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

Completed

• Conditions: Cancer
• Interventions: Behavioral: questionnaire administration followed by cognitive interviews

• Registration Number: NCT01436240
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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".

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-19
• Status Verified: 2017-05
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-22
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spanish-speaking Latino participants	questionnaire administration followed by cognitive interviews	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.

Primary Outcome Measures

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

Trial Locations

Locations (6)

University of Miami; 🇺🇸 Miami, Florida, United States

Md Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Ralph Lauren Center for Cancer Care and Prevention; 🇺🇸 New York, New York, United States

St Joseph'S Hospital; 🇺🇸 Los Angeles, California, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Hektoen /Stroger Hospital; 🇺🇸 Chicago, Illinois, United States