NCT04066868

Brief Summary

This open randomized trial investigates, if clinicians complete CTCAE ratings differently when receiving patients' patient-reported outcome (PRO) data prior to their CTCAE completion. The primary objective is 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,013

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

February 10, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2024

Completed
Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

4.8 years

First QC Date

August 19, 2019

Last Update Submit

April 16, 2025

Conditions

Cancer

Keywords

patient-reported outcomes (PRO)common terminology criteria for adverse events (CTCAE)quality of lifeelectronic data assessment

Outcome Measures

Primary Outcomes (3)

  • EORTC Quality of Life Questionnaire C30 and additional questions from the EORTC Item Library

    patient-reported quality of life

    single assessment of quality of life before the medical consultation

  • CTCAE V5.0

    physician 1 rates patient symptoms (17 CTCAE domains matching the EORTC C30 and additional questions)

    single assessment during the medical consultation with physician 1 on the same day of PRO assessment

  • CTCAE V5.0

    physician 2 rates patient symptoms (17 CTCAE domains matching the EORTC C30 and additional questions)

    single assessment during the medical consultation with physician 2 on the same day of PRO assessment

Study Arms (2)

PRO active

EXPERIMENTAL
Other: Patient-reported outcomes assessmentOther: CTCAE ratingOther: PRO data is displayed

PRO not active

ACTIVE COMPARATOR
Other: Patient-reported outcomes assessmentOther: CTCAE rating

Interventions

Patient-reported outcomes assessmentOTHER

Patient-reported outcomes are electronically assessed using EORTC QOL measures

PRO activePRO not active
CTCAE ratingOTHER

CTCAE Ratings are conducted by clinicians

PRO activePRO not active
PRO data is displayedOTHER

PRO data is displayed right next to the CTCAE rating

PRO active

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • any Cancer diagnosis
  • current treatment with chemotherapy or immunotherapy
  • symptom burden equal or greater score 3 of the screening question "On a scale of 0 to 10, to what degree did you experience physical or emotional symptoms/problems during the last week?"
  • ability to understand the questions linguistically and cognitively
  • written informed consent
  • psychiatric diagnosis or mental health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezirkskrankenhaus Kufstein

Kufstein, 6330, Austria

Location

Related Publications (2)

  • Wintner LM, Sztankay M, Abdel-Razeq H, Hamdan-Mansour R, Caocci G, Mouillet G, Kikawa Y, Shibata N, Krishnamurthy MN, Joshi A, Krishnatry R, Jain A, Pappot H, Petranovic D, Trobentar A, Schmidt H, Schulze S, Tararykova A, Zabernigg A, Giesinger JM, Holzner B; EORTC Quality of Life Group. Inter-rater reliability of CTCAE assessments with or without EORTC patient-reported outcome data in a mixed cancer population: a multinational, open-label, randomised controlled trial. Lancet Oncol. 2026 Jan 19:S1470-2045(25)00679-5. doi: 10.1016/S1470-2045(25)00679-5. Online ahead of print.

    PMID: 41570841DERIVED

  • Wintner LM, Giesinger JM, Sztankay M, Bottomley A, Holzner B; EORTC Quality of Life Group. Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial. Trials. 2020 Oct 13;21(1):849. doi: 10.1186/s13063-020-04745-w.

    PMID: 33050917DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2019

First Posted

August 26, 2019

Study Start

February 10, 2020

Primary Completion

December 6, 2024

Study Completion

December 6, 2024

Last Updated

April 20, 2025

Record last verified: 2025-04

Locations

AU(1)