A Study of Nivolumab in Participants With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO) (VOLUME-PRO)
2022年5月2日 更新者：Bristol-Myers Squibb
Nivolumab in the Real World in Patients With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)
The purpose of the study is to capture the utilization of nivolumab among participants with squamous cell carcinoma of the head and neck (SCCHN) since its approval, and to describe the health related quality of life (HRQoL) among participants treated with nivolumab in a real-world setting.
研究概览
详细说明
This is a phase 4 prospective chart review study with patient reported outcome (PRO) administration.
The study population consists of participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) and are being treated with nivolumab.
Eligible participants will be enrolled and observed from enrollment up to eight weeks.
Demographic and clinical characteristics will be collected at enrollment.
PROs will be administered at enrollment and again at a follow-up standard of care visit approximately eight weeks after enrollment.
研究类型
观察性的
注册 (实际的)
509
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New Jersey
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Mount Laurel、New Jersey、美国、08054
- Local Institution
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
The population for this study will be approximately 50 adult participants, with a diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) currently being treated with nivolumab in the United Kingdom, Switzerland, Spain, or Canada.
The study population will include participants with available data from medical records at enrollment who are willing to complete patient reported outcome (PRO) assessments.
描述
Inclusion Criteria:
- Diagnosis of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN)
- Age ≥18 years at time of nivolumab treatment initiation
- Investigator has decided that nivolumab is appropriate therapy and the participant had received at least one administration of nivolumab for the treatment of recurrent/metastatic SCCHN prior to enrolment in the study
- Charts/records include treatment start date of nivolumab
- Provide consent and is willing to self-complete on-site patient reported outcomes (PROs) on at least one occasion
Exclusion Criteria:
- Currently enrolled in an interventional clinical trial for their SCCHN
- Received systemic treatment for any other primary cancer within 6 months of study enrolment
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Cohort 1
Participants with squamous cell carcinoma of the head and neck (SCCHN) treated with nivolumab
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Participants in this study are being treated with nivolumab for SCCHN
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Month and year of birth
大体时间：At enrollment
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Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head & Neck (SCCHN)
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At enrollment
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Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Sex
大体时间：At enrollment
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At enrollment
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Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Race/ethnicity
大体时间：At enrollment
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At enrollment
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Distribution of demographic characteristics of R/M SCCHN participants treated with nivolumab: Smoking status
大体时间：At enrollment
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At enrollment
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Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Primary tumor location
大体时间：At enrollment
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At enrollment
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Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Metastasis locations
大体时间：At enrollment
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At enrollment
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Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Histology
大体时间：At enrollment
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At enrollment
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Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Date of diagnosis of R/M SCCHN
大体时间：At enrollment
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At enrollment
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Distribution of clinical characteristics of R/M SCCHN participants treated with nivolumab: Stage at locally advanced/metastatic SCCHN diagnosis
大体时间：At enrollment
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At enrollment
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Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Duration of nivolumab therapy
大体时间：Up to 8 weeks following enrollment
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Up to 8 weeks following enrollment
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Distribution of patterns of use of nivolumab treatment in participants with R/M SCCHN: Drug discontinuation
大体时间：Up to 8 weeks following enrollment
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Up to 8 weeks following enrollment
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Distribution of doses of nivolumab therapy in participants with R/M SCCHN
大体时间：Up to 8 weeks following enrollment
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Up to 8 weeks following enrollment
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Distribution of subsequent treatment in participants discontinuing nivolumab
大体时间：Up to 8 weeks following enrollment
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Up to 8 weeks following enrollment
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Distribution of patient reported health-related quality of life (HRQoL) measures through European Organisation for Research and Treatment of Cancer Quality of Life- Core Questionnaire in participants treated with nivolumab for R/M SCCHN
大体时间：At enrollment, Up to 8 weeks
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At enrollment, Up to 8 weeks
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Distribution of patient reported HRQoL measures through EQ-5D-5L in participants treated with nivolumab for R/M SCCHN
大体时间：At enrollment, Up to 8 weeks
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At enrollment, Up to 8 weeks
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Distribution of patient reported HRQoL measures through European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module in participants treated with nivolumab for R/M SCCHN
大体时间：At enrollment, Up to 8 weeks
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At enrollment, Up to 8 weeks
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Distribution of patient reported HRQoL measures through CTSQ in participants treated with nivolumab for R/M SCCHN
大体时间：At enrollment, Up to 8 weeks
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Cancer Therapy Satisfaction Questionnaire (CTSQ)
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At enrollment, Up to 8 weeks
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Distribution of patient reported HRQoL measures through WPAI:GH in participants treated with nivolumab for R/M SCCHN
大体时间：At enrollment, Up to 8 weeks
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Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)
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At enrollment, Up to 8 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年8月13日
初级完成 (实际的)
2021年10月18日
研究完成 (实际的)
2021年10月18日
研究注册日期
首次提交
2021年9月8日
首先提交符合 QC 标准的
2021年9月24日
首次发布 (实际的)
2021年10月6日
研究记录更新
最后更新发布 (实际的)
2022年5月5日
上次提交的符合 QC 标准的更新
2022年5月2日
最后验证
2022年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.