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临床试验/NCT06295783
NCT06295783
招募中
不适用

Prospective Evaluation of the Relation Between Different Questionnaires Measuring Radiation-induced Side-effect

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 300 人2024年6月10日

概览

阶段
不适用
干预措施
MDASI-HN
疾病 / 适应症
Radiation
发起方
M.D. Anderson Cancer Center
入组人数
300
试验地点
1
主要终点
Safety and adverse events (AEs)
状态
招募中
最后更新
3个月前

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.

注册库
clinicaltrials.gov
开始日期
2024年6月10日
结束日期
2027年2月1日
最后更新
3个月前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

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: 1. The MDASI-HN questionnaire (standard-of-care) has 28 questions. 2. The EORTC QLQ-HN35 questionnaire has 35 questions. 3. The EORTC QLQ-30 questionnaire has 30 questions.

干预措施: MDASI-HN

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: 1. The MDASI-HN questionnaire (standard-of-care) has 28 questions. 2. The EORTC QLQ-HN35 questionnaire has 35 questions. 3. The EORTC QLQ-30 questionnaire has 30 questions.

干预措施: EORTC QLQ-C30

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: 1. The MDASI-HN questionnaire (standard-of-care) has 28 questions. 2. The EORTC QLQ-HN35 questionnaire has 35 questions. 3. The EORTC QLQ-30 questionnaire has 30 questions.

干预措施: EORTC HN35

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)

研究点 (1)

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