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".

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: questionnaire administration followed by cognitive interviews

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States
      • St Joseph's Hospital
  • Florida
    • Miami, Florida, United States
      • University of Miami
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Hektoen /Stroger Hospital
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States
      • Ralph Lauren Center for Cancer Care and Prevention
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: M.D. Anderson Cancer Center; National Cancer Institute (NCI); University of Miami; Ralph Lauren Center for Cancer Care and Prevention; St. Joseph's Hospital, Los Angeles; Hektoen Stroger Hospital; FACITtrans, LLC
• Investigators: Principal Investigator: Ethan Basch, MD, MSc, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• Arnold B, Mitchell SA, Lent L, Mendoza TR, Rogak LJ, Barragan 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.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2011
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: September 14, 2011
• First Submitted That Met QC Criteria: September 15, 2011
• First Posted (Estimate): September 19, 2011

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: chemotherapy; Questionnaire; radiation therapy; Adverse Events; Patient-Reported Outcomes; PRO-CTCAE; Common Terminology Criteria for Adverse Events; Cognitive Interview; Native Spanish Speaking; Spanish Translation; 11-133; treatment in previous 6 months
• Other Study ID Numbers: 11-133