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

Conditions

• Advanced Lung Cancer
• Dyspnea

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Jan 1, 2026

Status verified

Sep 2025

Primary completion

Dec 31, 2029

Completion

Mar 31, 2030

Study Design

Enrollment

420 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

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.

Primary Outcome Measure

Patient-reported Dyspnea [ Time Frame: 8 weeks ]

Central Contacts

• Jennifer S. Temel, MD
  617-724-4000
  [email protected]
• Joseph A. Greer, PhD
  617-724-4000
  [email protected]

Locations (3)

Find similar trials in Coral Gables, FL

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