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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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT04857008
Study type Interventional
Source Blue Note Therapeutics
Contact Mark W Elfers
Phone 4152371682
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date April 2021
Completion date October 2021

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