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LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests LiveWell, a program that teaches skills to manage emotions, against usual care. It is for adults with non-small cell lung cancer that has spread and at least mild emotional distress. Researchers will see if the program is practical, is well received, and helps lower distress and improve well-being, symptoms, and quality of life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have stage IV non-small cell lung cancer, meaning it has spread to other parts of the body.
  • Are getting treatment that does not aim to cure the cancer, or are being closely watched without treatment.
  • Can use English.
  • Can understand the study and agree to take part.
  • Score at least 3 out of 10 on a distress screening test and report at least one emotional concern.

Who can't join

  • Have problems with thinking or memory.
  • Have a serious mental illness that is not being treated.
  • Are expected to live less than 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Cognitive impairment * Untreated serious mental illness * Expected survival \< 6 months

Study sites (1)

SC