LiveWell: Adapted DBT Skills Training for Metastatic Lung Cancer

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

Patients are living longer with metastatic lung cancer (i.e., metavivors) due to therapeutic advances, but face significant challenges. Most metavivors will ultimately die of cancer and must navigate the duality of living while dying. Unsurprisingly, metavivors endorse high psychological distress (e.g., anxiety, depression, illness non-acceptance), high symptom burden (e.g., fatigue, dyspnea, pain), and poor quality of life. Psychosocial interventions can improve outcomes, but existing paradigms are not designed to help metavivors navigate the emotional turbulence of living with metastatic disease. Dialectical Behavioral Therapy (DBT) Skills Training is an evidence-based treatment that teaches patients transdiagnostic, easy-to-use skills to both accept things as they are (mindfulness, distress tolerance) and change things within their control (emotion regulation, interpersonal effectiveness) to better navigate life challenges. However, DBT Skills Training has rarely been applied in patients with chronic illness. The investigators adapted DBT Skills Training (e.g., intervention dose, delivery, content) for patients living with metastatic lung cancer to create LiveWell, an 8-session Skills Training protocol delivered one-on-one via videoconference. Building on preliminary data and aligned with the ORBIT model for behavioral intervention development, the first phase of this study (K99, Aim 1, 1 year) aims to iteratively refine LiveWell using 1) qualitative exit interview data from a proof-of-concept study, 2) an advisory board of interested parties, 3) the Dynamic Sustainability Framework from implementation science, and 4) user testing (n= up to 10). The K99 phase will produce a standardized protocol and procedures for the second, independent phase of the study (R00) which will be registered separately. If successful, LiveWell will improve metavivor quality of life and provide a promising psychosocial intervention paradigm for other metavivors and patients with chronic illness.

Study Overview

• Status: Completed
• Conditions: Cancer Metastatic to Lung
• Intervention / Treatment: Behavioral: LiveWell: Adapted Dialectical Behavioral Therapy Skills Training

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
• Undergoing lung cancer treatment with non-curative intent
• Endorse >=3 out of 10 on the NCCN distress thermometer over the past week
• At least 18 years of age
• Able to understand, speak, and read English, and 5) be able to provide informed consent

Exclusion Criteria:

• Reported or suspected cognitive impairment
• Presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist
• Expected survival <6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: LiveWell: Adapted Dialectical Behavioral Therapy Skills Training; Participants randomized to LiveWell will receive the refined intervention protocol as informed by Aim 1 (K99). LiveWell is an 8-session protocol of Dialectical Behavioral Therapy Skills Training, adapted specifically for patients with metastatic lung cancer. Sessions are delivered one on one via telehealth, approximately weekly. Participants learn concrete, easy-to-use skills to: 1) tune into the present moment, and how they are thinking and feeling (mindfulness), understand emotions, how to change them, and how to experience more positive feelings (emotion regulation), tolerate distressing emotions and symptoms (e.g., fatigue, pain, dyspnea) and to accept reality as it is (distress tolerance), and tools to communicate wants and needs effectively with others (interpersonal effectiveness). The goal is to teach patients skills to live well, with metastatic cancer. All sessions follow a standardized structure that is customary in skills training and grounded in social cognitive theory.

Behavioral: LiveWell: Adapted Dialectical Behavioral Therapy Skills Training; An adapted dialectical behavioral therapy skills training intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Usability as Measured by the Total Number of Participants Who Complete the Study Questionnaires	Up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	A measure to assess quality of life is the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L). The FACT-L is a 36-item self-report instrument that measures multidimensional quality of life. Total score ranges from 0 to 180, where a higher score indicates greater quality of life.	Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)
Change in depression	A candidate measure to assess depression is the PROMIS Depression Short Form 8a. Final measure selection will be informed by user testing completed during the K99 phase.	Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)
Change in anxiety	A candidate measure to assess anxiety is the PROMIS Depression Short Form 8a. Final measure selection will be informed by user testing completed during the K99 phase.	Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)
Change in fatigue	A candidate measure to assess fatigue is the Fatigue Symptom Inventory (FSI). Final measure selection will be informed by user testing completed during the K99 phase.	Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)
Change in shortness of breath	Candidate measures to assess shortness of breath are the modified Medical Research Council (mMRC) dyspnea scale and the 10-item FACIT-Dyspnea short form. Final measure selection will be informed by user testing completed during the K99 phase.	Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)
Change in pain	A candidate measure to assess pain is the Brief Pain Inventory (BPI). Final measure selection will be informed by user testing completed during the K99 phase.	Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)
Change in emotion regulation	A candidate measure to assess emotion regulation is the Difficulty in Regulating Emotions Scale (DERS-18). Final measure selection will be informed by user testing completed during the K99 phase.	Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)
Change in illness acceptance	A candidate measure to assess illness acceptance is the Peace, Equanimity, and Acceptance in the Cancer (PEACE) scale. Final measure selection will be informed by user testing completed during the K99 phase.	Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)
Change in frequency of skill use	A candidate measure to assess patient-reported frequency of skill use is the DBT Ways of Coping Checklist(DBT-WCCL) -DBT Skills Subscale (DSS). Final measure selection will be informed by user testing completed during the K99 phase.	Baseline, post-intervention, 3 months post-intervention (approximately week 0, week 8, week 20)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Tamara Somers, Professor in Psychiatry and Behavioral Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2025
• Primary Completion (Actual): July 7, 2025
• Study Completion (Actual): August 6, 2025

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Pro00114867; 1K99CA286959 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No