Vibrent Smartphone Mobile Application
Condition: Mucositis
MeSH terms: Mucositis
Study type: Interventional

Summary: 
      This research is being done to evaluate whether or not a customized version of the VibrentTM
      (formerly FitNinjaTM) mobile app is a feasible way to help people manage and control the pain
      from radiation sores (also referred to as "mucositis") when treating head and neck cancers
      with radiation. The mobile app will be designed to help people better understand the pain
      from the radiation sores and how to better use their medications especially when they are
      away from the hospital.
    

Detailed description: 
      The proposed study will evaluate the feasibility of the VibrentTM smartphone application to
      evaluate radiation-induced mucositis pain "out of the clinic" and it's ability to enhance
      adherence to the prophylactic pain management algorithm. Successful completion of the
      proposed study will provide the foundation upon which a randomized trial can be conducted
      evaluating the efficacy of prophylactic gabapentin / narcotics for various toxicity,
      patient-reported and oncologic outcomes in patients receiving head and neck radiotherapy.
      Moreover, successful establishment of this pain analgesic approach may have future
      implications in other pain models where there is planned neuropathic tissue injury.

      Vibrent Management has established a policy and procedure regarding the Privacy of Protected
      Health Information (PHI) and Security of Electronic Protected Health Information (EPHI). This
      procedure applies to applicable Vibrent employees and contractors associated with the
      management of VibrentTM customer's Protected Health Information. VibrentTM products are HIPAA
      and HITECH Act compliant, and use the highest quality processes based on ISO13485 standard
      during software design and development. VibrentTM quality process has successfully passed
      quality audits from leaders in medical devices and pharmaceutical products. The security,
      privacy, quality processes and HIPAA compliance of VibrentTM LHS (Learning Healthcare System)
      Cloud hosted system has been cleared for commercial use by the DoD (US Army) to provide
      remote care management services for soldiers and civilians. In addition, this secure and
      HIPAA compliant VibrentTM LHS has received SSAE16 certification to prove operational controls
      needed to ensure such compliance.

      The Vibrent LHS security components include security of data in flight and data at rest
      throughout end-to-end system architecture. VibrentTM mobile and web applications are designed
      to be secure in handling information provided and stored within it. All data exchanges
      between mobile applications or web browsers and the website are encrypted. Once a complete
      patient consult is transmitted from the mobile device and the server acknowledges receipt,
      all data and photos would be removed automatically from the mobile device. Data stored in the
      mobile application as well as the website is secured and encrypted. Data is exchanged over
      the internet securely using HTTPS/SSL.

      The VibrentTM server has also been securely integrated with the Johns Hopkins Oncospace®
      analytic database server allowing secure one-way secure transmission of "out of clinic"
      assessment data to the "in clinic" Oncospace® analytic database which captures all
      treatment-related information including all radiotherapy dosimetry information and "in
      clinic" treatment toxicities and oncologic and toxicity outcome measures including
      patient-reported outcomes. Integration is particularly important as the radiotherapy dose,
      volume and the location of the upper aerodigestive tract that is irradiated can all affect
      the level of the pain experienced from radiation-induced mucositis. Oncospace® was developed
      to handle all continuous data-points in the dose-volume histogram (DVH) which summarizes the
      radiotherapy delivered to specific structures delineated in a radiotherapy plan as a series
      of analyzable relational tables within a database architecture thus facilitating
      quantification of the radiotherapy treatment and how it may affect radiation-induced
      mucositis pain.
    

Intervention name(s): Vibrogent Smartphone Application
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care