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

Study Overview
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Brief Summary
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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.

Official Title
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Double-blinded, Randomized, Adaptive Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices (Attune™ and Cerena™) as Interventions for Physical and Emotional Health in Adjunctive Oncology Treatment

Conditions
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Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8

Intervention / Treatment
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* Device: Attune™
* Device: Cerena™


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Attune™<br>Attune™ is a completely digital, 10-session, cognitive behavioral therapeutic intervention. | Device: Attune™<br>* Software as a medical device<br>|
| Active Comparator: Cerena™<br>Cerena™ is a completely digital, 10-session, health education and wellness intervention. | Device: Cerena™<br>* Software as a medical device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-related symptoms of anxiety (1) | Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety | Baseline up to Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-related symptoms of depression (1) | Percent reduction in PROMIS-D scores, reduction indicates reduced depression | Baseline up to Week 10 | 
| Cancer-related symptoms of anxiety (2) | Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety | Baseline up to Week 12 | 
| Cancer-related symptoms of anxiety (3) | Percent reduction in Clinical Global Impression Scale and Improvement scores, reduction indicates reduced anxiety | Baseline up to Week 10 | 
| Cancer-related symptoms of depression (4) | Percent reduction in Clinical Global Impression Scale and Improvement scores, reduction indicates reduced depression | Baseline up to Week 12 | 
| Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients | Higher scores indicate higher ease of use / easier to use applications | Baseline up to Week 10 |