Curebase and Blue Note Therapeutics Collaborate on Home-based Clinical Trial of Prescription Digital Therapeutics to Help People with Cancer Manage their Health

SAN FRANCISCO, March 11, 2022 /PRNewswire/ -- Curebase, a company committed to democratizing access to clinical studies, and Blue Note Therapeutics, a prescription digital therapeutics (PDT) company dedicated to easing the burden of cancer and improving outcomes, have announced a collaboration on a virtual clinical trial that will study the effectiveness of two digital therapeutics. Both digital therapeutics are anticipated to have an impact on mental and physical health when used adjunctively with multidisciplinary oncology care regimens. 

The goal of the joint trial with Curebase is to maximize our recruitment efforts with patients experiencing cancer-related distress and who may benefit from a fully virtual trial, including home-based subjects who can't or wouldn't want to travel to a trial site. This will enable Blue Note to access patient populations that have been underrepresented in traditional site-based clinical studies. People with cancer and an interest in this virtual trial can learn more here.

Curebase's decentralized clinical trial (DCT) platform will be used to recruit participants, screen, consent, and then help guide them through the reporting and activities required for the study. Curebase will utilize its extensive virtual site operations and study management to execute the study. Blue Note is recruiting 353 patients for the fully remote trial, which will begin in early March. The data from this trial is expected to support Blue Note Therapeutics' future regulatory submissions to the U.S. Food and Drug Administration.  

"Patients living with cancer frequently experience stress, anxiety, and depression. For many, these symptoms have heightened during the COVID-19 pandemic with healthcare restrictions and disruptions in cancer care," said Geoffrey Eich, CEO, Blue Note Therapeutics. "Our collaboration with Curebase is exciting as it brings together our unique capabilities to expand our reach in recruiting for this new, fully virtual clinical trial. Using the latest in digital technology, we're now able to offer patients a convenient way to participate and what we hope will be improved physical and mental health."

Curebase's DCT model ensures more diverse studies because unique populations – which typically are underrepresented in clinical trials – can be included. The company's virtual research sites also provide physicians with new and unique options to offer their patients, regardless of location.

"People who have been diagnosed with cancer not only deal with this disease on a physical level, they also frequently struggle with depression and negative thought patterns," said Tom Lemberg, CEO and founder, Curebase. "We're hopeful this trial will demonstrate that people with cancer can effectively get relief from their emotional distress within the comforts and convenience of their own homes." 

About Cancer-Related Distress
There are about 18 million cancer patients and survivors in the United States today.2 Nearly half of all cancer patients experience psychosocial distress, anxiety, or depression.3 If left untreated, these feelings can lower a cancer survivor's quality of life and may negatively affect survival.4 The National Comprehensive Cancer Network (NCCN) has established guidelines for the delivery of mental health care services in oncology, which include screening patients for signs of distress and implementing a treatment plan to address these needs with a mental health care specialist.5 Unfortunately, fewer than half of patients who experience cancer-related distress, which can be defined as any unpleasant feeling, emotion, or experience that affects a patient's quality of life or ability to cope with cancer diagnosis and treatment, are referred to mental health care specialists.6.7 Prescription digital therapeutics designed to treat cancer-related distress can help close this cancer treatment gap.

About Curebase
At Curebase, our mission is to bring quality medical innovations to patients faster and improve human wellbeing through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up. For more information, please visit www.curebase.com.

About Blue Note Therapeutics
Blue Note Therapeutics is a prescription digital therapeutics company singularly dedicated to serving patients suffering from cancer. We aim to make treatment accessible to any cancer patient, at any time, by merging deep scientific and clinical expertise, neuroscience, and digital innovation. Working closely with cancer research and patient communities, we are developing a pipeline of clinically validated prescription digital therapeutics to help reduce anxiety, depression, and other forms of cancer-related distress. For more information, visit www.bluenotetherapeutics.com.

About Prescription Digital Therapeutics (PDTs)
Prescription digital therapeutics (PDTs) are a therapeutic class of medical devices that use U.S. Food and Drug Administration (FDA) approvable software to treat diseases and conditions, such as anxiety and depression related to cancer diagnosis and treatment. Similar to prescription medicines, PDTs must demonstrate safety and efficacy in randomized clinical trials prior to their approval by the FDA.

Media Contact - Curebase
Shawn Malloy
[email protected] 
+1(315)882-5310

Media Contact - Blue Note Therapeutics
Kim King
[email protected]  
+1(805)410-0180

References
1 Shih ST-F, Butow P, Bowe SJ, et al. Cost-effectiveness of an intervention to reduce fear of cancer recurrence: The ConquerFear randomized controlled trial. Psycho-Oncology. 2019;28:1071-1079. https://doi.org/10.1002/pon.5056
2 American Cancer Society. Cancer Facts & Figures 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf.
3 Mehnert A, Hartung TJ, Friedrich M, et al. One in two cancer patients is significantly distressed: Prevalence and indicators of distress. Psychooncology. 2018;27:75-82.
4 Centers for Disease Control and Prevention. Anxiety and Depression Medicine Use Among Cancer Survivors. https://www.cdc.gov/cancer/dcpc/research/articles/anxiety_dep_med_survivors.htm.
5 National Comprehensive Cancer Network. Distress Management, Version 3.2019, NCCN Clinical Practice Guidelines in Oncology. https://jnccn.org/view/journals/jnccn/17/10/article-p1229.xml.
6 OncoLink. What is Cancer Related Distress? https://www.oncolink.org/support/practical-and-emotional/coping-communication-concerns/what-is-cancer-related-distress.
7 American Cancer Society. Cancer Treatment & Survivorship Facts & Figures 2019-2021. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-treatment-and-survivorship-facts-and-figures/cancer-treatment-and-survivorship-facts-and-figures-2019-2021.pdf.

SOURCE Curebase