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Testing a Spanish Version of a Patient Toxicity Questionnaire

This study is currently recruiting participants.
Verified October 2012 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01517152
First received: January 24, 2012
Last updated: May 23, 2013
Last verified: October 2012
History of Changes
  Purpose

Background:

  • The Common Terminology Criteria for Adverse Events (CTCAE) is a list of toxicities and side effects that may occur when people are having cancer treatment. Doctors and nurses use this list to describe the side effects patients experience from cancer treatment. We have developed a questionnaire to ask people having cancer treatment directly about common symptoms and side effects and to supply this information to their doctors and nurses. This questionnaire is known as PRO-CTCAE and is completed by a patient.
  • PRO-CTCAE was originally developed in English. Researchers want to develop a Spanish version of the patient questionnaire. To test whether the questions are well understood and whether it is easy to complete the questionnaire, the researchers will interview individuals whose primary language is Spanish and who are being treated for different types of cancer.

Objectives:

- To test a Spanish version of the PRO-CTCAE questionnaire.

Eligibility:

- Latinos at least 18 years of age who are having or have recently finished cancer treatments and whose main language is Spanish

Design:

  • Participants will complete a questionnaire in Spanish with selected questions from the translated PRO-CTCAE. They will discuss their answers and any difficulties they might have had in understanding or answer the questions with an interviewer, who will take notes and record comments and suggestions.
  • Literacy is not required for this study. Participants may opt to have the questions read aloud to them by an interviewer.

Condition
Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Spanish Translation and Linguistic Validation of the Patient- Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Linguistically validate a Spanish-language version of PRO-CTCAE symptom in the native Spanish-speaking population.

Estimated Enrollment: 120
Study Start Date: January 2012
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517152

Contacts
Contact: Sandra A Mitchell, C.R.N.P. (301) 435-6750 mitchlls@mail.nih.gov

Locations
United States, Maryland
National Cancer Institute (NCI), 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sandra A Mitchell, C.R.N.P. National Cancer Institute (NCI)
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT01517152     History of Changes
Other Study ID Numbers: 999912040, 12-C-N040
Study First Received: January 24, 2012
Last Updated: May 23, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cognitive Testing
Translation
Questionnaire
Adverse Events

ClinicalTrials.gov processed this record on May 23, 2013