LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living with Metastatic Lung Cancer - Patients are living longer with metastatic lung cancer (i.e., metavivors) due to therapeutic advances, but face significant challenges. Most metavivors will ultimately die of cancer and must navigate the duality of living while dying. Unsurprisingly, metavivors endorse high psychological distress (e.g., anxiety, depression, illness non- acceptance), high symptom burden (e.g., fatigue, dyspnea, pain), and poor quality of life. Psychosocial interventions can improve outcomes, but existing paradigms are not designed to help metavivors navigate the emotional turbulence of living with metastatic disease. Dialectical Behavioral Therapy (DBT) Skills Training is an evidence-based treatment that teaches patients transdiagnostic, easy-to-use skills to both accept things as they are (mindfulness, distress tolerance) and change things within their control (emotion regulation, interpersonal effectiveness) to better navigate life challenges. However, DBT Skills Training has rarely been applied in patients with chronic illness. We adapted DBT Skills Training (e.g., intervention dose, delivery, content) for patients living with metastatic lung cancer to create LiveWell, an 8-session Skills Training protocol delivered one-on-one via videoconference. Building on preliminary data and aligned with the ORBIT model for behavioral intervention development, the first phase of this study (K99, Aim 1, 1 year) aims to iteratively refine LiveWell using 1) qualitative exit interview data from a proof-of-concept study, 2) an advisory board of interested parties, 3) the Dynamic Sustainability Framework from implementation science, and 4) user testing (n=10). The K99 phase will produce a standardized protocol and procedures for the R00. The second, independent phase of the study (R00, Aim 2, 3 years) will be a Phase IIB randomized pilot trial to test study feasibility, acceptability and outcome patterns suggesting the efficacy of LiveWell compared to Enhanced Usual Care (EUC). Lung cancer metavivors (n=80, >20% non-White) receiving care at NCI-designated centers (N=2 sites) and endorsing distress >3/10 will be randomized to LiveWell or EUC. We hypothesize that: 1) LiveWell and EUC protocols and procedures will show evidence of feasibility (accrual N=80/20 months, >80% adherence to interventions and assessments, <20% attrition) and acceptability (>3/5 satisfaction study procedures, >3 mean intervention satisfaction LiveWell)), and 2) LiveWell will improve quality of life (primary outcome) and reduce psychological distress (depression, anxiety, illness acceptance) and symptom burden (fatigue, dyspnea, pain) (secondary outcomes) from baseline to post-treatment compared to EUC. We will explore emotion regulation as a mechanism of change. The objective of this Early K99/R00 is to provide Dr. Hyland with limited additional mentored training, then facilitate her transition to an independent investigator working to develop, test, and implement novel psychosocial interventions for cancer metavivors. Findings from this study will inform an R01 submission to conduct a Phase III efficacy trial of LiveWell. If successful, LiveWell will improve metavivor quality of life and provide a promising psychosocial intervention paradigm for other metavivors and patients with chronic illness.
