Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457594
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2024-06-09
Brief Title:
Prospective PROM and PREM Analysis Demonstrating Specification Advantage and Language Barriers
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Prospective Cohort Analysis - The Role of General and Specific Patient Reported Outcome and Experience Measures Among Head and Neck Cancer Patients
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Importance
Patient reported outcome and experience measures PROM and PREM constitute a cornerstone of the collective efforts to improve and personalize healthcare systems The EORTC quality of life QOL group developed instruments evaluating general and disease specific oncology QOL questionnaires and the quality of information received Implementation of PREM and relevant PROM is essential for equity better resources utility accessibility and patient centered treatment
Objectives
We describe the EORTC INFO 25 translation process followed by investigation of subpopulation where action is most needed We investigate which QOL questionnaire better reflects clinical parameters among head and neck cancer HNC patients
Design
A prospective cohort Setting Tertiary referral head and neck dedicated surgical service
Participants
Consecutive head and neck cancer adult patients surgically treated recruited between January to December 2022
Exposures
We prospectively analyzed the new EORTC INFO 25 Hebrew questionnaire together with previously established Arabic translated version and the general QLQ-C30 and specific QLQ - HN43 oncology QOL questionnaires
Main Outcomes and Measures
Analyzing the quality of information provided and desired in diverse HNC subgroup of patients
Analyzing which of PROM questionnaire better reflects HNC patients disease and treatment parameters which in turn may predict poorer QOL
Results
We recruited 60 patients consisting of equal female male ratio of which 1666 were native Arabic speaking Validated INFO 25 scores median 626175 were not associated with patients age sex education status disease and treatment parameters Yet the Arabic spoken sub-population had significantly lower scores p0001
In contrast to QLQ-C30 clinical imperative associations were demonstrated between QLQ - HN43 and patients disease stage P0001 admission days p00001 free flap reconstruction P0001 and adjuvant radiotherapy P0001
Conclusions and relevance
The final version of the native EORTC INFO25 translation was approved by the EORTC We demonstrate lower INFO25 scores among the Arabic speaking population suggesting frail equity and accessibility In order to improve patients centered treatment and resource utilization we reveal a strong association between disease severity and treatment aggressiveness and poor quality of life on specific HNC oriented EORTC QLQ - HN43 questionnaire that was not validated on EORTC QLQ-C30 which can be omitted
Patient reported outcome and experience measures PROM and PREM constitute a cornerstone of the collective efforts to improve and personalize healthcare systems The EORTC quality of life QOL group developed instruments evaluating general and disease specific oncology QOL questionnaires and the quality of information received Implementation of PREM and relevant PROM is essential for equity better resources utility accessibility and patient centered treatment
Objectives
We describe the EORTC INFO 25 translation process followed by investigation of subpopulation where action is most needed We investigate which QOL questionnaire better reflects clinical parameters among head and neck cancer HNC patients
Design
A prospective cohort Setting Tertiary referral head and neck dedicated surgical service
Participants
Consecutive head and neck cancer adult patients surgically treated recruited between January to December 2022
Exposures
We prospectively analyzed the new EORTC INFO 25 Hebrew questionnaire together with previously established Arabic translated version and the general QLQ-C30 and specific QLQ - HN43 oncology QOL questionnaires
Main Outcomes and Measures
Analyzing the quality of information provided and desired in diverse HNC subgroup of patients
Analyzing which of PROM questionnaire better reflects HNC patients disease and treatment parameters which in turn may predict poorer QOL
Results
We recruited 60 patients consisting of equal female male ratio of which 1666 were native Arabic speaking Validated INFO 25 scores median 626175 were not associated with patients age sex education status disease and treatment parameters Yet the Arabic spoken sub-population had significantly lower scores p0001
In contrast to QLQ-C30 clinical imperative associations were demonstrated between QLQ - HN43 and patients disease stage P0001 admission days p00001 free flap reconstruction P0001 and adjuvant radiotherapy P0001
Conclusions and relevance
The final version of the native EORTC INFO25 translation was approved by the EORTC We demonstrate lower INFO25 scores among the Arabic speaking population suggesting frail equity and accessibility In order to improve patients centered treatment and resource utilization we reveal a strong association between disease severity and treatment aggressiveness and poor quality of life on specific HNC oriented EORTC QLQ - HN43 questionnaire that was not validated on EORTC QLQ-C30 which can be omitted
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None