BNT001 Digital Therapeutic Feasibility Pilot Study

Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04857008
• Other study ID #: BNT001 VA Pilot Study_3_4_2021
• Status: Terminated
• Phase: N/A
• Start date: October 8, 2021
• Est. completion date: August 5, 2022

Study information

• Verified date: October 2022
• Source: Blue Note Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: August 5, 2022
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Durham Veterans Administration	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Blue Note Therapeutics	Durham VA Health Care System

Country where clinical trial is conducted

United States, 

Outcome

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