Recruiting

BREEZE+

Sponsor:

Massachusetts General Hospital

Code:

NCT06791057

Conditions

Advanced Lung Cancer

Dyspnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dyspnea Intervention

Enhanced Usual Care

Study Details

Brief 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.

Conditions

Advanced Lung Cancer

Dyspnea

Study ID

NCT06791057

Start date

Nov 1, 2026

Status verified date

Oct, 2026

Completion date

Jun 30, 2031

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Dyspnea Intervention

Patients will receive three nurse-delivered sessions that focus on: (1) psychoeducation about the relationship between dyspnea and the physiologic stress response, (2) behavioral techniques for managing acute episodes of breathlessness (i.e., pursed-lip breathing, postural positions, and fan therapy), and (3) skills for reducing physiologic stress and strengthening lung capacity (e.g., slow diaphragmatic breathing; mindful breathing). Patients will also receive a digital health app downloaded to their mobile phone to reinforce daily practice of the dyspnea management skills. Patients may receive any usual care for their dyspnea as deemed appropriate by their clinicians.

active comparator: Enhanced Usual Care

Patients will receive printed or electronic handouts regarding the common symptoms and side effects of lung cancer, including dyspnea, and recommendations for management from the American Cancer Society, with a link to their website of patient-education materials. Patients may receive any usual care for their dyspnea as deemed appropriate by their clinicians.

Interventions

Dyspnea Intervention

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

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.

Primary outcome measure

  • Patient-reported Dyspnea [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Jennifer S. Temel, MD

617-724-4000jtemel@mgh.harvard.edu

Joseph A. Greer, PhD

617-724-4000jgreer2@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jennifer S. Temel, MD

617-724-4000jtemel@mgh.harvard.edu

Joseph A. Greer, PhD

617-643-2143jgreer2@mgh.harvard.edu

Principal Investigator:

Jennifer S. Temel, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Keywords

  • Dyspnea
  • Breathlessness
  • Lung Cancer
  • Behavioral Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.