Background: Dyspnea is a common and debilitating symptom of advanced lung cancer, with approximately 50% of patients reporting marked breathlessness. Dyspnea is associated with impaired quality of life, decreased participation in social activities, symptoms of depression and anxiety, and even desire for death in patients with lung cancer. Unfortunately, limited data support efficacious treatments for dyspnea. Our multidisciplinary team recently conducted a pilot study examining the delivery of a brief, two-session behavioral intervention for dyspnea management in patients with advanced lung cancer. Trained nurse practitioners administered the intervention to patients in the infusion clinic to facilitate greater access and participation. We observed statistically and clinically significant effects on patient-reported breathlessness, quality of life, and depression symptoms, as well as high patient satisfaction with the intervention components and delivery.
Study Aims : For the proposed project, we seek to build on our prior positive findings by conducting a randomized controlled trial (RCT) of the intervention in a larger sample of patients with advanced lung cancers. We will first train oncology nurses to deliver the brief behavioral intervention for dyspnea management, again at the point of care within the infusion clinic as this approach was central to the feasibility and acceptability of the intervention in our pilot study.
The specific aims of this study are to demonstrate the efficacy of the brief behavioral intervention for improving self-reported dyspnea (primary outcome) as well as quality of life, mood, and activity level (secondary outcomes) in patients with advanced lung cancer. Study Design & Methods: We will enroll and randomly assign up to 200 patients diagnosed with advanced lung cancer (100 per study group) to receive either the brief behavioral intervention for dyspnea or usual care. The trial will take place at the Massachusetts General Hospital Cancer Center and the Dana-Farber Cancer Institute. Oncology nurses will deliver two, 45 minute interventions sessions for each participant within the infusion clinic. All participants will complete measures of dyspnea, quality of life, anxiety and depression symptoms, as well as activity level at baseline after completion of the intervention phase at 8, 16, and 24 weeks. Conclusions: Other than opioid medications, which offer little clinical benefit, data are lacking to support the efficacy of treatments for dyspnea, a highly impairing symptom in patients with advanced lung cancer. We plan to train oncology nurses in delivering a dyspnea management intervention that incorporates behavioral techniques shown to be effective for improving breathlessness and reducing stress in patients with cancer. By training medical clinicians to administer the behavioral intervention in the oncology care setting, we hope to maximize broad dissemination and patient access to essential symptom management. Data from this R01 will ultimately serve as the basis to apply for funding for a large-scale, multisite effectiveness and dissemination study of the intervention.

Public Health Relevance

At least 50% of patients with advanced lung cancer experience debilitating dyspnea that is associated with worse medical and psychosocial outcomes. The purpose of the present investigation is to test a brief behavioral intervention for dyspnea, delivered by oncology nurses within the outpatient cancer clinic. Through this study, we seek to increase access to much needed symptom management for those diagnosed with advanced lung cancers and ideally improve patients? overall quality of life.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
1R01NR016694-01
Application #
9216504
Study Section
Nursing and Related Clinical Sciences Study Section (NRCS)
Program Officer
Kehl, Karen
Project Start
2017-01-19
Project End
2021-12-31
Budget Start
2017-01-19
Budget End
2017-12-31
Support Year
1
Fiscal Year
2017
Total Cost
$533,179
Indirect Cost
$83,430
Name
Massachusetts General Hospital
Department
Type
Independent Hospitals
DUNS #
073130411
City
Boston
State
MA
Country
United States
Zip Code
02114