LiveWell: Pilot Feasibility Trial of an Adapted Dialectical Behavioral Therapy Skills Training Protocol in Patients With Metastatic Non-Small Cell Lung Cancer.

Abstract

BACKGROUND: People living longer with metastatic non-small cell lung cancer (mNSCLC) experience heightened psychological distress and decrements in quality of life. Therefore, we developed LiveWell, an 8-session adapted dialectical behavioral therapy skills training (DBT-ST) protocol delivered one-on-one via telehealth to reduce psychological distress. AIM: To conduct a single-arm pilot trial examining the feasibility and acceptability of LiveWell and explore change in outcome variables. METHODS: Patients receiving systemic therapy for mNSCLC with at least mild distress participated. Outcomes were feasibility (accrual N = 30 in 18 months, > 80% sessions attended, < 25% attrition) and acceptability (> 80% participant satisfaction). Distress (depression and anxiety symptoms; primary outcomes), intolerance of uncertainty, emotion regulation, illness acceptance, symptoms (e.g., fatigue, dyspnea, pain), skill use, and quality of life (secondary outcomes) were assessed at baseline, post-intervention (primary endpoint), and 1-month post-intervention and examined with paired sample t-tests. RESULTS: Thirty participants (Mage = 63 years, 77% female) consented and completed the baseline assessment. LiveWell met feasibility (accrual N = 30 in 8 months, 93% sessions attended, 87% retention at post-intervention) and acceptability (96% satisfaction) benchmarks. Participants demonstrated reductions in distress (depression d = 0.35, anxiety d = 0.22) from baseline to post-treatment. Intolerance of uncertainty (d = 0.71), emotion regulation (d = 0.49), and illness acceptance (d = 0.45) improved. Fatigue and pain remained stable or improved (d's 0.07-0.38). Skill use increased (d = 0.65) and quality of life improved (d = 0.21). Improvements were maintained or enhanced at 1-month follow-up. CONCLUSIONS: LiveWell was feasible and acceptable, and participants demonstrated promising improvement in primary and secondary outcomes. Findings support a larger randomized efficacy trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04973436.

Department

Description

Provenance

Subjects

dialectical behavioral therapy, emotion regulation, metastatic non‐small cell lung cancer, psychosocial oncology, Humans, Female, Carcinoma, Non-Small-Cell Lung, Male, Pilot Projects, Feasibility Studies, Middle Aged, Lung Neoplasms, Quality of Life, Aged, Psychological Distress, Depression, Anxiety, Telemedicine, Behavior Therapy, Stress, Psychological

Citation

Published Version (Please cite this version)

10.1002/pon.70357

Publication Info

Hyland, Kelly A, Andrada D Neacsiu, Hannah M Fisher, Colleen M Cowperthwait, Natalie Chou, Thomas E Stinchcombe, Kevin C Oeffinger, Laura S Porter, et al. (2025). LiveWell: Pilot Feasibility Trial of an Adapted Dialectical Behavioral Therapy Skills Training Protocol in Patients With Metastatic Non-Small Cell Lung Cancer. Psychooncology, 34(12). p. e70357. 10.1002/pon.70357 Retrieved from https://hdl.handle.net/10161/33783.

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Scholars@Duke

Neacsiu

Andrada Delia Neacsiu

Associate Professor of Psychiatry and Behavioral Sciences

I am a clinical psychologist with a primary interest in outpatient interventions for difficulties managing emotional experiences that interfere with well-being. As a clinician, I specialize in Dialectical Behavior Therapy (DBT) and Cognitive Behavioral Therapy (CBT) for adults who report a variety of mental health problems, including personality, mood, anxiety, eating, trauma, stress-related, adjustment, and impulse control disorders. My approach to psychotherapy includes working collaboratively with my patients to identify their unique life and therapy goals and implementing evidence-based interventions to achieve the identified goals. As an educator, I train clinicians nationally and teach graduate students, psychology and psychiatry residents in in how to effectively apply CBT and DBT in their clinical work. As a researcher, I focus on psychotherapy optimization and neuroscience-informed treatment development for emotion dysregulation. My research keeps me up to date with the latest evidence-based approaches to use in my clinical work, and my work with patients strongly influences the research that I do.  Outside of work, I enjoy traveling, gourmet food, nature adventures, and time with friends with family.

Fisher

Hannah Fisher

Assistant Professor of Psychiatry and Behavioral Sciences

Hannah Fisher, PhD is a Clinical Psychologist and Assistant Professor in the Department of Psychiatry and Behavioral Sciences at the Duke University School of Medicine. Dr. Fisher is a member of the Duke Pain Prevention and Treatment Research Program and the Duke Cancer Prevention and Control Program at the Duke Cancer Institute. Dr. Fisher completed her graduate training in clinical health psychology at the University of Miami and her clinical internship and postdoctoral fellowship at Duke University Medical Center. Her research focuses on developing, testing, and implementing behavioral sleep and symptom management interventions for patients with cancer.

Cowperthwait

Colleen M Cowperthwait

Assistant Professor of Psychiatry and Behavioral Sciences
Oeffinger

Kevin Charles Oeffinger

Professor of Medicine

Kevin Oeffinger, MD, is a family physician, Professor in the Department of Medicine, and a member of the Duke Cancer Institute (DCI). He is founding Director of the DCI Center for Onco-Primary Care, and Co-Director of the DCI Supportive Care and Survivorship Center. He has a long-standing track record of NIH-supported research in cancer screening, early cancer detection, and survivorship. He has published in high impact journals, including the New England Journal of Medicine, Lancet, and JAMA. Dr. Oeffinger is the Duke PI for Pathfinder-2, a multicenter study supported by Grail that is evaluating the utility of Galleri, a multi-cancer early detection blood test (MCED).

Dr. Oeffinger has served in a leadership capacity in various cancer-focused and primary care-focused national committees and organizations, including the American Society of Clinical Oncology, the American Cancer Society, and the American Academy of Family Physicians. He is a past Associate Editor for the Journal of the National Cancer Institute. He is also a member of the Executive Committee for the long-standing NCI-supported Childhood Cancer Survivor Study.

The three-fold mission of the DCI Center for Onco-Primary Care are are to: (1) deliver evidence-based, patient-centered, personalized health care across the cancer continuum by enhancing the interface between cancer specialists and primary care clinicians; (2) conduct innovative research with cutting-edge technology that can be translated to the community setting; and (3) train and educate the next generation of clinicians and researchers to extend this mission. 

Porter

Laura S Porter

Professor in Psychiatry and Behavioral Sciences

My research focuses on developing and evaluating behavioral interventions to help patients and their family members cope with the symptoms and psychological demands associated with chronic and life-limiting illness.

Keefe

Francis Joseph Keefe

Professor in Psychiatry and Behavioral Sciences

I am Director of the Duke Pain Prevention and Treatment Research Program, an active NIH funded clinical research program focused on developing new and more effective ways of assessing and treating patients having acute and persistent pain.  I have been active in nationally and internationally in shaping the pain research agenda.  For the past 10 years I served as Editor in Chief of PAIN the premier journal in pain research.  I also have served as the Chair of a number of NIH Study Sections.   Finally, I was a member of the Institute of Medicine committee that published a report in 2011 (Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research) that has played a key role in shaping national policies in pain research and pain care.

Over my career, I have played a key role in the development of clinical pain services and pain research programs at Duke Medical Center.  For over 20 years, I directed the Duke Pain Management Program and was a leader in the development of Duke Medical Center's multidisciplinary pain programs (both out-patient and in-patient.)  I collaborate actively with investigators in other countries (e.g. United Kingdom, South Africa, China, and Australia). 

Over the course of my career, I have collaborated closely with investigators both in and outside my lab.  Together we have developed and refined a number of treatment protocols for persistent pain conditions (e.g. pain in patients with advanced cancer; sickle cell disease, and persistent joint pain due to osteo- and rheumatoid arthritis) including partner and caregiver-assisted pain coping skills training interventions.  We have conducted a number of NIH- and foundation- funded randomized clinical trials testing the efficacy of these and other behavioral interventions (e.g. aerobic exercise protocols, yoga based interventions, mindfulness-based interventions, forgiveness-based interventions, loving kindness meditation, and emotional disclosure). 

I currently serve as a Co-Investigator on a number of NIH grants, a number of which are funded by the HEAL Initiative.  Many of these grants are testing novel strategies for delivering training in pain coping skills (e.g. video over internet, web-based training, virtual reality interventions, and apps for mobile devices).  Along these lines, I collaborated with Dr. Chris Rini to develop an internet-based program for training in pain coping skills called painTRAINER (available at mypaintrainer.org). This program is free to any individuals or health professionals who wish to use it.  I have a keen interest in exploring the efficacy of these and other strategies (e.g. training physical therapists, social workers, and nurses) promise to increase access to behavioral pain management interventions making them more widely available to the large population of patients and caregivers who might benefit from them.

I have published over 490 papers on topics ranging from pain coping strategies used during mammography to behavioral approaches to managing acute pain and pain at end of life.  I have a longstanding interest in mentoring students and early career professionals interested in developing, testing, and disseminating novel protocols for managing pain, stress, and medical symptoms.

 

Somers

Tamara J. Somers

Professor in Psychiatry and Behavioral Sciences

Tamara J. Somers, PhD, is a Clinical Psychologist and Faculty Member in the Department of Psychiatry and Behavioral Sciences. Dr. Somers conducts research developing, testing, and implementing behavioral interventions for pain and other symptoms in patients with chronic disease (e.g., cancer, arthritis). She is particularly interested in developing behavioral interventions that are personalized to the needs of individual patients and using innovative delivery methods to deliver the interventions. Grant awards from the NIH, American Cancer Society, and other funding agencies support her research. Dr. Somers also co-directs a clinical psychology training program at the Duke Cancer Institute (DCI) that trains graduate students, clinical psychology interns, and post-doctoral fellows in psychosocial and behavioral symptom management interventions. 


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