Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy (PSP)
2020年10月16日 更新者:Theis Trabjerg、University of Southern Denmark
Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy - a Randomized Controlled Trial
Background International guidelines underline the importance of strengthening the coordination and continuity of cancer care.
The different roles of general practitioners and oncologists with regard to treatment, follow-up and rehabilitation during and after cancer treatment are often obscure to cancer patients.
Parallel courses of healthcare are often taking place instead of coordinated care characterized by continuity and partnership between care providers.
Patients may feel uncertain about the health professionals' skills and area of responsibility.
Healthcare seeking and support during and after cancer treatment may, therefore, be inappropriate, leaving patients feeling insecure and lost between care providers.The study aims to design and evaluate a new way of communication and shared decision-making that brings the patient, the oncologist and general practitioner together in a shared video-consultation in the early phase of chemotherapeutic treatment.
The effect of the intervention in addition to usual care will be tested in a randomized controlled trial at Vejle Hospital in the Region of Southern Denmark.
Based on sample size calculation, investigators intent to include 300 patients at the Department of Oncology and their general practitioners.
Results and process outcomes will be evaluated qualitatively and quantitatively, questionnaires to patients, general practitioners and oncologists, and data from registers.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
281
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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-
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Vejle、丹麦、7100
- Department of Oncology, Vejle Hospital, Region of Southern Denmark
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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:
- Newly referred cancer patient scheduled for chemotherapy at the Department for Oncology, Vejle Hospital, Region of Southern Denmark
- Aged 18 years and over
- Able to speak and read Danish
- Mentally able to cooperate
- Listed with a general practitioner (98 % of the danish population)
- Written and verbal informed consent given
Exclusion Criteria:
- none
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Video consultation
Video consultation between cancer patient, general practitioner and oncologist at the start of chemotherapy treatment
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At the start of the patients chemotherapy treatment a shared video consultation between the patient, general practitioner and oncologist will bee arranged.
The video consultation should address distribution of roles, comorbidity, medicine, depression and anxiety symptoms, relatives and social resources.
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无干预:usual care
Usual care.
The patients General Practitioner will receive standard discharge summary and ambulant notes from the oncologist specialist
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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 |
---|---|---|
Shared Care questionnaire
大体时间:7 month after inclusion
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Patient reported outcome measure.
Cancer patients assessment of their cancer trajectory and their assessment of the cooperation between their General Practitioner and the oncologist specialist.
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7 month after inclusion
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Illness Intrusiveness Rating Scale (IIRS)
大体时间:4 and 7 month after inclusion
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Patient reported outcome measure.
Patients assessment of the cancer disease influence on their daily living.
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4 and 7 month after inclusion
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European Organisation for Research and Treatment of Cancer - Quality of Life questionnaire - Core 30 (EORTC QLQ C30)
大体时间:4 and 7 month after inclusion
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Patient reported outcome measure.
Cancer patients assessment of their quality of life
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4 and 7 month after inclusion
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European Organisation for Research and Treatment of Cancer - Quality of Life- information questionnaire (EORTC QLQ INFO25)
大体时间:4 and 7 month after inclusion
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4 and 7 month after inclusion
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Generalised Anxiety Disorder Assessment (GAD-7)
大体时间:4 and 7 month after inclusion
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Patient reported outcome measure.
Screening tool and severity measure for generalised anxiety disorder
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4 and 7 month after inclusion
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Patient Health Questionnaire (PHQ-9)
大体时间:4 and 7 month after inclusion
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Patient reported outcome measure.The questionnaire monitor the severity of depression and response to treatment.
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4 and 7 month after inclusion
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Oncologist assessment of a video consultation between the patient, General practitioner and oncologist.
大体时间:Directly after the video consultation intervention
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It measures the oncologist perception of the benefits with the video consultation intervention.
Only the intervention group
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Directly after the video consultation intervention
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General practitioners assessment of a video consultation between the patient, General practitioner and oncologist.
大体时间:Directly after the video consultation intervention
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It measures the General Practitioners perception of the benefits with the video consultation intervention.
Only the intervention group.
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Directly after the video consultation intervention
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Patients assessment of a video consultation between the patient, General practitioner and oncologist.
大体时间:Directly after the video consultation intervention
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It measures the patients perception of the benefits with the video consultation intervention.Only the intervention group
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Directly after the video consultation intervention
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General Practitioner cancer trajectory assessment
大体时间:4 month after the inclusion of the patient.
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The General Practitioners assessment of the cooperation between the primary and secondary care regarding af specific cancer patient.
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4 month after the inclusion of the patient.
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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
- Hansen DG, Trabjerg TB, Sisler JJ, Sondergaard J, Jensen LH. Cross-sectoral communication by bringing together patient with cancer, general practitioner and oncologist in a video-based consultation: a qualitative study of oncologists' and nurse specialists' perspectives. BMJ Open. 2021 May 5;11(5):e043038. doi: 10.1136/bmjopen-2020-043038.
- Trabjerg TB, Jensen LH, Sondergaard J, Sisler JJ, Hansen DG. Cross-sectoral video consultations in cancer care: perspectives of cancer patients, oncologists and general practitioners. Support Care Cancer. 2021 Jan;29(1):107-116. doi: 10.1007/s00520-020-05467-0. Epub 2020 Apr 21.
- Trabjerg TB, Jensen LH, Sondergaard J, Sisler JJ, Hansen DG. Improving continuity by bringing the cancer patient, general practitioner and oncologist together in a shared video-based consultation - protocol for a randomised controlled trial. BMC Fam Pract. 2019 Jun 25;20(1):86. doi: 10.1186/s12875-019-0978-8.
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 (实际的)
2016年5月1日
初级完成 (实际的)
2020年8月1日
研究完成 (实际的)
2020年8月1日
研究注册日期
首次提交
2016年3月3日
首先提交符合 QC 标准的
2016年3月22日
首次发布 (估计)
2016年3月23日
研究记录更新
最后更新发布 (实际的)
2020年10月20日
上次提交的符合 QC 标准的更新
2020年10月16日
最后验证
2020年10月1日
更多信息
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