Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing
|First Received Date ICMJE||December 11, 2009|
|Last Updated Date||March 14, 2014|
|Start Date ICMJE||November 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Patient comprehension of questions and terms used to describe possible symptoms they may experience in treatment (e.g., pain, fatigue, sleep disturbance)|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01031641 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Ease of navigation on the computerized system that administers the questionnaire.|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||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 ICMJE||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. In contrast to cancer treatment protocols, directly collecting symptom data is routine in symptom management clinical trials. Among investigators, regulatory agencies, and pharmaceutical sponsors, increasing attention is being paid to incorporating self-reports when documenting AEs. 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, ultimately, feasibility testing in a range of treatment settings among diverse groups of patients. This current protocol focuses on the procedure for cognitive interviewing and usability testing of the newly developed items.
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 primary objective is to evaluate patients understanding of the language. The secondary objective is to evaluate 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. Patients will be excluded who have significant cognitive impairment.
We will conduct up to three rounds of cognitive interviews in 100 cancer patients at participating cancer centers and satellite sites including MSKCC, Dana Farber Cancer Institute (DFCI), 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 second and third rounds as needed. The final PRO-CTCAE items will proceed to usability testing and validation. 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. The validation study will assess the convergent validity of each PRO-CTCAE item by comparing each item between patients with ECOG PS 0-1 versus 2-4 at the visit 1 time point. Convergent validity will be further assessed by repeating the primary analysis at time point 2.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Retrospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||1499|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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 and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01031641|
|Other Study ID Numbers ICMJE||999910026, 10-C-N026|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP