NCT07177846

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this pilot randomized controlled trial, patients with metastatic non-small cell lung cancer and at least mild distress (N=80) will be randomized to receive LiveWell, an adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol) or Usual Care. The investigators will evaluate feasibility, acceptability, and preliminary efficacy of LiveWell to reduce distress (primary outcome) and improve psychological well-being, symptom burden, and quality of life (secondary outcomes). The investigators will explore emotion regulation as a potential mechanism of change.

Detailed description

Participants will be randomized 1:1 to receive LiveWell, an eight-session, telehealth-delivered DBT Skills Training intervention tailored for lung cancer metavivors, or Usual Care. Participants will complete self-report measures at baseline, 8-week follow-up, and 3 month follow-up. It is hypothesized that: 1) RCT methods will demonstrate evidence of feasibility (accrual N=80/20 months, \>80% adherence to assigned interventions and assessments, \<25% attrition) and acceptability (\>3/5 satisfaction study procedures, \>3 mean intervention satisfaction LiveWell); 2) LiveWell participants will demonstrate reductions in distress (primary outcome) and improvements in psychological well-being (illness acceptance, positive affect, tolerance of uncertainty, mindfulness, self-efficacy to manage emotions and symptoms), symptom burden (fatigue, dyspnea, pain), and quality of life (secondary outcomes) compared to Usual Care participants at 8-week follow-up. H3. (Exploratory). To explore the role of emotion regulation as a potential mechanism of change.

Conditions

• Survivorship

Interventions

Type	Name	Description
BEHAVIORAL	LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program	LiveWell: Adapted DBT Skills Training for Patients with Metastatic Lung Cancer

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-06-01
• Completion: 2028-03-01
• First posted: 2025-09-17
• Last updated: 2026-04-16