目的 評估 CONNECT（腫瘤科護士為滿足支援性護理需求提供的護理管理）（一種由腫瘤科護士提供的主要姑息治療干預）對患者預後的影響。
設計、場所和參與者 該 CONNECT 干預與標準治療的集群隨機臨床試驗于 2016 年 7 月 25 日至 2020 年 10 月 6 日進行。該試驗在賓夕法尼亞州西部的 17 個社區腫瘤診所進行。數據分析遵循意向性治療原則。
干預 CONNECT 干預包括現有輸液室護士進行 3 個月隨訪，該護士接受過針對症狀、提供情感支援、參與預先護理計劃和協調護理的培訓。
主要結果和措施 主要結果是生活品質。在基線和 3 個月時，參與者完成了生活品質評估（慢性疾病治療功能評估 - 姑息治療：評分範圍，0-184，分數越高表示生活品質越好）、症狀負擔（埃德蒙頓症狀評估量表：評分範圍，0-90，分數越高表示症狀負擔越大）和情緒症狀（醫院焦慮和抑鬱量表 [HADS]：分數範圍，0-21，分數越高表示嚴重的焦慮和抑鬱）。使用線性混合效應模型估計 3 個月結果的調整後平均差異。進行了預先計劃的、強度調整的分析。
結果 共納入 672 名患者（平均年齡，69.3 [10.2] 歲；360 名女性 [53.6%]）。完成的 CONNECT 隨訪的平均 (SD) 數為 2.2 (1.0)。在 3 個月時，CONNECT 和標準護理組之間的平均 (SD) 生活品質評分沒有差異（130.7 [28.2] vs 134.1 [28.1]；調整後的平均差異，1.20；95% CI，-2.75 -5.15；P = .55）。同樣，組間 3 個月平均 (SD) 症狀負擔也沒有差異（23.2 [16.6] 對 24.0 [16.1]；調整後的平均差異，-2.64；95% CI，-5.85- 0.58；P = .11）或情緒症狀（HADS 抑鬱分量表評分：5.1 [3.4] vs 4.8 [3.7]，調整後的平均差，-0.08 [95% CI，-0.71 至 0.57]，P = .82; HADS 焦慮分量表評分：5.7 [3.9] vs 5.4 [4.2]，調整後的平均差，-0.31 [95% CI，-0.96 - 0.33]，P = .34）。強度調整分析顯示，對於接受全劑量（3 次就診）的 CONNECT 干預的患者，估計的治療效果更大。
結論和相關性 該集群隨機臨床試驗發現，由腫瘤科護士提供的初級姑息治療干預在 3 個月時並未改善患者報告的結果。具有較高劑量強度的初級姑息治療干預可能對大多數無法獲得姑息治療的晚期癌症患者有益。
試驗註冊 ClinicalTrials.gov ：NCT02712229
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