DBT for Metastatic Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients

Conditions
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Lung Cancer Metastatic

Intervention / Treatment
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* Behavioral: Dialectical Behavioral Therapy Skills Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol<br>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<br>* LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Feasibility as measured by study adherence | Adherence will be shown by at least 80% of intervention sessions completed | Post-intervention (approximately 8 weeks) | 
| Feasibility as measured by study attrition | Treatment feasibility will be shown by no more than 25% study attrition | Post-intervention (approximately 8 weeks) | 
| Acceptability as measured by client satisfaction ratings | Acceptability will be shown by at least 80% of participants reporting satisfaction with the intervention on the Client Satisfaction Questionnaire (CSQ) | Post-intervention (approximately 8 weeks) | 
| Change in psychological distress | Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) and Anxiety (7 items) Short Form Scales | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue | Fatigue (i.e., severity and interference) will be assessed using the Fatigue Symptom Inventory (FSI) | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) | 
| Change in dyspnea | Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (MMRCDS) | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) | 
| Change in pain | Pain (i.e., severity and interference) will be assessed using 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 | The Difficulties in Emotion Regulation Scale (DERS-18) will be used to assess emotion regulation and dysregulation | Baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12) | 
| Change in tolerance of uncertainty | The Intolerance of Uncertainty Scale (IUS) will be used to measure emotional, cognitive, and behavioral reactions to uncertain situations | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) | 
| Change in dialectical behavioral therapy skill use | 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 | Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dialectical behavioral therapy skills training, lung cancer