A Pilot Randomized Controlled Trial to Evaluate the Preliminary Efficacy of PAL-CHW-PDAC, a Digitally Enhanced CHW-led Intervention to Facilitate Stepped Palliative Care in Patients with Pancreatic Cancer.

Background Pancreatic Ductal Adenocarcinoma will be the 2nd-most common cause of cancer mortality by 2030. It is associated with rapid deterioration, severe symptoms, and significant quality-of-life concerns. Using input from patients, family caregivers (FCGs), and provider stakeholders, we designed an intervention, PAL-CHW-PDAC, delivered by a community health worker that involves proactive symptom monitoring and management, care navigation, and disease education. Methods We conducted a pilot randomized controlled trial of 60 patients with newly diagnosed PDAC (within 2 weeks of diagnosis) and their caregivers at Loma Linda University Health from 09/2025 to 05/2026. Patients were randomized 1:1 to receive the PAL-CHW-PDAC intervention (6 CHW visits over 3 months) or an attention control. The control comparator involved receiving standard handouts and videos on pancreatic cancer, along with check-in visits with research staff. The primary outcome was symptom burden, defined using the NCCN/FACT Hepatobiliary Symptom Index. Secondary outcomes included quality of life (QoL) measured by the FACT-Hep and psychological distress (measured by the NCCN-Distress Thermometer). Caregiver outcomes included burden, preparedness, quality of life, and psychological distress. Results: 60 out of 74 eligible (81%) were enrolled. The median age was 71, 60% of patients were Hispanic. 68% of patients presented with metastatic PDAC, 23% with borderline resectable disease and 9% with resectable PDAC. There was a trend towards improved symptom burden at 12 weeks (mean increase of 5.3 points vs. decrease of 3.2 points; p=0.093) with the intervention compared to the attention control. The intervention group also had improved psychological distress at 12 weeks (3.31 vs. 5.95, p=0.01), caregiver psychological distress (3.26 vs. 6.86, p<0.001) and caregiver preparedness (2.92 vs. 2.11) at 12 weeks. Telehealth utilization for symptom-focused visits improved with the intervention (82%) compared to the control. (14%, p=0.01) Hospice utilization also improved with the intervention (41% vs 7%, p-0.12). Conclusions: A pilot RCT of the PAL-CHW-PDAC intervention demonstrated preliminary efficacy with a trend towards improved symptom burden, psychological distress, and caregiver psychological distress and preparedness. A larger definitive clinical trial is needed to understand the impact of this promising intervention. ClinicalTrials.gov number, NCT07591571