Multi-site randomized trial of stepped palliative care (PC) for patients with advanced lung cancer.

12000 Background: Studies show that early PC (EPC) integrated with oncology care from the time of diagnosis of advanced cancer improves patient and caregiver outcomes. However, this care model has not been widely implemented given the shortage of PC clinicians and challenges in providing PC visits throughout the course of cancer treatment, especially as novel therapeutics prolong survival in this population. Therefore, to deliver more patient-centered and less resource-intensive PC, we evaluated a stepped PC (SPC) model in patients with advanced lung cancer. Methods: Between 2/12/18 and 12/15/22, we enrolled patients with advanced lung cancer, diagnosed in the past 12 weeks and an ECOG PS = 0-2 to a multi-site randomized trial of SPC versus EPC. All patients assigned to SPC started on Step 1, with an initial PC visit within four weeks of enrollment and subsequent PC visits scheduled only at the time of a change in cancer treatment or after a hospitalization. Patients on Step 1 also completed a measure of quality of life (QOL; Functional Assessment of Cancer Therapy-Lung FACT-L) every six weeks for up to 18 months from enrollment, and those with a greater than or equal to a 10-point decrease in their score from baseline were stepped up to meet with the PC clinician every four weeks (Step 2). Patients assigned to EPC had PC visits every four weeks from enrollment. The primary aim was to evaluate the non-inferiority of the effect of SPC versus EPC on QOL as measured by the FACT-L at week 24, using regression modeling. For the secondary outcomes, we conducted a superiority analysis of the number of PC visits between groups and non-inferiority analyses of patient-reported end-of-life (EOL) communication with clinicians and days enrolled in hospice, controlling for multiple comparisons with a False Discovery Rate of 0.15. Results: The sample (N = 507) included mostly patients with NSCLC (78.3%; mean age = 66.48 years; 51.4% female; 84.2% White). QOL scores at week 24 for patients assigned to SPC were non-inferior to those receiving EPC (adjusted means: 100.62 versus 97.75, p < 0.0001 for non-inferiority). Sixty-six patients (26.4%) assigned to SPC transitioned to Step 2 by 24 weeks. The mean number of PC visits by week 24 was lower for SPC versus EPC patients (adjusted means 2.44 v. 4.70, p < 0.0001). While the rate of EOL communication was non-inferior for SPC versus EPC (adjusted proportions: 0.30 v. 0.33, p = 0.09), non-inferiority was not demonstrated for days in hospice (adjusted means SPC = 19.72 v. EPC = 34.64, p = 0.9). Conclusions: A stepped care model, with PC visits scheduled only at key points in patients’ cancer trajectories and using a decrement in QOL to trigger more intensive PC exposure, results in significantly fewer PC visits without sacrificing the benefits for patients’ QOL. While SPC was associated with fewer days in hospice, this novel model holds promise as a more scalable way to deliver early PC to enhance patient-reported outcomes. Clinical trial information: NCT03337399 .