Prospective PROM and PREM Analysis Demonstrating Specification Advantage and Language Barriers

NCT06457594 | Completed

• 1 other identifier: QOL HMO-CTIL
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Questionnaire scores

  1 year

Interventions

Questionnaire OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive head and neck cancer patients were prospectively recruited between January to December 2022 at referral outpatient surgical clinics.

You may qualify if:

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

You may not qualify if:

• \* Illiterate

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 13, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: June 8, 2024
• Last Updated: March 19, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)