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Clinical Trial Summary

This is a non-significant risk, double-blinded, randomized, registrational study to compare the effectiveness of two digital, software only, medical devices (SaMD) (attune™ and cerena™) in reducing cancer-related anxiety and depression symptoms when used adjunctively with multidisciplinary (medical, psychosocial) oncology usual care regimens for up to 10 weeks. Study population will consist of up to 553 participants with stage I-III breast cancer or stage I-III NSCLC. The primary endpoint is percent improvement in anxiety symptoms at Week 10 and secondary endpoints of percent improvement in depressive symptoms will be assessed at Week 12. An interim analysis for efficacy and futility will be conducted once 236 participants have completed the study.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT04862195
Study type Interventional
Source Blue Note Therapeutics
Contact Raju Joshi, PhD
Phone (424) 332-3551
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date April 2021
Completion date August 2022

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