Testing a Spanish Version of a Patient Toxicity Questionnaire

NCT01517152 | Completed

• 2 other identifiers: 99991204012-C-N040
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Colon Cancer; Lung Cancer; Lymphoma; Myeloma

Keywords

Symptoms; Patient-Reported Outcomes; Linguistic Validation; Toxicity; PRO-CTCAE; Adverse Events; Translation; Questionnaire

Outcome Measures

Primary Outcomes (1)

• Perceptions of the clarity and ease of response to a series of questions

  At enrollment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Basch 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 BACKGROUND

• Bonomi 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 BACKGROUND

• Johnson 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Lung Neoplasms; Lymphoma; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sandra A Mitchell, C.R.N.P.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 25, 2012
• Study Start: January 4, 2012
• Study Completion: October 9, 2018
• Last Updated: December 16, 2019

Record last verified: 2018-10-09

Locations

US (1)