Clinical trial NCT06791057: Multi-site Trial of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
Official title: Multi-site Trial of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Advanced Lung Cancer
Dyspnea
Keywords: Dyspnea
Breathlessness
Lung Cancer
Behavioral Intervention
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: University of Miami
name: National Cancer Institute (NCI)
First posted: 2025-01-24
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The goal of this study is to improve dyspnea, one of the most common and debilitating symptoms experienced by patients with advanced lung cancer. Despite improvements in survival from novel targeted therapy and immunotherapy for patients with advanced lung cancer, the proportion of patients experiencing dyspnea (i.e., difficulty breathing) has not decreased. In fact, recent data show that the prevalence of dyspnea is now over 70%, higher than estimates reported in older cohorts. Although cancer burden, such as extensive disease in the lung or pleural effusions, certainly causes and exacerbates symptoms of breathlessness, psychological factors also underlie the experience of dyspnea. Patient-reported dyspnea is associated with impaired quality of life, decreased functioning at home and work, withdrawal from social activities, heightened symptoms of anxiety and depression, and even a desire for hastened death. Moreover, dyspnea leads to unscheduled visits to oncology clinics and the emergency department, often resulting in hospitalization. Recognizing the notable impact of breathlessness on patient functioning and health care utilization, the Quality Oncology Practice Initiative for the American Society of Clinical Oncology identified the assessment and management of dyspnea as a key measure of quality cancer care. Unfortunately, data are limited to support efficacious treatments for dyspnea. While clinicians commonly prescribe opioids to treat breathlessness, recent systematic reviews concluded that pharmacologic management did not improve dyspnea and carried potential harm. In a recent Agency for Healthcare Research and Quality Comparative Effectiveness Review of non-pharmacological interventions for dyspnea, the authors reported that behavioral and multicomponent interventions involving physical activity or rehabilitation hold the greatest promise for addressing dyspnea, despite having low strength of evidence to date. Therefore, comprehensive approaches to care incorporating behavioral interventions for dyspnea are greatly needed, given the degree of patient suffering and the lack of evidence-based protocols. To address this evidence gap, the investigators developed a brief, two-session behavioral intervention for dyspnea management in patients with advanced lung cancer called, "BREEZE." To ensure the potential for broad dissemination of BREEZE, the investigators purposefully limited the number of sessions, trained oncology nurses to serve as interventionists, and successfully transitioned to fully remote delivery during the pandemic. The investigators completed a single-center randomized controlled efficacy trial of BREEZE versus usual care in patients with advanced lung cancer and self-reported dyspnea. Patients assigned to BREEZE reported significant improvements in the primary outcome of self-reported dyspnea and functional wellbeing at week eight. However, intervention effects were not sustained by the six-month follow-up time point. The investigators now propose to build upon these encouraging findings by conducting a multi-site trial of BREEZE in a diverse patient population. Moreover, the investigators have enhanced the intervention by adding a nurse-led booster session and integrating the dyspnea management components from a digital health app that their team developed for patients with advanced lung cancer, to reinforce BREEZE's evidence-based skills and to sustain intervention effects while preserving the "low-touch" for dissemination. The investigators propose to conduct a multi-site type I hybrid effectiveness-implementation trial of BREEZE plus the booster and digital health app (i.e., BREEZE+) versus an enhanced usual care control (entailing educational resources on dyspnea management) in 420 patients with advanced lung cancer reporting dyspnea. Massachusetts General Hospital, Johns Hopkins University, and the University of Miami will serve as study sites. The nurse-led sessions and digital health app components will be available in Spanish and English to enable the recruitment of a diverse sample, and the investigators will centralize intervention delivery to facilitate implementation. Data from this study will ultimately serve as the basis for a follow-up large-scale, multi-site dissemination trial of BREEZE+.

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.

Primary outcomes:
measure: Patient-reported Dyspnea
timeFrame: 8 weeks
Secondary outcomes:
measure: Patient-reported Dyspnea-related Anxiety and Discomfort
timeFrame: 8 weeks
measure: Patient-reported Physical Function
timeFrame: 8 weeks
measure: Patient-reported Quality of Life
timeFrame: 8 weeks
measure: Patient-reported Coping with Dyspnea
timeFrame: 8 Weeks
Other outcomes:
measure: Patient-reported Dyspnea
timeFrame: Up to 24 weeks
measure: Patient-reported Dyspnea-related Anxiety and Discomfort
timeFrame: Up to 24 weeks
measure: Patient-reported Physical Function
timeFrame: Up to 24 weeks
measure: Patient-reported Quality of Life
timeFrame: Up to 24 weeks
measure: Patient-reported Coping with Dyspnea
timeFrame: Up to 24 weeks
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: Greer JA, MacDonald JJ, Vaughn J, Viscosi E, Traeger L, McDonnell T, Pirl WF, Temel JS. Pilot Study of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer. J Pain Symptom Manage. 2015 Dec;50(6):854-60. doi: 10.1016/j.jpainsymman.2015.06.010. Epub 2015 Jul 10.
citation: Greer JA, Post KE, Chabria R, Aribindi S, Brennan N, Eche-Ugwu IJ, Halpenny B, Fox E, Lo S, Waldman LP, Pintro K, Rabideau DJ, Pirl WF, Cooley ME, Temel JS. Randomized Controlled Trial of a Nurse-Led Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer. J Clin Oncol. 2024 Oct 20;42(30):3570-3580. doi: 10.1200/JCO.24.00048. Epub 2024 Aug 1.