CancerNCT04857008
BNT001 Digital Therapeutic Feasibility Pilot Study
A study testing BNT001 in people with Cancer, run by Blue Note Therapeutics at 1 site in United States.
Trial summary
This single arm phase II trial focused on cancer patients and cancer survivors in the Veterans Health Administration will gather data on feasibility, acceptability, ease of clinical implementation, and preliminary efficacy of BNT001, a prescription digital software application. Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- BNT001
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2021to 5 Aug 2022
- 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 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis or history of invasive cancer (excluding non-melanoma skin cancer).
- Patients showing mild to moderate anxiety or depression on the Veteran System Assessment Screen (VSAS), with anxiety or depression scored as 1-6 on a 0-10 scale.
- Fluent in English.
- Has access to iOS or Android smartphone, or tablet and capable of receiving text messages.
- Has an e-mail address.
Who cannot join
- Endorses thoughts of self-harm, history of suicidality.
- Currently participating in investigative behavioral intervention trial for treatment of anxiety or depression.
- Participant is unable to complete training, has cognitive deficits, major psychiatric conditions, psycho-social conditions; lack of access to reliable internet and accessible device; other social conditions that would interfere with adherence to self directed care, such that in investigator's opinion the participant would be unable to complete the study.
- Recently completed use of Blue Note Therapeutics COVID Cancer Care Program or other Blue Note Therapeutics sponsored study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham Veterans Administration
Durham, North Carolina, 27705
About this study
Official title: Phase II Pilot Study Evaluating the Feasibility of Delivery and Evaluation of BNT001, a Digital Cognitive-Behavioral Stress Management (CBSM) Software Application for Treatment of Anxiety and Depressive Symptoms in Veterans With Cancer
This single arm phase II trial focused on cancer patients and cancer survivors in the Veterans Health Administration will gather data on feasibility, acceptability, ease of clinical implementation, and preliminary efficacy of BNT001, a prescription digital software application. BNT001 delivers a 10-session digitally administered version of a published manualized therapy for stress management in adult cancer patients that has established efficacy in improving quality of life and mood.
Read the detailed description
This pilot will study specific implementation barriers and facilitators, procedures that are necessary to ensure adherence to utilization of the digital program, as well as any potential safety issues associated with recruiting and offering an intervention to cancer patients with moderate anxiety or mild depressive symptoms. Data relating to patient experience, adherence, satisfaction and pre-post intervention outcomes will also be tracked.
The study will run in two distinct phases to first assess the process of clinical implementation by prescribing oncology clinicians, and in a second more expanded phase, further assess the clinical implementation and impact on enrolled patients.
Study Phase 1: We aim to identify promoters and barriers to the clinical implementation of BNT001, a software application that delivers a 10-session digitally administered version of a published manualized therapy for stress management in adult cancer patients that has established efficacy in improving quality of life and mood.
Study Phase 2: We aim to further identify promoters and barriers to provider clinical implementation of BNT001, assess patient acceptability and feasibility including patient adherence to BNT's 10-sessions, and obtain preliminary data on BNT001's impact on cancer-related distress.
- Conditions
- Cancer
- Being tested
- BNT001
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT001Device
BNT001 is a commercially-available, prescription-only, software / medical device in the form of a digital application (digital app) for use on the participant's mobile device which delivers 10-sessions on cognitive behavioral therapy for cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| BNT001 | Experimental | BNT001 is a commercially-available, prescription-only, software / medical device in the form of a digital application (digital app) for use on the participant's mobile device which delivers 10-sessions on cognitive behavioral therapy for cancer patients. Receives: Device: BNT001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of promoters and barriers to clinical implementation
Identification of promoters and barriers to clinical implementation of BNT001, a software application that delivers a 10-session, cancer-specific, behavioral intervention called Cognitive-Behavioral Stress Management (CBSM), to adult patients currently undergoing cancer treatment.
Measured: Baseline to 4 weeks
To measure changes in pre and post cancer-related distress in patient participants.
Patient participants symptoms will be assessed with the Veterans Symptom Assessment Screen (VSAS). The VSAS is a clinical patient reported outcomes tool to document cancer-related symptoms to improve quality of life that has been adopted across VA hematology-oncology sites. The VSAS is comprised of 13 symptoms, rated on a 0 to 10 scale.
Measured: Baseline to 12 weeks
Secondary outcomes (2)
Patient completion rates
To measure patient completion rates via the BNT001's underlying device data capture system.
Measured: Baseline to 12 weeks
Patient feasibility and acceptability
To measure patient feasibility and acceptability via a midpoint and post-completion questionnaire.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start8 Oct 2021
- Primary completion5 Aug 2022
- Study completion5 Aug 2022
Why it stopped: recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blue Note Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Durham VA Health Care System
- Responsible party
- Sponsor
- Investigators
- Daphne Friedman, MD, Principal investigator, Durham Veterans Administration Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857008
- Sponsor's protocol ID
- BNT001 VA Pilot Study_3_4_2021
- Status last verified
- Oct 2022
- First submitted
- 20 Apr 2021
- Last updated
- 20 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Study Evaluating the Feasibility of Delivery and Evaluation of BNT001, a Digital Cognitive-Behavioral Stress Management (CBSM) Software Application for Treatment of Anxiety and Depressive Symptoms in Veterans With Cancer
- ClinicalTrials.gov ID
- NCT04857008
- Acronym / sponsor ID
- BNT001 VA Pilot Study_3_4_2021
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment challenges
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Blue Note TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Durham VA Health Care System
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 23 Apr 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 single arm phase II trial focused on cancer patients and cancer survivors in the Veterans Health Administration will gather data on feasibility, acceptability, ease of clinical implementation, and preliminary efficacy of BNT001, a prescription digital software application. BNT001 delivers a 10-session digitally administered version of a published manualized therapy for stress management in adult cancer patients that has established efficacy in improving quality of life and mood.
Detailed description
This pilot will study specific implementation barriers and facilitators, procedures that are necessary to ensure adherence to utilization of the digital program, as well as any potential safety issues associated with recruiting and offering an intervention to cancer patients with moderate anxiety or mild depressive symptoms. Data relating to patient experience, adherence, satisfaction and pre-post intervention outcomes will also be tracked.
The study will run in two distinct phases to first assess the process of clinical implementation by prescribing oncology clinicians, and in a second more expanded phase, further assess the clinical implementation and impact on enrolled patients.
Study Phase 1: We aim to identify promoters and barriers to the clinical implementation of BNT001, a software application that delivers a 10-session digitally administered version of a published manualized therapy for stress management in adult cancer patients that has established efficacy in improving quality of life and mood.
Study Phase 2: We aim to further identify promoters and barriers to provider clinical implementation of BNT001, assess patient acceptability and feasibility including patient adherence to BNT's 10-sessions, and obtain preliminary data on BNT001's impact on cancer-related distress.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BNT001 | Experimental | Device: BNT001BNT001 is a commercially-available, prescription-only, software / medical device in the form of a digital application (digital app) for use on the participant's mobile device which delivers 10-sessions on cognitive behavioral therapy for cancer patients. |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis or history of invasive cancer (excluding non-melanoma skin cancer).
- Patients showing mild to moderate anxiety or depression on the Veteran System Assessment Screen (VSAS), with anxiety or depression scored as 1-6 on a 0-10 scale.
- Fluent in English.
- Has access to iOS or Android smartphone, or tablet and capable of receiving text messages.
- Has an e-mail address.
Key exclusion criteria (4 listed)
- Endorses thoughts of self-harm, history of suicidality.
- Currently participating in investigative behavioral intervention trial for treatment of anxiety or depression.
- Participant is unable to complete training, has cognitive deficits, major psychiatric conditions, psycho-social conditions; lack of access to reliable internet and accessible device; other social conditions that would interfere with adherence to self directed care, such that in investigator's opinion the participant would be unable to complete the study.
- Recently completed use of Blue Note Therapeutics COVID Cancer Care Program or other Blue Note Therapeutics sponsored study.
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 |
|---|---|---|
| BNT001BNT001 is a commercially-available, prescription-only, software / medical device in the form of a digital application (digital app) for use on the participant's mobile device which delivers 10-sessions on cognitive behavioral therapy for cancer patients. | Device | BNT001 |
Primary outcome
Identification of promoters and barriers to clinical implementation
Time frame: Baseline to 4 weeks
Identification of promoters and barriers to clinical implementation of BNT001, a software application that delivers a 10-session, cancer-specific, behavioral intervention called Cognitive-Behavioral Stress Management (CBSM), to adult patients currently undergoing cancer treatment.
To measure changes in pre and post cancer-related distress in patient participants.
Time frame: Baseline to 12 weeks
Patient participants symptoms will be assessed with the Veterans Symptom Assessment Screen (VSAS). The VSAS is a clinical patient reported outcomes tool to document cancer-related symptoms to improve quality of life that has been adopted across VA hematology-oncology sites. The VSAS is comprised of 13 symptoms, rated on a 0 to 10 scale.
2 secondary outcomes
Patient completion rates
Time frame: Baseline to 12 weeks
Patient feasibility and acceptability
Time frame: Baseline to 12 weeks
Results and safety
The study was stopped early (reason given: recruitment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- 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.
Daphne Friedman, MD principal investigator
Durham Veterans Administration Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BNT001 in people with Cancer, 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 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 was stopped early (reason given: recruitment challenges). Results are not available in the source record.
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?
Identification of promoters and barriers to clinical implementation (time frame: Baseline to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2022.