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NCT Number: NCT06662929

Arabic PRO Measures for Head and Neck Cancer Radiotherapy.

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.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Mouth Diseases Mouth Neoplasms Nasopharyngeal Cancer Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oral Cancer Oral Neoplasm Oropharyngeal Neoplasms Oropharynx Cancer Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases Tongue Cancer Tongue Diseases Tongue Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Radiation

Radiation

Radiotherapy for the Head & Neck Cancer

Primary outcomes

  1. Summated Xerostomia Inventory (SXI)

    Time frame: 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.

  2. Patient-Reported Oral Mucositis Symptom (PROM) scale

    Time frame: 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.

  3. The Arabic University of Washington questionnaire (UW-QOL v4)

    Time frame: 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.

  4. The Arabic Brief Fatigue Inventory (ArBFI)

    Time frame: 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.

  5. Patient Concerns Inventory - Head and Neck (PCI-HNC)

    Time frame: 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 outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdullah M Alsoghier, PhD

CONTACT

[email protected]

+966114677423

Saif A Aljabab, DABR

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

Arabic Patient-reported Outcome Measures During Radiotherapy for Head and Neck Cancer: a Validation Study

Acronym: PROMs

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

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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