Common Terminology Criteria for Adverse Events) version questionnaire administration followed by cognitive interviews in Spanish-speaking Latino patients who are receiving cancer treatment or who have completed treatment for cancer within the past six months at one of the participating sites. | Behavioral: questionnaire administration followed by cognitive interviews<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient-Reported Outcomes, Common Terminology Criteria for Adverse Events, PRO-CTCAE, Native Spanish Speaking, Spanish Translation, Cognitive Interview, Questionnaire, 11-133, Adverse Events, chemotherapy, radiation therapy, treatment in previous 6 months