Clinical trial · Observational
Patient-Reported Outcomes Version of Common Terminology Criteria (CTCPRO) Cognitive Debriefing
Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Hematologic Diseases | — | UNRESOLVED | — |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interview | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Interview
- description
- Review list of 25 cancer symptoms, 20-30 minute audio-taped personal interview and 15-20 minute questionnaire.
- interventionNames
- Behavioral: Interview
Primary outcomes (1)
- measure
- Comprehension of Patient Reported Outcome (PRO) Criteria
- timeFrame
- 1 day
- description
- The primary assessment tool will be the cognitive interview protocol.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must be aged 18 and over 2. Able to read and understand English 3. Patients with a high school education or less 4. Patients who are undergoing chemotherapy or radiotherapy with curative or palliative intent. 5. Patient is able to provide informed consent. 6. All types of cancer diagnosis Exclusion Criteria: 1\) Significant cognitive impairment as determined by research staff's judgment
References
Publications (0)
Data not yet available