Clinical trial participation as part of end-of-life cancer care: associations with medical care and quality of life near death.

Context: Clinical trials are a common therapeutic option for patients with advanced incurable cancer.

Objectives: To examine the associations between trial participation and end-of-life (EOL) outcomes, including aggressive care and quality of life (QOL).

Methods: 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.

Results: 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).

Conclusion: Clinical trial participation is associated with aggressive EOL care. Aggressive EOL care appears to explain the association between trial participation and QOL near death.