A pilot trial of early specialty palliative care for patients with advanced pancreatic cancer: Challenges encountered and lessons learned.
110 Background: Palliative care trials face implementation barriers. We describe challenges encountered in a pilot trial of early specialty palliative care for patients with pancreatic cancer. METHODS We conducted a mixed methods pilot randomized controlled trial of early specialty physician led palliative care in advanced pancreatic cancer. Recently diagnosed patients with borderline, locally advanced, or metastatic pancreatic cancer and their caregivers (total N=60) were recruited from clinic at a comprehensive cancer center and randomized (2:1) to receive monthly specialty palliative care visits for 3 months in addition to standard oncology care vs. standard oncology care alone. Feasibility assessments included enrollment and intervention completion rates. Acceptability and perceived effectiveness were assessed via drop out rates and semi structured participant interviews. RESULTS The enrollment target was reached after 50 weeks, with a randomized: approached rate of 27% Mean patient age was 63 (SD 11) and 50% were male. Mean caregiver age was 62 (SD 12) 47% were male, and 80% were the spouse or partner of a patient. 70% of participants in the intervention group completed at least one specialty palliative care visit and 15% completed 3 palliative care visits within the 3 month time period. Two patients and 3 caregivers withdrew, and 4 patients died prior to 3 months. Enrollment barriers included patients not planning to continue receiving care from a participating oncologist and feeling too overwhelmed at the time of diagnosis to consider research participation. In semi structured interviews, patients and caregivers noted that long travel times to the cancer center, difficulty scheduling palliative care visits at a convenient time, and lengthy study assessments posed burdens. Oncologists and palliative care physicians recommended more in person communication between clinicians and tailoring palliative care visit content and schedules to match patient needs. CONCLUSIONS Future palliative care intervention trials must consider implementation challenges related to recruitment, retention, intervention fidelity, and participant burden. CLINICAL TRIAL INFORMATION NCT01885884.
Journal of clinical oncology official journal of the American Society of Clinical Oncology