Clinical trial NCT06662929: Arabic PRO Measures for Head and Neck Cancer Radiotherapy.
Official title: Arabic Patient-reported Outcome Measures During Radiotherapy for Head and Neck Cancer: a Validation Study
Study type: OBSERVATIONAL
Overall status: 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
Keywords: PROMs
Head and Neck Cancer
Radiotherapy
COSMIN
Cancer
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Target Population: The study is targeting males and females aged 18 years or above, and receiving radiotherapy for the HNC at the King Saud University Medical City.

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Summated Xerostomia Inventory (SXI)
timeFrame: 24 months
measure: Patient-Reported Oral Mucositis Symptom (PROM) scale
timeFrame: 24 months
measure: The Arabic University of Washington questionnaire (UW-QOL v4)
timeFrame: 24 months
measure: The Arabic Brief Fatigue Inventory (ArBFI)
timeFrame: 24 months
measure: Patient Concerns Inventory - Head and Neck (PCI-HNC)
timeFrame: 24 months
Secondary outcomes:
measure: To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics.
timeFrame: 24 months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University Medical City
Study officials:
References:
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