Blue Note Therapeutics Product BNT 103 Usability and User Engagement

October 18, 2022 updated by: Blue Note Therapeutics

BNT 103 Usability and User Engagement

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 93065
        • Blue Note Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BNT103
All participants receive BNT103. BNT103 provides 10 sessions over approximately 10 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients
Time Frame: Baseline up to Week 7
Higher scores indicate higher ease of use / easier to use applications
Baseline up to Week 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of Current Status - Anxiety (MOCS-A)
Time Frame: 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.
Baseline up to Week 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blue Note Therapeutics

Collaborators

Healthcare Innovation Technology Lab

Investigators

  • Principal Investigator: Dianne Shumay, PhD, Blue Note Therapeutics, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

October 26, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 2, 2021

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PROT002 - Test Plan 01 Rev A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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