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 Identifier: NCT01031641|
Recruitment Status : Completed
First Posted : December 14, 2009
Last Update Posted : April 5, 2018
|First Submitted Date||December 11, 2009|
|First Posted Date||December 14, 2009|
|Last Update Posted Date||April 5, 2018|
|Study Start Date||December 1, 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01031641 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing|
|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 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.
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.
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.
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
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
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.
<TAB>-initiating chemotherapy within the next 7 days or currently receiving chemotherapy; OR
<TAB>- receiving daily radiation therapy for greater than or equal to 21 more days (concurrent chemotherapy allowed).
<TAB>- Cohort Colorectal: Metastatic colorectal cancer patients initiating chemotherapy within the next 7 days or currently receiving chemotherapy.
<TAB>- Cohort Head/Neck/Gastroesophageal: Head/neck/gastroesophageal cancer patients receiving daily radiation therapy for greater thanor equal to 21 more days (concurrent chemotherapy allowed).
<TAB>- 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.
NOTE: Required for patients enrolling in Groups A and B only; not required for Group C.
- Clinically significant cognitive or memory impairment in the opinion of clinical or research staff.
|Ages||18 Years to 100 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||999910026
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )|
|Study Sponsor||National Cancer Institute (NCI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 25, 2017|