Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, California.
Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University, Stanford, California.
J Palliat Med. 2019 Sep;22(S1):44-57. doi: 10.1089/jpm.2019.0130.
Despite positive outcomes associated with specialist palliative care (PC) in diverse medical populations, little research has investigated specialist PC in surgical ones. Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortality persist, particularly for patients with upper gastrointestinal (GI) cancers. Our objective is to complete a multicenter, randomized controlled trial comparing surgeon-PC co-management with surgeon-alone management among patients pursuing curative-intent surgery for upper GI cancers. We hypothesize that perioperative PC will improve patient postsurgical quality of life. This study and design are based on >8 years of engagement and research with patients, family members, and clinicians surrounding major cancer surgery and advance care planning/PC for surgical patients. Randomized controlled superiority trial with two study arms (surgeon-PC team co-management and surgeon-alone management) and five data collection points over six months. The principal investigator and analysts are blinded to randomization. Four, geographically diverse, academic tertiary care hospitals. Data collection began December 20, 2018 and continues to December 2020. Patients recruited from surgical oncology clinics who are undergoing curative-intent surgery for an upper GI cancer. In the intervention arm, patients receive care from both their surgical team and a specialist PC team; the PC is provided before surgery, immediately after surgery, and at least monthly until three months postsurgery. Patients randomized to the usual care arm receive care from only the surgical team. Primary outcome: patient quality of life. Secondary outcomes: patient: symptom experience, spiritual distress, prognostic awareness, health care utilization, and mortality. Caregiver: quality of life, caregiver burden, spiritual distress, and prognostic awareness. Intent-to-treat analysis will be used. This study has been approved by the institutional review boards of all study sites and is registered on clinicaltrials.gov (NCT03611309, First received: August 2, 2018).
尽管在不同的医学人群中，专科姑息治疗（PC）都有积极的结果，但很少有研究调查外科人群中的专科 PC。尽管癌症手术主要是安全的，但手术可能广泛且不可预测，围手术期发病率和死亡率仍然存在，特别是对于上胃肠道（GI）癌症患者。我们的目的是完成一项多中心、随机对照试验，比较接受根治性手术治疗上胃肠道癌症的患者中，外科医生与 PC 医生共同管理与外科医生单独管理的效果。我们假设围手术期 PC 将改善患者术后生活质量。这项研究和设计基于与患者、家属和临床医生围绕主要癌症手术和外科患者的预立医疗照护计划/PC 进行了 8 年以上的合作和研究。随机对照优势试验，有两个研究组（外科医生-PC 团队共同管理和外科医生单独管理），在六个月内有五个数据收集点。主要研究者和分析人员对随机分组情况不知情。四个地理位置不同的学术三级保健医院。数据收集于 2018 年 12 月 20 日开始，持续到 2020 年 12 月。从接受根治性手术治疗上胃肠道癌症的外科肿瘤学诊所招募患者。在干预组中，患者同时接受他们的外科团队和专科 PC 团队的治疗；PC 在手术前、手术后立即以及术后至少每月一次提供，直到术后三个月。随机分配到常规护理组的患者仅接受外科团队的治疗。主要结果：患者生活质量。次要结果：患者：症状体验、精神困扰、预后意识、卫生保健利用和死亡率。护理人员：生活质量、护理人员负担、精神困扰和预后意识。将采用意向治疗分析。该研究已获得所有研究地点的机构审查委员会的批准，并在 clinicaltrials.gov 上注册（NCT03611309，首次接收：2018 年 8 月 2 日）。
