Multi-site Trial of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
Dyspnea, or breathlessness, is one of the most common and distressing symptoms experienced by patients with advanced lung cancer. The purpose of this multi-site trial is to test the effectiveness of a dyspnea intervention (called BREEZE+) that includes three brief nurse-delivered sessions and access to a digital health app that teaches and reinforces patients' use of skills for managing and coping with this highly debilitating symptom. This study will lay the groundwork for a follow-up pragmatic implementation trial integrating BREEZE+ into usual oncology care for patients with advanced lung cancer experiencing dyspnea.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Diagnosis of advanced lung cancer (i.e., non-small cell lung cancer or small cell lung cancer) or mesothelioma, not being treated with curative intent
Self-report at least moderate dyspnea per a rating ≥4 on the validated 0-10 breathlessness item of the Edmonton Symptom Assessment Scale-Revised
Functioning independently per an Eastern Cooperative Oncology Group Performance Status ≤2
Disqualifiers
Significant uncontrolled psychiatric disorder or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the patient's ability to participate in study procedures.
Trial design
Design model
Parallel
Treatments tested in this trial
Dyspnea Intervention
BehavioralBrief behavioral intervention for dyspnea management that includes three nurse-led sessions focused on psychoeducation, behavioral techniques for managing acute breathlessness, and relaxation training for reducing physiological stress as well as a digital health app to reinforce practice of breathing skills.
Enhanced Usual Care
BehavioralPatients will receive educational materials on the management of symptoms of lung cancer and its treatment as well as any usual care for dyspnea deemed appropriate by the clinical team.
Treatment groups
420 Participants
are divided into 2 treatment groupsGroup A: Dyspnea InterventionExperimental treatment 1 intervention
Group B: Enhanced Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient-reported Dyspnea
To compare patient-reported dyspnea between study groups at 8 weeks using the Modified Medical Research Council Dyspnea Scale, which is a one-item self-report scale to evaluate the degree of a patient's dyspnea (score range: 0-4), with a higher score indicating worse dyspnea.
Time frame
8 weeksSecondary outcomes
1
Patient-reported Dyspnea-related Anxiety and Discomfort
To compare patient-reported dyspnea-related anxiety and discomfort between study groups at 8 weeks using the Cancer Dyspnea Scale, which is a 12-item self-report scale that assesses the multidimensional nature of dyspnea in patients with cancer (total scale score range: 0-48), with higher scores reflecting worse dyspnea-related effort, anxiety, and physical discomfort.
Time frame
8 weeks2
Patient-reported Physical Function
To compare patient-reported physical function between study groups at 8 weeks using the PROMIS Physical Function 8b Short Form, which is an 8-item measure that evaluates self-perceived capability of one's upper dexterity, lower extremities, and activities of daily living (total scale raw score range: 8-40), with higher scores indicating a greater level of physical function.
Time frame
8 weeks3
Patient-reported Quality of Life
To compare patient-reported quality of life between study groups at 8 weeks using the Functional Assessment of Cancer Therapy-Lung Questionnaire, which is a 36-item self-report measure of physical, social, emotional, and functional wellbeing and lung-cancer specific symptoms (total scale score range: 0-136), with higher scores indicating better overall quality of life.
Time frame
8 weeks4
Patient-reported Coping with Dyspnea
To compare patient-reported coping with dyspnea between study groups at 8 weeks using the Chronic Respiratory Disease Questionnaire-Mastery Subscale, which is a 4-item measure assessing a patient's feeling of control and mastery over their dyspnea (score range: 1-7), with higher scores indicating greater perceived control in managing dyspnea.
Time frame
8 WeeksOther outcomes
1
Patient-reported Dyspnea
To compare average trajectories between study groups in patient-reported dyspnea across all four study time points from baseline to weeks 8, 16, and 24 using the Modified Medical Research Council Dyspnea Scale, which is a one-item self-report scale to evaluate the degree of a patient's dyspnea (score range: 0-4), with a higher score indicating worse dyspnea.
Time frame
Up to 24 weeks2
Patient-reported Dyspnea-related Anxiety and Discomfort
To compare average trajectories between study groups in patient-reported dyspnea-related anxiety and discomfort across all four study time points from baseline to weeks 8, 16, and 24 using the Cancer Dyspnea Scale, which is a 12-item self-report scale that assesses the multidimensional nature of dyspnea in patients with cancer (total scale score range: 0-48), with higher scores reflecting worse dyspnea-related effort, anxiety, and physical discomfort.
Time frame
Up to 24 weeks3
Patient-reported Physical Function
To compare average trajectories between study groups in patient-reported physical function across all four study time points from baseline to weeks 8, 16, and 24 using the PROMIS Physical Function 8b Short Form, which is an 8-item measure that evaluates self-perceived capability of one's upper dexterity, lower extremities, and activities of daily living (total scale raw score range: 8-40), with higher scores indicating a greater level of physical function.
Time frame
Up to 24 weeks4
Patient-reported Quality of Life
To compare average trajectories between study groups in patient-reported quality of life across all four study time points from baseline to weeks 8, 16, and 24 using the Functional Assessment of Cancer Therapy-Lung Questionnaire, which is a 36-item self-report measure of physical, social, emotional, and functional wellbeing and lung-cancer specific symptoms (total scale score range: 0-136), with higher scores indicating better overall quality of life.
Time frame
Up to 24 weeksSponsors and contacts
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Massachusetts General Hospital
Lead sponsor
Johns Hopkins University
Collaborator
University of Miami
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov
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