Testing a Spanish Version of a Patient Toxicity Questionnaire

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01517152
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : April 5, 2018
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


  • 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.

Condition or disease
Breast Cancer Colon Cancer Lung Cancer Lymphoma Myeloma

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 112 participants
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)
Study Start Date : January 4, 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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)

Responsible Party: National Cancer Institute (NCI) Identifier: NCT01517152     History of Changes
Other Study ID Numbers: 999912040
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: October 2, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Patient-Reported Outcomes
Linguistic Validation
Adverse Events