DBT-MLC: DBT for Metastatic Lung Cancer

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04973436
Collaborator
(none)
70
1
1
27.5
2.5

Study Details

Study Description

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 (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. 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
  • Behavioral: Dialectical Behavioral Therapy Skills Training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single Group AssignmentSingle Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients
Actual Study Start Date :
May 18, 2022
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Feasibility as measured by study accrual [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 [Post-intervention (approximately 12 weeks)]

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

  3. Feasibility as measured by study attrition [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 [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 [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke Cancer Institute Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Tamara Somers, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT04973436
Other Study ID Numbers:
  • Pro00108640
First Posted:
Jul 22, 2021
Last Update Posted:
Jun 21, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duke University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022