N/A N=30 Treatment

DBT for Metastatic Lung Cancer

Lung Cancer Metastatic

Bottom Line

View on ClinicalTrials.gov: NCT04973436 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Feasibility as Measured by Study Accrual — 31 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Dialectical Behavioral Therapy Skills Training (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility as Measured by Study Accrual	31	—
PRIMARY Adherence as Measured by Number of Participants Who Completed All Intervention Sessions	27	—
PRIMARY Feasibility as Measured by Number of Participants Lost From the Study Over Time	4	—
PRIMARY Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)	25	—
PRIMARY Psychological Distress as Measured by the PROMIS Depression Short Form Scales	51.82; 48.85; 48.18	—
PRIMARY Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales	54.03; 51.75; 48.39	—
SECONDARY Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)	3.86; 3.36; 3.14	—
SECONDARY Change in Dyspnea	0.97; 1.20; 1.00	—
SECONDARY Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)	1.84; 1.48; 1.74	—
SECONDARY Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)	1.99; 1.91; 1.64	—
SECONDARY Change in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18)	32.33; 28.73; 27.96	—
SECONDARY Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS)	25.50; 20.62; 20.88	—
SECONDARY Change in Dialectical Behavioral Therapy (DBT) Skill Use as Measured by the DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS)	1.95; 2.24; 2.25	—

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.

Eligibility Criteria

Inclusion Criteria

be diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
be undergoing systemic treatment (chemotherapy, targeted therapy, and/or immunotherapy) for lung cancer at Duke Cancer Institute
score >3 on the National Comprehensive Cancer Network Distress Thermometer for distress over the past week (Range: 0-10)
be > 18 years of age
be able to understand, speak, and read English
be able to provide informed consent

Exclusion Criteria

reported or suspected cognitive impairment subsequently informed by a Montreal Cognitive Assessment (MOCA) of <26
presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart, treating oncologist, or other medical provider
expected survival of 4 months or less

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04973436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.