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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2022-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Attune™

Attune™ is a completely digital therapeutic intervention.

Group Type ACTIVE_COMPARATOR

Device: Attune™

Intervention Type DEVICE

People enrolled in the study use the app to complete ten informational sessions, each approximately 60-minute in length. The app also include guided exercises and other interactive opportunities.

Cerena™

Cerena™ is a completely digital therapeutic intervention.

Group Type ACTIVE_COMPARATOR

Device: Cerena™

Intervention Type DEVICE

People enrolled in the study use the app to complete ten informational sessions, each approximately 60-minute in length. The app also include guided exercises and other interactive opportunities.

Interventions

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Device: Attune™

People enrolled in the study use the app to complete ten informational sessions, each approximately 60-minute in length. The app also include guided exercises and other interactive opportunities.

Intervention Type DEVICE

Device: Cerena™

People enrolled in the study use the app to complete ten informational sessions, each approximately 60-minute in length. The app also include guided exercises and other interactive opportunities.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No