BNT001 Digital Therapeutic Feasibility Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Device: BNT001

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham Veterans Administration

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BNT001; 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.	Device: BNT001; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient completion rates	To measure patient completion rates via the BNT001's underlying device data capture system.	Baseline to 12 weeks
Patient feasibility and acceptability	To measure patient feasibility and acceptability via a midpoint and post-completion questionnaire.	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Blue Note Therapeutics
• Collaborators: Durham VA Health Care System
• Investigators: Principal Investigator: Daphne Friedman, MD, Durham Veterans Administration Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Actual): August 5, 2022
• Study Completion (Actual): August 5, 2022

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BNT001 VA Pilot Study_3_4_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No