BACKGROUND The implementation of quality of life (QoL) concepts in routine care, is still an open matter. We followed the Medical Research Council framework for complex interventions to implement a model of QoL diagnosis and therapeutic options, and investigated its effectiveness in patients with colorectal cancer. METHODS This randomised, single-blind, multicentre, clinical trial enrolled patients diagnosed with primary colorectal cancer aged 18 years or older who were surgically treated in one of four recruiting hospitals in Germany. All patients received aftercare from one of 178 coordinating practitioners (CPs) who had access to 75 healthcare professionals providing tailored therapies. QoL was measured (EORTC QLQ-C30, QLQ-CR29) in all patients after surgery (baseline) and during aftercare (3, 6, 12, 18 months). Patients were randomised (1:1) into two groups: a care pathway, including QoL-profiles consisting of 13 QoL scales plus specific therapeutic recommendations forwarded to the patient's CP or standard postoperative care adhering to the German national guideline for colorectal cancer (control). The primary endpoint was the proportion of patients in each group with a need for QoL therapy 12 months after surgery. Analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02321813 and closed to accrual. FINDINGS Between Jan 13, 2014, and Oct 28, 2015, 220 patients were enrolled and randomly assigned (n = 110 per group). At baseline (in hospital after surgery), a need for QoL therapy was diagnosed in 92/103 (89%) of intervention and 86/104 (83%) of control group patients. At 12 months (primary endpoint) the proportion of patients with a need for QoL therapy was 35/83 (42%; 95% CI 31-54%) in the intervention group versus 50/87 (57%; 95% CI: 46-68%) in the control group (p = 0·046, number needed to treat = 7; 95% CI 3-225). INTERPRETATION Patients profited from the diagnosis of QoL deficits and tailored therapeutic options in their treatment of colorectal cancer. This trial confirmed the results of a previous RCT in breast cancer patients. The implementation of QoL concepts should become standard in treatment guidelines on cancer care. FUNDING Federal Ministry of Education and Research (BMBF; grant no. 01GY1339). CLINICAL TRIAL INFORMATION NCT02321813.

中文翻译：

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诊断生活质量缺陷并提供量身定制的治疗选择：一项针对220位大肠癌患者的随机试验结果。

背景技术在常规护理中实施生活质量（QoL）概念仍然是一个悬而未决的问题。我们遵循医学研究理事会针对复杂干预措施的框架实施了QoL诊断和治疗选择模型，并研究了其在结直肠癌患者中的有效性。方法该随机，单盲，多中心，临床试验纳入了诊断为18岁或以上的原发性结直肠癌的患者，这些患者在德国的四家招募医院中进行了手术治疗。所有患者均接受了178位协调医生（CP）之一的护理，这些患者可以与75位提供量身定制疗法的医疗保健专业人员联系。在手术后（基线）和术后护理（3、6、12、18个月）对所有患者进行QoL测量（EORTC QLQ-C30，QLQ-CR29）。患者随机分组（1：1）分为两组：一种护理途径，包括由13种QoL量表组成的QoL资料，以及转发给患者CP的具体治疗建议或遵循德国国家大肠癌指南（对照）的标准术后护理。主要终点是手术后12个月每组需要QoL治疗的患者比例。在意向治疗人群中进行了分析。该试验已在ClinicalTrials.gov上注册，编号为NCT02321813，并且已关闭。结果在2014年1月13日至2015年10月28日之间，共有220名患者入组并随机分配（每组n = 110）。在基线时（手术后在医院中），在92/103（89％）的干预措施和86/104（83％）的对照组患者中诊断出需要QoL治疗。在第12个月（主要终点），干预组中需要QoL治疗的患者比例为35/83（42％； 95％CI为31-54％），而50/87（57％； 95％CI：46） -68％）作为对照组（p = 0·046，需要治疗的人数= 7； 95％CI 3-225）。解释患者从QoL缺陷的诊断和量身定制的治疗结直肠癌的治疗方案中受益。该试验证实了先前在乳腺癌患者中进行RCT的结果。QoL概念的实施应成为癌症护理治疗指南中的标准。资金联邦教育和研究部（BMBF；授权号01GY1339）。临床试验信息NCT02321813。需要治疗的数量= 7；95％CI 3-225）。解释患者从QoL缺乏症的诊断和量身定制的大肠癌治疗选择中受益。该试验证实了先前在乳腺癌患者中进行RCT的结果。QoL概念的实施应成为癌症治疗指南中的标准。资金联邦教育和研究部（BMBF；授权号01GY1339）。临床试验信息NCT02321813。需要治疗的数量= 7；95％CI 3-225）。解释患者从QoL缺陷的诊断和量身定制的治疗结直肠癌的治疗方案中受益。该试验证实了先前在乳腺癌患者中进行RCT的结果。QoL概念的实施应成为癌症治疗指南中的标准。资金联邦教育和研究部（BMBF；授权号01GY1339）。临床试验信息NCT02321813。资金联邦教育和研究部（BMBF；授权号01GY1339）。临床试验信息NCT02321813。资金联邦教育和研究部（BMBF；授权号01GY1339）。临床试验信息NCT02321813。