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CompletedNCT04973436LiveWellUpdated Apr 27, 2025Results posted

DBT for Metastatic Lung Cancer

An interventional study of Dialectical Behavioral Therapy Skills Training in Lung Cancer Metastatic, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-27.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Cancer Metastatic

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Keywords

  • dialectical behavioral therapy skills training
  • lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 31 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol

    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.

    Behavioral: Dialectical Behavioral Therapy Skills Training

Interventions

  • BehavioralDialectical Behavioral Therapy Skills Training

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

06

What researchers measure

Primary outcomes

  1. Feasibility as Measured by Study Accrual

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

    Time frame: Post-intervention (approximately 8 weeks)

  2. Adherence as Measured by Number of Participants Who Completed All Intervention Sessions

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

    Time frame: Post-intervention (approximately 8 weeks)

  3. Feasibility as Measured by Number of Participants Lost From the Study Over Time

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

    Time frame: Post-intervention (approximately 8 weeks)

  4. Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)

    CSQ items are rated on a 4-point scale from 1 (quite dissatisfied) to 4 (very satisfied), then averaged to obtain an overall acceptability score. Acceptability was demonstrated by \>80% of participants reporting intervention satisfaction (an average CSQ score of 3 to 4). Reported as the number of participants who had an average CSQ score of 3 to 4.

    Time frame: Post-intervention (approximately 8 weeks)

  5. Psychological Distress as Measured by the PROMIS Depression Short Form Scales

    Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater distress.

    Time frame: Baseline, post-intervention (approximately week 0, week 8, week 12)

  6. Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales

    Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (7 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater distress.

    Time frame: Baseline, post-intervention (approximately week 0, week 8, week 12)

Secondary outcomes

  1. Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)

    Fatigue (i.e., severity and interference) will be assessed using the Fatigue Symptom Inventory (FSI). The FSI has a score range of 0 to 10, where a higher score indicates more fatigue.

    Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)

  2. Change in Dyspnea

    Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (MMRCDS). The MMRCDS has a score range of 0 to 4, where a higher score indicates worse dyspnea.

    Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)

  3. Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)

    The BPI-SF has a score range of 0 to 10, where a higher score indicates greater pain severity.

    Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)

  4. Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)

    The BPI-SF has a score range of 0 to 10, where a higher score indicates greater pain interference.

    Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)

  5. Change in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18)

    The Difficulties in Emotion Regulation Scale (DERS-18) will be used to assess emotion regulation. The DERS-18 has a score range of 18-80, where a higher score indicates greater difficulty with regulating emotions.

    Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12)

  6. Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS)

    The Intolerance of Uncertainty Short Form (IUS) will be used to measure emotional, cognitive, and behavioral reactions to uncertain situations. The IUS has a score range of 12-60, where a higher score indicates greater intolerance of uncertainty.

    Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)

  7. Change in Dialectical Behavioral Therapy (DBT) Skill Use as Measured by the DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS)

    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. The DBT-WCCL has a score range of 0 to 4, where a higher score indicates greater DBT skill use.

    Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)

07

Results

Posted Apr 27, 2025

Participant flow

Participant flow — Overall Study
MilestoneLiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Started30
Completed protocol27
Post-intervention assessment26
1-month follow-up assessment24
Completed24
Not completed6
Withdrew: Lost to follow-up3
Withdrew: Withdrawal by subject1
Withdrew: Death2

Outcome measures

PrimaryFeasibility as Measured by Study Accrual

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

Time frame:
Post-intervention (approximately 8 weeks)
Reported as:
Count of participants · Participants
Feasibility as Measured by Study Accrual
ParticipantsLiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Feasibility as Measured by Study Accrual31
PrimaryAdherence as Measured by Number of Participants Who Completed All Intervention Sessions

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

Time frame:
Post-intervention (approximately 8 weeks)
Reported as:
Count of participants · Participants
Adherence as Measured by Number of Participants Who Completed All Intervention Sessions
ParticipantsLiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Adherence as Measured by Number of Participants Who Completed All Intervention Sessions27
PrimaryFeasibility as Measured by Number of Participants Lost From the Study Over Time

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

Time frame:
Post-intervention (approximately 8 weeks)
Reported as:
Count of participants · Participants
Feasibility as Measured by Number of Participants Lost From the Study Over Time
ParticipantsLiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Feasibility as Measured by Number of Participants Lost From the Study Over Time4
PrimaryAcceptability as Measured by the Client Satisfaction Questionnaire (CSQ)

CSQ items are rated on a 4-point scale from 1 (quite dissatisfied) to 4 (very satisfied), then averaged to obtain an overall acceptability score. Acceptability was demonstrated by \>80% of participants reporting intervention satisfaction (an average CSQ score of 3 to 4). Reported as the number of participants who had an average CSQ score of 3 to 4.

Time frame:
Post-intervention (approximately 8 weeks)
Reported as:
Count of participants · Participants
Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)
ParticipantsLiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)25
PrimaryPsychological Distress as Measured by the PROMIS Depression Short Form Scales

Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater distress.

Time frame:
Baseline, post-intervention (approximately week 0, week 8, week 12)
Reported as:
Mean · score on a scale
Psychological Distress as Measured by the PROMIS Depression Short Form Scales
score on a scaleLiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Baseline51.82 ± 9.16
Week 848.85 ± 8.69
Week 1248.18 ± 9.73
PrimaryPsychological Distress as Measured by the PROMIS Anxiety Short Form Scales

Distress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (7 items) Short Form Scale. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater distress.

Time frame:
Baseline, post-intervention (approximately week 0, week 8, week 12)
Reported as:
Mean · score on a scale
Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales
score on a scaleLiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Baseline54.03 ± 8.25
Week 851.75 ± 7.51
Week 1248.39 ± 8.82
SecondaryFatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)

Fatigue (i.e., severity and interference) will be assessed using the Fatigue Symptom Inventory (FSI). The FSI has a score range of 0 to 10, where a higher score indicates more fatigue.

Time frame:
Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Reported as:
Mean · score on a scale
Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)
score on a scaleLiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Baseline3.86 ± 1.80
Week 83.36 ± 2.03
Week 123.14 ± 2.24
SecondaryChange in Dyspnea

Breathlessness will be assessed using the Modified Medical Research Council Dyspnea Scale (MMRCDS). The MMRCDS has a score range of 0 to 4, where a higher score indicates worse dyspnea.

Time frame:
Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Reported as:
Mean · score on a scale
Change in Dyspnea
score on a scaleLiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Baseline0.97 ± 0.87
Week 81.20 ± 1.08
Week 121.00 ± 1.02
SecondaryPain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)

The BPI-SF has a score range of 0 to 10, where a higher score indicates greater pain severity.

Time frame:
Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Reported as:
Mean · score on a scale
Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
score on a scaleLiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Baseline1.84 ± 1.80
Week 81.48 ± 1.78
Week 121.74 ± 1.97
SecondaryPain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)

The BPI-SF has a score range of 0 to 10, where a higher score indicates greater pain interference.

Time frame:
Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Reported as:
Mean · score on a scale
Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
score on a scaleLiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Baseline1.99 ± 2.06
Week 81.91 ± 2.36
Week 121.64 ± 2.01
SecondaryChange in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18)

The Difficulties in Emotion Regulation Scale (DERS-18) will be used to assess emotion regulation. The DERS-18 has a score range of 18-80, where a higher score indicates greater difficulty with regulating emotions.

Time frame:
Baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12)
Reported as:
Mean · score on a scale
Change in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18)
score on a scaleLiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Baseline32.33 ± 9.75
Week 828.73 ± 7.57
Week 1227.96 ± 7.50
SecondaryChange in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS)

The Intolerance of Uncertainty Short Form (IUS) will be used to measure emotional, cognitive, and behavioral reactions to uncertain situations. The IUS has a score range of 12-60, where a higher score indicates greater intolerance of uncertainty.

Time frame:
Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Reported as:
Mean · score on a scale
Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS)
score on a scaleLiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Baseline25.50 ± 7.89
Week 820.62 ± 4.82
Week 1220.88 ± 7.12
SecondaryChange in Dialectical Behavioral Therapy (DBT) Skill Use as Measured by the DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS)

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. The DBT-WCCL has a score range of 0 to 4, where a higher score indicates greater DBT skill use.

Time frame:
Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Reported as:
Mean · score on a scale
Change in Dialectical Behavioral Therapy (DBT) Skill Use as Measured by the DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS)
score on a scaleLiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Baseline1.95 ± 0.44
Week 82.24 ± 0.44
Week 122.25 ± 0.43

Adverse events

Collected over Up to approximately 16 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol2/30 (6.7%)0/30 (0%)0/30 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Mean62.3 ± 9.6
Sex: Female, Male
Sex: Female, Male(Participants)LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Female23
Male7
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Hispanic or Latino0
Not Hispanic or Latino30
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American3
White26
More than one race1
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
United States30
Time since lung cancer diagnosis
Time since lung cancer diagnosis(years)LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Mean4.62 ± 4.06
08

Study locations

1 site
  • Duke Cancer Institute
    Durham, North Carolina 27710, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 1, 2024
  • Informed consent form · Jul 31, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04973436
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Jul 22, 2021
Start date
May 18, 2022
Primary completion
Mar 11, 2024
Completion
Apr 25, 2024
Results posted
Apr 27, 2025
Last update
Apr 27, 2025

Study contacts

Tamara Somers, PhD
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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