NCT05227898 (RESTORE) is a NA clinical trial of Device: Attune™ in Cancer, sponsored by Blue Note Therapeutics.

Who is sponsoring NCT05227898?

NCT05227898 is sponsored by Blue Note Therapeutics.

What drugs are being tested in NCT05227898?

Interventions in NCT05227898: Device: Attune™, Device: Cerena™.

Is NCT05227898 still recruiting?

NCT05227898 is currently status unknown. Last updated 25 October 2022.

Last reviewed 2022-10-25 · How we verify

NCT05227898: RESTORE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown NA Last updated 25 October 2022

What this trial tests

NA trial testing Device: Attune™ in Cancer in 352 participants. Status unknown.

Timeline

10 March 2022

Primary endpoint
2 December 2022

15 December 2022

Quick facts

Lead sponsor	Blue Note Therapeutics
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	352
Start date	10 March 2022
Primary completion	2 December 2022
Estimated completion	15 December 2022
Sites	1 location across United States

Drugs / interventions tested

Device: Attune™
Device: Cerena™

Conditions studied

Cancer — all drugs for Cancer →

Sponsor

Blue Note Therapeutics

Who can join

18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effects of a Cognitive Behavioral Digital Therapeutic on Anxiety and Depression Symptoms in Patients With Cancer: A Randomized Controlled Trial.
Zion SR, Taub CJ, Heathcote LC, Ramiller A, et al · · 2023 · cited 11× · PMID 37862670 · DOI 10.1200/op.23.00210

Verify or expand the search:

Other recruiting trials for Cancer

Currently open trials in the same condition.

NCT07390045 — Exercise and Cognitive Rehabilitation Interventions for Older Cancer Survivors · NA · recruiting
NCT07528547 — Hypersight and Ethos In Pediatric Radiotherapy · NA · recruiting
NCT07481890 — Feasibility and Efficacy of the EMDR Toolbox Method in Cancer Patients. · NA · recruiting
NCT07402057 — Implementation and Evaluation of a Program Aimed at Facilitating Palliative Care Conversations · NA · recruiting
NCT07305740 — On-Trac: An Online Intervention for Cancer Survivors Managing Anxiety · NA · recruiting

Other Blue Note Therapeutics trials

Trials by the same sponsor.

NCT05647785 — Long-term Follow-up of RESTORE Study · unknown
NCT04857008 — BNT001 Digital Therapeutic Feasibility Pilot Study · NA · terminated
NCT05032404 — Blue Note Therapeutics Product BNT 103 Usability and User Engagement · NA · completed
NCT04862195 — Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment · NA · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05227898 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Blue Note Therapeutics
Last refreshed: 25 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05227898.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing