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

NCT01436240 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 112

Last updated 2017-05-23

No results posted yet for this study

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".

Conditions

Interventions

BEHAVIORAL

questionnaire administration followed by cognitive interviews

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.

Sponsors & Collaborators

  • Ralph Lauren Center for Cancer Care and Prevention

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • St. Joseph's Hospital, Los Angeles

    collaborator UNKNOWN

  • Hektoen Stroger Hospital

    collaborator UNKNOWN

  • University of Miami

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • FACITtrans, LLC

    collaborator OTHER

  • Memorial Sloan Kettering Cancer Center

    lead OTHER

Principal Investigators

  • Ethan Basch, MD, MSc · Memorial Sloan Kettering Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01436240 on ClinicalTrials.gov