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Virtual Trial to Test Digital Cancer Stress Therapies

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14 Mar. 2022. A home-based clinical trial is set to begin testing digital therapies for relieving anxiety and managing other health challenges among cancer patients. Blue Note Therapeutics, a developer of digital therapies for managing cancer-related stress, is conducting the trial with Curebase, a decentralized clinical trials company. Both businesses are in San Francisco.

Blue Note Therapeutics provides digital treatments by prescription as mobile apps to help people with cancer cope with their conditions. The company says says it applies principles of cognitive behavioral stress management, a form of cognitive behavioral therapy, to help cancer patients cope with mental health effects of their disease. Cognitive behavioral therapy seeks to identify negative or false patterns of beliefs, then test and restructure them. Addressing these patterns, say therapists, allows the individual, working with the therapist, to develop healthier ways of thinking that replace negative beliefs.

For people with serious diseases, cognitive behavioral stress management aims to provide tools for dealing with mental strains that accompany their physical disease symptoms. The tools include steps for aiding relaxation, understanding and restructuring negative thought patterns, and improving interpersonal skills. In Jan. 2021, Science & Enterprise reported on Blue Note’s collaboration with advocacy groups to provide electronic therapies for helping cancer patients deal with stresses from Covid-19.

Testing two Blue Note apps

Curebase offers systems for conducting decentralized clinical trials, where clinicians and patients provide data from remote locations rather than traveling to medical centers. The company says its eClinical software enables investigators to establish remote sites for data collection from telemedicine and wearable devices, gain informed consent from participants, and protect privacy. Curebase says its virtual sites make it possible to expand clinical trial participation to any part of the U.S., and include demographic groups often under-represented in trials.

Blue Note’s clinical study is using Curebase’s technology to test two of its apps, Attune and Cerena. Attune, says Blue Note, offers a personalized therapy based on cognitive behavioral therapy and stress management for cancer patients to build skills to help cope with anxiety and depression. The company says Cerena helps cancer patients deal with related health challenges that contribute to stress.

The clinical trial is enrolling adult cancer patients in stages 1 through 3, from an early localized tumor to spreading to nearby tissues or lymph nodes. Some 352 participants are randomly assigned to use from home either the Attune or Cerena app. Each app has 10 sessions of about 60 minutes in length, with related exercises. Participants are then tracked for 12 weeks, with researchers looking mainly at changes in scores in a standard eight-item scale for anxiety. The study team is also asking participants to report on several other mental health measures, rate the usability of the apps, and indicate other use of health care facilities.

“Patients living with cancer frequently experience stress, anxiety, and depression,” says Blue Note CEO Geoffrey Eich in a statement. Referring to the decentralized trial, Eich adds, “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.”

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