LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program.
- Who it may be relevant to
- Registry conditions: Survivorship. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Participants will be randomized 1:1 to receive LiveWell, an eight-session, telehealth-delivered DBT Skills Training intervention tailored for lung cancer metavivors, or Usual Care. Participants will complete self-report measures at baseline, 8-week follow-up, and 3 month follow-up. It is hypothesized that: 1) RCT methods will demonstrate evidence of feasibility (accrual N=80/20 months, \>80% adherence to assigned interventions and assessments, \<25% attrition) and acceptability (\>3/5 satisfaction study procedures, \>3 mean intervention satisfaction LiveWell); 2) LiveWell participants will demonstrate reductions in distress (primary outcome) and improvements in psychological well-being (illness acceptance, positive affect, tolerance of uncertainty, mindfulness, self-efficacy to manage emotions and symptoms), symptom burden (fatigue, dyspnea, pain), and quality of life (secondary outcomes) compared to Usual Care participants at 8-week follow-up. H3. (Exploratory). To explore the role of emotion regulation as a potential mechanism of change.
Interventions
- Behavioral LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program
LiveWell: Adapted DBT Skills Training for Patients with Metastatic Lung Cancer
Primary outcome measures
- PROMIS Anxiety Short Form (8a) [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
- PROMIS Depression Short Form (8a) [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
Secondary outcome measures (10)
- Intolerance of Uncertainty Scale - Short Form (IUS-12) [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
- Peace, Equanimity, and Acceptance in the Cancer (PEACE) - Peaceful Acceptance of Illness Subscale [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
- PROMIS Positive Affect Short Form (15a) [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
- Difficulty in Regulating Emotions Scale (DERS-18) [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
- Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
- PROMIS Self-Efficacy for Managing Symptoms Short Form (8a) [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
- PROMIS Self-Efficacy for Managing Emotions (8a) Short Form [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
- NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE) [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
- Functional Assessment of Cancer Therapy - Lung (FACT-L) [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
- DBT Ways of Coping Checklist (DBT-WCCL) - DBT Skills Subscale (DSS) [Time frame: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)]
Eligibility criteria
Inclusion criteria
- Age ≥ 18
- AJCC Stage IV non-small cell lung cancer
- Receiving treatment with non-curative intent
- English proficiency
- Able to provide informed consent
- National Comprehensive Cancer Network distress screening score ≥ 3/10
Exclusion criteria
- Cognitive impairment
- Untreated serious mental illness
- Expected survival < 6 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07177846 · Pro00144605 · R00CA286959