Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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.

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

Dialectical Behavioral Therapy Skills Training

Tamara Somers, PhD

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.

DBT for Metastatic Lung Cancer

Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients

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

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

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

Acceptability will be shown by at least 80% of participants reporting satisfaction with the intervention on the Client Satisfaction Questionnaire (CSQ)

Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) and Anxiety (7 items) Short Form Scales

Fatigue (i.e., severity and interference) will be assessed using the Fatigue Symptom Inventory (FSI)

Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (MMRCDS)

Pain (i.e., severity and interference) will be assessed using the Brief Pain Inventory-Short Form (BPI-SF)

The Difficulties in Emotion Regulation Scale (DERS-18) will be used to assess emotion regulation and dysregulation

The Intolerance of Uncertainty Scale (IUS) will be used to measure emotional, cognitive, and behavioral reactions to uncertain situations

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
DBT for Metastatic Lung Cancer	NCT04973436	Lung Cancer Met...	Dialectical Beh...	18 Years -	Duke University
DBT for Metastatic Lung Cancer	NCT04973436	Lung Cancer Met...	Dialectical Beh...	18 Years -	Duke University

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