本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(24)00015-1

摘要内容如下：

背景

目前对抑郁、疼痛和疲劳等症状的患者进行筛选和转诊治疗的护理标准并不有效。该试验旨在测试综合筛查和新型阶梯式协作护理干预与标准护理对患有以下至少一种症状（抑郁、疼痛或疲劳）的癌症患者的疗效。

方法

这项随机、平行的3期临床试验在美国UPMC Hillman癌症中心的29家肿瘤门诊诊所进行。患有任何癌症类型和抑郁、疼痛或疲劳（或所有这些）的临床水平的患者（年龄≥21岁）符合条件。符合条件的家庭照顾者年龄在21岁或以上，为同意参加本研究的诊断为癌症的患者提供护理。患者被随机分配（1:1）到阶梯式协作护理或标准护理，使用中央排列区块设计（大小为2、4和6），按性别和预后状态分层。生物统计学家、肿瘤学家和结果评估者对治疗分配不知情。阶梯式协作护理是由护理协调员通过远程医疗（如电话或视频会议）每周进行一次50-60分钟的认知行为治疗。如果治疗小组推荐或患者愿意，可以开始或改变针对症状的药物治疗。护理标准是筛查和转诊到保健提供者处治疗症状。主要结果是患者在6个月时的健康相关生活质量。在12个月时评估治疗效益的维持情况。包括在主要分析中的参与者是每个意向治疗，其中包括错过一次或两次随访评估的患者。该试验在ClinicalTrials.gov（NCT02939755）上注册。

调查结果

在2016年12月5日至2021年4月8日期间，共招募了459名患者和190名家庭照顾者。222名患者接受标准护理，237名患者接受阶梯式协作护理。459例患者中，201例（44%）为男性，258例（56%）为女性。与标准护理组患者相比，阶梯式协作护理组患者0-6个月的健康相关生活质量改善更大（P=0.013，效应量0.09）。阶梯式协作护理组维持了健康相关的生活质量（P=0.74，效应量0.01）。与标准护理组相比，阶梯式协作护理组患者在0-6个月内的情绪（P=0.012）、功能（P=0.042）和身体（P=0.033）健康状况改善更明显。两组患者均未报告不良事件，死亡被认为与本研究无关。

解释

与目前的护理标准相比，建议进行综合筛查和新的阶梯式协作护理干预，以改善健康相关的生活质量。这项研究的发现将推进指南一致性护理（筛查和治疗）的实施，并有可能在全国范围内改变筛查和治疗模式的实践，改善诊断为癌症的患者的结果。

英文原文如下：

Abstracts

BACKGROUND  The current standard of care of screening and referring patients for treatment for symptoms, such as depression, pain, and fatigue, is not effective. This trial aimed to test the efficacy of an integrated screening and novel stepped collaborative care intervention versus standard of care for patients with cancer and at least one of the following symptoms: depression, pain, or fatigue.

METHODS  This randomised, parallel, phase 3 trial was conducted in 29 oncology outpatient clinics associated with the UPMC Hillman Cancer Center in the USA. Patients (aged ≥21 years) with any cancer type and clinical levels of depression, pain, or fatigue (or all of these) were eligible. Eligible family caregivers were aged 21 years or older and providing care to a patient diagnosed with cancer who consented for this study. Patients were randomly assigned (1:1) to stepped collaborative care or standard of care using a central, permuted block design (sizes of 2, 4, and 6) stratified by sex and prognostic status. The biostatistician, oncologists, and outcome assessors were masked to treatment assignment. Stepped collaborative care was once-weekly cognitive behavioural therapy for 50-60 min from a care coordinator via telemedicine (eg, telephone or videoconferencing). Pharmacotherapy for symptoms might be initiated or changed if recommended by the treatment team or preferred by the patient. Standard of care was screening and referral to a health-care provider for treatment of symptoms. The primary outcome was health-related quality of life in patients at 6 months. Maintenance of the treatment benefits was assessed at 12 months. Participants included in the primary analysis were per intention to treat, which included patients missing one or both follow-up assessments. This trial was registered with ClinicalTrials.gov (NCT02939755).

FINDINGS  Between Dec 5, 2016, and April 8, 2021, 459 patients and 190 family caregivers were enrolled. 222 patients were assigned to standard of care and 237 to stepped collaborative care. Of 459 patients, 201 (44%) were male and 258 (56%) were female. Patients in the stepped collaborative care group had a greater 0-6-month improvement in health-related quality of life than patients in the standard-of-care group (p=0·013, effect size 0·09). Health-related quality of life was maintained for the stepped collaborative care group (p=0·74, effect size 0·01). Patients in the stepped collaborative care group had greater 0-6-month improvements than the standard-of-care group in emotional (p=0·012), functional (p=0·042), and physical (p=0·033) wellbeing. No adverse events were reported by patients in either group and deaths were considered unrelated to the study.

INTERPRETATION  An integrated screening and novel stepped collaborative care intervention, compared with the current standard of care, is recommended to improve health-related quality of life. The findings of this study will advance the implementation of guideline concordant care (screening and treatment) and has the potential to shift the practice of screening and treatment paradigm nationwide, improving outcomes for patients diagnosed with cancer.

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