Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage I Lung Cancer AJCC v8
Conditions
Brief summary
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.
Interventions
DEVICEAttune™
Software as a medical device
DEVICECerena™
Software as a medical device
Sponsors
Blue Note Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cancer-related symptoms of anxiety (1) | Baseline up to Week 10 | Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cancer-related symptoms of anxiety (2) | Baseline up to Week 12 | Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety |
| Cancer-related symptoms of depression (1) | Baseline up to Week 10 | Percent reduction in PROMIS-D scores, reduction indicates reduced depression |
| Cancer-related symptoms of anxiety (3) | Baseline up to Week 10 | Percent reduction in Clinical Global Impression Scale and Improvement scores, reduction indicates reduced anxiety |
| Cancer-related symptoms of depression (4) | Baseline up to Week 12 | Percent reduction in Clinical Global Impression Scale and Improvement scores, reduction indicates reduced depression |
| Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients | Baseline up to Week 10 | Higher scores indicate higher ease of use / easier to use applications |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient self-efficacy via the Measurement of Current Status (MOCS) Part A and Part B | Baseline, Week 6, and Week 10 | The Measure of Current Status (MOCS) scale comes from research on the effects of a multi-modal cognitive-behavioral stress management intervention on the psychosocial well-being of cancer patients. The MOCS has two sections. Part A is items measuring participants' current self-perceived status on several skills that are targeted by the intervention: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Part B assesses potential nonspecific effects of the intervention: feelings of normalcy vs. alienation, sense of cohesiveness with other patients, perceptions of care from persons around them, and a sense of being better off than other cancer patients. All items were framed in such a way that they are sensible to participants in both conditions. MOCS measurements will be taken at Baseline, Week 6, and Week 10. Higher scores indicate higher self-efficacy. |
| Immune cell transcription | Baseline up to Week 12 | Analyses will focus on inflammatory gene expression and related gene regulation pathways due to their established relevance for disease progression/recurrence in the aftermath of cancer diagnosis and treatment, and their role in promoting symptoms of depression or anxiety via effects on central nervous system function |
| Patient self-efficacy via the Patient Activation Measure-13 (PAM-13) | Weeks 10 | Patient Activation Measures-the knowledge, skills, and confidence to manage one's health is associated with improved self-management behaviors in cancer patients. A patient activation measure (PAM) using PAM-13 will be used to assess participant engagement at baseline after PROMIS-A and PROMIS-D are completed and at Week 10. Higher scores indicate higher self-efficacy. |
| Quality of life via PROMIS-Global Health v1.2 | Weeks 10 and Week 12 | The PROMIS Global Health measures assess an individual's physical, mental, and social health. The measures are generic, rather than disease-specific, and often use an In General item context as it is intended to globally reflect individuals' assessment of their health. The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health (Promis-Global Health Scoring Manual, 2017). Higher scores for responses always indicate better health. |
Countries
United States
Outcome results
None listed