Clinical trial NCT04973436: DBT for Metastatic Lung Cancer
Official title: Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer Metastatic
Keywords: dialectical behavioral therapy skills training
lung cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. be diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
2. be undergoing systemic treatment (chemotherapy, targeted therapy, and/or immunotherapy) for lung cancer at Duke Cancer Institute
3. score \>3 on the National Comprehensive Cancer Network Distress Thermometer for distress over the past week (Range: 0-10)
4. be \> 18 years of age
5. be able to understand, speak, and read English
6. be able to provide informed consent

Exclusion Criteria:

1. reported or suspected cognitive impairment subsequently informed by a Montreal Cognitive Assessment (MOCA) of \<26
2. presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart, treating oncologist, or other medical provider
3. expected survival of 4 months or less

Primary outcomes:
measure: Feasibility as Measured by Study Accrual
timeFrame: Post-intervention (approximately 8 weeks)
measure: Adherence as Measured by Number of Participants Who Completed All Intervention Sessions
timeFrame: Post-intervention (approximately 8 weeks)
measure: Feasibility as Measured by Number of Participants Lost From the Study Over Time
timeFrame: Post-intervention (approximately 8 weeks)
measure: Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)
timeFrame: Post-intervention (approximately 8 weeks)
measure: Psychological Distress as Measured by the PROMIS Depression Short Form Scales
timeFrame: Baseline, post-intervention (approximately week 0, week 8, week 12)
measure: Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales
timeFrame: Baseline, post-intervention (approximately week 0, week 8, week 12)
Secondary outcomes:
measure: Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)
timeFrame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
measure: Change in Dyspnea
timeFrame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
measure: Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
measure: Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
measure: Change in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18)
timeFrame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12)
measure: Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS)
timeFrame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
measure: Change in Dialectical Behavioral Therapy (DBT) Skill Use as Measured by the DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS)
timeFrame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Tamara Somers, PhD
role: PRINCIPAL_INVESTIGATOR
References: