DBT for Metastatic Lung Cancer
Public ClinicalTrials.gov record NCT04973436. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04973436
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 31 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 17, 2022
- Primary completion
- Mar 10, 2024
- Completion
- Apr 24, 2024
- Last update posted
- Apr 26, 2025
2022 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Duke Cancer Institute | Durham | North Carolina | 27710 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04973436, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 26, 2025 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04973436 live on ClinicalTrials.gov.