Importance Guidelines recommend early specialty palliative care for all patients with advanced cancer, but most patients lack access to such services. Objective To assess the effect of CONNECT (Care Management by Oncology Nurses to Address Supportive Care Needs), a primary palliative care intervention delivered by oncology nurses, on patient outcomes. Design, Setting, and Participants This cluster randomized clinical trial of the CONNECT intervention vs standard care was conducted from July 25, 2016, to October 6, 2020. Participants were adult patients with metastatic solid tumors who were undergoing oncological care and for whom an oncologist would agree with the statement "would not be surprised if the patient died in the next year." The trial was conducted at 17 community oncology practices in western Pennsylvania. Data analyses adhered to the intention-to-treat principle. Interventions The CONNECT intervention included 3 monthly visits with an existing infusion room nurse who was trained to address symptoms, provide emotional support, engage in advance care planning, and coordinate care. Main Outcomes and Measures The primary outcome was quality of life. At baseline and 3 months, participants completed assessments of quality of life (Functional Assessment of Chronic Illness Therapy-Palliative care: score range, 0-184, with higher scores indicating better quality of life), symptom burden (Edmonton Symptom Assessment Scale: score range, 0-90, with higher scores indicating greater symptom burden), and mood symptoms (Hospital Anxiety and Depression Scale [HADS]: score range, 0-21, with higher scores indicating substantial anxiety and depression). Linear mixed-effects models were used to estimate adjusted mean differences in 3-month outcomes. Preplanned, intensity-adjusted analyses were conducted. Results A total of 672 patients were enrolled (mean [SD] age, 69.3 [10.2] years; 360 women [53.6%]). The mean (SD) number of CONNECT visits completed was 2.2 (1.0). At 3 months, no difference in mean (SD) quality-of-life score was found between the CONNECT and standard care groups (130.7 [28.2] vs 134.1 [28.1]; adjusted mean difference, 1.20; 95% CI, -2.75 to 5.15; P = .55). Similarly, there was no difference between groups in 3-month mean (SD) symptom burden (23.2 [16.6] vs 24.0 [16.1]; adjusted mean difference, -2.64; 95% CI, -5.85 to 0.58; P = .11) or mood symptoms (HADS depression subscale score: 5.1 [3.4] vs 4.8 [3.7], adjusted mean difference, -0.08 [95% CI, -0.71 to 0.57], P = .82; HADS anxiety subscale score: 5.7 [3.9] vs 5.4 [4.2], adjusted mean difference, -0.31 [95% CI, -0.96 to 0.33], P = .34). Intensity-adjusted analyses revealed a larger estimated treatment effect for patients who received a full dose (3 visits) of the CONNECT intervention. Conclusions and Relevance This cluster randomized clinical trial found that a primary palliative care intervention that was delivered by oncology nurses did not improve patient-reported outcomes at 3 months. Primary palliative care interventions with a higher dose intensity may be beneficial for most patients with advanced cancer who lack access to palliative care specialists. Trial Registration ClinicalTrials.gov Identifier: NCT02712229.

中文翻译：

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肿瘤科护士主导的初级姑息治疗干预对晚期癌症患者的影响：CONNECT 集群随机临床试验。

重要性指南建议对所有晚期癌症患者进行早期专科姑息治疗，但大多数患者无法获得此类服务。目的 评估 CONNECT（由肿瘤科护士提供的护理管理以解决支持性护理需求）对患者预后的影响，这是一种由肿瘤科护士提供的初级姑息治疗干预措施。设计、设置和参与者 这项关于 CONNECT 干预与标准治疗的整群随机临床试验于 2016 年 7 月 25 日至 2020 年 10 月 6 日进行。参与者是接受肿瘤治疗的转移性实体瘤成年患者，肿瘤科医生为其提供治疗会同意“如果患者在明年死亡，也不会感到惊讶”的说法。该试验在宾夕法尼亚州西部的 17 个社区肿瘤学诊所进行。数据分析遵循意向治疗原则。干预 CONNECT 干预包括与现有输液室护士进行 3 个月的访问，该护士接受过处理症状、提供情感支持、参与预先护理计划和协调护理的培训。主要结果和措施 主要结果是生活质量。在基线和 3 个月时，参与者完成了生活质量评估（慢性病治疗功能评估-姑息治疗：分数范围，0-184，分数越高表明生活质量越好）、症状负担（埃德蒙顿症状评估量表：分数范围，0-90，分数越高表明症状负担越大）和情绪症状（医院焦虑和抑郁量表 [HADS]：分数范围，0-21，分数越高表明严重的焦虑和抑郁）。线性混合效应模型用于估计 3 个月结果的调整平均差异。进行了预先计划的强度调整分析。结果共纳入 672 名患者（平均 [SD] 年龄，69.3 [10.2] 岁；360 名女性 [53.6%]）。完成的 CONNECT 访问的平均 (SD) 次数为 2.2 (1.0)。在 3 个月时，CONNECT 组和标准护理组之间的平均 (SD) 生活质量评分没有差异（130.7 [28.2] vs 134.1 [28.1]；调整后的平均差，1.20；95% CI，-2.75 至5.15；P = .55）。同样，组间 3 个月平均 (SD) 症状负担没有差异（23.2 [16.6] vs 24.0 [16.1]；调整后的平均差，-2.64；95% CI，-5.85 至 0.58；P = .11）或情绪症状（HADS 抑郁分量表评分：5.1 [3.4] vs 4.8 [3.7]，调整均数差，-0.08 [95% CI，-0.71 至 0.57]，P = .82；HADS 焦虑分量表评分：5.7 [3.9] vs 5.4 [4.2]，调整后的平均差，-0.31 [95% CI，-0.96 至 0.33]，P = .34）。强度调整分析显示，对于接受全剂量（3 次就诊）CONNECT 干预的患者，估计的治疗效果更大。结论和相关性 该集群随机临床试验发现，由肿瘤科护士提供的初级姑息治疗干预并未改善 3 个月时患者报告的结果。具有较高剂量强度的初级姑息治疗干预可能对大多数无法获得姑息治疗专家的晚期癌症患者有益。试验注册 ClinicalTrials.gov 标识符：NCT02712229。强度调整分析显示，对于接受全剂量（3 次就诊）CONNECT 干预的患者，估计的治疗效果更大。结论和相关性 该集群随机临床试验发现，由肿瘤科护士提供的初级姑息治疗干预并未改善 3 个月时患者报告的结果。具有较高剂量强度的初级姑息治疗干预可能对大多数无法获得姑息治疗专家的晚期癌症患者有益。试验注册 ClinicalTrials.gov 标识符：NCT02712229。强度调整分析显示，对于接受全剂量（3 次就诊）CONNECT 干预的患者，估计的治疗效果更大。结论和相关性 该集群随机临床试验发现，由肿瘤科护士提供的初级姑息治疗干预并未改善 3 个月时患者报告的结果。具有较高剂量强度的初级姑息治疗干预可能对大多数无法获得姑息治疗专家的晚期癌症患者有益。试验注册 ClinicalTrials.gov 标识符：NCT02712229。结论和相关性 该集群随机临床试验发现，由肿瘤科护士提供的初级姑息治疗干预并未改善 3 个月时患者报告的结果。具有较高剂量强度的初级姑息治疗干预可能对大多数无法获得姑息治疗专家的晚期癌症患者有益。试验注册 ClinicalTrials.gov 标识符：NCT02712229。结论和相关性 该集群随机临床试验发现，由肿瘤科护士提供的初级姑息治疗干预并未改善 3 个月时患者报告的结果。具有较高剂量强度的初级姑息治疗干预可能对大多数无法获得姑息治疗专家的晚期癌症患者有益。试验注册 ClinicalTrials.gov 标识符：NCT02712229。