Group-based or Individual Information About Disease and Treatment Plan
Cancer Patients' Knowledge and Satisfaction After Group-based or Individual Information About Their Disease and Treatment Plan
The main aim of the current study is to investigate whether the addition of a standardized,group-based educational program to the information provided by health care personnel improves cancer patients' knowledge level about their disease, planned treatment and common side-effects of the treatment.
Secondary aims are to investigate if the addition of the educational program increases the likelihood of completing treatment as planned, reduces level of anxiety, reduces the frequency of serious side effects, increases patient reported health related quality of life, and increases the degree of patient satisfaction with respect to how they have received the information before, during and after treatment.
研究概览
详细说明
There are strong indications that group-based information provides better information for cancer patients about their disease, treatment options - and potential benefits and side effects of the planned therapy than information provided during a regular doctor consultation.
The investigators believe that standardizing and repeating the information as well as having more time for questions in an open environment for reflections will improve the amount of information patients can perceive. Furthermore, all patients will be given written information.
Better-informed patients may be more motivated and may contact health care personnel earlier than other patients when they develop side effects. This may reduce the risk of serious treatment-related complications and increase the chances of patients completing the planned treatment. But none have compared to what extent an organization like Vardesenteret improves the patients' knowledge and whether patients are more satisfied with these methods for informing them. Results from studies on the influence of patient anxiety and distress on patient's abilities to perceive information are conflicting.Two large groups of relatively homogenous cancer patients are patients with lower-stage breast cancer patients who are eligible for adjuvant chemotherapy and patients with localized prostate cancer eligible for curative radiotherapy.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Trondheim、挪威
- St Olavs Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria:
- Breast cancer patients that are candidates for adjuvant chemotherapy after surgery.
- Prostate cancer patients that are candidates for curative radiotherapy
- Signed informed consent
- Patient expected to be able to complete the planned treatment and the study procedures
- 18years or older
Exclusion Criteria:
-Patients not fulfilling inclusion criteria
学习计划
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:Group and Individual information
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
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The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
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无干预:Individual information
Standard information about disease and treatment from doctor and nurse given at 2 occasions.
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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 |
|---|---|---|
|
Knowledge
大体时间:1 week
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Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
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1 week
|
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Knowledge
大体时间:2 weeks
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Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
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2 weeks
|
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Knowledge
大体时间:9 weeks
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Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
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9 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of Life
大体时间:9 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30
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9 weeks
|
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Patients Subjective state of information
大体时间:1 week
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
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1 week
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Patients Subjective state of information
大体时间:2 weeks
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European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
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2 weeks
|
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Patients Subjective state of information
大体时间:9 weeks
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European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
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9 weeks
|
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Anxiety
大体时间:1 week
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STAI-State and Trait Anxiety Inventory
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1 week
|
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Anxiety
大体时间:2 weeks
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STAI-State and Trait Anxiety Inventory
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2 weeks
|
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Anxiety
大体时间:9 weeks
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STAI-State and Trait Anxiety Inventory
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9 weeks
|
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Adverse events
大体时间:2 weeks
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CTCEA, Common Terminology Criteria for Adverse Events
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2 weeks
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Adverse events
大体时间:9 weeks
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CTCEA, Common Terminology Criteria for Adverse Events
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9 weeks
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合作者和调查者
调查人员
- 首席研究员:Stein Kaasa, MD, Prof.、St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- 研究主任:Ola Berger, MD、St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- 学习椅:Bjørn H Gønberg, MD, PhD、St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- 学习椅:Kari Sand, Cand Philol、PRC, European Palliative Care Research Center
- 学习椅:Jo Å Lund, MD, PhD、St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- 学习椅:Jon H Loge, MD, Prof.、National Resource Centre for Studies of Late Effects after Cancer Treatment, Oslo University Hospital, Radiumhospitalet, Oslo, Norway; Department of Behavioral Sciences in Medicine, University of Oslo
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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