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

Medical University of South Carolina (MUSC)

Status: Not yet enrolling

Conditions: Survivorship

Treatments: Behavioral: LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07177846

R00CA286959 (U.S. NIH Grant/Contract)

Pro00144605

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program

Experimental group

Description:

Will receive 8 telehealth sessions delivered 1 on 1 via telehealth with a trained mental health professional. Sessions will be delivered approximately weekly and are 45-60 min in length. Sessions will teach skills from dialectical behavioral therapy (e.g., mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness) adapted for patients with metastatic lung cancer. Sessions follow a standardized structure, including 1) mindfulness practice, 2) home practice and diary card review, 3) learning and practicing new skills, and 4) closing ritual. Participants will have access to a resource library of skills training videos and mindfulness recordings.

Treatment:

Behavioral: LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program

Usual Care

No Intervention group

Description:

Will receive a handout with general support resources available at Hollings Cancer Center.