Spanish Translation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Cancer

Treatments: Behavioral: questionnaire administration followed by cognitive interviews

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01436240

11-133

Details and patient eligibility

About

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".

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

112 participants in 1 patient group

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.

Treatment:

Behavioral: questionnaire administration followed by cognitive interviews