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NCT04973436 · ClinicalTrials.gov registry record · NA
DBT for Metastatic Lung Cancer
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT04973436 is a NA study that has completed, run by Duke University. The registered enrollment target is 31 participants.
The verdict
NCT04973436, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study Summary
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.
Interventions
- BEHAVIORAL Dialectical Behavioral Therapy Skills Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-05-18 |
| Est. Completion | 2024-04-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04973436
The ClinicalTrials.gov registry entry for NCT04973436 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dialectical Behavioral Therapy Skills Training is the first listed.
NCT04973436 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04973436 about?
NCT04973436 is a clinical study titled "DBT for Metastatic Lung Cancer". 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 therap...
What is the current status of trial NCT04973436?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2022-05-18. Estimated completion is 2024-04-25.
What interventions are being tested in trial NCT04973436?
The interventions under investigation include: Dialectical Behavioral Therapy Skills Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT04973436?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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