晚期癌症患者症状筛查与目标性早期姑息治疗的 II 期临床试验。

Phase II Trial of Symptom Screening With Targeted Early Palliative Care for Patients With Advanced Cancer.

机构信息

1Department of Supportive Care, and.

2Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto.

出版信息

J Natl Compr Canc Netw. 2021 Sep 7;20(4):361-370.e3. doi: 10.6004/jnccn.2020.7803.

DOI:10.6004/jnccn.2020.7803

PMID:34492632

Abstract

BACKGROUND

Routine early palliative care (EPC) improves quality of life (QoL) for patients with advanced cancer, but it may not be necessary for all patients. We assessed the feasibility of Symptom screening with Targeted Early Palliative care (STEP) in a phase II trial.

METHODS

Patients with advanced cancer were recruited from medical oncology clinics. Symptoms were screened at each visit using the Edmonton Symptom Assessment System-revised (ESAS-r); moderate to severe scores (screen-positive) triggered an email to a palliative care nurse, who called the patient and offered EPC. Patient-reported outcomes of QoL, depression, symptom control, and satisfaction with care were measured at baseline and at 2, 4, and 6 months. The primary aim was to determine feasibility, according to predefined criteria. Secondary aims were to assess whether STEP identified patients with worse patient-reported outcomes and whether screen-positive patients who accepted and received EPC had better outcomes over time than those who did not receive EPC.

RESULTS

In total, 116 patients were enrolled, of which 89 (77%) completed screening for ≥70% of visits. Of the 70 screen-positive patients, 39 (56%) received EPC during the 6-month study and 4 (6%) received EPC after the study end. Measure completion was 76% at 2 months, 68% at 4 months, and 63% at 6 months. Among screen-negative patients, QoL, depression, and symptom control were substantially better than for screen-positive patients at baseline (all P<.0001) and remained stable over time. Among screen-positive patients, mood and symptom control improved over time for those who accepted and received EPC and worsened for those who did not receive EPC (P<.01 for trend over time), with no difference in QoL or satisfaction with care.

CONCLUSIONS

STEP is feasible in ambulatory patients with advanced cancer and distinguishes between patients who remain stable without EPC and those who benefit from targeted EPC. Acceptance of the triggered EPC visit should be encouraged.

CLINICALTRIALS

gov identifier: NCT04044040.

摘要

背景

常规早期姑息治疗（EPC）可提高晚期癌症患者的生活质量（QoL），但并非所有患者都需要。我们在一项 2 期试验中评估了使用症状筛查进行靶向早期姑息治疗（STEP）的可行性。

方法

从肿瘤内科门诊招募晚期癌症患者。每次就诊时使用 Edmonton 症状评估系统修订版（ESAS-r）进行症状筛查；中度至重度评分（筛查阳性）会向姑息治疗护士发送电子邮件，护士会打电话给患者并提供 EPC。在基线和 2、4 和 6 个月时测量患者报告的 QoL、抑郁、症状控制和护理满意度的结果。主要目的是根据预设标准确定可行性。次要目的是评估 STEP 是否可以识别出患者报告结局较差的患者，以及接受和接受 EPC 的筛查阳性患者是否比未接受 EPC 的患者随着时间的推移获得更好的结局。

结果

共有 116 名患者入组，其中 89 名（77%）完成了≥70%就诊次数的筛查。在 70 名筛查阳性患者中，有 39 名（56%）在 6 个月的研究期间接受了 EPC，有 4 名（6%）在研究结束后接受了 EPC。在 2 个月时的完成率为 76%，在 4 个月时为 68%，在 6 个月时为 63%。在筛查阴性患者中，基线时 QoL、抑郁和症状控制均明显优于筛查阳性患者（均 P<.0001），且随时间保持稳定。在筛查阳性患者中，接受并接受 EPC 的患者的情绪和症状控制随时间改善，而未接受 EPC 的患者则恶化（随时间的趋势 P<.01），而 QoL 或护理满意度没有差异。