LiveWell: Adapted DBT Skills Training for Metastatic Lung Cancer

NCT06464562 | Completed Results DMC

• 2 other identifiers: Pro001148671K99CA286959
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Metastatic to Lung

Outcome Measures

Primary Outcomes (1)

• Usability as Measured by the Total Number of Participants Who Complete the Study Questionnaires

  Up to 8 weeks

Study Arms (1)

LiveWell: Adapted Dialectical Behavioral Therapy Skills Training

EXPERIMENTAL

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

Interventions

LiveWell: Adapted Dialectical Behavioral Therapy Skills Training BEHAVIORAL

An adapted dialectical behavioral therapy skills training intervention

LiveWell: Adapted Dialectical Behavioral Therapy Skills Training

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Results Point of Contact

• Title: Tamara Somers, PhD
• Organization: Duke University School of Medicine

tamara.somers@duke.edu

919-416-3408

Study Officials

• Tamara Somers

  Professor in Psychiatry and Behavioral Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm for user testing

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: February 14, 2025
• Primary Completion: July 7, 2025
• Study Completion: August 6, 2025
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)