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Vibrent Smartphone Mobile Application

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02421536
Recruitment Status : Active, not recruiting
First Posted : April 20, 2015
Last Update Posted : November 7, 2018
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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.

Condition or disease Intervention/treatment Phase
Mucositis Other: Vibrogent Smartphone Application Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Feasibility Study of the VibrentTM Smartphone App for Head & Neck Cancer Patients: Supporting Pain Management of Radiation-Induced Mucositis
Actual Study Start Date : January 14, 2016
Actual Primary Completion Date : April 26, 2018
Estimated Study Completion Date : April 26, 2022

Arm Intervention/treatment
Experimental: Vibrent Smartphone Application
We propose to pilot the application of the mobile application "VibrentTM" (research procedure) during a course of head and neck radiotherapy for eligible study subjects. Study subjects will be prospective consented and enrolled and will have baseline "out of clinic" assessment with the Vibrent smartphone application (research procedure).
Other: Vibrogent Smartphone Application

Primary Outcome Measures :
  1. Change from baseline in "out of clinic" pain at 2 months [ Time Frame: 2 months ]
    We hypothesize that the interactive VibrentTM algorithm can be adopted to extend the current "in clinic" prophylactic pain regimen for the management of radiation-induced mucositis to improve "out of clinic" adherence and the effectiveness of this regimen. Feasibility of the VibrentTM smartphone application will be defined by patient utilization rates and satisfaction scores.

Secondary Outcome Measures :
  1. Change from baseline mucositis pain at 2 months [ Time Frame: 2 months ]
    We hypothesize that the effectiveness of the current prophylactic pain regimen (consisting of baseline continued dosing of gabapentin and prophylactic low dose oxycodone / narcotic), which is dependent on continued patient adherence to incrementally titrate the oxycodone/narcotic dose to prevent peripheral pain sensitization, will be more effective with continued reinforcement and guidance of these management principles "out of the clinic".

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Study subjects age ≥ 18 years of age.
  2. Study subject with a Karnofsky performance scale of 80 or greater.
  3. Study subjects capable of providing informed consent.
  4. Study subjects with a previously untreated head and neck cancer diagnosis requiring a definitive or postoperative course of radiotherapy requiring a prescribed dose of radiation therapy
  5. Study subjects who have either an Android or Apple iOS-based smartphone or tablet compatible with the VibrentTM software with sufficient monthly data plan (approximately 200 megabytes per month).

Exclusion Criteria:

a. No known hypersensitivity or intolerance to gabapentin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02421536

United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator: Harry Quon, M.D. The SKCCC at Johns Hopkins

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT02421536     History of Changes
Other Study ID Numbers: J14191
IRB00057815 ( Other Identifier: JHMIRB )
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases