Clinical trial · Observational
Testing a Spanish Version of a Patient Toxicity Questionnaire
Spanish Translation and Linguistic Validation of the Patient- Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Perceptions of the clarity and ease of response to a series of questions
- timeFrame
- At enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
* 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.
References
Publications (3)
- BACKGROUNDBasch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010 Mar 11;362(10):865-9. doi: 10.1056/NEJMp0911494. No abstract available. PMID 20220181
- BACKGROUNDBonomi AE, Cella DF, Hahn EA, Bjordal K, Sperner-Unterweger B, Gangeri L, Bergman B, Willems-Groot J, Hanquet P, Zittoun R. Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Qual Life Res. 1996 Jun;5(3):309-20. doi: 10.1007/BF00433915. PMID 8763799
- BACKGROUNDJohnson TP. Methods and frameworks for crosscultural measurement. Med Care. 2006 Nov;44(11 Suppl 3):S17-20. doi: 10.1097/01.mlr.0000245424.16482.f1. PMID 17060823