Enzinger Andrea C, Zhang Baohui, Weeks Jane C, Prigerson Holly G
Center for Psychosocial Epidemiology and Outcomes Research, Dana-Faber Cancer Institute, Boston, Massachusetts, USA; Department of Medical Oncology, Dana-Faber Cancer Institute, Boston, Massachusetts, USA; McGraw/Patterson Center for Population Sciences, Dana-Faber Cancer Institute, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA.
Center for Psychosocial Epidemiology and Outcomes Research, Dana-Faber Cancer Institute, Boston, Massachusetts, USA; McGraw/Patterson Center for Population Sciences, Dana-Faber Cancer Institute, Boston, Massachusetts, USA.
J Pain Symptom Manage. 2014 Jun;47(6):1078-90. doi: 10.1016/j.jpainsymman.2013.07.004. Epub 2013 Oct 5.
Clinical trials are a common therapeutic option for patients with advanced incurable cancer.
To examine the associations between trial participation and end-of-life (EOL) outcomes, including aggressive care and quality of life (QOL).
Coping with Cancer, a multicenter prospective cohort study of patients with metastatic cancer, progressed after at least first-line chemotherapy. Baseline chart review documented clinical trial participation. Baseline interviews assessed psychosocial characteristics and EOL preferences. Caregiver interview and chart review assessed medical care and QOL near death. The primary outcome was aggressive EOL care (ventilation, resuscitation, or intensive care unit admission in last week of life). Propensity score weighting balanced patient characteristics that differed by trial participation, including care preferences and EOL discussion. Propensity score-weighted regression models estimated the effect of trial participation on outcomes.
Of 352 patients followed to death, 37 were enrolled in a clinical trial at baseline. In propensity score-weighted analyses, trial participation was significantly associated with aggressive EOL care (21.6% vs. 12.0%, adjusted odds ratio [AOR] 2.04, 95% confidence interval [CI] 1.00-4.15), late hospice enrollment (51.4% vs. 42.2%, AOR 1.96, 95% CI 1.10-3.50), hospital death (48.6% vs. 25.7%, AOR 2.74, 95% CI 1.37-5.47), intensive care unit death (16.2% vs. 6.3%, AOR 3.53, 95% CI 1.29-9.65), and inferior QOL near death (least squares mean 5.93 vs. 7.69, P<0.001). Controlling for EOL care, trial enrollment was no longer associated with QOL near death (P=0.342).
Clinical trial participation is associated with aggressive EOL care. Aggressive EOL care appears to explain the association between trial participation and QOL near death.
临床试验是晚期无法治愈癌症患者常见的治疗选择。
研究参与试验与临终（EOL）结局之间的关联，包括积极治疗和生活质量（QOL）。
“应对癌症”是一项针对转移性癌症患者的多中心前瞻性队列研究，患者至少在一线化疗后病情进展。通过基线病历审查记录临床试验参与情况。基线访谈评估心理社会特征和临终偏好。对照顾者的访谈和病历审查评估临终前的医疗护理和生活质量。主要结局是积极的临终护理（在生命的最后一周进行通气、复苏或入住重症监护病房）。倾向评分加权平衡了因参与试验而不同的患者特征，包括护理偏好和临终讨论。倾向评分加权回归模型估计了参与试验对结局的影响。
在随访至死亡的352例患者中，37例在基线时参加了临床试验。在倾向评分加权分析中，参与试验与积极的临终护理显著相关（21.6%对12.0%，调整优势比[AOR]2.04，95%置信区间[CI]1.00 - 4.15）、临终关怀机构登记较晚（51.4%对42.2%，AOR 1.96，95%CI 1.10 - 3.50）、在医院死亡（48.6%对25.7%，AOR 2.74，95%CI 1.37 - 5.47）、在重症监护病房死亡（16.2%对6.3%，AOR 3.53，95%CI 1.29 - 9.65）以及临终前生活质量较差（最小二乘均值5.93对7.69，P<0.001）。在控制临终护理后，试验登记与临终前生活质量不再相关（P = 0.342）。
参与临床试验与积极的临终护理相关。积极的临终护理似乎解释了参与试验与临终前生活质量之间的关联。
