Changing cancer mindsets: A randomized controlled feasibility and efficacy trial

ObjectiveA cancer diagnosis and subsequent treatment can disrupt the full spectrum of physical, social, emotional, and functional quality of life. But existing psychological treatments are focused primarily on specific psychological symptoms as opposed to improving the overall patient experience. We studied the feasibility and efficacy of a novel digital intervention targeting patient mindsets-core assumptions about the nature and meaning of illness-designed to improve overall health-related quality of life (HRQoL) in newly diagnosed cancer patients undergoing treatment with curative intent. MethodsRecently diagnosed (<= 150 days) adult patients with non-metastatic cancers undergoing systemic treatment (N = 361) were recruited from across the United States to participate in this decentralized clinical trial. Patients were randomized 1:1 to receive the Cancer Mindset Intervention (CMI) or Treatment as Usual (TAU). Participants in the CMI group completed seven online modules over 10 weeks (2.5 h total) targeting mindsets about cancer and the body. The primary outcome was overall HRQoL, and secondary outcomes were coping behaviors and symptom distress. ResultsPatients in the CMI group reported significant (p < 0.001) improvements in adaptive mindsets about cancer and the body over time. Compared with the TAU condition, the CMI group reported significant improvements in overall HRQoL (B = 0.60; 95% CI 0.34-0.85; p < 0.001), increased engagement in adaptive coping behaviors (B = 0.03; 95% CI 0.02-0.04; p < 0.001), and reduced distress from physical symptoms (B = -0.29; 95% CI -0.44 to -0.14; p < 0.01). Effect sizes of these changes ranged from d = 0.42-d = 0.54. ConclusionA brief mindset-focused digital intervention was effective at improving physical, social, emotional, and functional HRQoL, increasing adaptive coping behaviors, and reducing physical symptom distress in newly diagnosed cancer patients.