Quality-Of-Life Assessment in Patients With Head and Neck Cancer Treated With Radiation Therapy
Impact of Quality of Life Assessment in Routine Oncology Practice for Head and Neck's Cancer Patients, Treated by Radiotherapy: Impact on the Satisfaction With Care, the Health Related Quality of Life and on the Toxicity
RATIONALE: Gathering information over time about patients' quality-of-life and satisfaction with care may help doctors plan the best treatment and help patients live more comfortably.
PURPOSE: This randomized clinical trial is studying quality-of-life assessment in patients with head and neck cancer treated with radiation therapy.
研究概览
详细说明
OBJECTIVES:
Primary
- To evaluate the impact of quality-of-life assessment in routine oncology practice on satisfaction with care, health-related quality-of-life, and toxicity in patients with primary nonmetastatic head and neck cancer treated with radiotherapy.
Secondary
- To evaluate the feasibility of using quality-of-life tools in routine oncology practice.
- To evaluate the impact on the occurrence of toxicity.
- To determine the impact on overall survival.
- To study the concordance between the toxicity reported by the clinician and those reported by the patient quality-of-life questionnaires.
OUTLINE: Patients are stratified according to sex, tumor localization, and TNM stage. Patients are randomized to 1 of 2 arms.
- Arm I: Patients complete quality-of-life questionnaires (EORTC tools only, including EORTC QLQ-SAT32, EORTC QLQ-C30, and specific module QLQ-H&N35/Euroqol EQ-5D) before each consultation with the clinician for one year.
- Arm II: Patients undergo standard follow-up care comprising consultation with the clinician for one year.
After completion of study, patients are followed up every 3 months for 1 year and then at 2 years.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Dijon、法国、21079
- 招聘中
- Centre de Lutte Contre le Cancer Georges-Francois Leclerc
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接触：
- Contact Person
- 电话号码：33-3-8073-7784
- 邮箱：pmaingon@dijon.fnclcc.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
- Diagnosis of primary nonmetastatic head and neck cancer
- No other primary cancer localizations
- No second tumor localization at the time of diagnosis
- Must be planning to be treated initially with radiotherapy
PATIENT CHARACTERISTICS:
- No cognitive impairment or psychiatric history
- No history of other cancer
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
学习计划
研究是如何设计的？
研究衡量的是什么？
主要结果指标
结果测量 |
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Satisfaction of care (EORTC QLQ-SAT32)
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Quality of life (EORTC QLQ-C30 and specific module QLQ-H&N35/Euroqol EQ-5D)
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次要结果测量
结果测量 |
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总生存期
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Toxicity (occurrence and length) according to NCI-CTC version 3.0
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合作者和调查者
调查人员
- 学习椅：Philippe Maingon, MD、Centre Georges Francois Leclerc
- Franck Bonnetain, PhD、Centre Georges Francois Leclerc
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- CGFL-QDV
- CDR0000683850 (注册表标识符：PDQ (Physician Data Query))
- CGFL-AFSSAPS-2008-A01468-47
- EU-21061
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