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
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
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Alberta
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Calgary、Alberta、加拿大、T2N 4N2
- Tom Baker Cancer Centre
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British Columbia
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Vancouver、British Columbia、加拿大
- British Columbia Cancer Agency
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Manitoba
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Winnipeg、Manitoba、加拿大、R3E 0V9
- Cancer Care Manitoba
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-
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:
- 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
|
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实验性的:Consultation Recording
Participant receives consultation recording
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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
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Subjective report of actual role played in decision making.
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1-week post-consultation
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Change from Baseline in Control Preferences Scale at 3-months post-consultation
大体时间:3-months post-consultation
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Subjective report of actual role played in decision making.
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3-months post-consultation
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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
|
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Change from Baseline in Patient Satisfaction with Cancer Care Scale at 3-months post-consultation
大体时间:3-months post-consultation
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3-months post-consultation
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Change from Baseline in Patient Satisfaction with Cancer Care Scale at 6-months post-consultation
大体时间:6-months post-consultation
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6-months post-consultation
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Change from Baseline in PrestMan Satisfaction with Doctor Scale at 1-week post-consultation
大体时间:1-week post-consultation
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1-week post-consultation
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Change from Baseline in PrestMan Satisfaction with Doctor Scale at 3-months post-consultation
大体时间:3-months post-consultation
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3-months post-consultation
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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
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Change from Baseline in Hospital Anxiety and Depression Scale at 1-week post-consultation
大体时间:1-week post-consultation
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1-week post-consultation
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Change from Baseline in Hospital Anxiety and Depression Scale at 3-months post-consultation
大体时间:3-months post-consultation
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3-months post-consultation
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Change from Baseline in Hospital Anxiety and Depression Scale at 6-months post-consultation
大体时间:6-months post-consultation
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6-months post-consultation
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Change from Baseline in Perception of Being Informed Scale at 1-week post-consultation
大体时间:1- week post-consultation
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1- week post-consultation
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Change from Baseline in Perception of Being Informed Scale at 3-months post-consultation
大体时间:3-months post-consultation
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3-months post-consultation
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Change from Baseline in Perception of Being Informed Scale at 6-months post-consultation
大体时间:6-months post-consultation
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6-months post-consultation
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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
其他相关的 MeSH 术语
其他研究编号
- H2013:085
- 126049 (其他赠款/资助编号:Canadian Institutes of Health Research/126049)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
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.