NCT03093649Unknown不适用
Measuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Patients With Nasopharyngeal Carcinoma Undergoing Intensity Modulated Radiation Therapy: A Randomised Controlled Trial
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2017年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Score of physical functioning in quality of life
研究概览
简要总结
Although patient-reported adverse events have been promoted as an essential element in clinical trials and daily managements, their efficacy remained unknown. The purpose of this trial was to determine the effect of the patient-reported adverse events during the treatment on the improvements on quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)
- •No evidence of distant metastasis (M0)
- •Performance status: PS 0~2
- •Receive standard treatment
- •Able to read and understand the questionnaires
- •Not exhibiting overt psychopathology
- •Willing to give feedback to physicians and written informed consent was obtained
排除标准
- •WHO type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- •Treatment with palliative intent.
- •Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
- •Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
- •Patient is pregnant or lactating
- •Severe intercurrent disease
结局指标
主要结局
Score of physical functioning in quality of life
时间窗: within 1 week of study completion
Score of physical functioning in quality of life
次要结局
- completion rate(within 1 week of study completion)
- 3-year progression-free survival(3 year after diagnosis)
- 3-year metastatic-free survival(3 year after diagnosis)
- 3-year overall survival(3 year after diagnosis)
- 3-year local-regional free survival(3 year after diagnosis)
- degrees of patients satisfaction regarding the treatment process(within 1 week of study completion)
- response rate(1 month after study completion)
研究者
Ying Sun
principal investigator
Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Validity and Reliability Evaluation of the PRO-CTCAE for Adult-type Diffuse Gliomas Patients in Chinese PopulationPatient Reported Outcome MeasuresSelf ReportAdverse EffectsGliomaNCT05486923Huashan Hospital450
已完成
不适用
Prostate Cancer SurveyProstate CancerNCT03128710University of Maryland, Baltimore224
已完成
不适用
Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's DiseaseParkinson's DiseaseNCT02289729AbbVie62
招募中
不适用
Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy (AVATAR)CancerNCT04696250University Hospital, Caen5,000,000
终止
不适用
Patient Reported Outcome Measures (PROMs) With TrabectedinSarcomaLeiomyosarcomaLiposarcomaNCT03959033University of Leeds7