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


N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer

Thank you

Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

the ability for the PRO-CTCAE system to be used in Spanish-speaking populations in the U.S.

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Ethan Basch, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-133

NCT ID:

NCT01436240

Start Date:

September 2011

Completion Date:

September 2013

Related Keywords:

  • Cancer
  • 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

Name

Location
MD Anderson Cancer Center Houston, Texas  77030-4096
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Miami Miami, Florida  33136
Ralph Lauren Center for Cancer Care and Prevention New York, New York  10035
St Joseph'S Hospital Los Angeles, California  
Hektoen /Stroger Hospital Chicago, Illinois  60612