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Completed

NCT Number: NCT05032404

Blue Note Therapeutics Product BNT 103 Usability and User Engagement

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

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Key information

Conditions

Breast Cancer Female

Age range

35 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Blue Note Therapeutics

San Francisco, California, 93065, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BNT103

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Blue Note Therapeutics

Industry

Collaborators

  • Healthcare Innovation Technology Lab

Registry information

Official study title

BNT 103 Usability and User Engagement

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 2, 2021
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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