Durham VA Health Care System and Blue Note Therapeutics Commence Phase 2 Study of First-of-its-Kind Prescription Digital Therapeutic to Address Cancer-Related Distress in Veterans

August 2021

On August 2, 2021, the Durham Veterans Affairs (VA) Health Care System and Blue Note Therapeutics announced a partnership to address cancer-related distress in veterans. With approximately 40,000 veterans diagnosed with cancer each year, and nearly all experiencing some form of distress, there is an immediate opportunity to improve and expand access to quality mental health care for veterans living with cancer.

The partnership includes a clinical study of a prescription digital therapeutic (PDT) created specifically for patients suffering from cancer-related distress. The Phase 2 study will assess the feasibility, ease of clinical implementation, and preliminary efficacy of BNT001, Blue Note’s lead PDT candidate. As a digital therapeutic, BNT001 helps to address the limitations of current face-to-face treatment methods by providing a completely digital solution based on evidence-based cognitive behavioral and stress management techniques. For veterans living in rural or remote locations, without easy access to psycho oncology services, BNT001 may provide a solution. The study is currently recruiting.

The single-arm, open-label, Phase 2 study will run in two distinct phases. The first will assess the process of clinical implementation by VA prescribing oncologists. The second, more expanded phase, will measure therapeutic benefit. Effectiveness in patient participants will be determined through measurement of changes in pre- and post-cancer-related distress symptoms. Symptoms will be assessed using the Veterans Symptom Assessment Screen (VSAS). The VSAS is a clinical patient reported outcomes tool to document cancer-related symptoms to improve quality of life that has been adopted across Veteran Administration hematology-oncology sites.

In June 2020, Blue Note received Breakthrough Device Designation for BNT001 from the U.S. Food and Drug Administration (FDA) by establishing that it offers a potentially more effective treatment for cancer-related distress delivered via breakthrough technology.

For more information about the study, visit https://ClinicalTrials.gov (NCT04857008).

This is the second Phase 2 study underway for BNT001. Learn more about the other study here.

For information regarding the Durham VA Health Care System, visit https://www.durham.va.gov/.

To learn more about Blue Note Therapeutics, and Veterans leading the company, see https://bluenotetherapeutics.com/.