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 June 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: June 25, 2014
Last verified: June 2014
  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: Retrospective
Official Title: Linguistic Validation of the Spanish Translation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Resource links provided by NLM:


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 ] [ 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


Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436240

Contacts
Contact: Ethan Basch, MD, MSc (919)843-3055
Contact: Talya Salz, PhD 646-735-8082

Locations
United States, California
St Joseph'S Hospital Active, not recruiting
Los Angeles, California, United States
United States, Florida
University of Miami Recruiting
Miami, Florida, United States
Contact: Suzanne Lechner, PhD         
Principal Investigator: Suzanne Lechner, PhD         
United States, Illinois
Hektoen /Stroger Hospital Active, not recruiting
Chicago, Illinois, United States, 60612
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Ethan Basch, MD, MSc    919-843-3055      
Contact: Talya Salz, PhD    646-735-8082      
Principal Investigator: Ethan Basch, MD         
Ralph Lauren Center for Cancer Care and Prevention Recruiting
New York, New York, United States
Contact: Joseph R Yoe, MD    212-987-1777 ext 5366      
Principal Investigator: Joseph R Yoe, MD         
United States, Texas
Md Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Tito Mendoza, PhD         
Principal Investigator: Tito Mendoza, PhD         
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
FACITtrans, LLC
Investigators
Principal Investigator: Ethan Basch, MD, MSc Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01436240     History of Changes
Other Study ID Numbers: 11-133
Study First Received: September 14, 2011
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on July 22, 2014