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

NCT07177846 | Not Yet Recruiting

• 2 other identifiers: Pro00144605R00CA286959
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• PROMIS Anxiety Short Form (8a)

  Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (8 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater anxiety symptomology.

  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)

  Depression will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater depressive symptomology.

  Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)

Secondary Outcomes (10)

• Intolerance of Uncertainty Scale - Short Form (IUS-12)

  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

  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)

  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)

  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)

  Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)

Study Arms (2)

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program

EXPERIMENTAL

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.

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

Usual Care

NO INTERVENTION

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

Interventions

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program BEHAVIORAL

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

LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kelly Hyland, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Moody

CONTACT

843-792-9698; moodykat@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 17, 2025
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Shared data for this study will be shared with the NDA and available for request no later than at time of publication of primary results or the end of performance period, whichever comes first. The shared data deposited in the NDA will exist indefinitely.
• Access Criteria: Data deposited to the NDA will exist indefinitely and may be accessed by any individual in alignment with the terms set forth by NIH on this NIH-sponsored data repository site (https://nda.nih.gov/nda/access-datainfo), as well as privacy and confidentiality protections such as the NIH Certificate of Confidentiality and applicable laws, regulations, and policies governing data derived from human participants. Access to scientific data will be controlled via safeguards and protections currently in place via the NDA. To ensure participant consent for data sharing, IRB paperwork and informed consent documents will include language describing plans for data management and sharing data, describing the motivation for sharing, and explaining that personal identifying information will be removed. To protect participant privacy and confidentiality, shared data will be de-identified by stripping all PHI data and including the GUID to link all research data.