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LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jun 1, 2027 → Oct 1, 2027
See other at-risk trials from Medical University of South Carolina

Record History

  1. Recruitment opened Start date: Sep 15, 2026 to Oct 15, 2026 · Primary completion pushed from Jun 1, 2027 to Oct 1, 2027 · Study sites: 0 to 1 · 3 more Show 6 more changesShow less
    • Start date: Sep 15, 2026 to Oct 15, 2026
    • Primary completion pushed from Jun 1, 2027 to Oct 1, 2027
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 10 of 10 entries
    • Study description shortened, about 4 words
  2. Start date: Jul 1, 2026 to Sep 15, 2026 Study description expanded, about 1 wordv7 Show 1 more changeShow less
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: May 1, 2026 to Jul 1, 2026v6
  4. Start date: Apr 1, 2026 to May 1, 2026 Secondary endpoints: details revised at 10 of 10 entriesv5 Show 1 more changeShow less
    • Secondary endpoints: details revised at 10 of 10 entries
  5. Start date: Mar 1, 2026 to Apr 1, 2026v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jan 5, 2026 to Mar 1, 2026v3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In this pilot randomized controlled trial, patients with metastatic non-small cell lung cancer and at least mild distress (N=80) will be randomized to receive LiveWell, an adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol) or Usual Care. The investigators will evaluate feasibility, acceptability, and preliminary efficacy of LiveWell to reduce distress (primary outcome) and improve psychological well-being, symptom burden, and quality of life (secondary outcomes). The investigators will explore emotion regulation as a potential mechanism of change.
Trial Details
NCT Number NCT07177846
Lead Sponsor Medical University of South Carolina
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)
Conditions Survivorship
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov