Vibrent Smartphone Mobile Application

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Hypersensitivity to gabapentin, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

48 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a smartphone app called VibrentTM to help people with head and neck cancer manage pain from radiation sores. The app provides information and reminders about pain and medication, and securely shares this data with doctors. It aims to improve pain management for patients undergoing radiation therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile app to manage pain from radiation sores.

What data supports the effectiveness of the Vibrent Smartphone Mobile Application treatment?

The research suggests that smartphone applications can help improve patient communication and health outcomes by allowing patients to report their health status electronically, as seen in studies with cancer patients and surgical care. This indicates that similar mobile applications, like the Vibrent Smartphone Mobile Application, could be effective in enhancing patient care and satisfaction. ^{1 2 3 4 5}

Is the Vibrent Smartphone Mobile Application safe for use in humans?

The Vibrent Smartphone Mobile Application has been used to report adverse events following vaccinations, and studies suggest it is well accepted and feasible for this purpose. However, concerns about data protection were noted, and no specific safety issues related to the app itself were reported. ^{6 7 8 9 10}

Research Team

Harry Quon, M.D.

Principal Investigator

The SKCCC at Johns Hopkins

Eligibility Criteria

Inclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants undergo head and neck radiotherapy while using the VibrentTM smartphone application to manage radiation-induced mucositis pain

8 weeks

Regular in-clinic visits for radiotherapy

Follow-up

Participants are monitored for changes in mucositis pain and adherence to pain management regimen

2 months

Treatment Details

Interventions

• Vibrent Smartphone Mobile Application

Participant Groups

Group I: Vibrent Smartphone Application Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Findings from Research

The study demonstrated that collecting daily self-reported sleep disturbance data from breast cancer patients undergoing chemotherapy via a smartphone app is feasible, with a compliance rate of 45% over 90 days.

Compliance was higher among unemployed women and those who began reporting immediately after enrollment, suggesting that targeting specific subgroups may enhance participation in future mobile health studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily collection of self-reporting sleep disturbance data via a smartphone app in breast cancer patients receiving chemotherapy: a feasibility study. Min, YH., Lee, JW., Shin, YW., et al.[2022]

A smartphone application was developed for prostate cancer patients to electronically report their health outcomes, which was evaluated by 21 patients and 10 specialists, showing a high user satisfaction score of 5.95 out of 7.

The application aims to enhance communication between patients and healthcare providers, improve quality of care, and facilitate timely data collection, potentially reducing unnecessary treatment visits and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic patient-reported outcome (ePRO) application for patients with prostate cancer. Mohseni, M., Ayatollahi, H., Arefpour, AM.[2023]

The study involved 444 patients undergoing elective colorectal surgery and found that the mobile application iColon improved adherence to Enhanced Recovery After Surgery (ERAS) items, with a 62.4% usage rate of the app and a 74.1% adherence to ERAS protocols.

Using iColon was associated with a significant reduction in 30-day readmission rates and received positive feedback from over 94% of users, indicating that digital health tools can enhance patient satisfaction and perceived quality of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

iColon, a patient-focused mobile application for perioperative care in colorectal surgery: Results from 444 patients. Bertocchi, E., Barugola, G., Masini, G., et al.[2023]

In a study involving 153 employees, 42% participated in testing an app designed for reporting adverse events following immunization (AEFI), with 63% of users rating the experience positively, indicating good acceptance of the app-based technology.

Concerns about data protection were the main reason for declining participation, suggesting that improving data security measures could enhance the acceptability and effectiveness of app-based AEFI reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. Nguyen, MTH., Ott, JJ., Caputo, M., et al.[2020]

A study involving 1139 participants from a larger trial found that 96% of respondents supported the use of SMS for monitoring vaccine safety after immunization, indicating a strong public acceptance of this method.

While most participants favored SMS surveillance, 62% believed that consent should be obtained beforehand, highlighting a need for addressing privacy concerns and understanding demographic factors that may affect compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer acceptability and validity of m-Health for the detection of adverse events following immunization - The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised control trial. Gold, MS., Lincoln, G., Bednarz, J., et al.[2021]

A mobile app was developed to facilitate reporting of adverse events following immunization (AEFI) for the influenza vaccine, and it successfully recorded 1104 data points from 38 participants, indicating its feasibility for AEFI reporting.

Despite the app's success in data collection, only 63% of participants downloaded it, and only 28% reported new or worsening health conditions after vaccination, suggesting barriers to wider adoption that need to be addressed in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of the feasibility and usability of a proof of concept mobile app for adverse event reporting post influenza vaccination. Wilson, K., Atkinson, KM., Westeinde, J., et al.[2022]

The proposed three-part framework for analyzing adverse events includes phases for documenting incidents, conducting in-depth reviews, and assessing the association between exposure and adverse events, which can enhance product safety.

By standardizing the evaluation of adverse events through this framework, companies can better manage risks and improve consumer products based on reliable data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. Kingston, R., Sioris, K., Gualtieri, J., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Electronic Image Documentation of Patient Reported Outcomes Using Mobile Technologies. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

Daily collection of self-reporting sleep disturbance data via a smartphone app in breast cancer patients receiving chemotherapy: a feasibility study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Electronic patient-reported outcome (ePRO) application for patients with prostate cancer. [2023]

4. England pubmed.ncbi.nlm.nih.gov

iColon, a patient-focused mobile application for perioperative care in colorectal surgery: Results from 444 patients. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Surgical smartphone applications across different platforms: their evolution, uses, and users. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Introduction of a Mobile Adverse Event Reporting System Is Associated With Participation in Adverse Event Reporting. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Consumer acceptability and validity of m-Health for the detection of adverse events following immunization - The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised control trial. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

An evaluation of the feasibility and usability of a proof of concept mobile app for adverse event reporting post influenza vaccination. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. [2022]