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The ENABLE III randomized controlled trial of concurrent palliative oncology care.
J Clin Oncol 32:5s, 2014 (suppl; abstr 9512)
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: Evidence from randomized controlled trials (RCTs) supports integration of oncology and palliative care; how soon after diagnosis to initiate palliative care has not been defined. Methods: We conducted a ‘fast track’ RCT of patients with advanced cancer in a rural, NCI-designated cancer center, VAMC, and community clinics in NH and VT to determine the effect of immediate vs. delayed (3 months after diagnosis) entry patients into the ENABLE concurrent oncology palliative care intervention on primary outcome measures: QOL (FACIT-pal), symptom impact (Symptom impact subscale of the QUAL-E, mood (CES-D), at 3 and 6 months and survival at 1 year (from enrollment to death or study completion). Other outcomes included: resource use (hospital and ICU days and ER visits-measured by chart review), and quality of EOL care. Results: Participants (immediate n=104; delayed=103) were mean age 65; 52% male; 65% married; 96% white; 42% lung; 46% newly diagnosed with advanced disease; 17% with brain metastases. The estimated treatment effects (TE) using a terminal decline model (Cohen’s d; immediate minus delayed) for patients from randomization to 3 months were: (mean [SE]: .13 (21.39) for QOL (P=.34), -.21 (3.63) for symptom impact (P=.09), and .04 (3.91) for depressed mood (P=.33). 104 participants died (immediate n=49; delayed n=55) during the study. Compared to delayed entry patients, the risk of death (hazard ratio [HR] (95% CI)) was lower for immediate participants at 1 year 0.72 (95% CI, 0.57-0.89) (P=0.003). Median survival for immediate entry patients was 18.3 months (95% CI, 13.2, 28.0) and 11.8 months (95% CI, 9.0, 24.1) for delayed entry patients (P=0.17). Overall median hospital days (3), ICU days (0), and ER visits (1) were identical. 55% (27) of 49 deaths in immediate and 49% (27) of delayed deaths occurred at home. Conclusions: Immediate vs delayed entry patients experienced a significant survival advantage at 1 year; however longitudinal TE were not statistically different. Future research is needed to define mechanisms of survival advantage in palliative care trials. Clinical trial information: NCT01245621.