Lung Cancer MetastaticLiveWellNCT04973436

DBT for Metastatic Lung Cancer

A study testing Dialectical Behavioral Therapy Skills Training in people with Lung Cancer Metastatic, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer Metastatic
What is being tested?: Dialectical Behavioral Therapy Skills Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 18 May 2022to 25 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke Cancer Institute
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients

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.

Conditions: Lung Cancer Metastatic
Being tested: Dialectical Behavioral Therapy Skills Training
Keywords: dialectical behavioral therapy skills training, lung cancer
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04973436
Study group	Role	What they receive
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol	Experimental	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. Receives: Behavioral: Dialectical Behavioral Therapy Skills Training

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility as Measured by Study Accrual
Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot)
Measured: Post-intervention (approximately 8 weeks)
Adherence as Measured by Number of Participants Who Completed All Intervention Sessions
Adherence will be shown by at least 80% of intervention sessions completed.
Measured: Post-intervention (approximately 8 weeks)
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.
Measured: Post-intervention (approximately 8 weeks)
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.
Measured: Post-intervention (approximately 8 weeks)
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.
Measured: Baseline, post-intervention (approximately week 0, week 8, week 12)
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.
Measured: Baseline, post-intervention (approximately week 0, week 8, week 12)

Secondary outcomes (7)

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.
Measured: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
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.
Measured: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
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.
Measured: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
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.
Measured: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
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.
Measured: Baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12)
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.
Measured: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
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.
Measured: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 May 202225 Apr 2024

First posted22 Jul 2021
Study start18 May 2022
Primary completion11 Mar 2024
Study completion25 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lung Cancer MetastaticStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single Group Assignment
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04973436
Sponsor's protocol ID: Pro00108640
Acronym: LiveWell
Status last verified: Apr 2025
First submitted: 13 Jul 2021
Last updated: 27 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hyland KA, Neacsiu AD, Fisher HM, Cowperthwait CM, Chou N, Stinchcombe TE, Oeffinger KC, Porter LS, Dorfman CS, Keefe FJ, Somers TJ. LiveWell: Pilot Feasibility Trial of an Adapted Dialectical Behavioral Therapy Skills Training Protocol in Patients With Metastatic Non-Small Cell Lung Cancer. Psychooncology. 2025 Dec;34(12):e70357. doi: 10.1002/pon.70357.
PubMed 41392376

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
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REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)
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All Lung Cancer Metastatic trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients
ClinicalTrials.gov ID: NCT04973436
Acronym / sponsor ID: LiveWell / Pro00108640
Conditions: Lung Cancer Metastatic
Keywords: dialectical behavioral therapy skills training, lung cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: 18 May 2022 (actual)
Primary completion: 11 Mar 2024 (actual)
Study completion: 25 Apr 2024 (actual)
First posted: 22 Jul 2021 (actual)
Results: Posted 27 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single Group Assignment

Arm	Type	Receives
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol	Experimental	Behavioral: Dialectical Behavioral Therapy Skills TrainingThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dialectical Behavioral Therapy Skills TrainingLiveWell: Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer	Behavioural	LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol

Primary outcome

Feasibility as Measured by Study Accrual
Time frame: Post-intervention (approximately 8 weeks)
Treatment feasibility will be shown by meeting study accrual target (N = 30 for single-arm pilot)
Adherence as Measured by Number of Participants Who Completed All Intervention Sessions
Time frame: Post-intervention (approximately 8 weeks)
Adherence will be shown by at least 80% of intervention sessions completed.
Feasibility as Measured by Number of Participants Lost From the Study Over Time
Time frame: Post-intervention (approximately 8 weeks)
Treatment feasibility will be shown by no more than 25% study attrition.
Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)
Time frame: Post-intervention (approximately 8 weeks)
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.
Psychological Distress as Measured by the PROMIS Depression Short Form Scales
Time frame: Baseline, post-intervention (approximately week 0, week 8, week 12)
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.
Psychological Distress as Measured by the PROMIS Anxiety Short Form Scales
Time frame: Baseline, post-intervention (approximately week 0, week 8, week 12)
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.

7 secondary outcomes

Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Change in Dyspnea
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Change in Emotion Regulation as Measured by the Emotion Regulation Scale (DERS-18)
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12)
Change in Intolerance of Uncertainty as Measured by the Intolerance of Uncertainty Short Form (IUS)
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)
Change in Dialectical Behavioral Therapy (DBT) Skill Use as Measured by the DBT Ways of Coping Checklist (DBT-WCCL) -DBT Skills Subscale (DSS)
Time frame: Baseline, post-intervention, one month post-intervention (approximately week 0, week 8, week 12)

Results and safety

Results posted to the registry on 27 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol	30	24

Primary outcome: Feasibility as Measured by Study Accrual

Time frame: Post-intervention (approximately 8 weeks). Count of participants. Unit: Participants

Measure	LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol n = 34
Value	31

Population analysed: Individuals who were eligible for consent.

Primary outcome: Adherence as Measured by Number of Participants Who Completed All Intervention Sessions

Time frame: Post-intervention (approximately 8 weeks). Count of participants. Unit: Participants

Measure	LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol n = 30
Value	27

Primary outcome: Feasibility as Measured by Number of Participants Lost From the Study Over Time

Time frame: Post-intervention (approximately 8 weeks). Count of participants. Unit: Participants

Measure	LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol n = 30
Value	4

Primary outcome: Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)

Time frame: Post-intervention (approximately 8 weeks). Count of participants. Unit: Participants

Measure	LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol n = 26
Value	25

Population analysed: Participants who completed the CSQ.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 16 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol	0 of 30 (0%)	0 of 30 (0%)	2 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41392376Hyland KA, Neacsiu AD, Fisher HM, Cowperthwait CM, Chou N, Stinchcombe TE, Oeffinger KC, Porter LS, Dorfman CS, Keefe FJ, Somers TJ. LiveWell: Pilot Feasibility Trial of an Adapted Dialectical Behavioral Therapy Skills Training Protocol in Patients With Metastatic Non-Small Cell Lung Cancer. Psychooncology. 2025 Dec;34(12):e70357. doi: 10.1002/pon.70357.
Individual participant dataSharing planned: No

Related trials for Lung Cancer Metastatic

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tamara Somers, PhD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dialectical Behavioral Therapy Skills Training in people with Lung Cancer Metastatic, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility as Measured by Study Accrual (time frame: Post-intervention (approximately 8 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04973436, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.