Testing a Spanish Version of a Patient Toxicity Questionnaire
Condition: Breast Cancer; Colon Cancer; Lung Cancer; Lymphoma; Myeloma
MeSH terms: Colonic Neoplasms
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Keywords: Symptoms; Patient-Reported Outcomes; Linguistic Validation; Toxicity; PRO-CTCAE; Adverse Events; Translation; Questionnaire