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Lung CancerNCT03089125

Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

A study testing Dyspnea Intervention in people with Lung Cancer, run by Massachusetts General Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study is evaluating a behavioral intervention designed to help people with advanced lung cancer manage dyspnea (i.e., breathlessness or shortness-of-breath). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Dyspnea Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
247 participants
Where
2 sitesUnited States
Study dates
15 May 2017to 6 Apr 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • A diagnosis of either NSCLC, SCLC, or mesothelioma, not being treated with curative intent
  • Self-reported shortness of breath (a score of 2 or greater on the Modified Medical Research Council Dyspnea Scale)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2 (symptomatic and in bed <50% of day)
  • The ability to read and respond to questions English
  • Primary cancer care at the Massachusetts General Hospital (MGH) Cancer Center or Dana-Farber Cancer Institute (DFCI)
  • Age >18 years

Who cannot join

  • Cognitive or psychiatric conditions prohibiting study consent or participation.
  • A treating clinician who reports that the patient is inappropriate for the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

This research study is evaluating a behavioral intervention designed to help people with advanced lung cancer manage dyspnea (i.e., breathlessness or shortness-of-breath).

Read the detailed description

Many individuals with advanced lung cancer experience debilitating breathlessness at some point during the course of their illness. Unfortunately, few interventions exist to treat this distressing symptom of cancer.

The purpose of this study is to test the efficacy of a brief behavioral intervention may help relieve breathlessness in individuals with advanced lung cancer. Participants will have a 50/50 chance of receiving the behavioral intervention or standard care. The principal investigator of the study, Dr. Joseph Greer, is a licensed clinical psychologist who has trained oncology nurses in how to deliver the behavioral intervention. The oncology nurses will meet with participants during their outpatient oncology appointments, such as chemotherapy infusions, to review the behavioral skills that may help with breathlessness. This intervention involves no medications but rather teaches patients skills for breathing control and relaxation of the body.

Conditions
Lung Cancer
Being tested
Dyspnea Intervention, Usual Care
Keywords
Lung Cancer
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dyspnea InterventionBehavioural

    Dyspnea intervention will be administered over two sessions

    Patients will receive:

    • Psychoeducation
    • Relaxation training for reducing physiological stress
    • Behavioral techniques for managing acute breathlessness

  • Usual CareOther

    Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians

Study groups in NCT03089125
Study groupRoleWhat they receive
Usual CareActive comparatorPatients will receive any usual care for their dyspnea as deemed appropriate by their clinicians.
Receives: Other: Usual Care
Dyspnea InterventionExperimentalDyspnea intervention will be administered over two sessions Patients will receive: * Psychoeducation * Relaxation training for reducing physiological stress * Behavioral techniques for managing acute breathlessness
Receives: Behavioral: Dyspnea Intervention; Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Medical Research Council Dyspnea Scale (mMRCDS)

    Compare the difference between study groups in the Modified Medical Research Council Dyspnea Scale severity score at 8 weeks. The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea.

    Measured: 8 weeks

  2. Cancer Dyspnoea Scale (CDS)

    Compare the difference between study groups in the Cancer Dyspnoea Scale scores at 8 weeks. The Cancer Dyspnoea Scale scores range from 0 (minimum) to 48 (maximum), with higher scores indicating worse dyspnea.

    Measured: 8 weeks

Secondary outcomes (5)

  1. Functional Assessment of Cancer Therapy - Lung (FACT-L)

    Compare the difference between study groups in the Functional Assessment of Cancer Therapy - Lung Scale scores at 8 weeks. The Functional Assessment of Cancer Therapy - Lung Scale scores range from 0 (minimum) to 136 (maximum), with higher scores indicating better quality of life.

    Measured: 8 weeks

  2. Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale

    Compare the difference between study groups in the Hospital Anxiety and Depression Scale - Anxiety Subscale scores at 8 weeks. The Hospital Anxiety and Depression Scale - Anxiety Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse anxiety symptoms.

    Measured: 8 weeks

  3. Hospital Anxiety and Depression Scale (HADS) - Depression Subscale

    Compare the difference between study groups in the Hospital Anxiety and Depression Scale - Depression Subscale scores at 8 weeks. The Hospital Anxiety and Depression Scale - Depression Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse depression symptoms.

    Measured: 8 weeks

  4. Activity Level (Self-report: Godin-Shephard Leisure Time Physical Activity Questionnaire)

    Compare the difference between study groups in the Godin-Shephard Leisure Time Physical Activity Questionnaire scores at 8 weeks. The Godin-Shephard Leisure Time Physical Activity Questionnaire is a 4-item measure that assesses the frequency and extent of physical activity during free time over the course of one week, with scores ranging from 0 (minimum; insufficiently active) to 24 or greater (maximum; active), with higher scores indicating greater physical activity.

    Measured: 8 weeks

  5. Activity Level (Objective Measure: Actigraphy)

    Compare the difference between study groups in the percentage of time spent immobile but awake over a consecutive three day period per actigraphy at 8 weeks. Scores range from 0% to 100%, with higher scores indicating a greater percentage of time spent immobile while awake over a consecutive three day period.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2017
  2. Study start15 May 2017
  3. Primary completion26 Oct 2022
  4. Study completion6 Apr 2023

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Nurse administered dyspnea intervention
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03089125
Sponsor's protocol ID
16-476
Status last verified
Feb 2025
First submitted
20 Mar 2017
Last updated
27 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Greer JA, Post KE, Chabria R, Aribindi S, Brennan N, Eche-Ugwu IJ, Halpenny B, Fox E, Lo S, Waldman LP, Pintro K, Rabideau DJ, Pirl WF, Cooley ME, Temel JS. Randomized Controlled Trial of a Nurse-Led Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer. J Clin Oncol. 2024 Oct 20;42(30):3570-3580. doi: 10.1200/JCO.24.00048. Epub 2024 Aug 1.

    PubMed 39088766

Questions about this trial

What is this clinical trial studying?

A study testing Dyspnea Intervention in people with Lung Cancer, run by Massachusetts General Hospital at 2 sites 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 27 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Medical Research Council Dyspnea Scale (mMRCDS) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03089125, which also lists 1 linked publication.

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 27 Feb 2025.

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