Recruiting

LiveWell

Sponsor:

Medical University of South Carolina

Code:

NCT07177846

Conditions

Survivorship

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program

Study Details

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.

Conditions

Survivorship

Study ID

NCT07177846

Start date

Oct 15, 2026

Status verified date

Jun, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18
  • AJCC Stage IV non-small cell lung cancer
  • Receiving treatment with non-curative intent or on active surveillance
  • English proficiency
  • Able to provide informed consent
  • National Comprehensive Cancer Network distress screening score ≥ 3/10 plus endorse at least 1 emotional concern.

Exclusion Criteria:

  • Cognitive impairment
  • Untreated serious mental illness
  • Expected survival < 6 months

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

Will receive 9 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.

no intervention: Usual Care

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

Interventions

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program

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

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Benjamin Axelrod

843-876-2645axelrod@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Benjamin Axelrod, BA

854 202 4449axelrod@musc.edu

Kelly Hyland, PhD

843-876-8861hylandk@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Oct 7, 2026

Last verified

Jun, 2026

Keywords

  • Dialectical Behavioral Therapy
  • Psychosocial Oncology
  • Lung Cancer
  • Psychological Distress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.