Breast Cancer FemaleNCT05032404
Blue Note Therapeutics Product BNT 103 Usability and User Engagement
A study testing BNT103 in people with Breast Cancer Female, run by Blue Note Therapeutics at 1 site in United States.
Trial summary
This test aims to explore product development-focused usability and user engagement. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- BNT103
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Any participant not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Blue Note Therapeutics
San Francisco, California, 93065
About this study
Official title: BNT 103 Usability and User Engagement
This test aims to explore product development-focused usability and user engagement.
Read the detailed description
Sponsor is testing an innovative peer-to-peer communication tool during this trial.
- Conditions
- Breast Cancer Female
- Being tested
- BNT103
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| BNT103 | Experimental | All participants receive BNT103. BNT103 provides 10 sessions over approximately 10 weeks. Receives: Device: BNT103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients
Higher scores indicate higher ease of use / easier to use applications
Measured: Baseline up to Week 7
Secondary outcomes (1)
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.
Measured: Baseline up to Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Sep 2021
- Primary completion26 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blue Note Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Healthcare Innovation Technology Lab
- Responsible party
- Sponsor
- Investigators
- Dianne Shumay, PhD, Principal investigator, Blue Note Therapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032404
- Sponsor's protocol ID
- PROT002 - Test Plan 01 Rev A
- Status last verified
- Oct 2022
- First submitted
- 31 Aug 2021
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 18835434
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BNT 103 Usability and User Engagement
- ClinicalTrials.gov ID
- NCT05032404
- Acronym / sponsor ID
- PROT002 - Test Plan 01 Rev A
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Blue Note TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Healthcare Innovation Technology Lab
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This test aims to explore product development-focused usability and user engagement.
Detailed description
Sponsor is testing an innovative peer-to-peer communication tool during this trial.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BNT103 | Experimental | Device: BNT103All participants receive BNT103. BNT103 provides 10 sessions over approximately 10 weeks. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Any participant not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNT103BNT-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. | Device | BNT103 |
Primary outcome
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
1 secondary outcome
Measure of Current Status - Anxiety (MOCS-A)
Time frame: Baseline up to Week 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Background: PubMed 18835434Antoni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dianne Shumay, PhD principal investigator
Blue Note Therapeutics, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BNT103 in people with Breast Cancer Female, run by Blue Note Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients (time frame: Baseline up to Week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05032404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.