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Ambulatory Cancer Pain Management: A Feasibility Study

2012年7月31日 更新者:M.D. Anderson Cancer Center

The primary purpose of this study is to examine the feasibility of collecting pain and other symptom data in outpatient treatment centers across multiple institutions in the Texas Medical Center (TMC). We will also examine the prevalence and severity of cancer-related pain and begin to identify other commonly reported symptoms in outpatient settings. Factors that interfere with management of pain will also be examined. Additionally, the study will explore patient satisfaction with pain management and pain education in outpatient settings. The specific aims of this study include:

Primary Objective:

-Explore the feasibility of a collaborative effort by oncology nurses to collect pain and symptom data across multiple institutions that care for ambulatory cancer patients in the TMC.

Secondary Objectives:

  • Describe the prevalence and severity of pain and other symptoms in persons with breast, colorectal, lung, or prostate cancer who are receiving chemotherapy in the outpatient setting.
  • Describe factors that interfere with adequate pain management in these patients.
  • Examine patient satisfaction with pain management and patient education about pain management.

研究概览

地位

完全的

详细说明

You will be asked to complete 3 questionnaires that will take a total of about 20 minutes to complete. Your name or medical record number will not appear on the questionnaires. You will be assigned a study subject code number. The study chair will keep a file that links your name to the code.

The first questionnaire will ask for basic demographic information (such as gender, ethnicity, and education) and your current chemotherapy and pain medications. If you cannot remember the names of these medications, researchers will locate them in your M. D. Anderson medical record.

The second questionnaire asks you to rate your pain and a variety of symptoms (for example, fatigue and nausea).

The last questionnaire includes 3 sections. The first section asks about your beliefs about pain and its treatment. The second part asks for your opinion about your pain management and about the education you have received about pain management. On the last page, you will be asked to use a picture of the outline of a body to show the researchers where you have pain.

Once you have completed these questionnaires, you will be considered off-study.

This is an investigational study. Up to 125 patients will take part in this study. Up to 35 will be enrolled at M. D. Anderson.

研究类型

观察性的

注册 (实际的)

30

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

    • Texas
      • Houston、Texas、美国、77030
        • U.T.M.D. Anderson Cancer Center
      • Houston、Texas、美国、77030
        • Memorial Hermann Hospital
      • Houston、Texas、美国、77030
        • Methodist Hospital
      • Houston、Texas、美国、77030
        • Michael E. DeBakey Veterans Administration Medical 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

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients receiving chemotherapy for breast, colon, lung, or prostate cancer.

描述

Inclusion Criteria:

  1. Diagnosis of breast, colorectal, lung, or prostate cancer (any histological type).
  2. Currently undergoing chemotherapy.
  3. Age 18 or older.
  4. Able to read, write, and speak English.
  5. Able to understand the purpose of this study.
  6. Must be a patient at one of the four participating institutions.
  7. Must be receiving the 2nd, 3rd, or 4th cycle of chemotherapy.

Exclusion Criteria:

  1. Receiving chemotherapy in preparation for a bone marrow or stem cell transplant
  2. Received a bone marrow or stem cell transplant
  3. Age 17 or younger
  4. Receiving weekly chemotherapy.
  5. Receiving hormonal therapy alone.
  6. Receiving radiation or chemoradiation.

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
Cancer Pain Management
Patients receiving chemotherapy for breast, colon, lung, or prostate cancer.
3 questionnaires that will take 20 minutes total to complete.
其他名称:
  • 民意调查

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Pain and symptom data across multiple institutions
大体时间:Survey data collection taking 30 minutes, collecation accomplished at multiple sites over 3 years
Survey data collection taking 30 minutes, collecation accomplished at multiple sites over 3 years

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。

调查人员

  • 首席研究员:Anita Broxson, RN、M.D. Anderson Cancer Center

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

2006年7月1日

初级完成 (实际的)

2009年7月1日

研究完成 (实际的)

2009年7月1日

研究注册日期

首次提交

2007年7月24日

首先提交符合 QC 标准的

2007年7月24日

首次发布 (估计)

2007年7月26日

研究记录更新

最后更新发布 (估计)

2012年8月1日

上次提交的符合 QC 标准的更新

2012年7月31日

最后验证

2012年7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.

Questionnaire的临床试验

3
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