Advanced CancersNCT00909207
Patient-Reported Outcomes Version of Common Terminology Criteria (CTCPRO) Cognitive Debriefing
An observational study of Advanced Cancers and Hematologic Diseases, run by M.D. Anderson Cancer Center at 4 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers, Hematologic Diseases, Solid Tumors
- What is being tested?
- Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2009to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals, age 18 years or older, receiving chemotherapy and/or radiation therapy.
Who may be able to join
- Patients must be aged 18 and over
- Able to read and understand English
- Patients with a high school education or less
- Patients who are undergoing chemotherapy or radiotherapy with curative or palliative intent.
- Patient is able to provide informed consent.
- All types of cancer diagnosis
Who cannot join
- 1) Significant cognitive impairment as determined by research staff's judgment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Duke University Medical Center
Durham, North Carolina, 27708
UT MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing
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.
Read the detailed description
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.
- Conditions
- Advanced Cancers, Hematologic Diseases, Solid Tumors
- Being tested
- Interview
- Keywords
- Advanced Cancers, Hematologic Disorders, Solid Tumors, Cognitive Interview, Patient-Reported Outcomes, PRO, Common Terminology Criteria for Adverse Events, CTCAE, PRO-CTCAE, Cancer Symptoms, Interview
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Review list of 25 cancer symptoms, 20-30 minute audio-taped personal interview and 15-20 minute questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Interview | Review list of 25 cancer symptoms, 20-30 minute audio-taped personal interview and 15-20 minute questionnaire. Receives: Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehension of Patient Reported Outcome (PRO) Criteria
The primary assessment tool will be the cognitive interview protocol.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tito Mendoza, PhD, MS, MED, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909207
- Sponsor's protocol ID
- 2009-0182
- Status last verified
- Jul 2014
- First submitted
- 22 May 2009
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing
- ClinicalTrials.gov ID
- NCT00909207
- Acronym / sponsor ID
- 2009-0182
- Conditions
- Advanced Cancers, Hematologic Diseases, Solid Tumors
- Keywords
- Advanced Cancers, Hematologic Disorders, Solid Tumors, Cognitive Interview, Patient-Reported Outcomes, PRO, Common Terminology Criteria for Adverse Events, CTCAE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2009
- Primary completion
- Jun 2013 (actual)
- First posted
- 27 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interview | – | Behavioral: InterviewReview list of 25 cancer symptoms, 20-30 minute audio-taped personal interview and 15-20 minute questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals, age 18 years or older, receiving chemotherapy and/or radiation therapy.
Key inclusion criteria (6 listed)
- Patients must be aged 18 and over
- Able to read and understand English
- Patients with a high school education or less
- Patients who are undergoing chemotherapy or radiotherapy with curative or palliative intent.
- Patient is able to provide informed consent.
Key exclusion criteria (1 listed)
- 1) Significant cognitive impairment as determined by research staff's judgment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewReview list of 25 cancer symptoms, 20-30 minute audio-taped personal interview and 15-20 minute questionnaire. | Behavioural | Interview |
Primary outcome
Comprehension of Patient Reported Outcome (PRO) Criteria
Time frame: 1 day
The primary assessment tool will be the cognitive interview protocol.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tito Mendoza, PhD, MS, MED study chair
UT MD Anderson Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancers and Hematologic Diseases, run by M.D. Anderson Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehension of Patient Reported Outcome (PRO) Criteria (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.