Optimizing supportive care for patients with metastatic lung cancer in the era of precision oncology.

Abstract

TPS12150 Background: Targeted therapy improves survival for patients with oncogene-driven non-small cell lung cancer (NSCLC). However, metastatic NSCLC remains incurable and patients often experience uncertainty about what to expect from their long and unpredictable illness trajectories. The aim of this trial is to pilot test a supportive care intervention that blends palliative care and survivorship for patients with metastatic oncogene-driven NSCLC. Methods: We will conduct a pilot randomized, controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of a novel supportive care intervention for patients with metastatic oncogene-drive NSCLC. We will enroll 90 patients with a recent (within 6 months) diagnosis of metastatic NSCLC with a mutation in EGFR, ALK, ROS1 or RET genes who are receiving targeted therapy. We will enroll the first ten patients in an open pilot and we will refine the intervention and study procedures based on pilot findings. We will randomize the remaining 80 patients 1:1 to the intervention or a usual care control. Participants randomized to the intervention arm will have four monthly visits with a palliative care clinician who has been trained to address the supportive care needs of patients with long illness trajectories. Sessions will cover 1) rapport building and baseline symptom and psychosocial assessment; 2) coping support and healthy lifestyle promotion; 3) cultivation of prognostic understanding; and 4) exploration of goals and values. Patients in both arms will complete surveys including secondary outcome measures at baseline, 12, and 20 weeks post-enrollment. The primary outcome of the study is feasibility of the palliative care intervention, defined as at least 60% enrollment among eligible patients and 75% completion of all four sessions and three surveys. We will also assess acceptability using measures of satisfaction and comfort with the intervention. We will evaluate the preliminary effects of this intervention on the following outcomes to inform a future large-scale efficacy trial: 1) distress related to prognostic uncertainty and 2) prognostic awareness (using the Prognostic Awareness Questionnaire: 34-item validated measure with items about likelihood of cure and impact of prognostic awareness on decisions, behaviors and mood); 3) confidence in chronic disease management using the Self-Efficacy of Management of Chronic Disease scale; and 4) documentation of discussions about goals and values in the medical record. We will analyze change within and between groups at 12 and 20 weeks using linear mixed models, controlling for baseline values and relevant demographic and clinical factors. Study accrual to the open pilot phase began in February 2022. Current enrollment: n = 0. Clinical trial information: NCT04900935.