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Dialectical Behavioral Therapy for Lung Cancer (LiveWell Trial)

N/A
Waitlist Available
Led By Tamara Somers, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing systemic treatment (chemotherapy, targeted therapy, and/or immunotherapy) for lung cancer at Duke Cancer Institute
Diagnosed with metastatic (AJCC stage IV) non-small cell lung cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12)
Awards & highlights

LiveWell Trial Summary

This trial is testing whether an adapted form of dialectical behavioral therapy, which teaches patients skills to cope with emotional and physical symptoms, can help reduce psychological distress in metastatic lung cancer patients.

Who is the study for?
This trial is for adults over 18 with stage IV non-small cell lung cancer, currently undergoing treatment at Duke Cancer Institute. They must score above 3 on a distress scale and be able to understand English. Those with cognitive impairment, untreated serious mental illness, or an expected survival of less than 4 months cannot join.Check my eligibility
What is being tested?
The study tests Dialectical Behavioral Therapy (DBT) skills training adapted for metastatic lung cancer patients to manage psychological distress. It involves focus groups and interviews in Phase I, followed by pilot testing the LiveWell program through sessions that can be attended in-person or via video call.See study design
What are the potential side effects?
Since DBT is a form of psychotherapy focusing on coping skills training rather than medication, it typically does not have physical side effects. However, participants may experience emotional discomfort as they work through personal issues during therapy.

LiveWell Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
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I am receiving treatment for lung cancer at Duke Cancer Institute.
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I have been diagnosed with stage IV non-small cell lung cancer.
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I am older than 18 years.

LiveWell Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention, one month post-intervention (approximately week 0, week 18, week 12) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability as measured by client satisfaction ratings
Change in psychological distress
Feasibility as measured by study accrual
+2 more
Secondary outcome measures
Behavior Therapy
Change in dyspnea
Change in emotion regulation
+3 more

LiveWell Trial Design

1Treatment groups
Experimental Treatment
Group I: LiveWell: A Dialectical Behavioral Therapy Skills Training ProtocolExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,351 Previous Clinical Trials
3,409,483 Total Patients Enrolled
Tamara Somers, PhDPrincipal InvestigatorDuke University

Media Library

Dialectical Behavioral Therapy Skills Training Clinical Trial Eligibility Overview. Trial Name: NCT04973436 β€” N/A
Lung Cancer Research Study Groups: LiveWell: A Dialectical Behavioral Therapy Skills Training Protocol
Lung Cancer Clinical Trial 2023: Dialectical Behavioral Therapy Skills Training Highlights & Side Effects. Trial Name: NCT04973436 β€” N/A
Dialectical Behavioral Therapy Skills Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04973436 β€” N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been recruited for this trial thus far?

"Affirmative, the clinicaltrials.gov data confirms that this trial is still welcoming applicants and was initially posted on May 18th 2022. This study has a need for 70 patients from 1 sites, with its information recently updated on June 14th 2022."

Answered by AI

Are there still available openings for participants in this experiment?

"Correct. According to clinicaltrials.gov, recruitment is still ongoing for this trial which was initially posted on May 18th 2022 and latest updated June 14th 2022; 70 individuals are required from one location."

Answered by AI

What outcome is this clinical experiment aiming to demonstrate?

"The goal of this investigation, which will be analysed over a 12 week period post-intervention is to assess its feasibility. Secondary objectives include an evaluation of emotional regulation via the Difficulties in Emotion Regulation Scale (DERS-18), fatigue using the Fatigue Symptom Inventory (FSI) and breathlessness with the Modified Medical Research Council Dyspnea Scale (MMRCDS)."

Answered by AI
~22 spots leftby Mar 2025