LiveWell: Adapted DBT Skills Training for Metastatic Lung Cancer
- Conditions
- Cancer Metastatic to Lung
- Registration Number
- NCT06464562
- Lead Sponsor
- Duke University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- be diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
- be undergoing lung cancer treatment with non-curative intent
- endorse >=3 out of 10 on the NCCN distress thermometer over the past week
- be > 18 years of age
- be able to understand, speak, and read English, and 5) be able to provide informed consent
- reported or suspected cognitive impairment
- presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist
- expected survival <6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Feasibility as measured by study accrual Post-intervention (approximately 8 weeks) Treatment feasibility will be shown by meeting study accrual target (N = 80)
Feasibility as measured by study attrition Post-intervention (approximately 8 weeks) Treatment feasibility will be shown by no more than 20% study attrition
Feasibility as measured by study adherence Post-intervention (approximately 8 weeks) Adherence will be shown by \>=80% of participants demonstrating adherence to assigned interventions and study assessments
Acceptability as measured by client satisfaction ratings Post-intervention (approximately 8 weeks) 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.
Change in quality of life Baseline, post-intervention (approximately week 0, week 8)] 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.
Acceptability of study procedures as measured by participant and provider ratings Post-intervention (approximately 8 weeks) 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.
- Secondary Outcome Measures
Name Time Method Change in quality of life Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20) 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.
Change in fatigue Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20) 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.
Change in frequency of skill use Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20) 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.
Change in depression Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20) 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.
Change in shortness of breath Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20) 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.
Change in pain Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20) 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.
Change in emotion regulation Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20) 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.
Change in illness acceptance Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20) 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.
Change in anxiety Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20) 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.
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States