NCT04973436Completed
DBT for Metastatic Lung Cancer
Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients
Source: ClinicalTrials.gov · Last updated 27 Apr 2025
Brief summary (registry, in English)
Metastatic lung cancer patients experience significantly greater psychological distress (i.e., depression, anxiety) compared to other cancers. Psychological distress is as a prognostic indicator for worse clinical outcomes and poorer overall survival in cancer patients. Dialectical behavioral therapy (DBT) is a trans-diagnostic, evidence-based psychotherapy that teaches participants a core set of behavioral skills (distress tolerance, emotion regulation, mindfulness, interpersonal effectiveness) to cope more effectively with emotional and physical symptoms. The proposed study seeks to adapt and pilot test DBT skills training for patients with metastatic lung cancer using the ADAPT-ITT framework. Participants will be metastatic lung cancer patients who score \>=3 on the National Comprehensive Cancer Network distress thermometer. Phase I aims to use focus groups and interviews with key stakeholders (metastatic lung cancer patients (N=20), thoracic oncology providers (N=6), clinicians with expertise in survivorship and behavioral symptom management (N=6)) to determine if and how DBT skills training must be modified for implementation with metastatic lung cancer patients. Adapted material will be reviewed by topical experts in DBT and implementation science to produce a manualized, adapted DBT skills training protocol for metastatic lung cancer patients (LiveWell). Phase II aims to pilot test LiveWell (N=30) to assess feasibility, acceptability, and examine pre-to-post intervention outcomes of psychological distress, (i.e., depression and anxiety) fatigue, dyspnea, pain, emotion regulation, tolerance of uncertainty, and DBT coping skill use. LiveWell will consist of coping skills training sessions delivered either in-person or via videoconferencing technology. Study measures will be collected at baseline, immediately post-intervention, and 1-month post-intervention.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 13 Jul 2021
- Start date
- 18 May 2022
- Primary completion date
- 11 Mar 2024
- Lead sponsor
- Duke University
- Diseases
- Lung cancer
- NCT number
- NCT04973436
What you commit to
- Study type: Interventional
- Participants enrolled: 31
- From 18 May 2022 to the primary completion date, 11 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- reported or suspected cognitive impairment subsequently informed by a Montreal Cognitive Assessment (MOCA) of \<26
- presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart, treating oncologist, or other medical provider
Other
- expected survival of 4 months or less
Who the study is looking for
- be diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
- be undergoing systemic treatment (chemotherapy, targeted therapy, and/or immunotherapy) for lung cancer at Duke Cancer Institute
- score \>3 on the National Comprehensive Cancer Network Distress Thermometer for distress over the past week (Range: 0-10)
- be \> 18 years of age
- be able to understand, speak, and read English
- be able to provide informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke Cancer Institute Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.