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Testing a Spanish Version of a Patient Toxicity Questionnaire

This study has been completed.
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) Identifier:
First received: January 24, 2012
Last updated: June 30, 2017
Last verified: September 21, 2016


  • 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.


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


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


  • 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.

Breast Cancer Colon Cancer Lung Cancer Lymphoma Myeloma

Study Type: Observational
Study Design: Observational Model: Cohort
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:

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

Primary Outcome Measures:
  • Perceptions of the clarity and ease of response to a series of questions [ Time Frame: At enrollment ]

Estimated Enrollment: 120
Study Start Date: January 2, 2012
  Show Detailed Description


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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.


  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01517152

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

Responsible Party: National Cancer Institute (NCI) Identifier: NCT01517152     History of Changes
Other Study ID Numbers: 999912040
Study First Received: January 24, 2012
Last Updated: June 30, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Patient-Reported Outcomes
Linguistic Validation
Adverse Events
Questionnaire processed this record on September 21, 2017