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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duke Cancer Institute
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.