Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C501- Malignant neoplasm of central portion of breast Health Condition 3: C060- Malignant neoplasm of cheek mucosa Health Condition 4: C562- Malignant neoplasm of left ovary Health Condition 5: C300- Malignant neoplasm of nasal cavity Health Condition 6: C508- Malignant neoplasm of overlappingsites of breast Health Condition 7: C348- Malignant neoplasm of overlappingsites of bronchus and lung Health Condition 8: C5
Conditions
Interventions
Intervention1: Adverse event assessment by using patient reported outcomes: The patients complaints/adverse events will be assessed by using a patient reported outcome measure.
These will be compared
Sponsors
Innsbruck Medical University
Eligibility
Inclusion criteria
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
Exclusion criteria: There are no exclusion criteria for this study. All types of cancer patients will be enrolled on the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall objective of the study is to evaluate the impact of providing PRO data to physicians 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. ï?· Primary objective: To demonstrate superior inter-rater reliability of CTCAE ratings from physicians relying on EORTC PRO data as additional data source over traditional CTCAE ratings not including PRO information.Timepoint: On the day of enrolment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: o To improve the sensitivity of AE detection in cancer patients through PRO assessments. o To compare the reliability of CTCAE ratings across different types of AEs. o To identify characteristics of physicians that impact on the reliability of CTCAE ratings.Timepoint: On the day of enrolment | — |
Countries
Austria, Denmark, France, Germany, India, Italy, Japan, Jordan
Contacts
Public ContactDr Manjunath Nookala Krishnamurthy
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre
Outcome results
None listed