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Completed

NCT Number: NCT04973436

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 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.

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Key information

Conditions

Lung Cancer Metastatic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Dialectical Behavioral Therapy Skills Training

Behavioral

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

Primary outcomes

  1. Feasibility as Measured by Study Accrual

    Time frame: Post-intervention (approximately 8 weeks)

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

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

    Time frame: Post-intervention (approximately 8 weeks)

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

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

    Time frame: Post-intervention (approximately 8 weeks)

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

  4. Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)

    Time frame: Post-intervention (approximately 8 weeks)

    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.

  5. Psychological Distress as Measured by the PROMIS Depression Short Form Scales

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

    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.

  6. Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales

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

    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.

Secondary outcomes

  1. Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)

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

    Fatigue (i.e., severity and interference) will be assessed using the Fatigue Symptom Inventory (FSI). The FSI has a score range of 0 to 10, where a higher score indicates more fatigue.

  2. Change in Dyspnea

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

    Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (MMRCDS). The MMRCDS has a score range of 0 to 4, where a higher score indicates worse dyspnea.

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

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

    The BPI-SF has a score range of 0 to 10, where a higher score indicates greater pain severity.

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

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

    The BPI-SF has a score range of 0 to 10, where a higher score indicates greater pain interference.

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

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

    The Difficulties in Emotion Regulation Scale (DERS-18) will be used to assess emotion regulation. The DERS-18 has a score range of 18-80, where a higher score indicates greater difficulty with regulating emotions.

  6. Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS)

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

    The Intolerance of Uncertainty Short Form (IUS) will be used to measure emotional, cognitive, and behavioral reactions to uncertain situations. The IUS has a score range of 12-60, where a higher score indicates greater intolerance of uncertainty.

  7. Change in Dialectical Behavioral Therapy (DBT) Skill Use as Measured by the DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS)

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

    The DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS) will be used to assess patient-reported frequency of skill use to manage difficult situations. The DBT-WCCL has a score range of 0 to 4, where a higher score indicates greater DBT skill use.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients

Acronym: LiveWell

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2021
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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