Spanish Translation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
This study is currently recruiting participants.
Verified January 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborators:
Ralph Lauren Center for Cancer Care and Prevention
M.D. Anderson Cancer Center
St. Joseph’s Hospital, Los Angeles
Hektoen Stroger Hospital
University of Miami
FACITtrans, LLC
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01436240
First received: September 14, 2011
Last updated: January 25, 2013
Last verified: January 2013
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Purpose
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".
| Condition | Intervention |
|---|---|
|
Cancer |
Behavioral: questionnaire administration followed by cognitive interviews |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | Linguistic Validation of the Spanish Translation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- the ability for the PRO-CTCAE system to be used in Spanish-speaking populations in the U.S. [ Time Frame: 2 years ] [ Designated as safety issue: No ]Patient Questionnaire (either via paper or read to them verbatim), and undergo a subsequent cognitive interview, as described in this protocol. Interviews will be conducted either by bilingual site staff who have been trained to conduct these interviews, or by trained bilingual interviewers from FACITtrans
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Spanish-speaking Latino participants
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.
|
Behavioral: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Eligible patients will be recruited from five different collaborating sites: MSKCC/Ralph Lauren Center for Cancer Care and Prevention, MD Anderson, University of Miami, Stroger Hospital, and St. Joseph's Hospital. Approximately 40 participants will be enrolled at MSKCC; 120 participants will be enrolled in total.
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436240
Contacts
| Contact: Ethan Basch, MD, MSc | (919)843-3055 | |
| Contact: Talya Salz, PhD | 646-735-8082 |
Locations
| United States, California | |
| St Joseph'S Hospital | Recruiting |
| Los Angeles, California, United States | |
| Contact: Jay Harness, MD | |
| Principal Investigator: Jay Harness, MD | |
| United States, Florida | |
| University of Miami | Recruiting |
| Miami, Florida, United States | |
| Contact: Suzanne Lechner, PhD | |
| Principal Investigator: Suzanne Lechner, PhD | |
| United States, Illinois | |
| Hektoen /Stroger Hospital | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: David Cella, PhD | |
| Principal Investigator: David Cella, PhD | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Ethan Basch, MD, MSc 919-843-3055 | |
| Contact: Talya Salz, PhD 646-735-8082 | |
| Principal Investigator: Ethan Basch, MD | |
| Ralph Lauren Center for Cancer Care and Prevention | Recruiting |
| New York, New York, United States | |
| Contact: Joseph R Yoe, MD 212-987-1777 ext 5366 | |
| Principal Investigator: Joseph R Yoe, MD | |
| United States, Texas | |
| Md Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Tito Mendoza, PhD | |
| Principal Investigator: Tito Mendoza, PhD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Ralph Lauren Center for Cancer Care and Prevention
M.D. Anderson Cancer Center
St. Joseph’s Hospital, Los Angeles
Hektoen Stroger Hospital
University of Miami
FACITtrans, LLC
Investigators
| Principal Investigator: | Ethan Basch, MD, MSc | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01436240 History of Changes |
| Other Study ID Numbers: | 11-133 |
| Study First Received: | September 14, 2011 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Patient-Reported Outcomes Common Terminology Criteria for Adverse Events PRO-CTCAE Native Spanish Speaking Spanish Translation Cognitive Interview |
Questionnaire 11-133 Adverse Events chemotherapy radiation therapy treatment in previous 6 months |
ClinicalTrials.gov processed this record on June 18, 2013