Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma, Nasopharyngeal Cancer, Oral Cancer, Oral Neoplasm, Oropharynx Cancer, Tongue Cancer
Conditions
Keywords
PROMs, Head and Neck Cancer, Radiotherapy, COSMIN, Cancer
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.
Interventions
RADIATIONRadiation
Radiotherapy for the Head & Neck Cancer
Sponsors
King Saud University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Saudi Arabia
Contacts
Primary ContactAbdullah M Alsoghier, PhD
Backup ContactSaif A Aljabab, DABR
Outcome results
None listed