Clinical trial NCT04857008: BNT001 Digital Therapeutic Feasibility Pilot 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Lead sponsor: Blue Note Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Durham VA Health Care System
First posted: 2021-04-23
Enrollment: 17
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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, 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Identification of promoters and barriers to clinical implementation
timeFrame: Baseline to 4 weeks
measure: To measure changes in pre and post cancer-related distress in patient participants.
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Patient completion rates
timeFrame: Baseline to 12 weeks
measure: Patient feasibility and acceptability
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham Veterans Administration
state: North Carolina
Study officials:
affiliation: Durham Veterans Administration Health Care System
name: Daphne Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References: