Arabic PRO Measures for Head and Neck Cancer Radiotherapy.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKing Saud University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Radiation

    Radiation

    Radiotherapy for the Head \& Neck Cancer

Treatment groups

125 Participants
are divided into 1 treatment group
Group A: Adult aged 18 years or above, and receiving radiotherapy for the HNC.1 intervention

Trial outcomes

Primary outcomes

1

Summated Xerostomia Inventory (SXI)

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.

Time frame
24 months
2

Patient-Reported Oral Mucositis Symptom (PROM) scale

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.

Time frame
24 months
3

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

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.

Time frame
24 months
4

The Arabic Brief Fatigue Inventory (ArBFI)

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.

Time frame
24 months

Secondary outcomes

1

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

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.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.