NCT06464562Completed
LiveWell: Adapted DBT Skills Training for Metastatic Lung Cancer
LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1 (actual)
- First submitted
- 13 Jun 2024
- Start date
- 14 Feb 2025
- Primary completion date
- 7 Jul 2025
- Lead sponsor
- Duke University
- Diseases
- Lung cancer
- NCT number
- NCT06464562
What you commit to
- Study type: Interventional
- Participants enrolled: 1
- From 14 Feb 2025 to the primary completion date, 7 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Reported or suspected cognitive impairment
- Presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist
Other
- Expected survival \<6 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.