Prospective Evaluation of the Relation Between Different Questionnaires Measuring Radiation-induced Side-effect
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Safety and adverse events (AEs)
研究概览
简要总结
To learn more about how you would rate the intensity or severity of your symptoms during or after radiation therapy using questionnaires with different rating scales.
详细描述
Primary Objectives:
• To investigate how different toxicity questionnaires with different scoring systems can be reliably translated to each other by estimating different measures of correlation between items and summary scores across different questionnaires.
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
- •Age ≥18 years
- •English as a primary language
- •Participants with a diagnosis of HNC undergoing active curative RT or having received curative RT within the past 5 years at MD Anderson
- •Ability to complete the survey(s) of their own volition
排除标准
- •Age < 18 years
- •Non-English speaking participants
- •Participants who are receiving or have received RT in a non-HN site.
- •Participants in follow up and over 5 years from post-treatment
- •Neurocognitive deficits that render patients unable to complete the survey(s) on their own.
研究组 & 干预措施
Head and Neck Cancer (HNC) Questionnaire
Participants will be asked to fill out three head and neck cancer (HNC) questionnaires during your visits to the clinic:
- The MDASI-HN questionnaire (standard-of-care) has 28 questions.
- The EORTC QLQ-HN35 questionnaire has 35 questions.
- The EORTC QLQ-30 questionnaire has 30 questions.
干预措施: MDASI-HN (Other)
Head and Neck Cancer (HNC) Questionnaire
Participants will be asked to fill out three head and neck cancer (HNC) questionnaires during your visits to the clinic:
- The MDASI-HN questionnaire (standard-of-care) has 28 questions.
- The EORTC QLQ-HN35 questionnaire has 35 questions.
- The EORTC QLQ-30 questionnaire has 30 questions.
干预措施: EORTC QLQ-C30 (Other)
Head and Neck Cancer (HNC) Questionnaire
Participants will be asked to fill out three head and neck cancer (HNC) questionnaires during your visits to the clinic:
- The MDASI-HN questionnaire (standard-of-care) has 28 questions.
- The EORTC QLQ-HN35 questionnaire has 35 questions.
- The EORTC QLQ-30 questionnaire has 30 questions.
干预措施: EORTC HN35 (Other)
结局指标
主要结局
Safety and adverse events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
次要结局
未报告次要终点