Phase 2 trial of Symptom screening with Targeted Early Palliative care (STEP) for patients with advanced cancer.

11604 Background: Routine early palliative care (EPC) by specialized teams improves quality of life for patients with advanced cancer, but may not be scalable. To plan for a larger randomized controlled trial, we conducted a phase 2 trial of STEP, a novel intervention of targeted EPC based on symptom screening. Methods: Participants with advanced cancer, ECOG 0-2, and clinical prognosis ≥6 months were recruited from lung, gastrointestinal, genitourinary, breast and gynecology outpatient clinics. Symptoms were screened at every outpatient visit using the Edmonton Symptom Assessment System-revised (ESAS-r). Moderate to severe symptom scores (≥4/10 for pain, nausea, dyspnea, depression, anxiety; ≥7/10 for fatigue, appetite, drowsiness, well-being) triggered an e-mail to a nurse, who called the patient, offering an EPC visit. Participants completed outcome measures at baseline, 2, 4 and 6 months (primary endpoint). Trial feasibility criteria were: i) ≥100 patients accrued in 12 months; ii) ≥70% complete screening for ≥70% of visits; iii) ≥60% of those for whom a call is triggered meet at least once with the EPC team; iv) ≥60% complete measures at each endpoint. Results: From 11/2016-1/2018, 116 patients were enrolled; 89/116 (77%) completed screening for ≥70% of visits and 59% (69/116) received a call triggered by symptoms. Of those receiving a call, 62% (43/69) received EPC; 3 further patients were referred by their oncologist. Measure completion was 79% (81/116) at 2, 61% (71/116) at 4, and 57% (66/116) at 6 months. By trial end (6 months), patients who received a call and accepted EPC involvement had better symptom control (ESAS-r-CS mean change in those receiving vs. deferring EPC: -0.07±16.9 vs 11.8±13.7, p = 0.02) and less deterioration in mood (PHQ-9: -0.4±3.4 vs 2.6±2.3, p = 0.003). There was no difference between those receiving versus deferring EPC in quality of life (FACIT-Sp: -4.7±13.6 vs -3.2±15.4, p = 0.75; QUAL-E: -2.6±8.4 vs -1.5±11.0, p = 0.62), or satisfaction with care (FAMCARE-P-16: -3.2±7.9 vs -3.5±6.1, p = 0.79). Conclusions: STEP is feasible in patients with advanced cancer. More than half of patients have moderate to severe symptoms, and acceptance of the triggered EPC visit should be encouraged.