Pilot trial of virtual and in-person symptom screening with targeted early palliative care (STEP2).

Abstract

12074 Background: Routine early palliative care (EPC) for patients with advanced cancer improves quality of life. To increase scalability, models of triggered EPC have been encouraged. We assessed feasibility of hybrid virtual/in person Symptom screening and Targeted Early Palliative care (STEP2) to provide EPC triggered by symptoms. Methods: Patients with advanced cancer, ECOG 0-2, prognosis 6-36 months, were recruited from lung, gastrointestinal, genitourinary, breast and gynecology outpatient oncology clinics. Symptoms were screened virtually/in person ≤48 hours before oncology visits using Edmonton Symptom Assessment System-revised (ESAS-r+). Moderate to severe symptom scores (“screen positive”) triggered an alert to a nurse, who called the patient, offering an EPC visit (in-person/virtual, as per patient preference). Participants completed measures at baseline, 2, 4, and 6 months. The primary endpoint was feasibility, with the following criteria: ≥40 patients accrued in 4 months; ≥60% complete screening for ≥70% of visits; ≥50% triggering a call have ≥1 EPC visit; ≥60% complete all measures. Results: From 30/03/2025-26/06/2025 40 patients were enrolled (median age [range], 62 [39-88]; 21/40 [53%] female). Disease site distribution was: 12/40 (30%) lung, 9/40 (23%) gynecology, 8/40 (20%) genitourinary, 6/40 (15%) gastrointestinal, 5/40 (13%) breast. Of the 40 patients enrolled, 36 (90%) completed screening for ≥70% of visits and 29 (73%) screened positive: 18 at baseline and 11 later during the trial. The most common triggering symptoms were anxiety (18/29, 62%), sleep (17/29, 59%), depression (10/29, 35%), pain (8/29, 28%), and dyspnea (8/29, 28%); 21/29 (72%) screen-positive and 0 screen-negative patients received EPC before trial end. Measure completion at 2, 4, and 6 months was 90% (36/40), 85% (34/40), and 83% (33/40). Initial EPC visits were in person for 14/21 (67%) and virtual for 7/21 (33%); 20/21 (95%) of patients received ≥2 follow-up visits. Results for measures at baseline and at trial end are shown in the Table. Conclusions: Virtual/in person STEP2 is feasible and directs EPC to those who most need it, with most screen-positive patients accepting EPC. A phase III trial is underway. Clinical trial information: NCT06326554 . Variable Measure (score range) Time point N Mean Standard Deviation Difference, 6 mo. vs. baseline (95% CI) Quality of life FACIT_PAL14 Baseline 40 42.2 7.2 0.3 (0-56; higher is better) 6 mo. 34 42.7 7.7 (-0.9, 1.6) Symptom ESAS_EDS Baseline 40 17.5 12.9 0.3 Control (0-90; higher is worse) 6 mo. 33 18.9 13.2 (-3.1, 3.7) Depression PHQ-9 Baseline 40 5.4 3.4 -1.0 (0-27; higher is worse) 6 mo. 34 4.6 3.1 (-1.9, 0.0) Anxiety GAD-7 Baseline 40 4.9 3.8 -1.4 (0-21; higher is worse) 6 mo. 34 3.7 3.5 (-2.3, -0.5) Satisfaction FAMCARE-P16 Baseline 40 72.8 7.2 -5.8 With care (16-80; higher is better) 6 mo. 34 67.1 12.0 (-10.1, -1.4)