This trial is active, not recruiting.

Condition cancer
Treatment questionnaire administration followed by cognitive interviews
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Ralph Lauren Center for Cancer Care and Prevention
Start date September 2011
End date September 2017
Trial size 120 participants
Trial identifier NCT01436240, 11-133


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".

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
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.
questionnaire administration followed by cognitive interviews
Each cognitive interviewing procedure will include two parts. Participants will first be asked to independently complete a series of PRO-CTCAE symptom items in a Patient Questionnaire. Following completion by the participant of the Patient Questionnaire containing PRO-CTCAE items, the bilingual interviewer will query participants regarding item comprehension, relevance, inclusiveness, cultural appropriateness, and cognitive processes used to generate responses, via a semi-scripted cognitive debriefing interview developed to assure consistency across interviews.

Primary Outcomes

the ability for the PRO-CTCAE system to be used in Spanish-speaking populations in the U.S.
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Linguistic Validation of the Spanish Translation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Principal investigator Ethan Basch, MD, MSc
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.