Clinical trial · Interventional
DBT for Metastatic Lung Cancer
Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer Metastatic | Lung Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dialectical Behavioral Therapy Skills Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
- description
- The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.
- interventionNames
- Behavioral: Dialectical Behavioral Therapy Skills Training
Primary outcomes (6)
- measure
- Feasibility as Measured by Study Accrual
- timeFrame
- Post-intervention (approximately 8 weeks)
- description
- Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot)
- measure
- Adherence as Measured by Number of Participants Who Completed All Intervention Sessions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. be diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer 2. be undergoing systemic treatment (chemotherapy, targeted therapy, and/or immunotherapy) for lung cancer at Duke Cancer Institute 3. score \>3 on the National Comprehensive Cancer Network Distress Thermometer for distress over the past week (Range: 0-10) 4. be \> 18 years of age 5. be able to understand, speak, and read English 6. be able to provide informed consent Exclusion Criteria: 1. reported or suspected cognitive impairment subsequently informed by a Montreal Cognitive Assessment (MOCA) of \<26 2. presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart, treating oncologist, or other medical provider 3. expected survival of 4 months or less
References
Publications (1)
- DERIVEDHyland KA, Neacsiu AD, Fisher HM, Cowperthwait CM, Chou N, Stinchcombe TE, Oeffinger KC, Porter LS, Dorfman CS, Keefe FJ, Somers TJ. LiveWell: Pilot Feasibility Trial of an Adapted Dialectical Behavioral Therapy Skills Training Protocol in Patients With Metastatic Non-Small Cell Lung Cancer. Psychooncology. 2025 Dec;34(12):e70357. doi: 10.1002/pon.70357. PMID 41392376