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Case management in oncology rehabilitation (CAMON): The effect of case management on the quality of life in patients with cancer after one year of ambulant rehabilitation. A study protocol for a randomized controlled clinical trial in oncology rehabilitation

机译:肿瘤康复中的病例管理(CAMON):进行一年的康复治疗后,病例管理对癌症患者生活质量的影响。肿瘤康复随机对照临床试验的研究方案

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Background Cancer diseases and their therapies have negative effects on the quality of life. The aim of this study is to assess the effectiveness of case management in a sample of oncological outpatients with the intent of rehabilitation after cancer treatment. Case management wants to support the complex information needs of the patients in addition to the segmented structure of the health care system. Emphasis is put on support for self-management in order to enhance health - conscious behaviour, learning to deal with the burden of the illness and providing the opportunity for regular contacts with care providers. We present a study protocol to investigate the efficacy of a case management in patients following oncology rehabilitation after cancer treatment. Methods The trial is a multicentre, two-arm randomised controlled study. Patients are randomised parallel in either 'usual care' plus case management or 'usual care' alone. Patients with all types of cancer can be included in the study, if they have completed the therapy with chemo- and/or radiotherapy/surgery with curative intention and are expected to have a survival time >1 year. To determine the health-related quality of life the general questionnaire FACT G is used. The direct correlation between self-management and perceived self-efficacy is measured with the Jerusalem & Schwarzer questionnaire. Patients satisfaction with the care received is measured using the Patient Assessment of Chronic Illness Care 5 As (PACIC-5A). Data are collected at the beginning of the trial and after 3, 6 and 12 months. The power analysis revealed a sample size of 102 patients. The recruitment of the centres began in 2009. The inclusion of patients began in May 2010. Discussion Case management has proved to be effective regarding quality of life of patients with chronic diseases. When it comes to oncology, case management is mainly used in cancer treatment, but it is not yet common in the rehabilitation of cancer patients. Case management in oncology rehabilitation is not well-established in Switzerland. A major challenge of the study will therefore probably be the recruitment of the patients due to the physicians' and patients' scarcely existing awareness of this issue. Trial registration ISRCTN41474586
机译:背景技术癌症疾病及其疗法对生活质量有负面影响。这项研究的目的是评估癌症治疗后康复目的的肿瘤门诊患者样本管理的有效性。案例管理不仅要满足医疗系统的分段结构,还要满足患者的复杂信息需求。重点支持自我管理,以增强健康意识的行为,学习应对疾病的负担并提供与护理提供者定期接触的机会。我们提出了一项研究方案,以调查在癌症治疗后的肿瘤康复后患者中进行病例管理的功效。方法该试验是一项多中心,两臂随机对照研究。患者在“常规护理”加病例管理或单独的“常规护理”中随机分组。如果已完成具有化学治疗和/或放射治疗/手术治疗的治愈性治疗,且预期生存时间> 1年,则可将所有类型的癌症患者纳入研究。为了确定健康相关的生活质量,使用了普通问卷FACTG。自我管理和感知的自我效能之间的直接相关性是通过Jerusalem&Schwarzer问卷进行测量的。使用对慢性病护理5 As的患者评估(PACIC-5A)来衡量患者对所接受护理的满意度。在试验开始时以及3、6和12个月后收集数据。功效分析显示样本量为102位患者。该中心的招募始于2009年。2010年5月开始招募患者。讨论事实证明,案例管理对慢性病患者的生活质量有效。在肿瘤学方面,病例管理主要用于癌症治疗,但在癌症患者的康复中尚不常见。在瑞士,肿瘤康复中的病例管理还不完善。因此,该研究的主要挑战可能是由于医师和患者对此问题的认识不高而招募患者。试用注册ISRCTN41474586

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