DBT for Metastatic Lung Cancer

Lung Cancer Metastatic Clinical Trial

— LiveWell  

Official title:

Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04973436
• Other study ID #: Pro00108640
• Status: Completed
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: April 25, 2024

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 25, 2024
• Est. primary completion date: March 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer Metastatic
• Lung Neoplasms

Intervention

Behavioral:
• Dialectical Behavioral Therapy Skills Training
LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer

Locations

Country	Name	City	State
United States	Duke Cancer Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Feasibility as measured by study adherence	Adherence will be shown by at least 80% of intervention sessions completed	Post-intervention (approximately 8 weeks)
Primary	Feasibility as measured by study attrition	Treatment feasibility will be shown by no more than 25% study attrition	Post-intervention (approximately 8 weeks)
Primary	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)
Primary	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 (approximately week 0, week 8)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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, one month post-intervention (approximately week 0, week 12)