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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

地位

终止

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

介入性

注册 (实际的)

98

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

      • Trondheim、挪威
        • St Olavs 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:

  • 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

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: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.
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
无干预:Individual information
Standard information about disease and treatment from doctor and nurse given at 2 occasions.

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
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
1 week
Knowledge
大体时间:2 weeks
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
2 weeks
Knowledge
大体时间:9 weeks
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
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
9 weeks
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
1 week
Patients Subjective state of information
大体时间:2 weeks
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
2 weeks
Patients Subjective state of information
大体时间:9 weeks
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
9 weeks
Anxiety
大体时间:1 week
STAI-State and Trait Anxiety Inventory
1 week
Anxiety
大体时间:2 weeks
STAI-State and Trait Anxiety Inventory
2 weeks
Anxiety
大体时间:9 weeks
STAI-State and Trait Anxiety Inventory
9 weeks
Adverse events
大体时间:2 weeks
CTCEA, Common Terminology Criteria for Adverse Events
2 weeks
Adverse events
大体时间:9 weeks
CTCEA, Common Terminology Criteria for Adverse Events
9 weeks

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。

合作者

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

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

2012年10月1日

初级完成 (实际的)

2015年7月1日

研究完成 (实际的)

2015年7月1日

研究注册日期

首次提交

2012年9月21日

首先提交符合 QC 标准的

2012年10月1日

首次发布 (估计)

2012年10月4日

研究记录更新

最后更新发布 (估计)

2017年1月26日

上次提交的符合 QC 标准的更新

2017年1月25日

最后验证

2017年1月1日

更多信息

与本研究相关的术语

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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