此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Clinical Trial of the Impact of Treatment Consultation Recordings on Cancer Patient Outcomes

2018年2月19日 更新者:Dr. Tom Hack、University of Manitoba

Impact of Treatment Consultation Recordings on Cancer Patient Outcomes: A Prospective, Parallel, Randomized Controlled Trial

The time period from diagnosis through to the end of treatment is challenging for patients. Patients need information, assistance with decision making, and emotional and social support to help cope with their diagnosis and treatment. The first meeting with the cancer doctor is especially anxiety-provoking for patients who will learn, for the first time, their treatment options and likelihood of being cured. This anxiety causes many patients to have difficulty remembering the important pieces of information that their cancer doctor tells them during this consultation. The main goal of this study is to demonstrate the benefits of giving cancer patients an audio-recording of their first consultation with their cancer doctor. The investigators will include newly diagnosed patients from cancer centres in Winnipeg and Calgary. The types of cancer that will be included in this study are brain and neuroendocrine. Patients with these types of cancer are more likely to have confused thinking, and therefore may have the most to gain from receiving their consultation recordings. The study will include 244 patients, and those who sign consent forms to participate will be assigned by chance to either receive their treatment consultation recording or not. Patients will receive their recording immediately after their consultation, and will be able to listen to the recording at any time either alone, or with family and friends. To figure out whether the consultation recording provides patients with benefits, the investigators will administer some questionnaires to patients at 1 week after the consultation, and again at 3 and 6 months after the consultation. These questionnaires will assess the following patient outcomes: i) anxiety and depression, ii) perception of being informed about the disease and treatment, iii) satisfaction with cancer care, iv) satisfaction with the doctor, and v) the extent to which patients are satisfied with their degree of involvement in treatment decision making. The investigators hypothesize that patients who receive their consultation recording will experience more benefits than patients who do not receive their consultation recording.

研究概览

地位

完全的

研究类型

介入性

注册 (实际的)

140

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

    • Alberta
      • Calgary、Alberta、加拿大、T2N 4N2
        • Tom Baker Cancer Centre
    • British Columbia
      • Vancouver、British Columbia、加拿大
        • British Columbia Cancer Agency
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3E 0V9
        • Cancer Care Manitoba

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

描述

Inclusion Criteria:

  • presenting with a primary diagnosis of non-recurrent or metastatic brain, or neuroendocrine cancer
  • 18 years of age or older
  • able to read and communicate using the English language
  • access to a computer to enable consultation playback

Exclusion Criteria:

  • deemed by a treating clinician (or primary nurse for the treating clinician) to have any severe psychiatric condition or cognitive dysfunction that precludes provision of free and informed consent to participate

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:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
无干预:No Consultation Recording
Participant does not receive consultation recording
实验性的:Consultation Recording
Participant receives consultation recording

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
Change from Baseline in Control Preferences Scale at 1-week post-consultation
大体时间:1-week post-consultation
Subjective report of actual role played in decision making.
1-week post-consultation
Change from Baseline in Control Preferences Scale at 3-months post-consultation
大体时间:3-months post-consultation
Subjective report of actual role played in decision making.
3-months post-consultation
Change from Baseline in Control Preferences Scale at 6-months post-consultation
大体时间:6-months post-consultation
Subjective report of actual role played in decision making.
6-months post-consultation
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 1-week post-consultation
大体时间:1-week post-consultation
1-week post-consultation
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 3-months post-consultation
大体时间:3-months post-consultation
3-months post-consultation
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 6-months post-consultation
大体时间:6-months post-consultation
6-months post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 1-week post-consultation
大体时间:1-week post-consultation
1-week post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 3-months post-consultation
大体时间:3-months post-consultation
3-months post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 6-months post-consultation
大体时间:6-months post-consultation
6-months post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 1-week post-consultation
大体时间:1-week post-consultation
1-week post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 3-months post-consultation
大体时间:3-months post-consultation
3-months post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 6-months post-consultation
大体时间:6-months post-consultation
6-months post-consultation
Change from Baseline in Perception of Being Informed Scale at 1-week post-consultation
大体时间:1- week post-consultation
1- week post-consultation
Change from Baseline in Perception of Being Informed Scale at 3-months post-consultation
大体时间:3-months post-consultation
3-months post-consultation
Change from Baseline in Perception of Being Informed Scale at 6-months post-consultation
大体时间:6-months post-consultation
6-months post-consultation

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:Thomas F Hack, PhD、University of Manitoba

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

2013年6月1日

初级完成 (实际的)

2017年2月1日

研究完成 (实际的)

2017年12月1日

研究注册日期

首次提交

2013年4月16日

首先提交符合 QC 标准的

2013年5月27日

首次发布 (估计)

2013年5月31日

研究记录更新

最后更新发布 (实际的)

2018年2月20日

上次提交的符合 QC 标准的更新

2018年2月19日

最后验证

2018年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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.

3
订阅