Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Randomised Trial in Colorectal Cancer Patients (DIQOL)
Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Protocol of a Randomised Clinical Trial in Colorectal Cancer Patients
研究概览
详细说明
There is a growing interest in using quality of life (QoL) data not only as relevant endpoint in clinical trials on cancer patients, but also in routine practice in order to improve patients' health during treatment. The investigators designed, implemented and evaluated an integrated quality of life diagnosis and therapy pathway (QoL pathway) for breast cancer patients (Klinkhammer-Schalke et al, 2008; 2012), guided by the UK Medical Research Council framework for developing and testing complex interventions. It could be demonstrated in a routine setting that breast cancer patients showed a benefit from tailored QoL diagnosis and therapy (Klinkhammer-Schalke et al, 2012).
But there is also requirement for managing QoL deficits of patients with other cancers and to replicate findings of the previous trial. To achieve this aim, the QoL pathway has been modified for colorectal cancer patients. The Tumor Center Regensburg provides the infrastructure of the present project (quality circles, project groups).
This is a two-arm randomised clinical trial with one intervention group and one control group. Patients' QoL is assessed with the EORTC QLQ-C30 and QLQ-CR29 at 0, 3, 6, 12, and 18 months after surgery.
In intervention group results of the QoL-measure are transferred to a QoL-profile including 13 dimensions on scales of 0-100 (cutoff for "diseased QoL <50). Three experts with varying professional background use the individual patient's QoL-profile and clinical and sociodemographic information in order to generate a QoL-report including therapy recommendation which is sent to the coordinating practitioner. Specific therapeutic options for the treatment of diseased QoL have been identified: pain therapy, psychotherapy, social support, nutrition counseling, stoma care, physiotherapy, fitness. To provide continuous medical education, quality circles for each therapy option have been founded. Coordinating practitioners receive a list with addresses of all quality circle members.
In control group QoL is also measured but the coordinating practitioner neither receives a QoL-profile nor a QoL-report.
The investigators expect that patients in the intervention group will experience a lower number of QoL-deficits (QoL < 50 points) in the first year after surgery compared with patients in the control group
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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Bavaria
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Regensburg、Bavaria、德国、93053
- Tumor Center Regensburg e.V., An-Institute of the University of Regensburg
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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:
- primary colorectal cancer
- operated in one of four participating certified cancer centres for colorectal cancer (Krankenhaus Barmherzige Brüder, Department of Surgery, Regensburg; Germany; Caritas-Krankenhaus St. Josef, Department of Surgery, Regensburg; Germany; Klinikum Neumarkt., Department of Surgery, Neumarkt; Germany; Klinikum St. Elisabeth Straubing, Department of Surgery, Straubing, Germany), documented in a population-based cancer registry (Tumor Center Regensburg e.V.)
- informed consent.
Exclusion Criteria:
- coordinating practitioner not implemented
- patient from district outside the study region (rural districts Regensburg, Neumarkt, Straubing, Straubing-Bogen, Kelheim, Schwandorf)
- patient unable to fill out the questionnaire for physical, psychological or language reasons (including dementia)
- age under 18 years
- pregnancy
- QoL clinician unavailable
- refusal to participate
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:intervention group
In the quality of life pathway results of the quality of life (QoL) measure are transferred to a QoL-profile.
Three experts with various professional background use the individual patient's QoL-profile and clinical and sociodemographic information in order to generate a QoL-report including therapy recommendation which is sent to the coordinating practitioner.
Specific therapeutic options for the treatment of diseased QoL have been identified: pain therapy, psychotherapy, social support, nutrition counseling, stoma care, physiotherapy, fitness.
To provide continuous medical education, quality circles for each therapy option haven been founded.
Coordinating practitioners receive a list with addresses of all quality circle members.
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Quality of life measurement, diagnosis and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)
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安慰剂比较:control group
In control group QoL is also measured but the coordinating practitioner neither receives a QoL-profile nor a QoL-report.
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Quality of life measurement
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension)
大体时间:1 year after the date of primary surgery for colorectal cancer
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1 year after the date of primary surgery for colorectal cancer
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次要结果测量
结果测量 |
大体时间 |
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rates of patients with diseased quality of life in each dimension of the profile
大体时间:0 (0-2 days before clinical discharge), 3, 6, 12, and 18 months after primary surgery for colorectal cancer
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0 (0-2 days before clinical discharge), 3, 6, 12, and 18 months after primary surgery for colorectal cancer
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合作者和调查者
调查人员
- 学习椅:Monika Klinkhammer-Schalke, MD, Ass. Prof.、Tumor Center Regensburg e.V., An-Institute of the University of Regensburg, Germany
- 首席研究员:Michael Koller, Ph.D., Prof.、Center for Clinical Trials, University Regensburg, Germany
- 首席研究员:Wilfried Lorenz, MD, Prof. Ɨ、Tumor Center Regensburg e.V., An-Institute of the University of Regensburg, Germany
- 首席研究员:Ferdinand Hofstädter, MD, Prof.、Johannes Kepler University Linz, Medical Faculty, Austria
- 首席研究员:Jeremy C Wyatt, MD, Prof.、Leeds Institute of Health Sciences, University of Leeds, UK
出版物和有用的链接
一般刊物
- Klinkhammer-Schalke M, Koller M, Steinger B, Ehret C, Ernst B, Wyatt JC, Hofstadter F, Lorenz W; Regensburg QoL Study Group. Direct improvement of quality of life using a tailored quality of life diagnosis and therapy pathway: randomised trial in 200 women with breast cancer. Br J Cancer. 2012 Feb 28;106(5):826-38. doi: 10.1038/bjc.2012.4. Epub 2012 Feb 7.
- Klinkhammer-Schalke M, Koller M, Ehret C, Steinger B, Ernst B, Wyatt JC, Hofstadter F, Lorenz W; Regensburg QoL Study Group. Implementing a system of quality-of-life diagnosis and therapy for breast cancer patients: results of an exploratory trial as a prerequisite for a subsequent RCT. Br J Cancer. 2008 Aug 5;99(3):415-22. doi: 10.1038/sj.bjc.6604505.
- Klinkhammer-Schalke M, Koller M, Wyatt JC, Steinger B, Ehret C, Ernst B, Hofstadter F, Lorenz W. Quality of life diagnosis and therapy as complex intervention for improvement of health in breast cancer patients: delineating the conceptual, methodological, and logistic requirements (modeling). Langenbecks Arch Surg. 2008 Jan;393(1):1-12. doi: 10.1007/s00423-007-0210-5. Epub 2007 Jul 28.
- Klinkhammer-Schalke M, Steinger B, Koller M, Zeman F, Furst A, Gumpp J, Obermaier R, Piso P, Lindberg-Scharf P; Regensburg QoL Study Group. Diagnosing deficits in quality of life and providing tailored therapeutic options: Results of a randomised trial in 220 patients with colorectal cancer. Eur J Cancer. 2020 May;130:102-113. doi: 10.1016/j.ejca.2020.01.025. Epub 2020 Mar 13.
- Klinkhammer-Schalke M, Lindberg P, Koller M, Wyatt JC, Hofstadter F, Lorenz W, Steinger B. Direct improvement of quality of life in colorectal cancer patients using a tailored pathway with quality of life diagnosis and therapy (DIQOL): study protocol for a randomised controlled trial. Trials. 2015 Oct 14;16:460. doi: 10.1186/s13063-015-0972-y.
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 (实际的)
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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生活质量的临床试验
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Swansea University完全的
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Yale-NUS College完全的
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Scripps Translational Science Institute完全的