LiveWell: Adapted DBT Skills Training for Metastatic Lung Cancer
NCT Number: NCT06464562
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer Metastatic to Lung
Interventions: BEHAVIORAL: LiveWell: Adapted Dialectical Behavioral Therapy Skills Training
Sponsor: Duke University
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10
Completion Date: 2025-02

Summary:
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. The investigators 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 an NCI-designated center and endorsing distress \>3/10 will be randomized 1:1. The investigators 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. The investigators will explore emotion regulation as a mechanism of change. Findings from this study will inform an R01 submission to conduct a Phase III efficacy trial. If successful, LiveWell will improve metavivor quality of life and provide a promising psychosocial intervention paradigm for other metavivors and patients with chronic illness.

Primary Outcome Measures: Feasibility as measured by study accrual, Treatment feasibility will be shown by meeting study accrual target (N = 80), Post-intervention (approximately 8 weeks)|Feasibility as measured by study adherence, Adherence will be shown by \>=80% of participants demonstrating adherence to assigned interventions and study assessments, Post-intervention (approximately 8 weeks)|Feasibility as measured by study attrition, Treatment feasibility will be shown by no more than 20% study attrition, Post-intervention (approximately 8 weeks)|Acceptability of study procedures as measured by participant and provider ratings, Acceptability of study procedures will be assessed for all participants and thoracic oncology providers using Likert scale ratings (e.g., 1-5 ratings of acceptability of recruitment procedures, length of questionnaires; benchmark \>3/5). A higher score indicates higher acceptability., Post-intervention (approximately 8 weeks)|Acceptability as measured by client satisfaction ratings, Acceptability will be shown by at least 80% of participants reporting satisfaction with the intervention on the Client Satisfaction Questionnaire (CSQ) (average score \>=3). A higher score indicates higher satisfaction/acceptability., Post-intervention (approximately 8 weeks)|Change in quality of life, A measure to assess quality of life is the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L). The FACT-L is a 36-item self-report instrument that measures multidimensional quality of life. Total score ranges from 0 to 180, where a higher score indicates greater quality of life., Baseline, post-intervention (approximately week 0, week 8)]
Secondary Outcome Measures: Change in quality of life, A measure to assess quality of life is the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L). The FACT-L is a 36-item self-report instrument that measures multidimensional quality of life. Total score ranges from 0 to 180, where a higher score indicates greater quality of life., Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)|Change in depression, A candidate measure to assess depression is the PROMIS Depression Short Form 8a. Final measure selection will be informed by user testing completed during the K99 phase., Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)|Change in anxiety, A candidate measure to assess anxiety is the PROMIS Depression Short Form 8a. Final measure selection will be informed by user testing completed during the K99 phase., Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)|Change in fatigue, A candidate measure to assess fatigue is the Fatigue Symptom Inventory (FSI). Final measure selection will be informed by user testing completed during the K99 phase., Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)|Change in shortness of breath, Candidate measures to assess shortness of breath are the modified Medical Research Council (mMRC) dyspnea scale and the 10-item FACIT-Dyspnea short form. Final measure selection will be informed by user testing completed during the K99 phase., Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)|Change in pain, A candidate measure to assess pain is the Brief Pain Inventory (BPI). Final measure selection will be informed by user testing completed during the K99 phase., Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)|Change in emotion regulation, A candidate measure to assess emotion regulation is the Difficulty in Regulating Emotions Scale (DERS-18). Final measure selection will be informed by user testing completed during the K99 phase., Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)|Change in illness acceptance, A candidate measure to assess illness acceptance is the Peace, Equanimity, and Acceptance in the Cancer (PEACE) scale. Final measure selection will be informed by user testing completed during the K99 phase., Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)|Change in frequency of skill use, A candidate measure to assess patient-reported frequency of skill use is the DBT Ways of Coping Checklist(DBT-WCCL) -DBT Skills Subscale (DSS). Final measure selection will be informed by user testing completed during the K99 phase., Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)