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NCT Number: NCT03089125

Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

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).

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Dyspnea Intervention

Behavioral

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 Care

Other

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

Primary outcomes

  1. Modified Medical Research Council Dyspnea Scale (mMRCDS)

    Time frame: 8 weeks

    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.

  2. Cancer Dyspnoea Scale (CDS)

    Time frame: 8 weeks

    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.

Secondary outcomes

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

  5. Activity Level (Objective Measure: Actigraphy)

    Time frame: 8 weeks

    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.

Other outcomes

  1. Modified Medical Research Council Dyspnea Scale (mMRCDS)

    Time frame: 24 weeks

    Compare the difference between study groups in the estimated slopes of the scores on the Modified Medical Research Council Dyspnea Scale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea.

  2. Cancer Dyspnoea Scale (CDS)

    Time frame: 24 weeks

    Compare the difference between study groups in the estimated slopes of the scores on the Cancer Dyspnoea Scale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Cancer Dyspnoea Scale scores range from 0 (minimum) to 48 (maximum), with higher scores indicating worse dyspnea.

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

    Time frame: 24 weeks

    Compare the difference between study groups in the estimated slopes of the scores on the Functional Assessment of Cancer Therapy - Lung Scale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Functional Assessment of Cancer Therapy - Lung Scale scores range from 0 (minimum) to 136 (maximum), with higher scores indicating better quality of life.

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

    Time frame: 24 weeks

    Compare the difference between study groups in the estimated slopes of the scores on the Hospital Anxiety and Depression Scale - Anxiety Subscale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Hospital Anxiety and Depression Scale - Anxiety Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse anxiety symptoms.

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

    Time frame: 24 weeks

    Compare the difference between study groups in the estimated slopes of the scores on the Hospital Anxiety and Depression Scale - Depression Subscale over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. The Hospital Anxiety and Depression Scale - Depression Subscale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating worse depression symptoms.

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

    Time frame: 24 weeks

    Compare the difference between study groups in the estimated slopes of the scores on the Godin-Shephard Leisure Time Physical Activity Questionnaire over all four assessment timepoints of 8-week intervals (i.e., baseline, 8 weeks, 16 weeks, and 24 weeks) using linear mixed effects models. 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.

  7. Examine Potential Mediators of Intervention Effects on Patient-reported Outcomes

    Time frame: 24 weeks

    Examine the degree to which intervention effects on patient reported outcomes are mediated by improved mastery in managing breathlessness (as measured by the Chronic Respiratory Disease Questionnaire)

  8. Examine Potential Moderators of Intervention Effects on Dyspnea

    Time frame: 24 weeks

    Examine whether differences in reported dyspnea are moderated by patient demographic and clinical factors

  9. Health Service Utilization

    Time frame: 24 weeks

    Examine differences between study groups in rates of emergency department and hospitalizations

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Dana-Farber Cancer Institute
  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Mar 24, 2017
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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