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

Blue Note Therapeutics

Status

Terminated

Conditions

Stage I Lung Cancer AJCC v8

Stage III Lung Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage I Breast Cancer AJCC v8

Stage II Lung Cancer AJCC v8

Treatments

Device: Cerena™

Device: Attune™

Study type

Interventional

Funder types

Industry

Identifiers

NCT04862195

PROT001

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Stage I-III breast cancer or Stage I-III NSCLC who are currently in active treatment or have completed initial cancer directed treatments (surgery, radiation, chemotherapy) within the past 3 months;
Are experiencing at least moderate anxiety (GAD-7 >10) or mild-to-moderate depression (PHQ-8 score 5-11);
Are fluent in English; and
Have access to smartphone, or tablet capable of running iOS or Android software.

Exclusion criteria

Previous history of cancer;
<2-yr survival prognosis as determined by treating clinician;
Currently participating in 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-sponsored study; and
PHQ-9 Q9 response >0 AND Columbia Suicide Severity Risk Scale (or equivalent) score of Category 2- "suicidal ideation" at screening.