A Stepped Intervention for Coping With Dyspnea in Patients With Lung Cancer-Phase A (Open Pilot)

NCT07728773 | Not Yet Recruiting

• 2 other identifiers: 26-149-ACSDG-25-1375324-01-CPHP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with lung cancer often experience shortness of breath, also known as dyspnea. It affects over 80% of patients with lung cancer at diagnosis and is linked to poorer quality of life and functioning. Unfortunately, current treatments-such as opioids, which are the most studied treatment for dyspnea-fail to provide patients with adequate care, and dyspnea can remain a chronic issue in many. Even when new treatments are developed, the benefit to public health is often limited by healthcare systems not having enough resources to use new treatments. The investigators' aim is to test a personalized treatment for dyspnea that can address patients' unique needs while efficiently using healthcare resources to make the treatment as accessible as possible for future widespread use. This project builds upon rhe investigators' prior work creating two promising psychological treatments for dyspnea. The first (a two-session behavioral treatment provided by nurses) targets dyspnea-related discomfort. The second (a five-session psychological treatment provided by psychologists) targets dyspnea-related anxiety and overall health outcomes. The investigators combined these complementary treatments with a stepped-care model into a treatment called INSPIRE. In INSPIRE, all patients will receive the brief treatment to learn basic behavioral coping skills to manage the discomfort of dyspnea before escalating to the more intensive treatment that focuses on providing patients with the confidence to cope with dyspnea and related anxiety, but only if patients' dyspnea does not improve after the first treatment. The investigators will first ask for initial feedback from patients who are receiving INSPIRE for dyspnea and the patients' study clinician to make sure the treatment and study procedures fit their needs. The investigators want to see if this approach can work in patients with lung cancer, is well-received, and shows early signs of improving dyspnea. The investigators' goal is to provide personalized relief for breathing difficulties while making the best use of healthcare resources. These findings will help the investigators learn more about how to support patients with dyspnea and provide information on how to further test INSPIRE. Additionally, this personalized supportive treatment for dyspnea may potentially help reduce the use of opioids currently used in the treatment of dyspnea.

Conditions

Dyspnea; Lung Cancer (Diagnosis)

Keywords

dyspnea; lung cancer; cognitive behavioral

Outcome Measures

Primary Outcomes (1)

• Qualitative patient feedback

  The investigators will collect the qualitative experience of study patients obtained through exit interviews and feedback.

  4 months

Study Arms (1)

INSPIRE

EXPERIMENTAL

a stepped-care cognitive-behavioral based intervention for dyspnea

Behavioral: INSPIRE

Interventions

INSPIRE BEHAVIORAL

a stepped-care cognitive-behavioral based intervention for dyspnea

INSPIRE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults (age ≥ 18) diagnosed with non-small cell lung cancer or small cell lung cancer
• report of at least moderate dyspnea (scoring ≥2 on the Modified Medical Research Council Dyspnea Scale)
• ≥3 months from cancer diagnosis without plans for surgical treatment for lung cancer
• primary cancer care at Mass General Brigham
• able to read and respond to questions in English

You may not qualify if:

• \- no comorbidity prohibiting informed consent and study participation per oncologist judgment.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Dyspnea; Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single group, open pilot

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: July 27, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

US (1)