Evaluating the Use of PRO Measures for Improving the Inter-Rater Reliability of CTCAE Ratings
- Registration Number
- CTRI/2023/10/058202
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.The study population will be adult cancer patients fulfilling the following inclusion criteria: patients
aged above 18.
2.Any cancer diagnosis (no more than 20% per diagnostic group) current treatment with chemotherapy or immunotherapy inpatient or day clinic setting
3.Scoring 3 or above on an initial screening question (On a scale of 0 to 10, to what degree did you experience physical or emotional symptoms/problems during the last week? ?).
4.No severe cognitive impairments written informed consent.
Inclusion criteria for physicians performing CTCAE ratings will be at least one year of professional experience in oncology. Chemotherapy has been selected because the EORTC QLQ-C30 covers common AEs associated with this treatment. Immunotherapy has been added for being an increasingly important treatment option.
There are no exclusion criteria for this study. All types of cancer patients will be enrolled on the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate superior inter-rater reliability of CTCAE ratings from physicians relying on EORTC PRO <br/ ><br>data as additional data source over traditional CTCAE ratings not including PRO information.Timepoint: Not applicable to this type of study. This is a single-day assessment study where data will be collected after the patient develops toxicities on receiving standard treatment.
- Secondary Outcome Measures
Name Time Method To compare the reliability of CTCAE ratings across different types of AEs.Timepoint: Not applicable to this type of study. This is a single-day assessment study where data will be collected after the patient develops toxicities on receiving standard treatment.;To identify characteristics of physicians that impact on the reliability of CTCAE ratings.Timepoint: Not applicable to this type of study. This is a single-day assessment study where data will be collected after the patient develops toxicities on receiving standard treatment.;To improve the sensitivity of AE detection in cancer patients through PRO assessments.Timepoint: Not applicable to this type of study. This is a single-day assessment study where data will be collected after the patient develops toxicities on receiving standard treatment.