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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436240
• Other study ID #: 11-133
• Status: Completed
• Phase: N/A
• First received: September 14, 2011
• Last updated: May 22, 2017
• Start date: September 2011
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Hektoen /Stroger Hospital	Chicago	Illinois
United States	Md Anderson Cancer Center	Houston	Texas
United States	St Joseph'S Hospital	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Ralph Lauren Center for Cancer Care and Prevention	New York	New York

Sponsors (8)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	FACITtrans, LLC, Hektoen Stroger Hospital, M.D. Anderson Cancer Center, National Cancer Institute (NCI), Ralph Lauren Center for Cancer Care and Prevention, St. Joseph’s Hospital, Los Angeles, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the ability for the PRO-CTCAE system to be used in Spanish-speaking populations in the U.S.	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	2 years

External Links

•   Memorial Sloan Kettering Cancer Center