DBT for Metastatic Lung Cancer

Not Applicable

Completed

• Conditions: Lung Cancer Metastatic
• Interventions: Behavioral: Dialectical Behavioral Therapy Skills Training

• Registration Number: NCT04973436
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-22
• Study Start: 2022-05-18
• Status Verified: 2024-03
• Primary Completion: 2024-03-11
• Study Completion: 2024-04-25
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol	Dialectical Behavioral Therapy Skills Training	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.

Primary Outcome Measures

Name	Time	Method
Feasibility as measured by study adherence	Post-intervention (approximately 8 weeks)	Adherence will be shown by at least 80% of intervention sessions completed
Change in psychological distress	Baseline, post-intervention (approximately week 0, week 8)	Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) and Anxiety (7 items) Short Form Scales
Feasibility as measured by study accrual	Post-intervention (approximately 8 weeks)	Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot)
Feasibility as measured by study attrition	Post-intervention (approximately 8 weeks)	Treatment feasibility will be shown by no more than 25% study attrition
Acceptability as measured by client satisfaction ratings	Post-intervention (approximately 8 weeks)	Acceptability will be shown by at least 80% of participants reporting satisfaction with the intervention on the Client Satisfaction Questionnaire (CSQ)

Secondary Outcome Measures

Name	Time	Method
Change in dyspnea	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)
Change in tolerance of uncertainty	Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)	The Intolerance of Uncertainty Scale (IUS) will be used to measure emotional, cognitive, and behavioral reactions to uncertain situations
Change in dialectical behavioral therapy skill use	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
Change in fatigue	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)
Change in pain	Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)	Pain (i.e., severity and interference) will be assessed using the Brief Pain Inventory-Short Form (BPI-SF)
Change in emotion regulation	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 and dysregulation
Change in psychological distress	Baseline, one month post-intervention (approximately week 0, week 12)	Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) and Anxiety (7 items) Short Form Scales

Trial Locations

Locations (1)

Duke Cancer Institute; 🇺🇸 Durham, North Carolina, United States