Multi-site Trial of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
BREEZE+
2 other identifiers
interventional
420
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2025
CompletedFirst Posted
Study publicly available on registry
January 24, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2030
September 24, 2025
September 1, 2025
4 years
January 18, 2025
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient-reported Dyspnea
To compare patient-reported dyspnea between study groups at 8 weeks using the Modified Medical Research Council Dyspnea Scale, which is a one-item self-report scale to evaluate the degree of a patient's dyspnea (score range: 0-4), with a higher score indicating worse dyspnea.
8 weeks
Secondary Outcomes (4)
Patient-reported Dyspnea-related Anxiety and Discomfort
8 weeks
Patient-reported Physical Function
8 weeks
Patient-reported Quality of Life
8 weeks
Patient-reported Coping with Dyspnea
8 Weeks
Other Outcomes (5)
Patient-reported Dyspnea
Up to 24 weeks
Patient-reported Dyspnea-related Anxiety and Discomfort
Up to 24 weeks
Patient-reported Physical Function
Up to 24 weeks
- +2 more other outcomes
Study Arms (2)
Dyspnea Intervention
EXPERIMENTALPatients 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.
Enhanced Usual Care
ACTIVE COMPARATORPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Johns Hopkins Universitycollaborator
- University of Miamicollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (3)
University of Miami
Coral Gables, Florida, 33124, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (2)
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.
PMID: 26166181BACKGROUNDGreer 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.
PMID: 39088766BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- co-Prinipal Investigator
Study Record Dates
First Submitted
January 18, 2025
First Posted
January 24, 2025
Study Start
January 1, 2026
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
March 31, 2030
Last Updated
September 24, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The data will be submitted to a publicly available database within three months of study completion and maintained in perpetuity.
- Access Criteria
- Most of the scientific data generated in this study, including the self-report and electronic health record data, will be made publicly available through the Harvard Dataverse. However, certain sociodemographic information and any other variables that are considered Protected Health Information and potentially identifying the patient participants (e.g., dates of birth and death) will be restricted. Restricted data would only be made available to users who demonstrate a valid research need and meet conditions of use. In accordance with the data repository methods, we will require the completion of a data use agreement form that stipulates data sharing under IRB-approved protocols.
The total scale, subscale scores, and item-level scores from the self-report measures, sociodemographic information, and electronic health record data will be preserved and stored within a secure computing environment. All participant identifiers will be removed and maintained in a separate secure file that will not be shared to protect confidentiality.