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Investigation of Pain and Symptom Burden in Patients With Newly Diagnosed Head and Neck Cancer

2012年9月7日更新者：Barbara Murphy, MD、Vanderbilt-Ingram Cancer Center

RATIONALE: Collecting information by questionnaire about the quality of life of patients with head and neck cancer may help doctors learn more about the disease.

PURPOSE: This clinical trial is testing a questionnaire for assessing pain control, head and neck symptoms, and general symptoms of illness, demographics, moods, alcohol and tobacco history, and quality of life related to cancer in patients with newly diagnosed head and neck cancer.

研究概览

地位

完全的

条件

头颈癌

干预/治疗

详细说明

OBJECTIVES:

To pilot test a questionnaire measuring the collection of the following data from patients with newly diagnosed head and neck cancer: head and neck cancer-related symptoms, general demographics, pain control, general symptoms, mood, smoking and drinking history, and quality of life.
To identify questions that may be unclear or difficult for patients to understand.
To determine the time required for each patient to complete the questionnaire and assess the feasibility and burden to the patient.
To determine the baseline incidence of symptoms and psychosocial issues in these patients.

OUTLINE: Patients complete a timed questionnaire comprising questions of head and neck symptoms, demographic information, pain control, symptom control, mood, smoking and drinking history, and anxiety and depression under the supervision of the investigator.

研究类型

观察性的

注册 (实际的)

100

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、37232-6838
    - Vanderbilt-Ingram Cancer Center

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

Newly diagnosed HNC patients.

描述

Inclusion Criteria:

Diagnosis of head or neck carcinoma
- Newly diagnosed disease
Able to speak English
Able to give informed consent

Exclusion Criteria:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

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：仅案例
时间观点：预期

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
Pilot questionnaire testing of related symptoms, general demographics, pain control, general symptoms, mood, smoking and drinking history, and quality of life 大体时间：at time of patient exam	collection of the following data from newly diagnosed HNC patients: head and neck cancer-related symptoms • general demographics • pain control general symptoms • mood • smoking and drinking history • quality of life Questions will be identified that may be unclear or difficult for patients to understand for future revision.	at time of patient exam

次要结果测量

结果测量	措施说明	大体时间
Time required for questionnaire completion by each patient 大体时间：at time of patient exam	The investigator will verbally explain the purpose of the study using a script (provided with this packet) and obtain verbal consent from the patient. The questionnaire will be handed to the patient with instructions on how to complete it. The investigator will remain available in the room to address any concerns regarding the questionnaire and to time how long the patient takes to complete the survey. When the patient has completed the questionnaire, the investigator will review it for completeness with the patient. The patient's participation in the study ends at this time.	at time of patient exam
Feasibility and patient burden assessment 大体时间：at time of patient exam		at time of patient exam
Baseline incidence of symptoms and psychosocial issues 大体时间：at time of patient exam		at time of patient exam

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-Ingram Cancer Center

合作者

National Cancer Institute (NCI)

调查人员

首席研究员：Barbara Murphy, MD、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5月1日

初级完成 (实际的)

2008年3月1日

研究完成 (实际的)

2008年5月1日

研究注册日期

首次提交

2008年4月8日

首先提交符合 QC 标准的