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BNT001 Digital Therapeutic Feasibility Pilot Study

NCT04857008 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-10-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Durham VA Health Care System

    collaborator FED

  • Blue Note Therapeutics

    lead INDUSTRY

Principal Investigators

  • Daphne Friedman, MD · Durham Veterans Administration Health Care System

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2022-08-05
Completion
2022-08-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04857008 on ClinicalTrials.gov