Cognitive-Behavioral Treatment for Breathlessness in Lung Cancer: A Randomized Controlled Trial.

Rationale: Dyspnea (breathlessness) commonly impacts patients with lung cancer, worsening depression, anxiety, quality of life, and functioning. Current treatments are limited. Objectives: To test the acceptability, feasibility, and preliminary efficacy of "Take a Breath" (TAB), a novel cognitive-behavioral treatment for dyspnea. Methods: A randomized controlled trial compared TAB with standard of care (SOC) in patients with lung cancer reporting at least moderate dyspnea (N = 45). TAB consisted of five 1-hour weekly individual sessions employing exposure-based interventions paired with pulse oximetry biofeedback, psychoeducation, and behavioral skills (e.g., pursed lip breathing). The Client Satisfaction Questionnaire-8 measured acceptability. Accrual, treatment retention, and homework completion measured feasibility. Primary outcomes were the American Thoracic Society Dyspnea Scale (dyspnea-related functioning) and Cancer Dyspnea Scale (dyspnea-related effort, discomfort, and anxiety). Secondary outcomes included depression (Patient Health Questionnaire-9), health-related quality of life (12-item Short Form Health Survey), physical activity (International Physical Activity Questionnaire Short Form), and functional status (Karnofsky performance status). Measurements occurred at baseline, midtreatment (3 wk), post-treatment (6 wk), and 1-month follow-up. Robust mixed-effects modeling tested group × time interactions. Results: TAB was at least "mostly satisfactory" for 75% of participants. The accrual was 25.6%, with 60% completing all sessions and an 88.7% homework completion rate. Intention-to-treat analysis revealed greater improvements in TAB than SOC for dyspnea-related functioning (Cohen's d = 0.82; P = 0.03) and anxiety (Cohen's d = 0.87; P < 0.01) at post-treatment and follow-up. TAB outperformed SOC in improving depressive symptoms, health-related quality of life, sedentary time, and performance status over time (all P < 0.05). Conclusions: TAB yielded symptom, psychological, and functional improvements, establishing its readiness for further testing as the first comprehensive cognitive-behavioral treatment for dyspnea and related sequelae. Clinical trial registered with www.clinicaltrials.gov (NCT05304793).