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.

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.

questionnaire administration followed by cognitive interviews

Ethan Basch, MD, MSc

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".

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

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

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

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

National Cancer Institute (NCI)

FACITtrans, LLC

Memorial Sloan Kettering Cancer Center

Blood and Lymph Conditions

All Conditions

Hematologic Diseases

Review list of 25 cancer symptoms, 20-30 minute audio-taped personal interview and 15-20 minute questionnaire.

Interview

Tito Mendoza, PhD, MS, MED

The scientific aim of this study is to evaluate patient comprehension of the 77 newly developed items as well as the extent to which the items correspond to the concepts of interest for each patient reported outcome (PRO).

A secondary aim of this study is to evaluate the usability of the technology interface for collecting the PRO data of the PRO-CTCAE system once it has been built to accommodate the learning garnered during the cognitive interviews.

Screening:

The study staff will talk to your doctor or nurse, and/or look at your medical record, to see if you are currently receiving treatment. The study staff will also look at your medical record to see if you have any future clinic visits at M. D. Anderson. This is the first step of "screening" to help the researchers decide if you are eligible to take part in this study.

If you are found to be possibly eligible to take part in this study based on the first step of screening, the second step of screening will occur:

At your clinic visit, the study staff will talk to you about this study. You will be asked questions about school, which should take about 2 minutes.

Study Visit If you are found to be eligible and you agree to take part in this study, you will look at a list of 34 cancer symptoms if you are a male or a list of 36 cancer symptoms if you are a female. You will fill out a questionnaire that asks you to mark each symptom that you may be experiencing at this time, and other information about the symptoms such as how often they occur.

After you complete the questionnaire, you will be interviewed by the study staff about how you answered some of the questions. For example, you will be asked if the words describing the symptoms were easy to understand or if other words may be more clear.

There are no right or wrong answers to any part of this study. Researchers are interested in your thoughts about the words.

Filling out the questionnaire will take about 10-15 minutes. The interview will take about 20-30 minutes.

Study Data:

The interview will be audio-recorded. Only the study staff will hear the recording. The recording will be saved on a password-protected computer that can only be accessed by the study staff.

Your responses will be coded without using your name or other personal identifying information. Only the study staff will have access to the code numbers and be able to identify you.

Your responses will not be shared with your doctor without your consent.

In some of the questions, you will be asked about your feelings (for example, whether you feel unhappy or anxious). If your responses show that you may be having emotional difficulties, you will be given a list of community agencies that provide services for emotional issues. You may also speak to your doctor about your feelings.

Length of Study:

After the study visit, your active participation will be over. In some cases, the study staff may call you to ask that you clarify some of your answers. Your medical record may also be checked to confirm the cancer diagnosis and your treatments.

This is an investigational study. Up to 100 patients will take part in this study. Up to 20 will be enrolled at M. D. Anderson.

Patient-Reported Outcomes Version of Common Terminology Criteria (CTCPRO) Cognitive Debriefing

Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing

The primary assessment tool will be the cognitive interview protocol.

Patients receiving active treatment for cancer or initiating treatment for cancer in the next 7 days

Amylou C. Dueck, PhD

This study is being done to try out questions from a large set of questions called the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE is a set of questions which asks patients about their symptoms. This study will look at properties of these questions and will provide information about how these questions can be improved for research studies. PRO-CTCAE questions were developed under a contract from the National Cancer Institute (NCI) to allow patients to self-report symptoms in future cancer clinical trials. Patients with cancer receiving treatment will complete a web-based questionnaire containing PRO-CTCAE questions and a paper booklet containing a commonly used questionnaire for assessing quality of life, functioning, and symptoms at two visits one to six weeks apart. Some patients will additionally complete web-based questionnaires containing PRO-CTCAE questions weekly for four to five weeks, while completing a daily questionnaire containing PRO-CTCAE questions using an automated telephone system. Lastly, a small number of patients will complete only a single visit in which a web-based, telephone-based, and paper-based questionnaire containing PRO-CTCAE items is completed in addition to a paper booklet containing a commonly used questionnaire for assessing quality of life, functioning, and symptoms. The primary hypothesis is that scores for PRO-CTCAE questions will differ between patients with high versus low general well-being as measured by your doctor using a scale called the Eastern Cooperative Oncology Group Performance Score.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Spanish Translation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	NCT01436240	Cancer	questionnaire a...	18 Years -	Memorial Sloan Kettering Cancer Center
Spanish Translation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	NCT01436240	Cancer	questionnaire a...	18 Years -	Memorial Sloan Kettering Cancer Center
Patient-Reported Outcomes Version of Common Terminology Criteria (CTCPRO) Cognitive Debriefing	NCT00909207	Advanced Cancer... Hematologic Dis... Solid Tumors	Interview	18 Years -	M.D. Anderson Cancer Center
Validation Study of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	NCT02158637	Cancer		18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for common terminology criteria for adverse events