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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Qualitative exit interviews with patients will be conducted to inform potential changes."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests INSPIRE, a step-by-step treatment to help adults with lung cancer cope with shortness of breath. Patients first learn coping skills in two sessions with a nurse. If their breathing symptoms do not improve, they receive five sessions with a psychologist to help with coping and anxiety.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older with non-small cell or small cell lung cancer.
  • At least moderate shortness of breath, with a score of 2 or higher on the study’s breathing scale.
  • Diagnosed with lung cancer at least 3 months ago, with no plans for lung cancer surgery.
  • Receive main cancer care at Mass General Brigham.
  • Able to read and answer questions in English.

Who can't join

  • Another health condition that, in the cancer doctor’s judgment, prevents you from giving informed consent or taking part in the study. Informed consent means understanding the study and agreeing to join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: \- no comorbidity prohibiting informed consent and study participation per oncologist judgment.

Study sites (1)

MA