Status:
TERMINATED
BNT001 Digital Therapeutic Feasibility Pilot Study
Lead Sponsor:
Blue Note Therapeutics
Collaborating Sponsors:
Durham VA Health Care System
Conditions:
Cancer
Eligibility:
All Genders
17-75 years
Phase:
NA
Brief 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, an...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04857008
Start Date
October 8 2021
End Date
August 5 2022
Last Update
October 20 2022
Active Locations (1)
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1
Durham Veterans Administration
Durham, North Carolina, United States, 27705