Virtual Trial to Compare Two Digital Therapeutics as Interventions for Physical and Mental Health in People With Cancer
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 patients with cancer. The study will be completely virtual, meaning participants can take part completely from home without visiting a clinic or study site. The digital software devices, called called attune™ and cerena™, are designed to be used for approximately 12 weeks alongside oncology usual care regimens (medical, psychosocial). The study will enroll at least 352 stage I-III cancer patients with elevated anxiety symptoms who are currently receiving systemic treatment (radiation, chemotherapy, immunotherapy), have received systemic treatment within the last 6 months, or who have an established treatment plan that includes systemic treatment.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 25, 2022 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Blue Note Therapeutics
- Interventions being studied
- Device: Device: Attune™; Device: Device: Cerena™
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Www.Restoreclinicaltrial.ComSan Francisco, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 25, 2022. Always confirm current availability with the study team.