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Spanish Translation and Linguistic Validation 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

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Trial Information

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


This study describes a study to assess a newly created Spanish version of the National
Cancer Institute's (NCI's) patient toxicity questionnaire, the Patient Reported Outcomes
Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), via
semi-structured interviews among Spanish-speaking patients with cancer in the United States.

Inclusion 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 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 renders
them unable to understand the items or report on his/her symptoms from the last 7
days.

- 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:

Time Perspective: Prospective

Outcome Measure:

Linguistically validate a Spanish-language version of PRO-CTCAE symptom in the native Spanish-speaking population.

Principal Investigator

Sandra A Mitchell, C.R.N.P.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999912040

NCT ID:

NCT01517152

Start Date:

January 2012

Completion Date:

Related Keywords:

  • Cancer
  • Cognitive Testing
  • Translation
  • Questionnaire
  • Adverse Events

Name

Location

National Cancer Institute (NCI), 9000 Rockville PikeBethesda, Maryland  20892