LiveWell: Adapted DBT Skills Training for Metastatic Lung Cancer

Not Applicable

Completed

• 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= up to 10). The K99 phase will produce a standardized protocol and procedures for the second, independent phase of the study (R00) which will be registered separately. 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

Study Timeline

• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-18
• Study Start: 2025-02-14
• Status Verified: 2025-06
• Primary Completion: 2025-07-07
• Study Completion: 2025-08-06
• Last Update Submitted: 2025-08-26
• Last Update Posted: 2025-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. be diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
2. be undergoing lung cancer treatment with non-curative intent
3. endorse >=3 out of 10 on the NCCN distress thermometer over the past week
4. be > 18 years of age
5. be able to understand, speak, and read English, and 5) be able to provide informed consent

Exclusion Criteria

1. reported or suspected cognitive impairment
2. presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist
3. expected survival <6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Usability testing as measured by the percentage of user testers who complete the study questionnaires	Baseline, post-intervention (8 weeks)

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States