Palliative care of E-warm model for driver-gene-negative non-small cell lung cancer patients: A single-center randomized controlled trial

BackgroundPalliative care has been proved important for the advanced non-squamous non-small cell lung cancer (NSCLC) patients. Our group previously put forward the concept of early integration of interdisciplinary palliative care model (E-warm), while its roles in patients with driver-gene-negative non-small-cell lung cancer (NSCLC) still remain to be elucidated.MethodsThis study was a two-group parallel 1:1 single-blind single-center randomized controlled trial of combined early palliative care (CEPC) and standard oncological care (SC). Eligible patients were age 18+ years, newly diagnosed with a driver-gene-negative NSCLC, referred for first-/second-line chemotherapy or targeted therapy or immunotherapy, and had an Eastern Cooperative Oncology Group performance status of 0-2. The quality of life was measured with the Functional Assessment of Cancer Therapy-Lung (FACT-L) scale, and the psychological function was measured with the Hospital Anxiety and Depression Scale (HADS), and the Patient Health Questionnaire-9 (PHQ-9). The pain and nutrition levels were respectively evaluated with the Numerical Rating Scale (NRS) and Patient Generated Subjective Global Assessment (PG-SGA). The primary outcome was quality of life (QoL). Secondary outcomes included the overall survival (OS), psychological functioning, pain, and nutrition state. The intention-to-treat method was applied for analysis.ResultsOf the 156 patients enrolled in the CEPC and SC groups, 66 and 90 respectively completed the research. The CEPC group presented higher QoL than the SC group (p < 0.05). Additionally, fewer patients presented depressive symptoms in the CEPC group than in the SC group (p < 0.05), as well as better pain management (p < 0.05), although no significance was observed in nutritional status and OS between CEPC and SC groups.ConclusionsCombined early palliative care model (E-warm) brings better quality of life in driver-gene-negative NSCLC patients receiving systemic anticancer treatment. E-warm model interventions can be routinely considered in NSCLC patients as the start of systemic anticancer treatment.Clinical trial identificationChiCTR2300076684.Legal entity responsible for the studyChongqing University Cancer Hospital.FundingChongqing Science and Health medical scientific research Project (No.2021MSXM128), Chongqing Talents Program (cstc2021ycjh-bgzxm0256).DisclosureAll authors have declared no conflicts of interest.