Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Healthcare Innovation Technology Lab | INDUSTRY |
Not provided
Not provided
This test aims to explore product development-focused usability and user engagement.
Sponsor is testing an innovative peer-to-peer communication tool during this trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BNT103 | Experimental | All participants receive BNT103. BNT103 provides 10 sessions over approximately 10 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNT103 | Device | BNT-103â„¢ is a prescription digital therapeutic specifically designed to treat the symptoms of anxiety and depression related to cancer. There are 10 sessions provided over approximately 10 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Current Status - Anxiety (MOCS-A) | The MOCS-A is a 13-item self-report measure developed to assess participants' current self-perceived status on: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed, higher scores indicate greater self-perceived proficiency with these skills. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Diagnosed with breast cancer
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dianne Shumay, PhD | Blue Note Therapeutics, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blue Note Therapeutics | San Francisco | California | 93065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18835434 | Background | Antoni MH, Lechner S, Diaz A, Vargas S, Holley H, Phillips K, McGregor B, Carver CS, Blomberg B. Cognitive behavioral stress management effects on psychosocial and physiological adaptation in women undergoing treatment for breast cancer. Brain Behav Immun. 2009 Jul;23(5):580-91. doi: 10.1016/j.bbi.2008.09.005. Epub 2008 Sep 20. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline up to Week 7 |