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Recruiting
NCT06791057
Multi-site Trial of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
Conditions: Advanced Lung Cancer, Dyspnea
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 420
Sponsor: Massachusetts General Hospital
Location: University of Miami Coral Gables Florida
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.
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.
Source: ClinicalTrials.gov (NCT06791057). StuddyBuddy aggregates publicly available trial information.