Evaluating palliative care needs of early-phase clinical trial patients.

Abstract

12086 Background: Specialty palliative care (PC) is increasingly recognized as essential for patients (pts) in early phase clinical trials (EPT), as highlighted by ASCO's 2024 PC guideline. However, concerns persist regarding trigger referrals' impact on resource-constrained PC services. In a pilot, we employed a trigger PC referral system for patients referred to EPT to increase access in this population. Methods: We conducted a retrospective cohort study comparing EPT and non-EPT pts seen by outpatient PC between January 1, 2021 and June 30, 2023. We evaluated demographic characteristics, clinical variables, symptom severity at the initial PC visit and end-of-life (EOL) outcomes. Mann-Whitney U tests were used for continuous variables; chi-square or Fisher's exact tests for categorical variables. Multiple comparisons were adjusted using the Benjamini-Hochberg method. Results: A total of 1068 pts were included, 136 (12.7%) EPT pts with 67 (6.3%) started on trial. 86 (63.2%) were seen by EPT before outpatient PC and 54 (39%) were referred to PC by EPT team through trigger referral system. EPT pts were younger (median age 61 vs 64 years; p=0.001), had better PS (ECOG 0-1: 57.4% vs 46.5%; p=0.020), and referred after more lines of therapy (median 3 vs. 1; p<0.001). Cancer type distribution differed significantly between groups (p=0.005), with EPT pts having higher proportions of GI (41.9% vs 26.5%) and GYN cancers (16.2% vs 9.2%). Physical discomfort was the most prevalent symptom in both EPT and non-EPT groups (86.9% vs 84.9%), followed by inactivity (74.2% vs 76.3%). While most symptoms showed similar prevalence between groups, EPT pts had higher rates of constipation (65.4% vs 50.7%, adjusted p=0.025) and nausea (48.1% vs 38.0% (adjusted p=0.193). After adjustment for multiple comparisons, there were no significant differences in symptom severity between groups. Of those on trial(n=67), 46 (69%) came off trial due to progression and 16 (24%) due to toxicity or worsening PS. After trial discontinuation, 35 (56.5%) received further treatment, and 37 (59.7%) had PC follow-up. Among deceased pts (EPT n=70 (18%), non-EPT n=320 (82%)), there were no differences in EOL outcomes: hospice enrollment (37.1% vs 29.1%, p=0.198), hospital death (58.6% vs 58.4%, p=1.000), chemotherapy in the last 30 days (22.9% vs 18.8%, p=0.411), and median hospital length of stay in the last 30 days (7 vs 5 days, p=0.825). Conclusions: EPT pts accounted for 12.7% of new pts to specialty PC over 30 months. Despite demographic and clinical differences between EPT and non-EPT patients, EOL outcomes and symptom severity were largely comparable between groups. These results highlight the feasibility of a trigger-based PC referral system for EPT patients without overburdening resource-constrained PC services, supporting its continued use and potential refinement to address specific symptom management needs.