Improvement of Information to Cancer Patients' Caregivers
2019年1月18日 更新者：Mogens Groenvold、Bispebjerg Hospital
Improvement of Information to Cancer Patients' Caregivers: a Randomised Intervention Study
The purpose of this study is to investigate whether a systematic early assessment of uncovered needs for information, supplemented by an interview about the needs with the patient's nurse who seeks to provide the information requested, will improve the caregivers' and the patients' satisfaction with information and communication and potentially also decrease anxiety and depression.
研究概览
研究类型
介入性
注册 (实际的)
211
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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Herlev、丹麦、2730
- Department of Oncology, Herlev Hospital
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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
Patient Inclusion Criteria:
- Cancer patient
- Newly refered to (i.e., this is the patient's first visit in) Department of Oncology, Herlev Hospital, in order to start medical treatment (e.g. chemotherapy)
- Written informed consent
Caregiver Inclusion Criteria:
- Attends the first visit in the Department of Oncology with the patient
- Has lacked information about at least one of the 13 aspects of information asked about in the questionnaire
- Written informed consent
Exclusion Criteria:
- Patient and/or caregiver do not understand Danish well enough to participate in the study
- The patient has an expected survival of less than six months
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：卫生服务研究
- 分配：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 |
|---|---|
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实验性的：Immediate intervention
Immediately after enrollment in the project, caregivers and patients receive the intervention
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The intervention consists of an interview about the caregiver's responses (baseline measurement) to a list about 'lack of information' within 13 areas.
For each area, the patient's nurse will enquire about what information is requested by the caregiver and the patient.
Subsequently, the nurse provides the requested information.
She may involve the doctor and arrange follow-up visits or phone calls until the need is covered
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其他：Delayed intervention (3 weeks later)
This group receives the same intervention as in the experimental group, but after the outcome assessment at 2 weeks
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The intervention consists of an interview about the caregiver's responses (baseline measurement) to a list about 'lack of information' within 13 areas.
For each area, the patient's nurse will enquire about what information is requested by the caregiver and the patient.
Subsequently, the nurse provides the requested information.
She may involve the doctor and arrange follow-up visits or phone calls until the need is covered
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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 |
|---|---|---|
|
Satisfaction with information from health care professionals
大体时间：Change from baseline (enrollment) at 2 weeks
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Measure: The "Cancer Caregiving Tasks, Consequences and Needs Questionnaire" (CaTCoN) item 24
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Change from baseline (enrollment) at 2 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Satisfaction with information from health care professionals
大体时间：Change from baseline (enrollment) at 2 weeks
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Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)
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Change from baseline (enrollment) at 2 weeks
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Satisfaction with communication with health care professionals
大体时间：Change from baseline (enrollment) at 2 weeks
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Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"
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Change from baseline (enrollment) at 2 weeks
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Satisfaction with support from health care professionals
大体时间：Change from baseline (enrollment) at 2 weeks
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Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers' wellbeing"
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Change from baseline (enrollment) at 2 weeks
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Satisfaction with support from health care professionals
大体时间：Change from baseline (enrollment) at 2 weeks
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Measures: CaTCoN subscale "Need for help from health care professionals"
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Change from baseline (enrollment) at 2 weeks
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Anxiety and depression
大体时间：Change from baseline (enrollment) at 2 weeks
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Measure: The Hospital Anxiety and Depression Scale (HADS)
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Change from baseline (enrollment) at 2 weeks
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Fulfillment of needs
大体时间：Change from baseline (enrollment) at 2 weeks
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Measure: Family Inventory of Needs (FIN)
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Change from baseline (enrollment) at 2 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The time spent on information as reported by health care professionals
大体时间：Weeks 0-6 from baseline
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Investigated in focus group interviews with the health care professionals
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Weeks 0-6 from baseline
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Satisfaction with information from health care professionals
大体时间：Change from baseline (enrollment) at 12 weeks
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Measure: CaTCoN item 24
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Change from baseline (enrollment) at 12 weeks
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Satisfaction with information from health care professionals
大体时间：Change from baseline (enrollment) at 12 weeks
|
Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)
|
Change from baseline (enrollment) at 12 weeks
|
|
Satisfaction with communication with health care professionals
大体时间：Change from baseline (enrollment) at 12 weeks
|
Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"
|
Change from baseline (enrollment) at 12 weeks
|
|
Satisfaction with support from health care professionals
大体时间：Change from baseline (enrollment) at 12 weeks
|
Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers' wellbeing"
|
Change from baseline (enrollment) at 12 weeks
|
|
Satisfaction with support from health care professionals
大体时间：Change from baseline (enrollment) at 12 weeks
|
Measures: CaTCoN subscale "Need for help from health care professionals"
|
Change from baseline (enrollment) at 12 weeks
|
|
Anxiety and depression
大体时间：Change from baseline (enrollment) at 12 weeks
|
Measure: The Hospital Anxiety and Depression Scale (HADS)
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Change from baseline (enrollment) at 12 weeks
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Fulfillment of needs
大体时间：Change from baseline (enrollment) at 12 weeks
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Measure: Family Inventory of Needs (FIN)
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Change from baseline (enrollment) at 12 weeks
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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。
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。
一般刊物
- Lund L, Ross L, Petersen MA, Groenvold M. The interaction between informal cancer caregivers and health care professionals: a survey of caregivers' experiences of problems and unmet needs. Support Care Cancer. 2015 Jun;23(6):1719-33. doi: 10.1007/s00520-014-2529-0. Epub 2014 Nov 29.
- Lund L, Ross L, Groenvold M. The initial development of the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN). Acta Oncol. 2012 Nov;51(8):1009-19. doi: 10.3109/0284186X.2012.681697. Epub 2012 May 8.
- Lund L, Ross L, Petersen MA, Groenvold M. The validity and reliability of the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN). Acta Oncol. 2014 Jul;53(7):966-74. doi: 10.3109/0284186X.2014.888496. Epub 2014 Mar 16.
- Lund L, Ross L, Petersen MA, Sengelov L, Groenvold M. Improving information to caregivers of cancer patients: the Herlev Hospital Empowerment of Relatives through More and Earlier information Supply (HERMES) randomized controlled trial. Support Care Cancer. 2020 Feb;28(2):939-950. doi: 10.1007/s00520-019-04900-3. Epub 2019 Jun 8.
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
2015年4月1日
初级完成 (实际的)
2016年5月1日
研究完成 (实际的)
2016年8月1日
研究注册日期
首次提交
2015年1月29日
首先提交符合 QC 标准的
2015年3月2日
首次发布 (估计)
2015年3月5日
研究记录更新
最后更新发布 (实际的)
2019年1月22日
上次提交的符合 QC 标准的更新
2019年1月18日
最后验证
2019年1月1日
更多信息
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.