Dyspnea Intervention for Lung Cancer

(BREEZE+ Trial)

Recruiting at 2 trial locations

Overseen By Jennifer S. Temel, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Uncontrolled psychiatric disorder, dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

420 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the Dyspnea Intervention treatment for lung cancer?

Non-drug treatments for breathlessness, like breathing exercises and psychological support, have been shown to help manage lung cancer-related dyspnea (difficulty breathing) and improve quality of life. These approaches are part of a broader strategy that includes both medical and supportive care to address this common symptom. ^{1 2 3 4 5}

Is the Dyspnea Intervention for Lung Cancer generally safe for humans?

The safety data for treatments related to lung cancer, such as immune checkpoint inhibitors, show that common side effects include tiredness and nausea, while less common but serious side effects can include inflammation of the lungs and intestines. These findings suggest that while some treatments are generally safe, they can have significant side effects that need to be managed. ^{6 7 8 9 10}

How does the Dyspnea Intervention treatment for lung cancer differ from other treatments?

The Dyspnea Intervention treatment for lung cancer is unique because it focuses on non-drug approaches, using techniques from chronic pulmonary disease rehabilitation and nursing strategies, rather than relying solely on medications. This approach includes breathing exercises and psychosocial support to manage breathlessness, offering a comprehensive way to improve patient comfort and quality of life. ^{1 4 11 12 13}

What is the purpose of 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

This trial is for patients with advanced lung cancer who are experiencing significant breathlessness. Participants should be able to attend three nurse-led sessions and use a digital health app designed to help manage their symptoms.

Inclusion Criteria

I can read and answer questions in English or Spanish.

Receiving primary cancer care at one of the participating institutions

I have advanced lung cancer or mesothelioma and am not being treated to cure it.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BREEZE+ intervention, which includes three nurse-delivered sessions and access to a digital health app for dyspnea management

8 weeks

3 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at weeks 8, 16, and 24

16 weeks

3 visits (virtual)

Treatment Details

Interventions

• Dyspnea Intervention

Trial Overview The study is testing BREEZE+, a behavioral intervention aimed at helping lung cancer patients cope with dyspnea. It involves brief sessions with nurses and the use of an app, compared against the standard care these patients usually receive.

Participant Groups

Group I: Dyspnea Intervention Experimental Treatment 1 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.

Group II: Enhanced Usual Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A qualitative study involving nine patients with lung cancer or pleural mesothelioma revealed that non-pharmacological breathlessness management programs significantly improve patients' functional capacity and coping strategies.

The benefits of the program are attributed to a combination of effective breathing techniques, activity management, and the supportive qualities of the therapists, highlighting the importance of personalized care in managing dyspnoea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual experiences and impacts of a physiotherapist-led, non-pharmacological breathlessness programme for patients with intrathoracic malignancy: a qualitative study. Wood, H., Connors, S., Dogan, S., et al.[2015]

In a meta-analysis of 51 studies with 12,600 participants, the development of immune-related adverse events (irAEs) was linked to improved overall survival (OS) and objective response rate (ORR) in advanced non-small cell lung cancer (NSCLC).

Checkpoint inhibitor pneumonitis (CIP) did not significantly affect overall survival but was associated with a better treatment response, indicating that while CIP may not be detrimental to survival, it can enhance the effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Immune-Related Adverse Events and Pneumonitis on Prognosis in Advanced Non-Small Cell Lung Cancer: A Comprehensive Systematic Review and Meta-analysis. Li, Y., Zhang, Y., Jia, X., et al.[2022]

Immune checkpoint inhibitors are now a standard treatment for non-small cell lung cancer (NSCLC), but they can cause immune-related adverse events (irAEs), which are unique inflammatory side effects that can complicate treatment.

Recognizing and managing these irAEs is crucial for healthcare providers, as they can lead to severe toxicities that may influence treatment decisions for patients with NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune-Related Toxicity in Non-small cell Lung Cancer: Current State-of-The-Art and Emerging Clinical Challenges. O'Leary, CL., Pierce, N., Patel, SP., et al.[2023]

In a study of 16,527 non-small cell lung cancer patients, the most common adverse events linked to pharmacotherapy were hypocalcemia, elevated creatine phosphokinase, and hypertriglyceridemia, highlighting the need for monitoring these conditions during treatment.

The modified Apriori algorithm proved to be more effective than the conventional method in identifying associations between chemotherapy drugs and adverse events, suggesting it could be a valuable tool for improving patient safety in cancer pharmacotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discovering Associations of Adverse Events with Pharmacotherapy in Patients with Non-Small Cell Lung Cancer Using Modified Apriori Algorithm. Chen, W., Yang, J., Wang, HL., et al.[2022]

In a study of 5278 patients with advanced-stage non-small-cell lung cancer, the most common safety events after starting immune checkpoint inhibitors were malaise/fatigue (70.7 incidents per 100 person-years) and nausea/vomiting (32.4 incidents).

Less common but notable immune-mediated events included colitis (7.11 incidents) and pneumonitis (5.47 incidents), which were still more frequent than after other systemic cancer treatments, indicating a unique safety profile for ICIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of safety events after immune checkpoint inhibitor initiation for advanced-stage non-small-cell lung cancer: a real-world study. Beachler, DC., Lamy, FX., Kolitsopoulos, F., et al.[2022]

A systematic review of 119 studies on stage III non-small cell lung cancer (NSCLC) revealed that adverse events (AEs) were inconsistently reported, with 94.12% of studies documenting grade 3 AEs and 92.44% reporting grade 4 AEs, but only 53.78% and 63.03% for grade 1 and 2 AEs, respectively.

In studies involving surgical procedures, AEs were often underreported, with 10 out of 31 surgical treatment arms not mentioning any AEs, highlighting a significant gap in patient-relevant information that could impact treatment decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events reporting in stage III NSCLC trials investigating surgery and radiotherapy. Iseli, T., Berghmans, T., Glatzer, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Individual experiences and impacts of a physiotherapist-led, non-pharmacological breathlessness programme for patients with intrathoracic malignancy: a qualitative study. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Current dyspnea among long-term survivors of early-stage non-small cell lung cancer. [2021]

3. England pubmed.ncbi.nlm.nih.gov

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5. United States pubmed.ncbi.nlm.nih.gov

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6. United States pubmed.ncbi.nlm.nih.gov

Effect of Immune-Related Adverse Events and Pneumonitis on Prognosis in Advanced Non-Small Cell Lung Cancer: A Comprehensive Systematic Review and Meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Immune-Related Toxicity in Non-small cell Lung Cancer: Current State-of-The-Art and Emerging Clinical Challenges. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Discovering Associations of Adverse Events with Pharmacotherapy in Patients with Non-Small Cell Lung Cancer Using Modified Apriori Algorithm. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Incidence of safety events after immune checkpoint inhibitor initiation for advanced-stage non-small-cell lung cancer: a real-world study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Adverse events reporting in stage III NSCLC trials investigating surgery and radiotherapy. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Developing a nursing approach to managing dyspnoea in lung cancer. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

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13. United States pubmed.ncbi.nlm.nih.gov

Prevalence and screening of dyspnea interfering with daily life activities in ambulatory patients with advanced lung cancer. [2022]