Dyspnea Intervention for Lung Cancer

(BREEZE+ Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist people with advanced lung cancer who experience dyspnea (breathlessness). Participants will engage in a program called BREEZE+, which includes three sessions with a nurse to learn breathing techniques and access to a phone app for daily practice. The goal is to determine if this approach can manage breathlessness more effectively than usual care, which provides educational materials. People with advanced lung cancer who frequently feel out of breath and can still perform daily activities might be suitable for this trial. As an unphased trial, this study offers participants the chance to explore innovative methods for managing breathlessness.

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 prior data suggests that the BREEZE+ intervention is safe for patients with advanced lung cancer?

Research shows that the BREEZE+ program helps manage breathlessness in patients with advanced lung cancer. In a previous study, patients in a similar nurse-led program reported less breathlessness than those receiving regular care, suggesting the program's effectiveness and patient tolerance.

The program teaches techniques like pursed-lip and mindful breathing to manage breathlessness. Since it uses non-drug methods, it usually poses minimal risk of side effects. A digital health app supports patients by reinforcing these skills daily, improving comfort and self-management of symptoms.

Overall, this approach is considered safe as it doesn't involve medication but instead teaches skills to manage symptoms. It's important for patients to consult healthcare providers for personalized advice, but current research supports the program's safety and potential benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Dyspnea Intervention for lung cancer because it offers a comprehensive, non-drug approach to managing breathlessness. Unlike traditional treatments that often rely on medications or oxygen therapy, this intervention equips patients with practical skills like pursed-lip breathing and mindful breathing to manage their symptoms actively. Additionally, the use of a digital health app to reinforce these techniques ensures that patients can practice and benefit from them daily, potentially enhancing their lung capacity and reducing stress. This innovative blend of education, behavioral strategies, and technology sets it apart from standard care options.

What evidence suggests that the BREEZE+ intervention is effective for managing dyspnea in lung cancer patients?

Research has shown that treatments focusing on managing breathlessness can greatly reduce symptoms in patients with advanced lung cancer. In this trial, participants in the Dyspnea Intervention arm will receive nurse-led sessions similar to those in the BREEZE+ program. These sessions teach patients to control breathlessness using techniques such as pursed-lip breathing and mindful breathing. One study found that many patients experienced a significant reduction in shortness of breath after these sessions. Additionally, approaches that combine education and practical skills have effectively eased the distress caused by breathlessness. Overall, these strategies have shown promise in improving the quality of life for patients facing this challenging symptom. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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

Receiving primary cancer care at one of the participating institutions

I can read and answer questions in English or Spanish.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11483213/

Randomized Controlled Trial of a Nurse-led Brief ... As shown in Figure 2, the majority of intervention and control participants experienced a clinically meaningful reduction in dyspnea, though a ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2347562525000198

Comparative effectiveness of pharmacological and non ... This study aimed to evaluate and rank the effectiveness of pharmacological and non-pharmacological interventions for managing dyspnea severity, anxiety, ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.20.03465

Management of Dyspnea in Advanced Cancer The results suggested that holistic breathlessness services may reduce distress because of dyspnea. Clinical interpretation. Patients with ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01937637

Improving Management of Breathlessness in Patients With ... The data from this study will help inform improvements to the intervention in order to make it feasible and effective for treating breathlessness in patients ...

5. jpsmjournal.com jpsmjournal.com/article/S0885-3924(25)00584-6/abstract

Depression and Anxiety as Moderators for a Behavioral ... Dyspnea (breathlessness) is a distressing and disabling symptom affecting over 70% of patients with advanced lung cancer.

6. esmoopen.com esmoopen.com/article/S2059-7029(20)32759-9/fulltext

Management of breathlessness in patients with cancer High-flow oxygen therapy may be considered in selected patients for treatment of breathlessness, especially if they have hypoxaemic respiratory failure (II, B).

7. sciencedirect.com sciencedirect.com/science/article/pii/S1976131720300724

The Effects of the Respiratory Rehabilitation Program on ... This study aims to examine the effects of the respiratory rehabilitation program on perceived self-efficacy and dyspnea in patients with lung cancer.