BNT001 Digital Therapeutic Feasibility Pilot Study

NCT04857008 | Terminated

• 1 other identifier: BNT001 VA Pilot Study_3_4_2021
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Patient completion rates

  Baseline to 12 weeks

• Patient feasibility and acceptability

  Baseline to 12 weeks

Study Arms (1)

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.

Device: BNT001

Interventions

BNT001 DEVICE

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.

BNT001

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blue Note Therapeutics: lead
• Durham VA Health Care System: collaborator

Study Sites (1)

Durham Veterans Administration

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Daphne Friedman, MD

  Durham Veterans Administration Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: October 8, 2021
• Primary Completion: August 5, 2022
• Study Completion: August 5, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)