DBT for Metastatic Lung Cancer

NCT04973436 | Completed Results

• 1 other identifier: Pro00108640
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer Metastatic

Keywords

dialectical behavioral therapy skills training; lung cancer

Outcome Measures

Primary Outcomes (6)

• Feasibility as Measured by Study Accrual

  Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot)

  Post-intervention (approximately 8 weeks)

• Adherence as Measured by Number of Participants Who Completed All Intervention Sessions

  Adherence will be shown by at least 80% of intervention sessions completed.

  Post-intervention (approximately 8 weeks)

• Feasibility as Measured by Number of Participants Lost From the Study Over Time

  Treatment feasibility will be shown by no more than 25% study attrition.

  Post-intervention (approximately 8 weeks)

• Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)

  CSQ items are rated on a 4-point scale from 1 (quite dissatisfied) to 4 (very satisfied), then averaged to obtain an overall acceptability score. Acceptability was demonstrated by \>80% of participants reporting intervention satisfaction (an average CSQ score of 3 to 4). Reported as the number of participants who had an average CSQ score of 3 to 4.

  Post-intervention (approximately 8 weeks)

• Psychological Distress as Measured by the PROMIS Depression Short Form Scales

  Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater distress.

  Baseline, post-intervention (approximately week 0, week 8, week 12)

• Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales

  Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (7 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater distress.

  Baseline, post-intervention (approximately week 0, week 8, week 12)

Secondary Outcomes (7)

• Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)

  Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)

• Change in Dyspnea

  Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)

• Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)

  Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)

• Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)

  Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)

• Change in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18)

  Baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12)

Study Arms (1)

LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol

EXPERIMENTAL

The intervention, "LiveWell" will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. Informed by feedback from patients and providers collected in Phase of of the study, the LiveWell intervention consists of of 8 sessions delivered one-on-one, approximately weekly. Sessions will last approximately 45-60 minutes each.

Behavioral: Dialectical Behavioral Therapy Skills Training

Interventions

Dialectical Behavioral Therapy Skills Training BEHAVIORAL

LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer

LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• expected survival of 4 months or less

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Hyland KA, Neacsiu AD, Fisher HM, Cowperthwait CM, Chou N, Stinchcombe TE, Oeffinger KC, Porter LS, Dorfman CS, Keefe FJ, Somers TJ. LiveWell: Pilot Feasibility Trial of an Adapted Dialectical Behavioral Therapy Skills Training Protocol in Patients With Metastatic Non-Small Cell Lung Cancer. Psychooncology. 2025 Dec;34(12):e70357. doi: 10.1002/pon.70357.

  PMID: 41392376 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Tamara Somers, PhD
• Organization: Duke University School of Medicine

tamara.somers@duke.edu

9194163408

Study Officials

• Tamara Somers, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: May 18, 2022
• Primary Completion: March 11, 2024
• Study Completion: April 25, 2024
• Last Updated: April 27, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)