This clinical trial tests how well the BREEZE+ behavioral intervention works for reducing shortness of breath (dyspnea) in patients with lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Patient-reported dyspnea is associated with impaired quality of life, decreased functioning at home and work, withdrawal from social activities, heightened symptoms of anxiety and depression, and even a desire for hastened death. Medications to treat dyspnea have not been found to be effective and behavioral and multicomponent interventions involving physical activity or rehabilitation hold the greatest promise for addressing dyspnea. The BREEZE+ intervention uses a digital app and nurse led sessions to address dyspnea symptoms. The BREEZE+ intervention may be effective for reducing dyspnea in patients with advanced lung cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06791057.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer InstituteStatus: Active
Contact: Jennifer Gold Temel
Phone: 617-724-4000
Massachusetts General Hospital Cancer CenterStatus: Active
Contact: Jennifer Gold Temel
Phone: 617-724-4000
PRIMARY OBJECTIVES:
I. To evaluate the effect of BREEZE+ on self-reported dyspnea in patients with advanced lung cancer.
II. To evaluate the effect of BREEZE+ on physical function, quality of life, and coping with dyspnea (secondary outcomes) in patients with advanced lung cancer and to explore coping as a moderator of intervention effects.
III. To identify critical facilitators and barriers of BREEZE+ adoption and implementation using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) QuEST (Qualitative Evaluation for Systematic Translation) mixed methods framework.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients attend nurse led BREEZE+ sessions, over 30-40 minutes each, focusing on education about dyspnea, behavioral coping strategies for acute episodes of dyspnea, stress reduction of bodily stress, strengthening of lung capacity and problem solving, in weeks 0, 4 and 12. Patients also receive access to an application (app) that provides weekly reminders, ongoing reinforcement of home-based practice of skills and videos and audio-recordings of the breathing exercises discussed in the nurse-delivered session, in weeks 0-24. Patients also receive text message reminders to encourage practice weekly for weeks 0-24.
ARM II: Patients receive printed or digital handouts regarding the common symptoms and side effects of lung cancer, including dyspnea, and recommendations for management from the American Cancer Society, with a link to their website of patient-education materials. Upon completion of study procedures at week 24, patients are offered a BREEZE+ session as described above and access to the digital app.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorJennifer Gold Temel
