LymphomasNCT01031641
Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing
An observational study of Lymphomas and Leukemias, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
Background: Currently, National Cancer Institute treatment trials use clinical staff reporting to monitor adverse side effects. The clinical staff reports draw on items from the Common Terminology Criteria for Adverse Events (CTCAE). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lymphomas, Leukemias, Multiple Cancers
- How many people
- 1,448 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Nov 2009to 16 Jul 2020
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients receiving chemotherapy or radiation treatment.@@@
Who may be able to join
- Note: Patients meeting the below inclusion criteria who are registered to the study should be assigned by the individual enrolling/registering institution to one of the three Patient Groups as defined in Section 5.1.
- Age greater than or equal to18 years.
- Disease and treatment matching 1 of the 6 following cohorts:
- Cohort Breast: Breast cancer patients initiiating chemotherapy within the next 7 days or currently receiving chemotherapy.
- Cohort Lymphoma/Myeloma: Lymphoma/myeloma cancer patients initiating chemotherapy within the next 7 days or currently receiving chemotherapy.
- Cohort Prostate/Bladder: Metastatic prostate or bladder cancer patients initiating chemotherapy within the next 7 days or currently receiving chemotherapy.
Show all 21Show fewer
- Cohort Lung: Metastatic or locally advanced lung cancer patients EITHER:
- initiating chemotherapy within the next 7 days or currently receiving chemotherapy; OR
- receiving daily radiation therapy for greater than or equal to 21 more days (concurrent chemotherapy allowed).
- Cohort Colorectal: Metastatic colorectal cancer patients initiating chemotherapy within the next 7 days or currently receiving chemotherapy.
- Cohort Head/Neck/Gastroesophageal: Head/neck/gastroesophageal cancer patients receiving daily radiation therapy for greater thanor equal to 21 more days (concurrent chemotherapy allowed).
- Cohort NCCCP: Cancer patients with cancer type NOT matching one of the previous six cohorts listed above and enrolled through an NCCCP site. Patient must be initiating active anti-cancer treatment (chemotherapy, targeted agents/biologics, and/or radiation therapy; hormonal therapy alone is not allowed) within the next 7 days or currently receiving active anti-cancer treatment (chemotherapy, targeted agents/biologics, and/or radiation therapy; hormonal therapy alone is not allowed).
- NOTE: A patient registered through an NCCCP site matching one of the previous six cohorts should be registered through that cohort. Only NCCCP patients NOT matching one of the previous six cohorts should be registered through this cohort.
- Willing to return to registering institution in 1-6 weeks.
- ECOG Performance Status (PS):0-4.
- Ability to understand English and read questions on a computer screen (or listen to questions via headphones and then select responses on a screen).
- Ability to hear and respond to questions in English using a telephone keypad.
- NOTE: Required for patients enrolling in Groups A and B only; not required for Group C.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Provide informed written consent.
- Willing to be reached at a single telephone number (without extension or operator involvement) for the next 21 to 28 days. NOTE: Required for patients enrolling in Groups A and B only; not required for Group C.
Who cannot join
- Clinically significant cognitive or memory impairment in the opinion of clinical or research staff.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MD Anderson Cancer Center
Houston, Texas, 77030-4096
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
About this study
Background:
- Currently, National Cancer Institute treatment trials use clinical staff reporting to monitor adverse side effects. The clinical staff reports draw on items from the Common Terminology Criteria for Adverse Events (CTCAE).
- Several of the items in the CTCAE can be adapted for use in patient self-reporting of side effects. Researchers are interested in developing a patient-reported outcome (PRO) approach to the CTCAE.
Read more
Objectives:
- To develop questions that can be used to create a patient-reported outcome version of the CTCAE (PRO-CTCAE).
- To evaluate patient comprehension of and test the usefulness of the PRO-CTCAE questions among diverse groups of patients.
Eligibility:
- Individuals 18 years of age and older who are receiving chemotherapy or radiotherapy as cancer treatment.
- Participants must be able to speak and understand English.
Design:
- Researchers will conduct up to three rounds of interviews with patients currently receiving chemotherapy or radiation therapy treatments for cancer.
- Participants will be recruited independently from four different clinical treatment sites. At least 25 percent of patients will have an educational attainment of high school or less.
- Each patient will complete a two-part protocol, including a set of PROs that will be followed by a series of questions to evaluate patient comprehension, memory, perceived clarity, and judgment of the PROs.
- The research will be completed in approximately 1 hour, and participants will receive a small amount of compensation for their time and participation.
Read the detailed description
Background:
The current approach to monitoring adverse symptom events in NCI-sponsored treatment trials is clinical staff reporting, using items from the Common Terminology Criteria for Averse Events (CTCAE). Of the 1,059 discrete items in the CTCAE, approximately 77 contain a subjective component sufficient enough to be amenable to patient self-reporting such as pain, fatigue, nausea,
and hair loss. There is general agreement that the patient, via a self-report, is the best source for reporting symptoms. Studies have shown that when compared to clinician reports, patients report earlier onset, greater severity, and longer duration of symptoms.
In September 2008, the NCI awarded a contract (N02-PC-85002-29; PI: Basch; Co-I: Hay) to support the development of an electronic-based and psychometrically robust patient-reported outcomes version of the symptom-related AEs listed in the CTCAE in an effort to improve the accuracy and precision of grading of this class of AEs. To achieve this goal, we will conduct cognitive interviews with 77 newly-developed PRO items that will subsequently be subjected to psychometric analysis, usability testing, and feasibility testing in a range of treatment settings among diverse groups of patients.
Objectives:
The overall goal of this proposed study is to evaluate patient comprehension of 77 newly developed PRO items in a range of treatment settings among diverse groups of cancer patients. The objectives are to evaluate: 1) patients understanding of the language and 2) the usability of the technology interface for collecting the PRO data of the PRO-CTCAE system.
Eligibility:
Patients will be eligible for the study if they are 1) aged 18 or older; 2) English-fluent; 3) undergoing chemotherapy and/or radiotherapy with curative or palliative intent; and 4) can provide informed consent.
Design:
We will conduct up to three rounds of cognitive interviews in 100 cancer patients at participating cancer centers including MSKCC, Dana Farber Cancer Institute, Duke and M.D. Anderson. After completion of the first round of interviews, results will be analyzed for problematic items. Revised items will be reviewed in subsequent rounds as needed. The final PRO-CTCAE items will proceed to usability testing. Usability testing will comprise three main components: 1) observation of users interacting with the web-based assessment system coupled with think aloud protocols and extensive field notes; 2) user feedback using semi-structured interviews and short surveys; and 3) web analytics including tracking for different web pages, with clickstream analysis. Usability testing will be conducted with 60 clinical research staff and 60 patients.
- Conditions
- Lymphomas, Leukemias, Multiple Cancers
- Keywords
- Patient-Reported Outcomes, Symptoms, Instrument Development, Adverse Events, Questionnaire, Patient Reported Outcomes
- Medical subject headings
- Lymphoma, Leukemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate patients understanding of measurement tool items
Patient report of symptom experience
Measured: Study completion
Evaluate the usability of the technology interface for collecting the PRO data of the PRO-CTCAE system
Patient report of technology usability
Measured: Study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study start19 Nov 2009
- Primary completion1 Jun 2012
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for LymphomasStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 1,448 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kathleen Castro, R.N., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031641
- Sponsor's protocol ID
- 999910026
- Other IDs
- 10-C-N026
- Status last verified
- Jul 2020
- First submitted
- 11 Dec 2009
- Last updated
- 17 Jul 2020
- Results posted
- No
Publications
Clark MA, Armstrong G, Bonacore L. Measuring sexual orientation and gender expression among middle-aged and older women in a cancer screening study. J Cancer Educ. 2005 Summer;20(2):108-12. doi: 10.1207/s15430154jce2002_12.
PubMed 16083375Diefenbach MA, Weinstein ND, O'Reilly J. Scales for assessing perceptions of health hazard susceptibility. Health Educ Res. 1993 Jun;8(2):181-92. doi: 10.1093/her/8.2.181.
PubMed 10148827Friedenreich CM, Courneya KS, Bryant HE. Relation between intensity of physical activity and breast cancer risk reduction. Med Sci Sports Exerc. 2001 Sep;33(9):1538-45. doi: 10.1097/00005768-200109000-00018.
PubMed 11528344Atkinson TM, Reeve BB, Dueck AC, Bennett AV, Mendoza TR, Rogak LJ, Basch E, Li Y. Application of a Bayesian graded response model to characterize areas of disagreement between clinician and patient grading of symptomatic adverse events. J Patient Rep Outcomes. 2018 Dec 4;2(1):56. doi: 10.1186/s41687-018-0086-x.
PubMed 30515599Schoen MW, Basch E, Hudson LL, Chung AE, Mendoza TR, Mitchell SA, St Germain D, Baumgartner P, Sit L, Rogak LJ, Shouery M, Shalley E, Reeve BB, Fawzy MR, Bhavsar NA, Cleeland C, Schrag D, Dueck AC, Abernethy AP. Software for Administering the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study. JMIR Hum Factors. 2018 Jul 16;5(3):e10070. doi: 10.2196/10070.
PubMed 30012546
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. 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
- NCT01031641
- Acronym / sponsor ID
- 999910026
- Conditions
- Lymphomas, Leukemias, Multiple Cancers
- Keywords
- Patient-Reported Outcomes, Symptoms, Instrument Development, Adverse Events, Questionnaire, Patient Reported Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,448 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 19 Nov 2009 (actual)
- Primary completion
- 1 Jun 2012 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 14 Dec 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.
Background:
- Currently, National Cancer Institute treatment trials use clinical staff reporting to monitor adverse side effects. The clinical staff reports draw on items from the Common Terminology Criteria for Adverse Events (CTCAE).
- Several of the items in the CTCAE can be adapted for use in patient self-reporting of side effects. Researchers are interested in developing a patient-reported outcome (PRO) approach to the CTCAE.
Objectives:
- To develop questions that can be used to create a patient-reported outcome version of the CTCAE (PRO-CTCAE).
- To evaluate patient comprehension of and test the usefulness of the PRO-CTCAE questions among diverse groups of patients.
Eligibility:
- Individuals 18 years of age and older who are receiving chemotherapy or radiotherapy as cancer treatment.
- Participants must be able to speak and understand English.
Design:
- Researchers will conduct up to three rounds of interviews with patients currently receiving chemotherapy or radiation therapy treatments for cancer.
- Participants will be recruited independently from four different clinical treatment sites. At least 25 percent of patients will have an educational attainment of high school or less.
- Each patient will complete a two-part protocol, including a set of PROs that will be followed by a series of questions to evaluate patient comprehension, memory, perceived clarity, and judgment of the PROs.
- The research will be completed in approximately 1 hour, and participants will receive a small amount of compensation for their time and participation.
Detailed description
Background:
The current approach to monitoring adverse symptom events in NCI-sponsored treatment trials is clinical staff reporting, using items from the Common Terminology Criteria for Averse Events (CTCAE). Of the 1,059 discrete items in the CTCAE, approximately 77 contain a subjective component sufficient enough to be amenable to patient self-reporting such as pain, fatigue, nausea,
and hair loss. There is general agreement that the patient, via a self-report, is the best source for reporting symptoms. Studies have shown that when compared to clinician reports, patients report earlier onset, greater severity, and longer duration of symptoms.
In September 2008, the NCI awarded a contract (N02-PC-85002-29; PI: Basch; Co-I: Hay) to support the development of an electronic-based and psychometrically robust patient-reported outcomes version of the symptom-related AEs listed in the CTCAE in an effort to improve the accuracy and precision of grading of this class of AEs. To achieve this goal, we will conduct cognitive interviews with 77 newly-developed PRO items that will subsequently be subjected to psychometric analysis, usability testing, and feasibility testing in a range of treatment settings among diverse groups of patients.
Objectives:
The overall goal of this proposed study is to evaluate patient comprehension of 77 newly developed PRO items in a range of treatment settings among diverse groups of cancer patients. The objectives are to evaluate: 1) patients understanding of the language and 2) the usability of the technology interface for collecting the PRO data of the PRO-CTCAE system.
Eligibility:
Patients will be eligible for the study if they are 1) aged 18 or older; 2) English-fluent; 3) undergoing chemotherapy and/or radiotherapy with curative or palliative intent; and 4) can provide informed consent.
Design:
We will conduct up to three rounds of cognitive interviews in 100 cancer patients at participating cancer centers including MSKCC, Dana Farber Cancer Institute, Duke and M.D. Anderson. After completion of the first round of interviews, results will be analyzed for problematic items. Revised items will be reviewed in subsequent rounds as needed. The final PRO-CTCAE items will proceed to usability testing. Usability testing will comprise three main components: 1) observation of users interacting with the web-based assessment system coupled with think aloud protocols and extensive field notes; 2) user feedback using semi-structured interviews and short surveys; and 3) web analytics including tracking for different web pages, with clickstream analysis. Usability testing will be conducted with 60 clinical research staff and 60 patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients receiving chemotherapy or radiation treatment.@@@
Key inclusion criteria (21 listed)
- Note: Patients meeting the below inclusion criteria who are registered to the study should be assigned by the individual enrolling/registering institution to one of the three Patient Groups as defined in Section 5.1.
- Age greater than or equal to18 years.
- Disease and treatment matching 1 of the 6 following cohorts:
- Cohort Breast: Breast cancer patients initiiating chemotherapy within the next 7 days or currently receiving chemotherapy.
- Cohort Lymphoma/Myeloma: Lymphoma/myeloma cancer patients initiating chemotherapy within the next 7 days or currently receiving chemotherapy.
Key exclusion criteria (1 listed)
- Clinically significant cognitive or memory impairment in the opinion of clinical or research staff.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate patients understanding of measurement tool items
Time frame: Study completion
Patient report of symptom experience
Evaluate the usability of the technology interface for collecting the PRO data of the PRO-CTCAE system
Time frame: Study completion
Patient report of technology usability
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 17 Jul 2020.
- Background: PubMed 16083375Clark MA, Armstrong G, Bonacore L. Measuring sexual orientation and gender expression among middle-aged and older women in a cancer screening study. J Cancer Educ. 2005 Summer;20(2):108-12. doi: 10.1207/s15430154jce2002_12.
- Background: PubMed 10148827Diefenbach MA, Weinstein ND, O'Reilly J. Scales for assessing perceptions of health hazard susceptibility. Health Educ Res. 1993 Jun;8(2):181-92. doi: 10.1093/her/8.2.181.
- Background: PubMed 11528344Friedenreich CM, Courneya KS, Bryant HE. Relation between intensity of physical activity and breast cancer risk reduction. Med Sci Sports Exerc. 2001 Sep;33(9):1538-45. doi: 10.1097/00005768-200109000-00018.
- Derived from this study: PubMed 30515599Atkinson TM, Reeve BB, Dueck AC, Bennett AV, Mendoza TR, Rogak LJ, Basch E, Li Y. Application of a Bayesian graded response model to characterize areas of disagreement between clinician and patient grading of symptomatic adverse events. J Patient Rep Outcomes. 2018 Dec 4;2(1):56. doi: 10.1186/s41687-018-0086-x.
- Derived from this study: PubMed 30012546Schoen MW, Basch E, Hudson LL, Chung AE, Mendoza TR, Mitchell SA, St Germain D, Baumgartner P, Sit L, Rogak LJ, Shouery M, Shalley E, Reeve BB, Fawzy MR, Bhavsar NA, Cleeland C, Schrag D, Dueck AC, Abernethy AP. Software for Administering the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study. JMIR Hum Factors. 2018 Jul 16;5(3):e10070. doi: 10.2196/10070.
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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.
Kathleen Castro, R.N. principal investigator
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphomas and Leukemias, run by National Cancer Institute (NCI) at 2 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 21 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 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Evaluate patients understanding of measurement tool items (time frame: Study completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01031641, which also lists 5 linked publications.
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 17 Jul 2020.