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DBT for Metastatic Lung Cancer (DBT-MLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04973436
Recruitment Status : Not yet recruiting
First Posted : July 22, 2021
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
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 (DBT-MLC). Phase II aims to pilot test DBT-MLC 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. DBT-MLC 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Metastatic Behavioral: Dialectical Behavioral Therapy Skills Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients
Estimated Study Start Date : January 30, 2022
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Dialectical Behavioral Therapy Skills Training
The DBT-MLC intervention will teach participants dialectical behavioral therapy-based skills to reduce psychological distress through improved physical symptom management, emotion regulation, and tolerance of uncertainty. The DBT-MLC intervention will consist of 8-10 weekly sessions that will last approximately 60 minutes each.
Behavioral: Dialectical Behavioral Therapy Skills Training
Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer




Primary Outcome Measures :
  1. Feasibility as measured by study accrual [ Time Frame: Post-intervention (approximately 12 weeks) ]
    Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot)

  2. Feasibility as measured by study adherence [ Time Frame: Post-intervention (approximately 12 weeks) ]
    Adherence will be shown by at least 80% of intervention sessions completed

  3. Feasibility as measured by study attrition [ Time Frame: Post-intervention (approximately 12 weeks) ]
    Treatment feasibility will be shown by no more than 25% study attrition

  4. Acceptability as measured by client satisfaction ratings [ Time Frame: Post-intervention (approximately 12 weeks) ]
    Acceptability will be shown by at least 80% of participants reporting satisfaction with the intervention on the Client Satisfaction Questionnaire (CSQ)

  5. Change in psychological distress [ Time Frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 12, week 16) ]
    Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) and Anxiety (7 items) Short Form Scales


Secondary Outcome Measures :
  1. Change in fatigue [ Time Frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 12, week 16) ]
    Fatigue (i.e., severity and interference) will be assessed using the Fatigue Symptom Inventory (FSI)

  2. Change in dyspnea [ Time Frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 12, week 16) ]
    Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (MMRCDS)

  3. Change in pain [ Time Frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 12, week 16) ]
    Pain (i.e., severity and interference) will be assessed using the Brief Pain Inventory-Short Form (BPI-SF)

  4. Change in emotion regulation [ Time Frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 12, week 16) ]
    The Difficulties in Emotion Regulation Scale (DERS-18) will be used to assess emotion regulation and dysregulation

  5. Change in tolerance of uncertainty [ Time Frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 12, week 16) ]
    The Intolerance of Uncertainty Scale (IUS) will be used to measure emotional, cognitive, and behavioral reactions to uncertain situations

  6. Change in dialectical behavioral therapy skill use [ Time Frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 12, week 16) ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. be diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
  2. be undergoing first line 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04973436


Contacts
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Contact: Kelly A Hyland, PhD 978 844 2763 kelly.hyland@duke.edu

Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Tamara Somers, PhD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04973436    
Other Study ID Numbers: Pro00108640
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
dialectical behavioral therapy skills training
lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases