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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:
ClinicalTrials.gov Identifier:
NCT01436240
First Posted: September 19, 2011
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
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".

Condition Intervention
Cancer Behavioral: questionnaire administration followed by cognitive interviews

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Linguistic Validation of the Spanish Translation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • 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


Enrollment: 112
Actual Study Start Date: September 2011
Study Completion Date: May 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436240


Locations
United States, California
St Joseph'S Hospital
Los Angeles, California, United States
United States, Florida
University of Miami
Miami, Florida, United States
United States, Illinois
Hektoen /Stroger Hospital
Chicago, Illinois, United States, 60612
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Ralph Lauren Center for Cancer Care and Prevention
New York, New York, United States
United States, Texas
Md Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
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
Investigators
Principal Investigator: Ethan Basch, MD, MSc Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01436240     History of Changes
Other Study ID Numbers: 11-133
First Submitted: September 14, 2011
First Posted: September 19, 2011
Last Update Posted: May 23, 2017
Last Verified: May 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
Patient-Reported Outcomes
Common Terminology Criteria for Adverse Events
PRO-CTCAE
Native Spanish Speaking
Spanish Translation
Cognitive Interview
Questionnaire
11-133
Adverse Events
chemotherapy
radiation therapy
treatment in previous 6 months