Multi-site Trial of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

NCT ID: NCT06791057

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2030-03-31

Brief Summary

Dyspnea, or breathlessness, is one of the most common and distressing symptoms experienced by patients with advanced lung cancer. The purpose of this multi-site trial is to test the effectiveness of a dyspnea intervention (called BREEZE+) that includes three brief nurse-delivered sessions and access to a digital health app that teaches and reinforces patients' use of skills for managing and coping with this highly debilitating symptom. This study will lay the groundwork for a follow-up pragmatic implementation trial integrating BREEZE+ into usual oncology care for patients with advanced lung cancer experiencing dyspnea.

Detailed Description

The goal of this study is to improve dyspnea, one of the most common and debilitating symptoms experienced by patients with advanced lung cancer. Despite improvements in survival from novel targeted therapy and immunotherapy for patients with advanced lung cancer, the proportion of patients experiencing dyspnea (i.e., difficulty breathing) has not decreased. In fact, recent data show that the prevalence of dyspnea is now over 70%, higher than estimates reported in older cohorts. Although cancer burden, such as extensive disease in the lung or pleural effusions, certainly causes and exacerbates symptoms of breathlessness, psychological factors also underlie the experience of dyspnea. Patient-reported dyspnea is associated with impaired quality of life, decreased functioning at home and work, withdrawal from social activities, heightened symptoms of anxiety and depression, and even a desire for hastened death. Moreover, dyspnea leads to unscheduled visits to oncology clinics and the emergency department, often resulting in hospitalization. Recognizing the notable impact of breathlessness on patient functioning and health care utilization, the Quality Oncology Practice Initiative for the American Society of Clinical Oncology identified the assessment and management of dyspnea as a key measure of quality cancer care. Unfortunately, data are limited to support efficacious treatments for dyspnea. While clinicians commonly prescribe opioids to treat breathlessness, recent systematic reviews concluded that pharmacologic management did not improve dyspnea and carried potential harm. In a recent Agency for Healthcare Research and Quality Comparative Effectiveness Review of non-pharmacological interventions for dyspnea, the authors reported that behavioral and multicomponent interventions involving physical activity or rehabilitation hold the greatest promise for addressing dyspnea, despite having low strength of evidence to date. Therefore, comprehensive approaches to care incorporating behavioral interventions for dyspnea are greatly needed, given the degree of patient suffering and the lack of evidence-based protocols. To address this evidence gap, the investigators developed a brief, two-session behavioral intervention for dyspnea management in patients with advanced lung cancer called, "BREEZE." To ensure the potential for broad dissemination of BREEZE, the investigators purposefully limited the number of sessions, trained oncology nurses to serve as interventionists, and successfully transitioned to fully remote delivery during the pandemic. The investigators completed a single-center randomized controlled efficacy trial of BREEZE versus usual care in patients with advanced lung cancer and self-reported dyspnea. Patients assigned to BREEZE reported significant improvements in the primary outcome of self-reported dyspnea and functional wellbeing at week eight. However, intervention effects were not sustained by the six-month follow-up time point. The investigators now propose to build upon these encouraging findings by conducting a multi-site trial of BREEZE in a diverse patient population. Moreover, the investigators have enhanced the intervention by adding a nurse-led booster session and integrating the dyspnea management components from a digital health app that their team developed for patients with advanced lung cancer, to reinforce BREEZE's evidence-based skills and to sustain intervention effects while preserving the "low-touch" for dissemination. The investigators propose to conduct a multi-site type I hybrid effectiveness-implementation trial of BREEZE plus the booster and digital health app (i.e., BREEZE+) versus an enhanced usual care control (entailing educational resources on dyspnea management) in 420 patients with advanced lung cancer reporting dyspnea. Massachusetts General Hospital, Johns Hopkins University, and the University of Miami will serve as study sites. The nurse-led sessions and digital health app components will be available in Spanish and English to enable the recruitment of a diverse sample, and the investigators will centralize intervention delivery to facilitate implementation. Data from this study will ultimately serve as the basis for a follow-up large-scale, multi-site dissemination trial of BREEZE+.

Conditions

Advanced Lung Cancer; Dyspnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Dyspnea Intervention

Patients will receive three nurse-delivered sessions that focus on: (1) psychoeducation about the relationship between dyspnea and the physiologic stress response, (2) behavioral techniques for managing acute episodes of breathlessness (i.e., pursed-lip breathing, postural positions, and fan therapy), and (3) skills for reducing physiologic stress and strengthening lung capacity (e.g., slow diaphragmatic breathing; mindful breathing). Patients will also receive a digital health app downloaded to their mobile phone to reinforce daily practice of the dyspnea management skills. Patients may receive any usual care for their dyspnea as deemed appropriate by their clinicians.

Group Type: EXPERIMENTAL

Dyspnea Intervention

Intervention Type: BEHAVIORAL

Brief behavioral intervention for dyspnea management that includes three nurse-led sessions focused on psychoeducation, behavioral techniques for managing acute breathlessness, and relaxation training for reducing physiological stress as well as a digital health app to reinforce practice of breathing skills.

Enhanced Usual Care

Patients will receive printed or electronic handouts regarding the common symptoms and side effects of lung cancer, including dyspnea, and recommendations for management from the American Cancer Society, with a link to their website of patient-education materials. Patients may receive any usual care for their dyspnea as deemed appropriate by their clinicians.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: BEHAVIORAL

Patients will receive educational materials on the management of symptoms of lung cancer and its treatment as well as any usual care for dyspnea deemed appropriate by the clinical team.

Interventions

Dyspnea Intervention

Brief behavioral intervention for dyspnea management that includes three nurse-led sessions focused on psychoeducation, behavioral techniques for managing acute breathlessness, and relaxation training for reducing physiological stress as well as a digital health app to reinforce practice of breathing skills.

Intervention Type: BEHAVIORAL

Enhanced Usual Care

Patients will receive educational materials on the management of symptoms of lung cancer and its treatment as well as any usual care for dyspnea deemed appropriate by the clinical team.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• Diagnosis of advanced lung cancer (i.e., non-small cell lung cancer or small cell lung cancer) or mesothelioma, not being treated with curative intent
• Self-report at least moderate dyspnea per a rating ≥4 on the validated 0-10 breathlessness item of the Edmonton Symptom Assessment Scale-Revised
• Functioning independently per an Eastern Cooperative Oncology Group Performance Status ≤2
• Ability to read and respond to questions in English or Spanish
• Receiving primary cancer care at one of the participating institutions

Exclusion Criteria

• Significant uncontrolled psychiatric disorder or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the patient's ability to participate in study procedures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Temel, MD

co-Prinipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Miami

Coral Gables, Florida, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Jennifer S. Temel, MD

Role: CONTACT

jtemel@mgh.harvard.edu

617-724-4000

Joseph A. Greer, PhD

Role: CONTACT

jgreer2@mgh.harvard.edu

617-724-4000

Facility Contacts

Lara Traeger, PhD

Role: primary

ltraeger@miami.edu

305-284-3012

Josephine (Joy) Feliciano, MD

Role: primary

jfelici4@jhmi.edu

410-550-1711

Jennifer S. Temel, MD

Role: primary

jtemel@mgh.harvard.edu

617-724-4000

Joseph A. Greer, PhD

Role: backup

jgreer2@mgh.harvard.edu

617-724-4000

References

Greer JA, MacDonald JJ, Vaughn J, Viscosi E, Traeger L, McDonnell T, Pirl WF, Temel JS. Pilot Study of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer. J Pain Symptom Manage. 2015 Dec;50(6):854-60. doi: 10.1016/j.jpainsymman.2015.06.010. Epub 2015 Jul 10.

Reference Type: BACKGROUND

PMID: 26166181 (View on PubMed)

Greer JA, Post KE, Chabria R, Aribindi S, Brennan N, Eche-Ugwu IJ, Halpenny B, Fox E, Lo S, Waldman LP, Pintro K, Rabideau DJ, Pirl WF, Cooley ME, Temel JS. Randomized Controlled Trial of a Nurse-Led Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer. J Clin Oncol. 2024 Oct 20;42(30):3570-3580. doi: 10.1200/JCO.24.00048. Epub 2024 Aug 1.

Reference Type: BACKGROUND

PMID: 39088766 (View on PubMed)

Other Identifiers

R01CA292902

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24-657

Identifier Type: -

Identifier Source: org_study_id