Adverse events during early phase clinical trials in oncology
Research type
Research Study
Full title
Adverse events during early phase clinical trials in oncology: do patient reported toxicities differ from clinician recorded data?
IRAS ID
243087
Contact name
Amy Quinton
Contact email
Sponsor organisation
Velindre NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Adverse events in cancer clinical trials for new cytotoxic drugs are recorded by study investigators using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. However, there is emerging evidence that there may be discord between how adverse effects of trial drugs are described by patients, and how they are documented using the CTCAE format. Significant qualitative information – such as the impact of chronic unpleasant and distressing symptoms on daily life – can be lost in translation when classified using the CTCAE.
In light of this, the National Cancer Institute has developed a specific questionnaire for patients, the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™). The questionnaire arranges 78 symptomatic adverse effects into discrete groups; for each symptom, patients rate 1) frequency of symptoms, 2) severity of symptoms, and 3) interference with daily life on a five-point Likert scale.
The PRO-CTCAE questionnaire has been validated and adopted internationally. However, the benefits of its use have not been evaluated at the Velindre Cancer Centre trials unit, where all research studies mandate the use of CTCAE V4.03. The aim of this project is therefore to assess whether adopting this questionnaire alongside the trial-directed clinician reported CTCAE V4.03 will result in improved understanding of the impact of new and emerging drugs on patients’ quality of life.
Patients will be recruited from existing cancer drug trials at Velindre Cancer Centre. When attending their routine appointment with their trials lead clinician, they will be asked about any adverse symptoms experienced over the last 7 days (as is current practice). Following that appointment, they will be consented and asked to complete a modified version of the PRO-CTCAE questionnaire (shortened to evaluate just 5 of the most commonly reported adverse effects, for ease of analysis in this pilot feasibility study).
REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0083
Date of REC Opinion
25 Feb 2019
REC opinion
Favourable Opinion