A randomized, controlled pilot trial of a neuromodulatory digital therapeutic for individuals with breast cancer.

1579 Background: Fatigue, pain, and mood symptoms are common side effects of cancer therapy and cancer patients. Frontoparietal circuitry has been implicated in chemotherapy-induced cognitive impairment as well as post-treatment fatigue. We hypothesized that a smartphone-based multimodal multistable bias modification (MMBM) intervention could improve fatigue, mood, and pain-related attentional biases in breast cancer patients by correcting the neurocircuitry alterations caused by uncertainty stress induced by cancer diagnosis, as well as alterations resulting from chemotherapy, correcting frontoparietal circuitry changes resulting from cancer or its treatment. Methods: A randomized, single-blinded exploratory study in patients with breast cancer (n = 81) was conducted. Participants were randomized 1:1 to an active MMBM app or a control app and instructed to use it for 7 minutes daily over 4 weeks. Clinical endpoints included PROMIS-29+2, Brief Pain Inventory (BPI), and Pain Catastrophizing Scale (PCS). Feasibility and acceptability of app usage were also evaluated. Results: The MMBM app group showed significant improvements over control in PROMIS-29 fatigue (-3.4, p < 0.05), depressive symptoms (-2.8, p < 0.05), and symptoms of anxiety (-3.0, p < 0.05) domains. There were also several pain measures that showed significant improvement over time in the MMBM group, but not the control group, such as the PROMIS-29 pain intensity measure (-0.9, p < 0.001), the BPI average pain intensity (-0.7, p < 0.001) and current pain intensity (-0.7, p < 0.01), and the PCS total score (-3.3, p < 0.01). Conclusions: This study provides preliminary evidence that the MMBM intervention may alleviate fatigue and mood-related symptoms in breast cancer patients, with potential for improving pain-related symptoms as well. These findings underscore the potential of digital neuromodulation as an innovative approach to enhance the quality of life of patients with complex conditions, specifically breast cancer. Clinical trial information: NCT06136923 .