Testing a Spanish Version of a Patient Toxicity Questionnaire

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.

Background:

The NCI s PRO-CTCAE initiative has developed and preliminarily validated a library of items
in English intended for patient self-reporting of treatment toxicity and symptoms during
participation in cancer clinical trials. These items have also been translated into Spanish,
using a methodology consistent with internationally agreed-upon guidelines for developing
global translations.

Objective:

To linguistically validate a Spanish-language version of PRO-CTCAE symptom items to assure
that they are culturally, semantically, and linguistically proficient to the native
Spanish-speaking population with cancer in the United States.

Eligibility:

Research participants must be (i) 18 years or older; (ii) able to provide informed consent;
(iii) currently undergoing systemic cancer treatment or immediately post-treatment; (iv)
speak Spanish as their primary language.

Design:

Two rounds of PRO-CTCAE questionnaire administration followed by cognitive interviews will be
conducted with Spanish speakers residing in the US. Between 40-60 interviews will be
conducted in the first round, and up to 20 additional interviews will be conducted in an
optional second round; total accrual will be 80 participants. Participating sites have been
selected to assure access to participants from a range of Spanish-speaking countries of
origin, and those with lower levels of educational attainment and acculturation.

Cognitive interviewing methodology provides an approach to determining that language
adaptations produced through forward and back translation are conceptually equivalent to the
English source document, and cross-culturally valid. Data derived from cognitive interviewing
permit a conclusion that item meanings are qualitatively equivalent after translation and
across individuals, and permit refinement, as necessary, to render terminologies and phrasing
that are culturally acceptable and relevant to the target population.

A large number of PRO-CTCAE symptom items will be evaluated in this study, and in addition,
several of the items are gender-specific. To minimize patient burden and ensure that the item
pool is uniformly evaluated relative to participant gender, education, acculturation and
country of origin, items have been distributed across four questionnaires, each matched with
a tailored interview schedule. Each participant will complete one questionnaire and
participate in one interview.

Interviewers are Bachelor- and Masters-prepared research staff who are bilingual and have
experience with cognitive interviewing in clinical research and/or cancer treatment settings.

Interview summaries will be produced in English by each interviewer; audiotapes will be
reviewed as necessary. These summaries together with relevant field notes will be assembled
into a report, and used to further refine the translated PRO-CTCAE items.

- 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.