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

NCT05227898 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2022-10-25

No results posted yet for this study

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 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.

Conditions

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Curebase Inc.

    collaborator INDUSTRY

  • Blue Note Therapeutics

    lead INDUSTRY

Principal Investigators

  • Dianne M Shumay · Blue Note Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2022-12-02
Completion
2022-12-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05227898 on ClinicalTrials.gov