SurvivorshipNCT07177846
LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer
A study testing LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program in people with Survivorship, run by Medical University of South Carolina at 1 site in United States.
Trial summary
In this pilot randomized controlled trial, patients with metastatic non-small cell lung cancer and at least mild distress (N=80) will be randomized to receive LiveWell, an adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol) or Usual Care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Survivorship
- What is being tested?
- LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 1 Mar 2028
- Phase
- Interventional
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
- Age ≥ 18
- AJCC Stage IV non-small cell lung cancer
- Receiving treatment with non-curative intent or on active surveillance
- English proficiency
- Able to provide informed consent
- National Comprehensive Cancer Network distress screening score ≥ 3/10 plus endorse at least 1 emotional concern.
Who cannot join
- Cognitive impairment
- Untreated serious mental illness
- Expected survival < 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Benjamin Axelrod, BA, 854 202 4449, axelrod@musc.edu
Kelly Hyland, PhD, 843-876-8861, hylandk@musc.edu
About this study
In this pilot randomized controlled trial, patients with metastatic non-small cell lung cancer and at least mild distress (N=80) will be randomized to receive LiveWell, an adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol) or Usual Care. The investigators will evaluate feasibility, acceptability, and preliminary efficacy of LiveWell to reduce distress (primary outcome) and improve psychological well-being, symptom burden, and quality of life (secondary outcomes). The investigators will explore emotion regulation as a potential mechanism of change.
Read the detailed description
Participants will be randomized 1:1 to receive LiveWell, an eight-session, telehealth-delivered DBT Skills Training intervention tailored for lung cancer metavivors, or Usual Care. Participants will complete self-report measures at baseline, 9-week follow-up, and 3 month follow-up. It is hypothesized that: 1) RCT methods will demonstrate evidence of feasibility (accrual N=80/20 months, >80% adherence to assigned interventions and assessments, <25% attrition) and acceptability (>3/5 satisfaction study procedures, >3 mean intervention satisfaction LiveWell); 2) LiveWell participants will demonstrate reductions in emotional distress (primary outcome) and improvements in psychological well-being (illness acceptance, positive affect, tolerance of uncertainty, mindfulness, self-efficacy to manage emotions and symptoms), symptom burden (fatigue, dyspnea, pain), and quality of life (secondary outcomes) compared to Usual Care participants at 9-week follow-up. H3. (Exploratory). To explore the role of emotion regulation as a potential mechanism of change.
- Conditions
- Survivorship
- Being tested
- LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program
- Keywords
- Dialectical Behavioral Therapy, Psychosocial Oncology, Lung Cancer, Psychological Distress
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training ProgramBehavioural
LiveWell: Adapted DBT Skills Training for Patients with Metastatic Lung Cancer
| Study group | Role | What they receive |
|---|---|---|
| LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program | Experimental | Will receive 9 telehealth sessions delivered 1 on 1 via telehealth with a trained mental health professional. Sessions will be delivered approximately weekly and are 45-60 min in length. Sessions will teach skills from dialectical behavioral therapy (e.g., mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness) adapted for patients with metastatic lung cancer. Sessions follow a standardized structure, including 1) mindfulness practice, 2) home practice and diary card review, 3) learning and practicing new skills, and 4) closing ritual. Participants will have access to a resource library of skills training videos and mindfulness recordings. Receives: Behavioral: LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Program |
| Usual Care | No intervention | Will receive a handout with general support resources available at Hollings Cancer Center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Anxiety Short Form (8a)
Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (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 anxiety symptomology.
Measured: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)
PROMIS Depression Short Form (8a)
Depression 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 depressive symptomology.
Measured: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)
Secondary outcomes (10)
Intolerance of Uncertainty Scale - Short Form (IUS-12)
The 12-item Intolerance of Uncertainty Scale (IUS) Short Form 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 (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)
Peace, Equanimity, and Acceptance in the Cancer (PEACE) - Peaceful Acceptance of Illness Subscale
The 5-item Peace, Equanimity, and Acceptance in the Cancer (PEACE) - Peaceful Acceptance of Illness Subscale will be used to assess patient-reported acceptance, inner peace, and tranquility in the context of cancer. The subscale has a score range of 5-20, where a higher score indicates greater peaceful acceptance of illness.
Measured: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)
PROMIS Positive Affect Short Form (15a)
The PROMIS Positive Affect Short Form 15a will be used to assess patient-reported positive emotions and well-being over the past 7 days. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater positive affect.
Measured: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)
Difficulty in Regulating Emotions Scale (DERS-18)
The DERS-18 will be used to assess emotion dysregulation. The DERS-18 has a score range of 18-80, where a higher score indicates greater difficulty with regulating emotions.
Measured: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
The 10-item Cognitive and Affective Mindfulness Scale-Revised will be used to assess patient-reported mindfulness qualities, including present-moment awareness, acceptance, and attention. The CAMS-R has a score range of 10-40, where a higher score indicates greater mindfulness.
Measured: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)
PROMIS Self-Efficacy for Managing Symptoms Short Form (8a)
The PROMIS Self-Efficacy for Managing Symptoms 8-item Short Form will be used to assess patient-reported confidence in managing symptoms and limiting their interference with daily life. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater self-efficacy for managing symptoms.
Measured: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)
PROMIS Self-Efficacy for Managing Emotions (8a) Short Form
The PROMIS Self-Efficacy for Managing Emotions 8-item Short Form will be used to assess patient-reported confidence in managing negative emotions and emotional distress related to chronic illness. PROMIS scores are expressed as T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater self-efficacy for managing emotions.
Measured: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)
NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE)
The NCI-PRO-CTCAE will be used to assess patient-reported symptom frequency, severity, and interference related to lung cancer and its treatment. Items are rated on a 5-point Likert scale, with higher scores indicating greater symptom burden.
Measured: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)
Functional Assessment of Cancer Therapy - Lung (FACT-L)
The FACT-L will be used to assess patient-reported quality of life across physical, social/family, emotional, and functional domains, as well as lung cancer-specific concerns. Items are rated on a 5-point Likert scale (0 = Not at all to 4 = Very much) and summed to form subscale and total scores. Higher subscale and total scores indicate better quality of life.
Measured: Baseline (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)
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 (week 0), mid-point of intervention (week 5), post-intervention (week 11), and 3 month follow-up (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start15 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kelly Hyland, Medical University of South Carolina
- Investigators
- Kelly Hyland, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177846
- Sponsor's protocol ID
- Pro00144605
- Other IDs
- R00CA286959
- Status last verified
- Jun 2026
- First submitted
- 8 Sep 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final datasets for analyses will include outcome measures and any derived variables necessary to answer the Specific Aims along with demographic characteristics. Raw data will be collected via self-report survey links from the research participants and stored in the REDCap research database. Data will be exported to SAS for data cleaning and derivation of outcome variables, as necessary. Any changes to the raw data will be corrected directly in REDCap while logging reasons for the edits. All datasets that can be shared will be deposited in the NIMH Data Archive (NDA; https://nda.nih.gov), a publicly maintained data archive whose mission is to accelerate scientific research and discovery through data sharing, data harmonization, and the reporting of research results. The NDA provides metadata, persistent identifiers, and long-term access. This repository is supported by the NIH. The PI, Dr. Hyland, will be responsible for ensuring compliance with the data management sharing plan.