Vibrent Smartphone Mobile Application

NCT02421536 | Completed

• 2 other identifiers: J14191IRB00057815
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Mucositis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in "out of clinic" pain at 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.

  2 months

Secondary Outcomes (1)

• Change from baseline mucositis pain at 2 months

  2 months

Study Arms (1)

Vibrent Smartphone Application

EXPERIMENTAL

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

Interventions

Vibrogent Smartphone Application OTHER

Vibrent Smartphone Application

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study subjects age ≥ 18 years of age.
• Study subject with a Karnofsky performance scale of 80 or greater.
• Study subjects capable of providing informed consent.
• 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
• 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).

You may not qualify if:

• a. No known hypersensitivity or intolerance to gabapentin.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Mucositis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Harry Quon, M.D.

  The SKCCC at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 20, 2015
• Study Start: January 14, 2016
• Primary Completion: April 26, 2018
• Study Completion: December 31, 2022
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

US (1)