LiveWell: Adapted DBT Skills Training for Metastatic Lung Cancer

Duke University

Status: Completed

Conditions: Cancer Metastatic to Lung

Treatments: Behavioral: LiveWell: Adapted Dialectical Behavioral Therapy Skills Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06464562

Pro00114867

1K99CA286959 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. be diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
2. be undergoing lung cancer treatment with non-curative intent
3. endorse >=3 out of 10 on the NCCN distress thermometer over the past week
4. be > 18 years of age
5. be able to understand, speak, and read English, and 5) be able to provide informed consent

Exclusion criteria

1. reported or suspected cognitive impairment
2. presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist
3. expected survival <6 months

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1 participants in 1 patient group

LiveWell: Adapted Dialectical Behavioral Therapy Skills Training

Experimental group

Description:

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.

Treatment:

Behavioral: LiveWell: Adapted Dialectical Behavioral Therapy Skills Training