Purpose: Although early palliative care is recommended, resource limitations prevent its routine implementation. We report on the preliminary ndings of a mixed methods study involving a randomized controlled trial (RCT) of Symptom screening with Targeted Early Palliative care (STEP) and qualitative interviews.Methods: Adults with advanced solid tumors and an oncologist-estimated prognosis of 6-36 months were randomized to STEP or symptom screening alone. STEP involved symptom screening at each outpatient oncology visit; moderate to severe scores triggered an email to a palliative care nurse, who offered referral to in-person outpatient palliative care. Patient-reported outcomes of quality of life (FACT-G7), depression (PHQ-9), symptom control (ESAS-r-CS), and satisfaction with care (FAMCARE P-16) were measured at baseline and 2, 4, and 6 months. Semi-structured interviews were conducted with a subset of participants.Results: From Aug/2019 to Mar/2020 (trial halted due to COVID-19 pandemic), 69 participants were randomized to STEP (n=33) or usual care (n=36). At 6 months, 45% of STEP arm patients and 17% of screening alone participants had received palliative care (p=0.009). Nonsigni cant trends for all outcomes favored STEP: difference in change scores for FACT-G7=1.67 (95% CI: -1.43,4.77); ESAS-r-CS=-5.51 (-14.29,3.27); FAMCARE P-16=4.10(-0.31,8.51); PHQ-9=-2.41 (-5.02,0.20). Sixteen patients completed qualitative interviews, describing symptom screening as helpful to initiate communication; triggered referral as initially jarring but ultimately bene cial; and referral to palliative care as timely.Conclusion: STEP improves access to palliative care. Despite lack of power, preliminary results are encouraging and qualitative results demonstrate acceptability. Findings will inform an RCT of combined in-person and virtual STEP.ClinicalTrials.gov Identi er: NCT03987906
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