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

NCT ID: NCT07177846

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2028-03-01

Brief Summary

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.

Conditions

Survivorship

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program

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.

Group Type: EXPERIMENTAL

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program

Intervention Type: BEHAVIORAL

LiveWell: Adapted DBT Skills Training for Patients with Metastatic Lung Cancer

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program

LiveWell: Adapted DBT Skills Training for Patients with Metastatic Lung Cancer

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Kelly Hyland

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kelly Hyland, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Central Contacts

Kathryn Moody

Role: CONTACT

moodykat@musc.edu

843-792-9698

Other Identifiers

R00CA286959

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00144605

Identifier Type: -

Identifier Source: org_study_id