Study of Digital Mind-Body Therapy Using Music and Biofeedback for Women 18 and Older With Locally Advanced Breast Cancer Receiving Neoadjuvant Treatment

What this Trial Is About

Researchers are evaluating a Digital Mind-Body Therapy based on digital music and biofeedback DMBT for patients with locally advanced breast cancer undergoing neoadjuvant treatment. This randomized controlled trial aims to assess the therapys effects on symptoms like insomnia, distress, depression, anxiety, quality of life, cognitive function, and cancer-related fatigue during treatment. Participants are randomly assigned to either an experimental group receiving the DMBT intervention or a control group with no additional intervention. The study involves a single center and follows patients from the start of neoadjuvant therapy through 24 weeks, monitoring various psychological and physical symptoms. During the study, participants will complete psychosomatic assessments and use a smartphone app to engage with the therapy if assigned to the experimental arm. Researchers will measure insomnia severity as the primary outcome and other symptoms such as distress, depression, anxiety, quality of life, cognitive function, and fatigue as secondary outcomes. The study includes follow-up evaluations over 24 weeks to track changes and effects of the therapy throughout treatment.

Digital Mind-Body Therapy for Neoadjuvant Breast Cancer