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Neurocognitive Functioning in Patients With Newly Diagnosed Upper Aerodigestive Tract Cancer Receiving Treatment at Henry-Joyce Cancer Clinic

2017年4月5日 更新者：Vanderbilt University Medical Center

Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers

RATIONALE: Gathering information about how often problems with neurocognitive functioning occur in patients with newly diagnosed upper aerodigestive tract cancers may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying neurocognitive functioning in patients with newly diagnosed upper aerodigestive tract cancers receiving treatment at Henry-Joyce Cancer Clinic.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

Primary

  • To establish an estimate of the prevalence of baseline neurocognitive impairment prior to initiation of outpatient cancer treatment.
  • To establish an estimate of the incidence of neurocognitive impairment during outpatient cancer treatment.
  • To describe how neurocognitive functioning changes over time during cancer treatment.

Secondary

  • To identify sociodemographic and clinical factors associated with neurocognitive impairment.
  • To examine health-related outcomes associated with neurocognitive impairment.

OUTLINE: Patients undergo interview to complete measures of domain-specific neurocognitive functioning, global neurocognitive functioning, subjective neurocognitive functioning, delirium, physical functioning, symptom prevalence and distress, mood states, and medications at baseline before initiation of cancer treatment, at scheduled treatment visits, and at the follow-up visit 3 months after completion of cancer treatment.

Measures of comorbidity, alcohol use, sensory functioning (vision and hearing), and sociodemographic are completed at baseline only. Cancer-related information (diagnosis, staging, and sites of metastasis, if applicable), treatment-related information (planned treatment regimen - chemotherapy and/or radiation therapy), and current medications are obtained at baseline by medical record review.

Health service use and complications are assessed at each scheduled treatment visit and at the 3-month post-treatment follow-up visit. Measures of domain-specific neurocognitive functioning, coping, and quality of life are completed at baseline and at the 3-month follow-up visit.

研究类型

观察性的

注册 (实际的)

86

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

  • 美国
    • Tennessee
      • Nashville、Tennessee、美国、37208
        • MBCCOP - Meharry Medical College - Nashville
      • Nashville、Tennessee、美国、37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville、Tennessee、美国、37064
        • Vanderbilt-Ingram Cancer Center - Cool Springs
      • Nashville、Tennessee、美国、37064
        • Vanderbilt-Ingram Cancer Center at Franklin

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

21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

Patients with newly diagnosed upper aerodigestive system cancers (head and neck, lung, and esophagus)

描述

DISEASE CHARACTERISTICS:

  • Newly diagnosed solid tumors of the upper aerodigestive system, including cancers of the head and neck, esophagus, or lung
  • Receiving treatment at the Henry-Joyce Cancer Clinic at the Vanderbilt-Ingram Cancer Center
  • No known brain metastasis

PATIENT CHARACTERISTICS:

  • Able to hear, speak, and understand English
  • No prior diagnosis of other cancer except basal cell carcinoma

PRIOR CONCURRENT THERAPY:

  • No treatment plans including prophylactic cranial irradiation

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

队列和干预

团体/队列
干预/治疗
Treatment
Patients undergoing treatment for head and neck, lung, and esophagus cancers
其他：Assessment of therapy complications
Assessment of neurocognitive function, functional status, symptom prevalence and distress, and mood alterations
其他：Neurocognitive assessment
Assessment of neurocognitive domains: attention/concentration, executive function, verbal learning, verbal memory, verbal fluency
其他：Quality-of-life assessment
Assessment of quality of life using Cantrill's Ladder at baseline and 3 months post-treatment

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Domain-Specific Neurocognitive Functioning measuring attention, executive functioning, mental processing speed, verbal memory, language, and visuospatial construction at baseline and 3 months after completion of treatment
大体时间：Baseline and 3 months post-treatment
Baseline and 3 months post-treatment
Global neurocognitive functioning as measured by the Mini-Mental State Examination (MMSE)
大体时间：Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Self-reported neurocognitive symptoms as measured by the Alertness Behavior Subscale of the Sickness Impact Profile
大体时间：Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Delirium and delirium symptoms by the NEECHAM Confusion Scale and Confusion Assessment Method (CAM)
大体时间：Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment

次要结果测量

结果测量
大体时间
Alcohol, tobacco, and drug use as measured by the Alcohol Use Disorders Identification Test (AUDIT)
大体时间：Baseline
Baseline
Premorbid intellectual functioning as measured by the North American Adult Reading Test (NAART)
大体时间：Baseline
Baseline
Functional status measured by the Duke Older Americans Resources and Services (OARS) Activities of Daily Living Scale
大体时间：Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Symptom prevalence and distress measured using the short form of the Memorial Symptom Assessment Scale (MSASSF)
大体时间：Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Mood State measured by the Profile of Mood States (POMS-SF)
大体时间：Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Overall quality of life measured using Cantril's Ladder
大体时间：Baseline and 3 months post-treatment
Baseline and 3 months post-treatment
Coping measured by the Mini-Mental Adjustment to Cancer Scale (Mini-MAC)
大体时间：Baseline and 3 months post-treatment
Baseline and 3 months post-treatment
Hospitalizations, emergency department visits, and unscheduled clinic visits
大体时间：At each scheduled treatment visit and 3 months post-treatment
At each scheduled treatment visit and 3 months post-treatment
Falls, injuries, and other complications
大体时间：At each scheduled treatment visit and 3 months post-treatment
At each scheduled treatment visit and 3 months post-treatment

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。

赞助

Vanderbilt University Medical Center

合作者

National Cancer Institute (NCI)

调查人员

  • 学习椅：Stewart M. Bond, PhD, RN、Vanderbilt-Ingram Cancer Center

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

2007年10月1日

初级完成 (实际的)

2010年5月1日

研究完成 (实际的)

2013年6月1日

研究注册日期

首次提交

2007年9月20日

首先提交符合 QC 标准的

2007年9月20日

首次发布 (估计)

2007年9月24日

研究记录更新

最后更新发布 (实际的)

2017年4月7日

上次提交的符合 QC 标准的更新

2017年4月5日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CDR0000565963
  • P30CA068485 (美国 NIH 拨款/合同)
  • VU-VICC-SUPP-0751

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.

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