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2 Phase Use Of Educational Materials In Head And Neck Cancer Center

2017年5月24日 更新者：Lori J. Wirth, MD、Massachusetts General Hospital

A Two-phase Study to Evaluate the Use of Educational Materials in the Head and Neck Cancer Center

The goal of this study is to assess the experience of our patients with head and neck cancer in regard to the information they receive, their symptoms, and their understanding of their diagnosis, to determine ways to improve upon these aspects of patient care in the future.

研究概览

地位

完全的

条件

干预/治疗

详细说明

There will be two phases of the study. In "Phase I", 30 participants will be recruited for assessment of information satisfaction, psychological stress, illness perception, and symptom burden throughout their head and neck cancer treatment without any intervention. This group will represent the current standard of care in the head and neck group and serve as a "historical control" for the second group. In "Phase II", which will occur after "Phase I" group, 30 new participants will be recruited to receive a handbook and to have it integrated into their cancer care. The same participant reported outcome measures of information satisfaction, psychological stress, illness perception, and symptom burden will be assessed such that comparisons between phases can be made. This will serve as a pilot study of the implementation and maintenance of an educational intervention in clinical practice and how it affects participant-reported outcomes. Comparison of these two groups of participants will provide the baseline data to plan future interventions.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

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
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital

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

描述

Inclusion Criteria:

  • Adult patients (greater than 18 years old) with a new diagnosis of head and neck cancer.
  • Patients who have a treatment plan including both chemotherapy and radiation.
  • Patients who will be undergoing treatment at Massachusetts General Hospital Cancer Center.
  • Ability to speak and read in English in order to be able to complete questionnaires with minimal assistance required from a family member.

Exclusion Criteria:

  • Patients with head and neck cancer who have a treatment plan only including single modality therapy (ie just radiation, just surgery, or just systemic therapy)
  • Patients who cannot speak, read and write in English with minimal assistance from a family member.
  • Patients with cognitive impairment that would preclude the patient signing informed consent or understanding the materials.
  • Patients who will not be receiving their cancer treatment at MGH.

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

  • 主要用途：支持治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Head and Neck Educational Handbook
  • Prior to starting treatment, patients will be approached for trial participation and baseline questionnaires (demographics, psychological distress, symptom burden, and illness perception).
  • After enrollment and baseline data collection, the participant will be given the handbook. The clinician giving out the handbook will give an overview of the handbook and flip through the important sections. The clinician will encourage the participant to bring it back and forth.
  • Participants will complete questionnaires at 3 weeks into treatment and 2 weeks after treatment has ended (information satisfaction, psychological distress, symptom burden, and illness perception).
其他：Head and Neck Educational Handbook
无干预：Non Head and Neck Educational Handbook
  • Prior to starting treatment, patients will be approached for trial participation and baseline questionnaires (demographics, psychological distress, symptom burden, and illness perception).
  • The first group of participants will not receive the handbook but will receive the current standard care in the head and neck disease center.
  • Participants will complete questionnaires at 3 weeks into treatment and 2 weeks after treatment has ended (information satisfaction, psychological distress, symptom burden, and illness perception).
  • At completion of "Phase I", all 30 participants will also be given a copy of the handbook and an accompanying questionnaire.

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
Information Satisfaction Questionnaire (ISQ)
大体时间：Baseline, 4 Months, 6 Months
The primary endpoint will be the difference in scores on the Information Satisfaction Questionnaire (ISQ) between participants in Phase I and Phase II at 3 weeks into their treatment.
Baseline, 4 Months, 6 Months

次要结果测量

结果测量
大体时间
Percentage of participant change of scores of psychological distress
大体时间：Baseline, 4 Months, 6 Months
Baseline, 4 Months, 6 Months
Percentage of change participant symptom burden
大体时间：Baseline, 4 Months, 6 Months
Baseline, 4 Months, 6 Months
Percentage of Participant illness perception
大体时间：Baseline, 4 Months, 6 Months
Baseline, 4 Months, 6 Months

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

Massachusetts General Hospital

调查人员

  • 首席研究员：Lori Wirth, MD、Massachusetts General Hospital

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)

2014年8月12日

初级完成 (实际的)

2016年12月22日

研究完成 (实际的)

2016年12月22日

研究注册日期

首次提交

2014年7月29日

首先提交符合 QC 标准的

2014年7月29日

首次发布 (估计)

2014年7月30日

研究记录更新

最后更新发布 (实际的)

2017年5月25日

上次提交的符合 QC 标准的更新

2017年5月24日

最后验证

2017年5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

  • 14-244

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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