A brief nurse-delivered program plus a digital app to help with breathlessness in advanced lung cancer
Official title: Multi-site Trial of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
Run by Massachusetts General Hospital · NCT06791057 · Data updated 2026-11-12
This trial tests whether a short, nurse-led program plus a digital app can help reduce breathlessness in adults with advanced lung cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 420 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Coral Gables, Florida and 1 other locations) |
| Status | Recruiting |
| Started | November 4, 2026 |
| Main results expected | December 31, 2030 |
| Study ends | June 30, 2031 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT06791057 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults ≥18 years with advanced lung cancer (NSCLC, SCLC, or mesothelioma) experiencing at least moderate dyspnea (ESAS-R breathlessness ≥4), ECOG 0-2, and able to participate in English or Spanish at the participating centers.
✕Probably not a fit
Patients with uncontrolled psychiatric illness or other conditions that preclude participation may not benefit or be excluded from the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi-site interventional study will test the BREEZE+ dyspnea intervention, consisting of three brief nurse-delivered sessions and access to a supportive digital health app, in adults with advanced lung cancer experiencing moderate to severe breathlessness. The goal is to determine if this approach improves dyspnea and related quality of life compared with enhanced usual care, and to lay the groundwork for integrating the program into standard oncology care. Participants must have advanced lung cancer, be 18 or older, and report at least moderate breathlessness, with preserved functional status (ECOG 0-2) and ability to read English or Spanish. The study is led by Massachusetts General Hospital with collaboration from the University of Miami and the National Cancer Institute, and will enroll participants at both sites. The intervention addresses psychological as well as physiological contributors to dyspnea and aims to reduce health care utilization related to breathlessness.
Why it matters
Potential benefit: If successful, patients may experience less breathlessness and improved quality of life, with potential reductions in urgent clinic or ED visits.
How similar studies have gone: Previous dyspnea-management efforts in cancer care show promise, but this trial applies a brief nurse-led approach plus digital tools in a multi-site oncology setting, representing a pragmatic advancement.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
University of Miami
Coral Gables, Florida, United States Not yet recruiting
Study contacts
- Study coordinator: Jennifer S. Temel, MD
- Email: jtemel@mgh.harvard.edu
- Phone: 617-724-4000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.