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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Massachusetts General Hospital • ClinicalTrials.gov ID: NCT06791057

Registry updated: 2026-10-19
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Description

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.

Interventions

  • Dyspnea Intervention (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 (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.

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.

Conditions

Advanced Lung Cancer Dyspnea

Locations

  • University of Miami — Coral Gables, Florida, United States
  • Massachusetts General Hospital — Boston, Massachusetts, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record