Clinical trial NCT06464562: LiveWell: Adapted DBT Skills Training for Metastatic Lung Cancer
Official title: LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Metastatic to Lung
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-06-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm for user testing
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Usability testing as measured by the percentage of user testers who complete the study questionnaires
timeFrame: Baseline, post-intervention (8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Professor in Psychiatry and Behavioral Sciences
name: Tamara Somers
role: PRINCIPAL_INVESTIGATOR
References: