Arabic PRO Measures for Head and Neck Cancer Radiotherapy.

Recruiting

• Conditions: Head and Neck Cancer; Head and Neck Neoplasms; Head and Neck Squamous Cell Carcinoma; Oropharynx Cancer; Nasopharyngeal Cancer; Oral Cancer; Tongue Cancer; Oral Neoplasm

• Registration Number: NCT06662929
• Lead Sponsor: King Saud University

Brief Summary

The goal of Arabic patient-reported outcome measures during radiotherapy for head and neck cancer is to test the patient-reported outcome measure (PROM) tools. PROM tools are not validated cross-culturally in Arabic-speaking patient populations, which limits their use in our clinical setting. Validation of these PROM tools will allow clinicians to identify the concerns related to our patient population and measure the outcome of our interventions. Main objectives are:

* To further validate (cross-culture) the PROM instruments related to head and neck cancer (HNC) in Arabic patients.

* To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics.

The participants will be given tasks to complete 6 tools survey before, during, and after radiotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-10-19
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-26
• Last Update Submitted: 2024-10-26
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-06-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Adults aged 18 or above and who is planned for receiving and who is currently receiving and who had already received radiotherapy for the HNC at King Saud University Medical City.

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Exclusion Criteria

• Individuals who are less than 18 years, presence of debilitating disease (e.g. heart failure) or who lack the capacity to read, understand and sign the informed consent and those.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Summated Xerostomia Inventory (SXI)	24 months	The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
Patient-Reported Oral Mucositis Symptom (PROM) scale	24 months	The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
The Arabic University of Washington questionnaire (UW-QOL v4)	24 months	The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
The Arabic Brief Fatigue Inventory (ArBFI)	24 months	The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.
Patient Concerns Inventory - Head and Neck (PCI-HNC)	24 months	The study aimed to assess the validity (face, content and construct) and reliability (internal consistency and test-retest) of this inventory in patients who received radiotherapy for head and neck cancer. These will be conducted in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.

Secondary Outcome Measures

Name	Time	Method
To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics.	24 months	Descriptive statistics \[frequencies with percentage (%) for categorical variables, and the mean (±SD) and median for numerical variables collected\] will be used to for patients' demographic and clinical characteristics and study measures using SPSS v.22 (IBM, Armonk, New York). Level of significance will be set at or below 0.05. Correlations between study findings will be assessed using Pearson or Spearman's correlation coefficients - based on normality of data. Regression analyses for patient characteristics and measurement variables.

Trial Locations

Locations (1)

King Saud University Medical City; 🇸🇦 Riyadh, Saudi Arabia