NCT04973436

DBT for Metastatic Lung Cancer

Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Metastatic lung cancer patients experience significantly greater psychological distress (i.e., depression, anxiety) compared to other cancers. Psychological distress is as a prognostic indicator for worse clinical outcomes and poorer overall survival in cancer patients. Dialectical behavioral therapy (DBT) is a trans-diagnostic, evidence-based psychotherapy that teaches participants a core set of behavioral skills (distress tolerance, emotion regulation, mindfulness, interpersonal effectiveness) to cope more effectively with emotional and physical symptoms. The proposed study seeks to adapt and pilot test DBT skills training for patients with metastatic lung cancer using the ADAPT-ITT framework. Participants will be metastatic lung cancer patients who score \>=3 on the National Comprehensive Cancer Network distress thermometer. Phase I aims to use focus groups and interviews with key stakeholders (metastatic lung cancer patients (N=20), thoracic oncology providers (N=6), clinicians with expertise in survivorship and behavioral symptom management (N=6)) to determine if and how DBT skills training must be modified for implementation with metastatic lung cancer patients. Adapted material will be reviewed by topical experts in DBT and implementation science to produce a manualized, adapted DBT skills training protocol for metastatic lung cancer patients (LiveWell). Phase II aims to pilot test LiveWell (N=30) to assess feasibility, acceptability, and examine pre-to-post intervention outcomes of psychological distress, (i.e., depression and anxiety) fatigue, dyspnea, pain, emotion regulation, tolerance of uncertainty, and DBT coping skill use. LiveWell will consist of coping skills training sessions delivered either in-person or via videoconferencing technology. Study measures will be collected at baseline, immediately post-intervention, and 1-month post-intervention.

Conditions

• Lung Cancer Metastatic

Interventions

Type	Name	Description
BEHAVIORAL	Dialectical Behavioral Therapy Skills Training	LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer

Timeline

• Start date: 2022-05-18
• Primary completion: 2024-03-11
• Completion: 2024-04-25
• First posted: 2021-07-22
• Last updated: 2025-04-27
• Results posted: 2025-04-27

Locations

1 site across 1 country: United States