Department of Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA; Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA; Department of Psychology, Dietrich School of Arts and Sciences, University of Pittsburgh, Pittsburgh, PA, USA.
School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, USA.
Lancet. 2024 Apr 6;403(10434):1351-1361. doi: 10.1016/S0140-6736(24)00015-1. Epub 2024 Mar 12.
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.
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).
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.
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.
US National Cancer Institute.
目前，针对抑郁、疼痛和疲劳等症状进行筛查和转介治疗的标准护理并不有效。本试验旨在测试综合筛查和新型分级协作护理干预与标准护理相比，对患有癌症且至少存在以下一种症状（抑郁、疼痛或疲劳，或全部）的患者的疗效。
这是一项在美国匹兹堡大学希尔曼癌症中心的 29 家肿瘤门诊进行的随机、平行、3 期临床试验。入组患者（年龄≥21 岁）患有任何类型的癌症且临床存在抑郁、疼痛或疲劳（或全部）。符合条件的家庭护理人员年龄≥21 岁，正在照顾一名同意参与本研究的癌症患者。患者按 1:1 比例随机分配（使用中央、随机区组设计[大小为 2、4 和 6]）至分级协作护理或标准护理，按性别和预后分层。生物统计学家、肿瘤学家和结局评估者对治疗分配设盲。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）每周提供一次 50-60 分钟的认知行为疗法。如果治疗团队建议或患者首选，可启动或更改症状的药物治疗。标准护理是对症状进行筛查并转介给医疗保健提供者进行治疗。主要结局是 6 个月时患者的健康相关生活质量。12 个月时评估治疗获益的维持情况。意向治疗纳入了所有参与者，包括遗漏一次或两次随访评估的患者。该试验在 ClinicalTrials.gov（NCT02939755）注册。
2016 年 12 月 5 日至 2021 年 4 月 8 日期间，共纳入 459 名患者和 190 名家庭护理人员。222 名患者被分配至标准护理组，237 名患者被分配至分级协作护理组。在 459 名患者中，201 名（44%）为男性，258 名（56%）为女性。与标准护理组相比，分级协作护理组患者在 0-6 个月时的健康相关生活质量改善更大（p=0·013，效应大小 0·09）。分级协作护理组的健康相关生活质量得以维持（p=0·74，效应大小 0·01）。与标准护理组相比，分级协作护理组患者在 0-6 个月时的情绪（p=0·012）、功能（p=0·042）和身体（p=0·033）健康方面的改善更大。两组患者均未报告不良事件，死亡被认为与研究无关。
与当前的标准护理相比，综合筛查和新型分级协作护理干预被推荐用于改善健康相关生活质量。本研究的结果将推动符合指南的护理（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，改善被诊断为癌症的患者的结局。
美国国立癌症研究所。
