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

This study has been completed.
Sponsor:
Collaborators:
Ralph Lauren Center for Cancer Care and Prevention
M.D. Anderson Cancer Center
St. Joseph’s Hospital, Los Angeles
Hektoen Stroger Hospital
University of Miami
National Cancer Institute (NCI)
FACITtrans, LLC
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01436240
First received: September 14, 2011
Last updated: May 22, 2017
Last verified: May 2017
September 14, 2011
May 22, 2017
September 2011
May 2017   (Final data collection date for primary outcome measure)
the ability for the PRO-CTCAE system to be used in Spanish-speaking populations in the U.S. [ Time Frame: 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
Same as current
Complete list of historical versions of study NCT01436240 on ClinicalTrials.gov Archive Site
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Spanish Translation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Linguistic Validation of the Spanish Translation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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".
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Eligible patients will be recruited from five different collaborating sites: MSKCC/Ralph Lauren Center for Cancer Care and Prevention, MD Anderson, University of Miami, Stroger Hospital, and St. Joseph's Hospital. Approximately 40 participants will be enrolled at MSKCC; 120 participants will be enrolled in total.
Cancer
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.
Spanish-speaking Latino participants
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.
Intervention: Behavioral: questionnaire administration followed by cognitive interviews
Arnold B, Mitchell SA, Lent L, Mendoza TR, Rogak LJ, Barragán NM, Willis G, Medina M, Lechner S, Penedo FJ, Harness JK, Basch EM; PRO-CTCAE Spanish Translation and Linguistic Validation Study Group. Linguistic validation of the Spanish version of the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Support Care Cancer. 2016 Jul;24(7):2843-51. doi: 10.1007/s00520-015-3062-5. Epub 2016 Feb 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
May 2017
May 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01436240
11-133
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Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
  • Ralph Lauren Center for Cancer Care and Prevention
  • M.D. Anderson Cancer Center
  • St. Joseph’s Hospital, Los Angeles
  • Hektoen Stroger Hospital
  • University of Miami
  • National Cancer Institute (NCI)
  • FACITtrans, LLC
Principal Investigator: Ethan Basch, MD, MSc Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP