Multi-site Trial of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Dyspnea Intervention
- Enhanced Usual Care
Treatment groups
420 Participants
are divided into 2 treatment groupsLocations
3University of Miami33124, Coral GablesFlorida, United States
Johns Hopkins University21224, BaltimoreMaryland, United States
Massachusetts General Hospital02114, BostonMassachusetts, United States
Sponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Johns Hopkins University
Collaborator
University of Miami
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov