DBT Skills Training for Lung Cancer

Overseen By Tamara Somers, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Cognitive impairment, Untreated serious mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on psychological skills training, so it's unlikely to require changes to your medication, but you should confirm with the trial coordinators.

What data supports the effectiveness of the treatment LiveWell: Adapted DBT Skills Training for lung cancer?

Research shows that behavioral therapies, like Cognitive Behavioral Therapy (CBT), can help improve anxiety, depression, and quality of life in lung cancer patients. This suggests that similar approaches, such as DBT (Dialectical Behavior Therapy), might also be beneficial in managing symptoms and enhancing quality of life for those with lung cancer. ^{1 2 3 4 5}

Is DBT Skills Training safe for humans?

The available research does not specifically address the safety of DBT Skills Training for lung cancer, but behavioral interventions, in general, are considered safe and are often used to improve symptoms and quality of life in cancer patients. ^{1 3 6 7 8}

How is the LiveWell: Adapted DBT Skills Training treatment different from other treatments for lung cancer?

LiveWell: Adapted DBT Skills Training is unique because it focuses on teaching skills to manage emotions and behaviors, which can improve quality of life for lung cancer patients. Unlike traditional treatments that target the cancer itself, this approach helps patients cope with the psychological and emotional challenges of living with cancer. ^{1 2 5 9 10}

What is the purpose of this trial?

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.

Research Team

Tamara Somers

Principal Investigator

Professor in Psychiatry and Behavioral Sciences

Eligibility Criteria

This trial is for adults over 18 with stage IV non-small cell lung cancer, currently undergoing treatment without the aim of cure. Participants must experience distress levels of at least 3 out of 10 and be able to understand and communicate in English.

Inclusion Criteria

I am older than 18 years.

I have been diagnosed with stage IV non-small cell lung cancer.

I am receiving treatment for lung cancer that is not aimed at curing it.

Exclusion Criteria

Presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist

Reported or suspected cognitive impairment

Expected survival <6 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Refinement

Iterative refinement of the LiveWell protocol using qualitative exit interview data, advisory board input, and user testing

1 year

Treatment

Participants receive the LiveWell intervention, an 8-session Dialectical Behavioral Therapy Skills Training protocol delivered via videoconference

8 weeks

8 sessions (virtual)

Follow-up

Participants are monitored for changes in quality of life, psychological distress, and symptom burden

3 months

Treatment Details

Interventions

• LiveWell: Adapted DBT Skills Training

Trial Overview The LiveWell program, an adapted form of Dialectical Behavioral Therapy Skills Training delivered via videoconference, is being tested against Enhanced Usual Care to see if it improves quality of life and reduces psychological distress and physical symptoms in metastatic lung cancer patients.

Participant Groups

Group I: LiveWell: Adapted Dialectical Behavioral Therapy Skills Training Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A systematic review of 27 studies on rehabilitation interventions for lung cancer and mesothelioma patients revealed that while many behavior change techniques (BCTs) were used, their application was not optimal, with only a few studies explicitly employing behavioral change theory.

The most commonly used BCTs focused on enabling behaviors, such as providing instructions and action planning, while techniques aimed at addressing barriers were less frequently utilized, suggesting that improving the use of BCTs could enhance participation and effectiveness of rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing health behaviour with rehabilitation in thoracic cancer: A systematic review and synthesis. Bayly, J., Wakefield, D., Hepgul, N., et al.[2022]

Cognitive behavior therapy (CBT) significantly reduced anxiety and depression symptoms in pre-diagnosed lung cancer patients, with average decreases of 8.38 points in anxiety and 6.75 points in depression on standardized scales after 6 sessions.

Patients receiving CBT also reported a notable improvement in their quality of life, with an average increase of 16.80 points on the WHOQOL-BREF scale, compared to those who did not receive the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Cognitive Behavioral Therapy on Improving Anxiety, Depression, and Quality of Life in Pre-Diagnosed Lung Cancer Patients. Sutanto, YS., Ibrahim, D., Septiawan, D., et al.[2022]

Behavioral interventions, such as breathing exercises that focus on diaphragm use and altering breathing rhythms, can significantly help lung cancer patients manage feelings of breathlessness and improve their quality of life.

Oncology professionals should incorporate these psychosocially oriented strategies alongside medical treatments to effectively address the debilitating symptom of breathlessness in lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral interventions for lung cancer-related breathlessness. Gallo-Silver, L., Pollack, B.[2019]

Cognitive Behaviour Therapy (CBT) has proven effective for various psychological disorders, and there is increasing interest in its application for cancer patients, although it has not been extensively tested in this population.

This paper outlines a structured 12-session CBT program specifically designed for cancer patient groups, addressing the need for tailored interventions in psycho-oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description of a group Cognitive Behaviour Therapy programme with cancer patients. Edelman, S., Kidman, AD.[2018]

Behavioral interventions, when combined with medical treatment for lung cancer, can significantly alleviate symptoms such as nausea, vomiting, pain, and anxiety, thereby improving patients' quality of life.

These mind/body approaches not only reduce emotional distress but also enhance coping mechanisms, promote a sense of control, and foster hopefulness among patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial issues and lung cancer: a behavioral approach. Ryan, LS.[2019]

The Breathe Easier trial aims to improve physical and emotional health in survivors of localized non-small-cell lung cancer (NSCLC) and their supportive partners through a 12-week, home-based intervention focusing on physical activity, smoking reduction, and stress management.

This pilot study will involve 30 dyads (60 participants) and assess the feasibility and preliminary effects of the intervention, which includes educational content, breathing exercises, goal setting, and support from trained staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study Protocol for the Breathe Easier Trial: A Pilot RCT of a Dyad-Based, Multiple-Behavior Intervention for Improving Physical and Emotional Health in Survivors Facing Lung Cancer. McDonnell, KK., Andrews, JO., Yang, CH., et al.[2023]

In a study of depressed cancer patients undergoing a brief 9-session behavioral activation therapy, 50% experienced significant sudden gains, averaging an improvement of 11.8 points on the BDI-II depression scale, which correlated with better treatment outcomes and sustained benefits at a 3-month follow-up.

Patients who experienced sudden gains tended to have less severe depression and anxiety, better physical functioning, and fewer daily activity problems, suggesting that certain baseline characteristics may influence the likelihood of achieving these gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sudden gains in depressed cancer patients treated with behavioral activation therapy. Hopko, DR., Robertson, SM., Carvalho, JP.[2009]

The telephone-delivered behavioral intervention for breast cancer survivors was implemented with high fidelity, achieving a global quality rating of 4.6, indicating effective delivery of the program.

Participants in the behavioral intervention reported significantly greater benefits in areas such as goal setting, adjusting habits, and increasing exercise compared to those in the attention control group, suggesting the intervention's efficacy in improving social role satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Process Evaluation of Intervention Delivery for a Cancer Survivorship Rehabilitation Clinical Trial Conducted during the COVID-19 Pandemic. Stevens, CJ., Wechsler, S., Ejem, DB., et al.[2023]

The study assessed a self-regulation theory (SRT)-based intervention for 45 adults with advanced lung cancer undergoing chemotherapy, achieving a participation rate of 79% and a retention rate of 62%.

While the intervention was delivered with high fidelity and was well-accepted by participants, the feasibility findings suggest that it may not be suitable for replication in this population due to participant loss primarily from disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Delivered Symptom Assessment for Individuals With Advanced Lung Cancer. Flannery, M., Stein, KF., Dougherty, DW., et al.[2023]

In a study of 604 lung cancer survivors, 60% reported using psychosocial services, with higher usage (69%) among those who received radiation therapy, indicating a significant interest in psychological and social support among these patients.

Factors influencing the use of psychosocial services included being female, having poor emotional functioning, and being younger, highlighting the need for targeted outreach to ensure these services are accessible to those who may benefit most.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of psychosocial services by lung cancer survivors in Germany : Results of a German multicenter study (LARIS). Eichler, M., Hechtner, M., Wehler, B., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Changing health behaviour with rehabilitation in thoracic cancer: A systematic review and synthesis. [2022]

2. Thailand pubmed.ncbi.nlm.nih.gov

Effect of Cognitive Behavioral Therapy on Improving Anxiety, Depression, and Quality of Life in Pre-Diagnosed Lung Cancer Patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Behavioral interventions for lung cancer-related breathlessness. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Description of a group Cognitive Behaviour Therapy programme with cancer patients. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Psychosocial issues and lung cancer: a behavioral approach. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Study Protocol for the Breathe Easier Trial: A Pilot RCT of a Dyad-Based, Multiple-Behavior Intervention for Improving Physical and Emotional Health in Survivors Facing Lung Cancer. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Sudden gains in depressed cancer patients treated with behavioral activation therapy. [2009]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Process Evaluation of Intervention Delivery for a Cancer Survivorship Rehabilitation Clinical Trial Conducted during the COVID-19 Pandemic. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Nurse-Delivered Symptom Assessment for Individuals With Advanced Lung Cancer. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Use of psychosocial services by lung cancer survivors in Germany : Results of a German multicenter study (LARIS). [2020]