Virtual Trial to Compare Two Digital Therapeutics as Interventions for Physical and Mental Health in People With Cancer (RESTORE)

Blue Note Therapeutics

Status

Active, not recruiting

Conditions

Cancer

Treatments

Device: Device: Attune™

Device: Device: Cerena™

Study type

Interventional

Funder types

Industry

Identifiers

NCT05227898

PROT004

Details and patient eligibility

About

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.

Enrollment

352 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.