Prospective PROM and PREM Analysis Demonstrating Specification Advantage and Language Barriers
NCT ID: NCT06457594
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2022-01-01
2024-06-08
Brief Summary
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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:
The investigators describe the EORTC INFO 25 translation process followed by investigation of subpopulation where action is most needed. The investigators 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:
The investigators prospectively analyzed the new EORTC INFO 25 Hebrew questionnaire together with previously established Arabic translated version and the general (QLQ-C30) and specific (QLQ - H\&N43) 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:
The investigators recruited 60 patients, consisting of equal female: male ratio, of which 16.66% were native Arabic speaking. Validated INFO 25 scores (median 62.6±17.5) were not associated with patients' age, sex, education status, disease, and treatment parameters. Yet, the Arabic spoken sub-population had significantly lower scores (p\<0.001).
In contrast to QLQ-C30, clinical imperative associations were demonstrated between QLQ - H\&N43 and patients' disease stage (P\<0.001), admission days (p\<0.0001), free flap reconstruction (P\<0.001) and adjuvant radiotherapy (P\<0.001).
Conclusions and relevance:
The final version of the native EORTC INFO25 translation was approved by the EORTC. The investigators demonstrate lower INFO25 scores among the Arabic speaking population, suggesting frail equity and accessibility. In order to improve patients' centered treatment and resource utilization, the investigators reveal a strong association between disease severity and treatment aggressiveness and poor quality of life on specific, HNC oriented, EORTC QLQ - H\&N43 questionnaire that was not validated on EORTC QLQ-C30, which can be omitted.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Questionnaire
EORTC QLQ-INFO25 EORTC QLQ - H\&N43 and EORTC QLQ-C30
Eligibility Criteria
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Inclusion Criteria
* Head and Neck cancer patients surgically treated
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Locations
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Hadassah Medical Organization
Jerusalem, , Israel
Countries
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Other Identifiers
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QOL HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id
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