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

Dyspnea (breathlessness) commonly impacts patients with lung cancer, worsening depression, anxiety, quality of life, and functioning. Current treatments are limited. To test the acceptability, feasibility, and preliminary efficacy of "Take a Breath" (TAB), a novel cognitive-behavioral treatment for dyspnea. 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 5 one-hour, weekly, individual sessions employing exposure-based interventions paired with pulse oximetry biofeedback, psychoeducation, and behavioral skills (e.g., pursed lip breathing). Robust mixed-effects modeling tested group x time interactions. The Client Satisfaction Questionnaire-8 measured acceptability. Accrual, treatment retention, and homework completion measured feasibility. Primary outcomes were the ATS Dyspnea Scale (dyspnea-related functioning) and Cancer Dyspnea Scale (dyspnea-related effort, discomfort, and anxiety). Secondary outcomes included depression (PHQ-9), health-related quality of life (SF-12), physical activity (IPAQ-SF), and functional status (KPS). Measurements occurred at baseline, mid-treatment (3 weeks), post-treatment (6 weeks), and 1-month follow-up. TAB was ≥"mostly satisfactory" for 75% of participants. The accrual was 25.6%, with 60% completing all sessions and an 88.7% homework completion rate. Intent-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 (p's<0.05). 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 registration available at www. gov, ID: NCT05304793.