Arabic Patient-reported Outcome Measures During Radiotherapy for Head and Neck Cancer: a Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Summated Xerostomia Inventory (SXI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Summated Xerostomia Inventory (SXI)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics.(24 months)
研究者
Abdullah Mohamed Alsoghier, PhD
Consultant, Assistant Professor
King Saud University