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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05032404
Other study ID # PROT002 - Test Plan 01 Rev A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date December 31, 2021

Study information

Verified date October 2022
Source Blue Note Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This test aims to explore product development-focused usability and user engagement.


Description:

Sponsor is testing an innovative peer-to-peer communication tool during this trial.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
BNT103
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.

Locations

Country Name City State
United States Blue Note Therapeutics San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
Blue Note Therapeutics Healthcare Innovation Technology Lab

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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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