Breast Cancer Female
Conditions
Brief summary
This test aims to explore product development-focused usability and user engagement.
Detailed description
Sponsor is testing an innovative peer-to-peer communication tool during this trial.
Interventions
DEVICEBNT103
BNT-103™ 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.
Sponsors
Healthcare Innovation Technology Lab
Blue Note Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Patient can read, write, and speak in English * Patient is between the ages of 35-55 * Diagnosed with Stage I-III breast cancer * In active treatment or within 3 months of ending active treatment and under the care of a clinician at time of study * Apple mobile phone or tablet user * Willing to participate in study protocol
Exclusion criteria
* Any participant not meeting inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients | Baseline up to Week 7 | Higher scores indicate higher ease of use / easier to use applications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Current Status - Anxiety (MOCS-A) | Baseline up to Week 7 | 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. |
Countries
United States
Outcome results
None listed