Patient reported outcome measure for Common Terminology Criteria for Adverse Event Ratings
Not Applicable
- Registration Number
- CTRI/2023/04/051665
- Lead Sponsor
- Innsbruck Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Patients aged above 18
2)Any cancer diagnosis (no more than 20% per diagnostic group)
3)Current treatment with chemotherapy or immunotherapy
4)Inpatient or day clinic setting
5)Scoring 3 or above on an initial screening question (â??On a scale of 0 to 10, to what degree did you experience physical or emotional symptoms/problems during the last week?â??)
6)No severe cognitive impairments
7)Written informed consent
Exclusion Criteria
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 The overall objective of the study is to evaluate the impact of providing PRO data to physicians <br/ ><br>on the accuracy of AE information, assessed by using CTCAE ratings. As there is no goldstandard for AE ratings available, accuracy will be investigated in terms of inter-rater reliability. <br/ ><br>ï?· Primary objective: To demonstrate superior inter-rater reliability of CTCAE ratings <br/ ><br>from physicians relying on EORTC PRO data as additional data <br/ ><br>source over traditional CTCAE ratings not including PRO <br/ ><br>information.Timepoint: On the day of enrolment
- Secondary Outcome Measures
Name Time Method Secondary objectives: <br/ ><br>o To improve the sensitivity of AE detection in cancer patients through PRO <br/ ><br>assessments. <br/ ><br>o To compare the reliability of CTCAE ratings across different types of AEs. <br/ ><br>o To identify characteristics of physicians that impact on the reliability of CTCAE <br/ ><br>ratings.Timepoint: On the day of enrolment