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作者：SCI天天读
SCI
24 March 2024
Patient, family caregiver, and economic outcomes of an integrated screening and novel stepped collaborative care intervention in the oncology setting in the USA (CARES): a randomised, parallel, phase 3 trial
(LANCET, IF: 168.90)
Jennifer L Steel, Charles J George, Lauren Terhorst, Jonathan G Yabes, Vincent Reyes, Dan P Zandberg, Marci Nilsen, Gauri Kiefer, Jonas Johnson, Christopher Marsh, Jason Bierenbaum, Nishant Tageja, Michal Krauze, Robert VanderWeele, Gaurav Goel, Gopala Ramineni, Michael Antoni, Yoram Vodovotz, Jon Walker, Samer Tohme, Timothy Billiar, David A Geller
CORRESPONDENCE TO: steejl@upmc.edu
Background 背景
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.
目前以筛查和转诊患者来治疗抑郁、疼痛和疲劳等症状的护理标准是无效的。本试验旨在测试综合筛查和新型分级协作护理对比癌症患者标准护理的效果，这些患者至少有以下症状之一：抑郁、疼痛或疲劳。
Methods 方法
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).
这项随机、平行、3期试验在美国UPMC Hillman癌症中心的29家肿瘤门诊进行。罹患任一癌症和并存在临床抑郁、疼痛或疲劳（或所有这些）的患者（年龄≥21岁）都符合条件。符合条件的家庭护理人员年龄在21岁或21岁以上，并为参与本研究的癌症患者提供护理。患者被随机（1:1）分为阶梯式协作护理或标准护理，采用按性别和预后状况分层的中央排列块设计（数量为2、4和6）。生物统计学家、肿瘤学家和结果评估人员被匿名于治疗分配。分级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）每周进行一次认知行为治疗，持续50-60分钟。如果治疗团队建议或患者意愿，可以接受或使用改善症状的药物进行治疗。标准护理包括筛查并转诊给医疗机构进行对症治疗。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。纳入主要分析的参与者按意向治疗，其中包括错过一次或两次随访评估的患者。该试验已在ClinicalTrials.gov（NCT02939755）上注册。
Findings 结果
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.
在2016年12月5日至2021年4月8日期间，共有459名患者和190名家庭护理人员参与研究。222名患者被分配到标准护理组，237名患者被分配到阶梯式协作护理组。在459名患者中，201名（44%）为男性，258名（56%）为女性。阶梯式协作护理组的患者在0-6个月内健康相关生活质量的改善情况优于标准护理组（p=0∙013，效应值0·09）。阶梯式协作护理组的患者健康相关生活质量（p=0∙74，效应值0∙01）原水平维持。阶梯式协作护理组的患者在情绪（p=0·012）、功能（p=0·042）和身体（p=0·033）健康方面比标准护理组有更大的改善。两组患者均未报告不良事件，死亡事件被认为与研究无关。
Interpretation 理解
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.
与目前的护理标准相比，建议采用综合筛查和新的分级协作护理，以提高健康相关的生活质量。这项研究的结果将推动指导一致性护理（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，改善癌症患者的预后。
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