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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01031641
First received: December 11, 2009
Last updated: March 14, 2014
Last verified: August 2013
  Purpose

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.

Condition
Adverse Events
Usability Testing
Cognitive Testing

Study Type: Observational
Study Design: Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Patient comprehension of questions and terms used to describe possible symptoms they may experience in treatment (e.g., pain, fatigue, sleep disturbance)

Secondary Outcome Measures:
  • Ease of navigation on the computerized system that administers the questionnaire.

Estimated Enrollment: 1499
Study Start Date: November 2009
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. 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.

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 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.

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. Patients will be excluded who have significant cognitive impairment.

Design:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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.
  • Cohort Lung: Metastatic or locally advanced lung cancer patients EITHER:

< 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.

  • 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.

EXCLUSION CRITERIA:

- Clinically significant cognitive or memory impairment in the opinion of clinical or research staff.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031641

Locations
United States, Maryland
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Investigators
Principal Investigator: Kathleen Castro, R.N. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01031641     History of Changes
Other Study ID Numbers: 999910026, 10-C-N026
Study First Received: December 11, 2009
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cognitive Testing
Usability Testing
Patient-Reported Outcomes
Questionnaire
Adverse Events
Patient Reported Outcomes

ClinicalTrials.gov processed this record on April 23, 2014