CompletedNot applicableNCT06464562
Official study title

LiveWell: Adapted DBT Skills Training for Metastatic Lung Cancer

Study 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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedLiveWell: Adapted Dialectical Behavioral Therapy Skills Training

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 12, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Duke University

Study sponsor

01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
Duke University
Interventions being studied
Behavioral: LiveWell: Adapted Dialectical Behavioral Therapy Skills Training
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
  • Undergoing lung cancer treatment with non-curative intent
  • Endorse \>=3 out of 10 on the NCCN distress thermometer over the past week
  • At least 18 years of age
  • Able to understand, speak, and read English, and 5) be able to provide informed consent
Reasons someone may not be able to joinExclusion criteria
  • Reported or suspected cognitive impairment
  • Presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist
  • Expected survival \<6 months

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Duke University Medical CenterDurham, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 12, 2026. Always confirm current availability with the study team.

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