NCT05032404

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

August 31, 2021

Last Update Submit

October 18, 2022

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Measure of Current Status - Anxiety (MOCS-A)

    Baseline up to Week 7

Study Arms (1)

BNT103

EXPERIMENTAL

All participants receive BNT103. BNT103 provides 10 sessions over approximately 10 weeks.

Device: BNT103

Interventions

BNT103DEVICE

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.

BNT103

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsDiagnosed with breast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blue Note Therapeutics

San Francisco, California, 93065, United States

Location

Related 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.

    PMID: 18835434BACKGROUND

Study Officials

  • Dianne Shumay, PhD

    Blue Note Therapeutics, Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 2, 2021

Study Start

September 1, 2021

Primary Completion

October 26, 2021

Study Completion

December 31, 2021

Last Updated

October 19, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)