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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
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
FACITtrans, LLC
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01436240
First received: September 14, 2011
Last updated: August 13, 2014
Last verified: August 2014

September 14, 2011
August 13, 2014
September 2011
September 2015   (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 ] [ Designated as safety issue: No ]
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: Retrospective
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
September 2015
September 2015   (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.
Both
18 Years and older
No
Contact: Ethan Basch, MD, MSc (919)843-3055
Contact: Talya Salz, PhD 646-735-8082
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
August 2014

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