Clinical trialNCT04862195TerminatedInterventional

Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment

SponsorBlue Note TherapeuticsEnrollment31Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Stage I Lung Cancer AJCC v8Stage II Lung Cancer AJCC v8Stage III Lung Cancer AJCC v8

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a non-significant risk, double-blinded, randomized, registrational study to compare the effectiveness of two digital, software only, medical devices (SaMD) (attune™ and cerena™) in reducing cancer-related anxiety and depression symptoms when used adjunctively with multidisciplinary (medical, psychosocial) oncology usual care regimens for up to 10 weeks. Study population will consist of up to 553 participants with stage I-III breast cancer or stage I-III NSCLC. The primary endpoint is percent improvement in anxiety symptoms at Week 10 and secondary endpoints of percent improvement in depressive symptoms will be assessed at Week 12. An interim analysis for efficacy and futility will be conducted once 236 participants have completed the study.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Patricia A Ganz, MD
University of California, Los Angeles
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

13 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Opn Healthcare
Glendale, California, United States
Oncology Physicians Network Healthcare
Los Alamitos, California, United States
Redlands Oncology
Redlands, California, United States
Eastern Ct Hematology and Oncology Associates
Norwich, Connecticut, United States
Illinios Cancer Care
Peoria, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Rogel Cancer Center | University of Michigan
Ann Arbor, Michigan, United States
Scl Health
Billings, Montana, United States
New Jersey Center for Cancer Research
Brick, New Jersey, United States
New York Cancer & Blood Specialists
Port Jefferson Station, New York, United States
Tri-County Hematology and Oncology-Massillon
Massillon, Ohio, United States
Md Anderson
Houston, Texas, United States
Northwest Medical Specialty
Tacoma, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 15 May 2021
Primary completion: 1 Sept 2022
Completion: 1 Sept 2022
Last update posted: 13 Sept 2022
Registered enrollment: 31
Registry id: NCT04862195

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.