Clinical trial · Observational
Spanish Translation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Linguistic Validation of the Spanish Translation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
NCT01436240CI-TRIAL-00027757completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to see if questions in English about symptoms that patients may have during cancer treatment are understandable when translated into Spanish. These questions will later be used in future studies to give a better understanding of patient symptoms".
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| questionnaire administration followed by cognitive interviews | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Spanish-speaking Latino participants
- description
- The investigators will conduct up to two rounds of PRO-CTCAE (patient-reported outcome- Common Terminology Criteria for Adverse Events) version questionnaire administration followed by cognitive interviews in Spanish-speaking Latino patients who are receiving cancer treatment or who have completed treatment for cancer within the past six months at one of the participating sites.
- interventionNames
- Behavioral: questionnaire administration followed by cognitive interviews
Primary outcomes (1)
- measure
- the ability for the PRO-CTCAE system to be used in Spanish-speaking populations in the U.S.
- timeFrame
- 2 years
- description
- Patient Questionnaire (either via paper or read to them verbatim), and undergo a subsequent cognitive interview, as described in this protocol. Interviews will be conducted either by bilingual site staff who have been trained to conduct these interviews, or by trained bilingual interviewers from FACITtrans
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 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 (chemotherapy or radiation therapy) 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 or study coordinators renders them unable to understand the items or report on his/her symptoms from the last 7 days. * Participants who have only received surgery are not eligible * If participants request to have the consent form in English, they will not be eligible for participation in this study.
References
Publications (1)
- DERIVEDArnold B, Mitchell SA, Lent L, Mendoza TR, Rogak LJ, Barragan NM, Willis G, Medina M, Lechner S, Penedo FJ, Harness JK, Basch EM; PRO-CTCAE Spanish Translation and Linguistic Validation Study Group. Linguistic validation of the Spanish version of the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Support Care Cancer. 2016 Jul;24(7):2843-51. doi: 10.1007/s00520-015-3062-5. Epub 2016 Feb 2. PMID 26838022