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

Cancer Clinical Trial

Official title:
Two-arm, Double-blind, Randomized Controlled Trial to Compare Efficacy of Two Digital Software Medical Devices as Interventions for Physical and Mental Health in Patients With Stage I-III Cancer

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05227898
Study type Interventional
Source Blue Note Therapeutics
Contact
Status Active, not recruiting
Phase N/A
Start date March 10, 2022
Completion date December 15, 2022
View Details
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