Spanish Translation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
This trial is active, not recruiting.
|Treatment||questionnaire administration followed by cognitive interviews|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Collaborator||Ralph Lauren Center for Cancer Care and Prevention|
|Start date||September 2011|
|End date||September 2017|
|Trial size||120 participants|
|Trial identifier||NCT01436240, 11-133|
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".
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Los Angeles, CA||St Joseph'S Hospital||no longer recruiting|
|Miami, FL||University of Miami||no longer recruiting|
|Chicago, IL||Hektoen /Stroger Hospital||no longer recruiting|
|New York, NY||Memorial Sloan Kettering Cancer Center||no longer recruiting|
|New York, NY||Ralph Lauren Center for Cancer Care and Prevention||no longer recruiting|
|Houston, TX||Md Anderson Cancer Center||no longer recruiting|
the ability for the PRO-CTCAE system to be used in Spanish-speaking populations in the U.S.
time frame: 2 years
Male or female participants at least 18 years old.
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.
|Official title||Linguistic Validation of the Spanish Translation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)|
|Principal investigator||Ethan Basch, MD, MSc|
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