Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04973436
Study type Interventional
Source Duke University
Contact
Status Active, not recruiting
Phase N/A
Start date May 18, 2022
Completion date April 15, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05452005 - Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer Phase 1
Completed NCT03179150 - Clinical Validation of the M5L Lung CAD N/A
Recruiting NCT03693339 - Capmatinib in Patients With Non-small Cell Lung Cancer Harboring cMET exon14 Skipping Mutation Phase 2
Completed NCT03970564 - Neck Ultrasound by Respiratory Physicians in Patients With Lung Cancer
Completed NCT03184571 - Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced NSCLC Phase 2
Terminated NCT02308865 - Early Palliative Care in Metastatic Lung Cancer in Northern France N/A
Not yet recruiting NCT03703596 - Anlotinib Versus Docetaxel as the Second-line Treatment in EGFR Wild Type Patients With Advanced NSCLC Phase 2
Terminated NCT04069936 - Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC Phase 2
Completed NCT04233476 - A Study of 99mTc-3PRGD2 Injection in Lung Cancer Patient Phase 3
Recruiting NCT05537922 - I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
Active, not recruiting NCT04986670 - NutriCare Plus a Medically Tailored Meal Intervention Among Patients With Lung Cancer N/A
Completed NCT03755102 - A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib. Early Phase 1
Not yet recruiting NCT03638765 - Dendritic Cell Therapy for Brain Metastases From Breast- or Lung Cancer Phase 1
Recruiting NCT02976740 - SBRT Combination With rhGM-CSF and Tα1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy Phase 2
Active, not recruiting NCT04085315 - Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer Phase 1
Recruiting NCT03693326 - PDR001 in Patients With Non-small Cell Lung Cancer Harboring KRAS/NRAS Mutation or no Actionable Genetic Abnormalities Phase 2
Recruiting NCT05860296 - Testing Experimental Anti-cancer Drug SLC-391 With an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers Phase 1/Phase 2
Active, not recruiting NCT04964960 - Pembro+Chemo in Brain Mets Phase 2
Recruiting NCT05078047 - Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients With Metastatic Cancer in Response After 6 Months of Standard IO Phase 3
Active, not recruiting NCT03057106 - Durvalumab and Tremelimumab ± Platinum-Based Chemotherapy in Patients With Metastatic Squamous or Non-Squamous NSCLC Phase 2