SAN FRANCISCO, March 11, 2022 /PRNewswire/ — Curebase, a company committed to democratizing access to clinical studies, and Blue Note Therapeutics, a digital prescription therapy (PDT) company dedicated to reducing the burden of cancer and improving outcomes, have announced a collaboration on a virtual clinical trial that will study the effectiveness of two digital therapies. Both digital therapies are expected to impact mental and physical health when used alongside multidisciplinary cancer care regimens.
The goal of the joint trial with Curebase is to maximize our efforts to recruit patients with cancer-related distress who could benefit from a fully virtual trial, including home subjects who cannot or do not want to not get to a test place. This will allow Blue Note to access patient populations that have been underrepresented in traditional site-based clinical studies. People with cancer who are interested in this virtual trial can find out more here.
Curebase’s Decentralized Clinical Trials (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 use 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. Data from this trial should support future regulatory submissions by Blue Note Therapeutics to the U.S. Food and Drug Administration.
“Cancer patients frequently suffer from stress, anxiety and depression. For many, these symptoms have intensified during the COVID-19 pandemic with health care 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 extend our reach in recruiting for this new, fully virtual clinical trial. Using the latest digital technologies, we are 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 are typically underrepresented in clinical trials – can be included. The company’s virtual research sites also provide physicians with unique new 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, but they also frequently struggle with depression and negative thought patterns,” said Tom Lemberg, CEO and Founder, Curebase. “We hope this trial will demonstrate that people with cancer can effectively obtain relief from their emotional distress in the comfort and convenience of their own home.”
About Cancer Distress
There are approximately 18 million cancer patients and survivors in United States today.2 Nearly half of all cancer patients suffer from psychosocial distress, anxiety or depression.3 If left untreated, these feelings can reduce a cancer survivor’s quality of life. cancer and negatively affect its survival.4 The National Comprehensive Cancer Network (NCCN) has established guidelines for the provision of oncology mental health care services, which include screening patients for signs of distress and implementing a treatment plan to address those needs with a mental health care specialist.5 Unfortunately, less than half of patients who experience cancer-related distress, which can be defined as any unpleasant feeling, emotion, or experience that affects the a patient’s quality of life, or ability to cope with cancer diagnosis and treatment, are referred to mental health care specialists.6.7 Digital prescription therapies designed to treat cancer-related distress may help fill this gap in cancer treatment.
At Curebase, our mission is to bring quality medical innovations to patients faster and improve human well-being through more effective clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians around the world to recruit patients from the communities where they live. By applying state-of-the-art 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 digital prescription therapy company exclusively dedicated to serving cancer patients. Our goal is to make treatment accessible to any cancer patient, at any time, by fusing 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 digital prescription therapies to help reduce anxiety, depression and other forms of cancer-related distress. For more information, visit www.bluenotetherapeutics.com.
About Prescription Digital Therapeutics (PDT)
Prescription Digital Therapies (PDTs) are a therapeutic class of medical devices that use US Food and Drug Administration (FDA)-approved software to treat diseases and conditions, such as anxiety and depression related to the diagnosis and treatment of cancer. As with prescription drugs, PDTs must demonstrate their safety and effectiveness in randomized clinical trials before they are approved by the FDA.
Media contact – Curebase
Media Contact – Blue Note Therapeutics
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 and 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 out of two cancer patients is significantly in distress: prevalence and indicators of distress. Psycho-oncology. 2018;27:75-82.
4 Centers for Disease Control and Prevention. Use of medications for anxiety and depression in cancer survivors. https://www.cdc.gov/cancer/dcpc/research/articles/anxiety_dep_med_survivors.htm.
5 Comprehensive National Cancer Control Network. Managing Distress, Version 3.2019, NCCN Clinical Practice Guidelines in Oncology. https://jnccn.org/view/journals/jnccn/17/10/article-p1229.xml.
6 Onco Link. What is Cancer Distress? https://www.oncolink.org/support/practical-and-emotional/coping-communication-concerns/what-is-cancer-related-distress.
7 American Cancer Society. Facts and figures about cancer treatment and survivorship 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.