Cancer Metastatic to LungNCT06464562
LiveWell: Adapted DBT Skills Training for Metastatic Lung Cancer
A study testing LiveWell: Adapted Dialectical Behavioral Therapy Skills Training in people with Cancer Metastatic to Lung, run by Duke University at 1 site in United States.
Trial summary
Patients are living longer with metastatic lung cancer (i.e., metavivors) due to therapeutic advances, but face significant challenges. Most metavivors will ultimately die of cancer and must navigate the duality of living while dying. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Metastatic to Lung
- What is being tested?
- LiveWell: Adapted 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
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2025to 6 Aug 2025
- 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
- Diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
- Undergoing lung cancer treatment with non-curative intent
- Endorse >=3 out of 10 on the NCCN distress thermometer over the past week
- At least 18 years of age
- Able to understand, speak, and read English, and 5) be able to provide informed consent
Who cannot join
- Reported or suspected cognitive impairment
- Presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist
- Expected survival <6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer
Patients are living longer with metastatic lung cancer (i.e., metavivors) due to therapeutic advances, but face significant challenges. Most metavivors will ultimately die of cancer and must navigate the duality of living while dying. Unsurprisingly, metavivors endorse high psychological distress (e.g., anxiety, depression, illness non-acceptance), high symptom burden (e.g., fatigue, dyspnea, pain), and poor quality of life. Psychosocial interventions can improve outcomes, but existing paradigms are not designed to help metavivors navigate the emotional turbulence of living with metastatic disease. Dialectical Behavioral Therapy (DBT) Skills Training is an evidence-based treatment that teaches patients transdiagnostic, easy-to-use skills to both accept things as they are (mindfulness, distress tolerance) and change things within their control (emotion regulation, interpersonal effectiveness) to better navigate life challenges. However, DBT Skills Training has rarely been applied in patients with chronic illness. The investigators adapted DBT Skills Training (e.g., intervention dose, delivery, content) for patients living with metastatic lung cancer to create LiveWell, an 8-session Skills Training protocol delivered one-on-one via videoconference. Building on preliminary data and aligned with the ORBIT model for behavioral intervention development, the first phase of this study (K99, Aim 1, 1 year) aims to iteratively refine LiveWell using 1) qualitative exit interview data from a proof-of-concept study, 2) an advisory board of interested parties, 3) the Dynamic Sustainability Framework from implementation science, and 4) user testing (n= up to 10). The K99 phase will produce a standardized protocol and procedures for the second, independent phase of the study (R00) which will be registered separately. If successful, LiveWell will improve metavivor quality of life and provide a promising psychosocial intervention paradigm for other metavivors and patients with chronic illness.
- Conditions
- Cancer Metastatic to Lung
- Being tested
- LiveWell: Adapted Dialectical Behavioral Therapy Skills Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiveWell: Adapted Dialectical Behavioral Therapy Skills TrainingBehavioural
An adapted dialectical behavioral therapy skills training intervention
| Study group | Role | What they receive |
|---|---|---|
| LiveWell: Adapted Dialectical Behavioral Therapy Skills Training | Experimental | Participants randomized to LiveWell will receive the refined intervention protocol as informed by Aim 1 (K99). LiveWell is an 8-session protocol of Dialectical Behavioral Therapy Skills Training, adapted specifically for patients with metastatic lung cancer. Sessions are delivered one on one via telehealth, approximately weekly. Participants learn concrete, easy-to-use skills to: 1) tune into the present moment, and how they are thinking and feeling (mindfulness), understand emotions, how to change them, and how to experience more positive feelings (emotion regulation), tolerate distressing emotions and symptoms (e.g., fatigue, pain, dyspnea) and to accept reality as it is (distress tolerance), and tools to communicate wants and needs effectively with others (interpersonal effectiveness). The goal is to teach patients skills to live well, with metastatic cancer. All sessions follow a standardized structure that is customary in skills training and grounded in social cognitive theory. Receives: Behavioral: LiveWell: Adapted Dialectical Behavioral Therapy Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability as Measured by the Total Number of Participants Who Complete the Study Questionnaires
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start14 Feb 2025
- Primary completion7 Jul 2025
- Study completion6 Aug 2025
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.
- Other trials for Cancer Metastatic to LungStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm for user testing
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tamara Somers, Principal investigator, Professor in Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464562
- Sponsor's protocol ID
- Pro00114867
- Other IDs
- 1K99CA286959
- Status last verified
- Jan 2026
- First submitted
- 13 Jun 2024
- Last updated
- 12 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer
- ClinicalTrials.gov ID
- NCT06464562
- Acronym / sponsor ID
- Pro00114867
- Conditions
- Cancer Metastatic to Lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 6 Aug 2025 (actual)
- First posted
- 18 Jun 2024 (actual)
- Results
- Posted 12 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients are living longer with metastatic lung cancer (i.e., metavivors) due to therapeutic advances, but face significant challenges. Most metavivors will ultimately die of cancer and must navigate the duality of living while dying. Unsurprisingly, metavivors endorse high psychological distress (e.g., anxiety, depression, illness non-acceptance), high symptom burden (e.g., fatigue, dyspnea, pain), and poor quality of life. Psychosocial interventions can improve outcomes, but existing paradigms are not designed to help metavivors navigate the emotional turbulence of living with metastatic disease. Dialectical Behavioral Therapy (DBT) Skills Training is an evidence-based treatment that teaches patients transdiagnostic, easy-to-use skills to both accept things as they are (mindfulness, distress tolerance) and change things within their control (emotion regulation, interpersonal effectiveness) to better navigate life challenges. However, DBT Skills Training has rarely been applied in patients with chronic illness. The investigators adapted DBT Skills Training (e.g., intervention dose, delivery, content) for patients living with metastatic lung cancer to create LiveWell, an 8-session Skills Training protocol delivered one-on-one via videoconference. Building on preliminary data and aligned with the ORBIT model for behavioral intervention development, the first phase of this study (K99, Aim 1, 1 year) aims to iteratively refine LiveWell using 1) qualitative exit interview data from a proof-of-concept study, 2) an advisory board of interested parties, 3) the Dynamic Sustainability Framework from implementation science, and 4) user testing (n= up to 10). The K99 phase will produce a standardized protocol and procedures for the second, independent phase of the study (R00) which will be registered separately. If successful, LiveWell will improve metavivor quality of life and provide a promising psychosocial intervention paradigm for other metavivors and patients with chronic illness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm for user testing
| Arm | Type | Receives |
|---|---|---|
| LiveWell: Adapted Dialectical Behavioral Therapy Skills Training | Experimental | Behavioral: LiveWell: Adapted Dialectical Behavioral Therapy Skills TrainingParticipants randomized to LiveWell will receive the refined intervention protocol as informed by Aim 1 (K99). LiveWell is an 8-session protocol of Dialectical Behavioral Therapy Skills Training, adapted specifically for patients with metastatic lung cancer. Sessions are delivered one on one via telehealth, approximately weekly. Participants learn concrete, easy-to-use skills to: 1) tune into the present moment, and how they are thinking and feeling (mindfulness), understand emotions, how to change them, and how to experience more positive feelings (emotion regulation), tolerate distressing emotions and symptoms (e.g., fatigue, pain, dyspnea) and to accept reality as it is (distress tolerance), and tools to communicate wants and needs effectively with others (interpersonal effectiveness). The goal is to teach patients skills to live well, with metastatic cancer. All sessions follow a standardized structure that is customary in skills training and grounded in social cognitive theory. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
- Undergoing lung cancer treatment with non-curative intent
- Endorse >=3 out of 10 on the NCCN distress thermometer over the past week
- At least 18 years of age
- Able to understand, speak, and read English, and 5) be able to provide informed consent
Key exclusion criteria (3 listed)
- Reported or suspected cognitive impairment
- Presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist
- Expected survival <6 months
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 |
|---|---|---|
| LiveWell: Adapted Dialectical Behavioral Therapy Skills TrainingAn adapted dialectical behavioral therapy skills training intervention | Behavioural | LiveWell: Adapted Dialectical Behavioral Therapy Skills Training |
Primary outcome
Usability as Measured by the Total Number of Participants Who Complete the Study Questionnaires
Time frame: Up to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 principal investigator
Professor in Psychiatry and Behavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiveWell: Adapted Dialectical Behavioral Therapy Skills Training in people with Cancer Metastatic to Lung, 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 5 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 12 Feb 2026. 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 12 Feb 2026). 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?
Usability as Measured by the Total Number of Participants Who Complete the Study Questionnaires (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2026.