跳至主要内容
临床试验/NCT01866228
NCT01866228已完成不适用

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

University of Manitoba5 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2013年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
5
主要终点
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 3-months post-consultation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

No Consultation Recording

No Intervention

Participant does not receive consultation recording

Consultation Recording

Experimental

Participant receives consultation recording

干预措施: Consultation Recording (Other)

结局指标

主要结局

Change from Baseline in PrestMan Satisfaction with Doctor Scale at 3-months post-consultation

时间窗: 3-months post-consultation

Change from Baseline in Perception of Being Informed Scale at 1-week post-consultation

时间窗: 1- week post-consultation

Change from Baseline in Patient Satisfaction with Cancer Care Scale at 1-week post-consultation

时间窗: 1-week post-consultation

Change from Baseline in Patient Satisfaction with Cancer Care Scale at 3-months post-consultation

时间窗: 3-months post-consultation

Change from Baseline in PrestMan Satisfaction with Doctor Scale at 1-week post-consultation

时间窗: 1-week post-consultation

Change from Baseline in Perception of Being Informed Scale at 3-months post-consultation

时间窗: 3-months post-consultation

Change from Baseline in Control Preferences Scale at 6-months post-consultation

时间窗: 6-months post-consultation

Subjective report of actual role played in decision making.

Change from Baseline in Control Preferences Scale at 3-months post-consultation

时间窗: 3-months post-consultation

Subjective report of actual role played in decision making.

Change from Baseline in Patient Satisfaction with Cancer Care Scale at 6-months post-consultation

时间窗: 6-months post-consultation

Change from Baseline in PrestMan Satisfaction with Doctor Scale at 6-months post-consultation

时间窗: 6-months post-consultation

Change from Baseline in Control Preferences Scale at 1-week post-consultation

时间窗: 1-week post-consultation

Subjective report of actual role played in decision making.

Change from Baseline in Hospital Anxiety and Depression Scale at 1-week post-consultation

时间窗: 1-week post-consultation

Change from Baseline in Hospital Anxiety and Depression Scale at 3-months post-consultation

时间窗: 3-months post-consultation

Change from Baseline in Hospital Anxiety and Depression Scale at 6-months post-consultation

时间窗: 6-months post-consultation

Change from Baseline in Perception of Being Informed Scale at 6-months post-consultation

时间窗: 6-months post-consultation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Tom Hack

Professor

University of Manitoba

研究点 (5)

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