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NCT06464562 · ClinicalTrials.gov registry record · NA
LiveWell: Adapted DBT Skills Training for Metastatic Lung Cancer
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT06464562 is a NA study that has completed, run by Duke University. The registered enrollment target is 1 participants.
The verdict
NCT06464562, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
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 chroni
Interventions
- BEHAVIORAL LiveWell: Adapted Dialectical Behavioral Therapy Skills Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2025-02-14 |
| Est. Completion | 2025-08-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06464562
The ClinicalTrials.gov registry entry for NCT06464562 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LiveWell: Adapted Dialectical Behavioral Therapy Skills Training is the first listed.
NCT06464562 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06464562 about?
NCT06464562 is a clinical study titled "LiveWell: Adapted DBT Skills Training for Metastatic Lung Cancer". 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...
What is the current status of trial NCT06464562?
This trial is currently completed. It is a NA study. The enrollment target is 1 participants. The study started on 2025-02-14. Estimated completion is 2025-08-06.
What interventions are being tested in trial NCT06464562?
The interventions under investigation include: LiveWell: Adapted Dialectical Behavioral Therapy Skills Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT06464562?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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