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

Study acronym: BREEZE+
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2029 → Dec 31, 2030
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Record History

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  1. Primary completion pushed from Dec 31, 2029 to Dec 31, 2030 Show 8 more changesShow less
    • Recruitment opened
    • Start date: Sep 1, 2026 to Nov 1, 2026
    • Study completion pushed from Mar 31, 2030 to Jun 30, 2031
    • Study sites: 3 to 2
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (4)
    • Collaborators: 3 to 2
    • Publications: details revised at 2 of 2 entries
  2. Start date: Jan 1, 2026 to Sep 1, 2026v4
  3. Start date: Jul 1, 2025 to Jan 1, 2026v3
  4. Interventions: BREEZE+ Dyspnea Intervention (Behavioral), Enhanced Usual Care (Behavioral) to Dyspnea Intervention (Behavioral), Enhanced Usual Care (Behavioral)
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 6 words
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06791057
Lead Sponsor Massachusetts General Hospital
Collaborators: University of Miami, National Cancer Institute (NCI)
Conditions
(from sponsor)		 Advanced Lung Cancer, Dyspnea
Related terms Dyspnea, Lung Neoplasms
Enrollment 420 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov