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Prospective PROM and PREM Analysis Demonstrating Specification Advantage and Language Barriers

Prospective Cohort Analysis - the Role of General and Specific Patient Reported Outcome and Experience Measures Among Head and Neck Cancer Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06457594
Enrollment
60
Registered
2024-06-13
Start date
2022-01-01
Completion date
2024-06-08
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

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: 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.

Interventions

OTHERQuestionnaire

EORTC QLQ-INFO25 EORTC QLQ - H&N43 and EORTC QLQ-C30

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Main inclusion Criteria: * Adult patients (≥18 years) * Head and Neck cancer patients surgically treated Main

Exclusion criteria

\* Illiterate

Design outcomes

Primary

MeasureTime frame
Questionnaire scores1 year

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026