Status:
UNKNOWN
Virtual Trial to Compare Two Digital Therapeutics as Interventions for Physical and Mental Health in People With Cancer
Lead Sponsor:
Blue Note Therapeutics
Collaborating Sponsors:
Curebase Inc.
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a 2-arm randomized controlled study comparing how effective two therapeutic digital software devices are at improving anxiety and other indicators of psychological and physical health in patie...
Eligibility Criteria
Inclusion
- Stage I-III cancer diagnosis
- Currently in active systemic treatment of chemotherapy, radiation or immunotherapy, have completed systemic treatment within the past 6 months, or have a treatment plan including planned systemic treatment.
- Are experiencing at least moderate anxiety
- 18 years of age or older
- Are fluent in English
- Have access to a smartphone (a mobile phone that performs many of the functions of a computer, typically having a touchscreen interface, internet access, and an operating system capable of running downloaded applications) or tablet that runs iOS or Android software, with cellular data service or wifi access.
- Willing to download software onto smartphone or tablet from Apple store or Android store
Exclusion
- Systemic treatment plan includes only endocrine therapy.
- Treatment plan includes stem cell/bone marrow transplant.
- Currently participating in any other investigative CBT trial for treatment of anxiety or depression.
- Participant is unable to complete training, has cognitive deficits, more severe psychiatric conditions, lack of access to internet accessible device or psycho-social conditions (e.g., other social conditions, that would interfere with adherence to self-directed care), such that in investigator's opinion the participant would be unable to complete the study
- Recently completed use of Blue Note Therapeutics Covid Cancer Care Program or other Blue Note Therapeutics device or Blue Note Therapeutics-sponsored study
- Are experiencing severe levels of depression OR indicate suicidal risk (measured by surveys during screening for the study)
- Are experiencing anxiety below the required level (measured by a survey during screening for the study)
- Cancer diagnosis is melanoma, multiple myeloma, unstaged cancer.
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2022
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT05227898
Start Date
March 10 2022
End Date
December 15 2022
Last Update
October 25 2022
Active Locations (1)
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1
Www.Restoreclinicaltrial.Com
San Francisco, California, United States, 94104