A Pilot Feasibility Study Evaluating a Novel Digitally-Enhanced Community Health Worker-Led Intervention Delivering Early Stepped Palliative Care, Care Navigation, Patient Education and Clinical Trial Engagement in Pancreatic Cancer Patients

Background Pancreatic Ductal Adenocarcinoma (PDAC) is associated with substantial morbidity, poor quality of life, and poor overall survival. Early palliative care (PC) has been shown to improve quality of life and reduce symptom burden in PDAC, but specialty PC services are often unavailable for this fast progressing illness and even then are only utilized by a minority of PDAC patients. In response, we developed a digitally enhanced CHW-led intervention. This paper focuses on the feasibility of this PDAC intervention.

Adults (aged ≥18 years) with newly diagnosed PDAC (within 2 weeks of diagnosis) were enrolled in a single-arm pilot feasibility mixed-methods study from January to August 2025 (N=48). Based on qualitative feedback from patients and caregivers the intervention involved early palliative care engagement, patient education, care navigation, and providing targeted financial resources for patients and family caregivers (FCGs). The digital component involves using short YouTube educational videos and Twilio Short Message Service (SMS) to administer the Edmonton Symptom Assessment Scale weekly with patients with high symptom scores stepped up to PC visits. The CHW-led intervention was delivered over 4 weeks with data collection occurring over an additional 8 weeks. Feasibility outcomes were patient engagement with the CHW and completion of the intervention. The acceptability outcome was defined using the RE-AIM framework. Secondary outcomes include Quality of Life (QoL), Advanced Care Planning (ACP) compliance rates, financial toxicity, and time toxicity.

The median age of pts (N=48) was 69 (IQR 62-76), and 29 (60%) were Hispanic. 52% (25) had metastatic PDAC, 14 (29.1%) had borderline resectable PDAC, and 9 (18.8%) had resectable PDAC at diagnosis. Four patients died prior to the intervention completion, while the remaining patients completed the intervention. Regarding acceptability, 94% of patients completely agreed that the intervention met their approval. Themed common responses highlighted by patients centered around the critically important role of the CHW in the process, including in appointment an referral scheduling, especially as symptoms worsened. Patient’s physical HRQoL, symptom burden, and rates of financial toxicity decreased from baseline to 12 weeks, while 83% of patients completed ACP by 12 weeks.

Our digitally-enhanced CHW-led intervention delivering early stepped PC was feasible and acceptable to PDAC patients. The intervention was associated with improvement in symptom burden, reduction in financial and time toxicity and improved ACP planning rates. Future prospective comparative studies are needed to understand the intervention’s ability to help manage the inevitable disease progression involved in late stage PDAC, including in QoL, financial and time toxicity, and ACP. Competing Interest Statement The authors have declared no competing interest. Funding Statement This study was funded by the Department of Defense/Congressionally Directed Medical Reseach Program (PA230343) Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics committee/IRB of Loma Linda University gave ethical approval for this work I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes Conflicts of interest: Funding: This study was supported by a grant from the Bockus Society of Gastroenterology. Data Availability Data produced in the study are not available for use to protect participant confidentiality.