Breast Cancer Female Clinical Trial
Official title:
BNT 103 Usability and User Engagement
Verified date | October 2022 |
Source | Blue Note Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This test aims to explore product development-focused usability and user engagement.
Status | Completed |
Enrollment | 15 |
Est. completion date | December 31, 2021 |
Est. primary completion date | October 26, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 35 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Blue Note Therapeutics | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Blue Note Therapeutics | Healthcare Innovation Technology Lab |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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. | Baseline up to Week 7 |
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