DyspneaINSPIRENCT07728773
A Stepped Intervention for Coping With Dyspnea in Patients With Lung Cancer-Phase A (Open Pilot)
A study testing INSPIRE in people with Dyspnea and Lung Cancer (Diagnosis), run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Lung Cancer (Diagnosis)
- What is being tested?
- INSPIRE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- no comorbidity prohibiting informed consent and study participation per oncologist judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mass General Brigham
Boston, Massachusetts, 02114
Stephen Lo Principal Investigator, PhD, 617-726-2000, slo2@mgh.harvard.edu
About this study
Official title: INSPIRE: A Stepped Intervention for Coping With Dyspnea in Patients With Lung Cancer-Phase A (Open Pilot)
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.
Read the detailed description
Background: Dyspnea is a debilitating symptom prevalent in more than 80% of patients with lung cancer at diagnosis and is associated with worse quality of life, functioning, and mental health. Unfortunately, current treatments for dyspnea are limited and fail to provide adequate care. Although supportive care interventions are needed, they must be personalized to the patient to address the dyspnea's diverse presentations in a resource-efficient approach, scalable for broad dissemination. The investigators developed two psychological interventions with promising efficacy for dyspnea: the first is a two-session, nurse-led behavioral intervention improving dyspnea-related discomfort, and the second is a five-session, psychologist-led cognitive-behavioral intervention improving dyspnea-related anxiety and other health outcomes. In this proposal, the investigators seek to combine these treatments using a stepped-care approach and pilot test a stepped intervention for dyspnea (INSPIRE) to offer personalized dyspnea care that optimizes healthcare resource utilization.
Specific Aims: 1) Refine INSPIRE and its stepped-care algorithm based on patient and clinician feedback.
Objective/Hypothesis: Patients with lung cancer reporting at least moderate dyspnea are the focus of the study. This first phase of the study aims to refine the study intervention and procedures.
Study Design: The investigators will use an open-pilot study of INSPIRE to gather initial feedback on the intervention (Aim 1). In INSPIRE (delivered in-person or virtually), patients receive BREEZE (Step 1) before escalating to the more intensive TAB (Step 2) if dyspnea does not improve. Qualitative exit interviews with patients will be conducted to inform potential changes. The investigators will refine the intervention and study procedures for the subsequent pilot randomized clinical trial (RCT) and for a future pilot RCT.
- Conditions
- Dyspnea, Lung Cancer (Diagnosis)
- Being tested
- INSPIRE
- Keywords
- dyspnea, lung cancer, cognitive behavioral
- Medical subject headings
- Dyspnea, Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSPIREBehavioural
a stepped-care cognitive-behavioral based intervention for dyspnea
| Study group | Role | What they receive |
|---|---|---|
| INSPIRE | Experimental | a stepped-care cognitive-behavioral based intervention for dyspnea Receives: Behavioral: INSPIRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative patient feedback
The investigators will collect the qualitative experience of study patients obtained through exit interviews and feedback.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, open pilot
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Stephen Lo, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728773
- Sponsor's protocol ID
- 26-149-A
- Other IDs
- CSDG-25-1375324-01-CPHP
- Acronym
- INSPIRE
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSPIRE: A Stepped Intervention for Coping With Dyspnea in Patients With Lung Cancer-Phase A (Open Pilot)
- ClinicalTrials.gov ID
- NCT07728773
- Acronym / sponsor ID
- INSPIRE / 26-149-A
- Conditions
- Dyspnea, Lung Cancer (Diagnosis)
- Keywords
- dyspnea, lung cancer, cognitive behavioral
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Jan 2027 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Dyspnea is a debilitating symptom prevalent in more than 80% of patients with lung cancer at diagnosis and is associated with worse quality of life, functioning, and mental health. Unfortunately, current treatments for dyspnea are limited and fail to provide adequate care. Although supportive care interventions are needed, they must be personalized to the patient to address the dyspnea's diverse presentations in a resource-efficient approach, scalable for broad dissemination. The investigators developed two psychological interventions with promising efficacy for dyspnea: the first is a two-session, nurse-led behavioral intervention improving dyspnea-related discomfort, and the second is a five-session, psychologist-led cognitive-behavioral intervention improving dyspnea-related anxiety and other health outcomes. In this proposal, the investigators seek to combine these treatments using a stepped-care approach and pilot test a stepped intervention for dyspnea (INSPIRE) to offer personalized dyspnea care that optimizes healthcare resource utilization.
Specific Aims: 1) Refine INSPIRE and its stepped-care algorithm based on patient and clinician feedback.
Objective/Hypothesis: Patients with lung cancer reporting at least moderate dyspnea are the focus of the study. This first phase of the study aims to refine the study intervention and procedures.
Study Design: The investigators will use an open-pilot study of INSPIRE to gather initial feedback on the intervention (Aim 1). In INSPIRE (delivered in-person or virtually), patients receive BREEZE (Step 1) before escalating to the more intensive TAB (Step 2) if dyspnea does not improve. Qualitative exit interviews with patients will be conducted to inform potential changes. The investigators will refine the intervention and study procedures for the subsequent pilot randomized clinical trial (RCT) and for a future pilot RCT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, open pilot
| Arm | Type | Receives |
|---|---|---|
| INSPIRE | Experimental | Behavioral: INSPIREa stepped-care cognitive-behavioral based intervention for dyspnea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- no comorbidity prohibiting informed consent and study participation per oncologist judgment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INSPIREa stepped-care cognitive-behavioral based intervention for dyspnea | Behavioural | INSPIRE |
Primary outcome
Qualitative patient feedback
Time frame: 4 months
The investigators will collect the qualitative experience of study patients obtained through exit interviews and feedback.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INSPIRE in people with Dyspnea and Lung Cancer (Diagnosis), run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative patient feedback (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.