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Completed

NCT Number: NCT06457594

Prospective PROM and PREM Analysis Demonstrating Specification Advantage and Language Barriers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hadassah Medical Organization

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main inclusion Criteria:

  • Adult patients (≥18 years)
  • Head and Neck cancer patients surgically treated

Main exclusion Criteria:

  • Illiterate

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. Questionnaire scores

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2024
First posted
Jun 13, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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