DBT for Metastatic Lung Cancer (LiveWell)
Primary Purpose
Lung Cancer Metastatic
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialectical Behavioral Therapy Skills Training
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer Metastatic focused on measuring dialectical behavioral therapy skills training, lung cancer
Eligibility Criteria
Inclusion Criteria:
- be diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
- be undergoing systemic treatment (chemotherapy, targeted therapy, and/or immunotherapy) for lung cancer at Duke Cancer Institute
- score >3 on the National Comprehensive Cancer Network Distress Thermometer for distress over the past week (Range: 0-10)
- be > 18 years of age
- be able to understand, speak, and read English
- be able to provide informed consent
Exclusion Criteria:
- reported or suspected cognitive impairment subsequently informed by a Montreal Cognitive Assessment (MOCA) of <26
- presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart, treating oncologist, or other medical provider
- expected survival of 4 months or less
Sites / Locations
- Duke Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Arm Description
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.
Outcomes
Primary Outcome Measures
Feasibility as measured by study accrual
Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot)
Feasibility as measured by study adherence
Adherence will be shown by at least 80% of intervention sessions completed
Feasibility as measured by study attrition
Treatment feasibility will be shown by no more than 25% study attrition
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)
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
Secondary Outcome Measures
Change in fatigue
Fatigue (i.e., severity and interference) will be assessed using the Fatigue Symptom Inventory (FSI)
Change in dyspnea
Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (MMRCDS)
Change in pain
Pain (i.e., severity and interference) will be assessed using the Brief Pain Inventory-Short Form (BPI-SF)
Change in emotion regulation
The Difficulties in Emotion Regulation Scale (DERS-18) will be used to assess emotion regulation and dysregulation
Change in tolerance of uncertainty
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04973436
Brief Title
DBT for Metastatic Lung Cancer
Acronym
LiveWell
Official Title
Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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 (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer Metastatic
Keywords
dialectical behavioral therapy skills training, lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavioral Therapy Skills Training
Intervention Description
LiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
Primary Outcome Measure Information:
Title
Feasibility as measured by study accrual
Description
Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot)
Time Frame
Post-intervention (approximately 8 weeks)
Title
Feasibility as measured by study adherence
Description
Adherence will be shown by at least 80% of intervention sessions completed
Time Frame
Post-intervention (approximately 8 weeks)
Title
Feasibility as measured by study attrition
Description
Treatment feasibility will be shown by no more than 25% study attrition
Time Frame
Post-intervention (approximately 8 weeks)
Title
Acceptability as measured by client satisfaction ratings
Description
Acceptability will be shown by at least 80% of participants reporting satisfaction with the intervention on the Client Satisfaction Questionnaire (CSQ)
Time Frame
Post-intervention (approximately 8 weeks)
Title
Change in psychological distress
Description
Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) and Anxiety (7 items) Short Form Scales
Time Frame
Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Secondary Outcome Measure Information:
Title
Change in fatigue
Description
Fatigue (i.e., severity and interference) will be assessed using the Fatigue Symptom Inventory (FSI)
Time Frame
Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Title
Change in dyspnea
Description
Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (MMRCDS)
Time Frame
Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Title
Change in pain
Description
Pain (i.e., severity and interference) will be assessed using the Brief Pain Inventory-Short Form (BPI-SF)
Time Frame
Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Title
Change in emotion regulation
Description
The Difficulties in Emotion Regulation Scale (DERS-18) will be used to assess emotion regulation and dysregulation
Time Frame
Baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12)
Title
Change in tolerance of uncertainty
Description
The Intolerance of Uncertainty Scale (IUS) will be used to measure emotional, cognitive, and behavioral reactions to uncertain situations
Time Frame
Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Title
Change in dialectical behavioral therapy skill use
Description
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
Time Frame
Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
be diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
be undergoing systemic treatment (chemotherapy, targeted therapy, and/or immunotherapy) for lung cancer at Duke Cancer Institute
score >3 on the National Comprehensive Cancer Network Distress Thermometer for distress over the past week (Range: 0-10)
be > 18 years of age
be able to understand, speak, and read English
be able to provide informed consent
Exclusion Criteria:
reported or suspected cognitive impairment subsequently informed by a Montreal Cognitive Assessment (MOCA) of <26
presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart, treating oncologist, or other medical provider
expected survival of 4 months or less
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly A Hyland, PhD
Phone
978 844 2763
Email
kelly.hyland@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara Somers, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly A Hyland, PhD
Phone
919-660-2737
Email
kelly.hyland@duke.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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DBT for Metastatic Lung Cancer
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