Vibrent App for Head and Neck Cancer

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile app called Vibrent can help manage pain from radiation sores, which often occur during treatment for head and neck cancers. The app guides users in understanding and managing their pain, especially when they are not at the hospital. It suits those diagnosed with head and neck cancer who need radiation treatment and have a smartphone with a data plan. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance pain management for future patients.

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 prior data suggests that the Vibrent mobile app is safe for managing pain from radiation sores?

Research has shown that mobile apps like VibrentTM can assist patients undergoing radiation treatment for cancer. These apps support patients, particularly in managing treatment side effects. While specific safety information about the Vibrent app is unavailable, using apps during radiation therapy is generally considered safe. Studies on similar apps have not reported major problems, suggesting that using VibrentTM to manage pain from radiation sores is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Vibrent Smartphone Mobile Application because it offers a novel approach to supporting patients undergoing head and neck radiotherapy. Unlike traditional treatment options, which mainly focus on the direct medical aspects of cancer care, this app aims to enhance patient experience and engagement through digital health technology. The app allows for remote, out-of-clinic assessments, potentially improving patient monitoring and personalized care without the need for frequent hospital visits. This could lead to more tailored treatment plans and better overall outcomes for patients.

What evidence suggests that the Vibrent mobile app is effective for managing pain from radiation sores?

Research shows that the Vibrent smartphone app, which participants in this trial will use, might help manage pain from radiation sores, also known as mucositis, during head and neck cancer treatments. Studies have found that many patients effectively use mobile devices to track symptoms and manage their treatment. The Vibrent app is designed to help users understand and manage their pain better, especially when they are not at the hospital. Although direct evidence of pain reduction is not yet available, the app's focus on managing symptoms and medication use suggests it could be helpful. Overall, the app aims to make it easier for patients to handle their pain by providing support accessible at any time. ^{1 6 7 8 9}

Who Is on the Research Team?

Harry Quon, M.D.

Principal Investigator

The SKCCC at Johns Hopkins

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Vibrent Smartphone Mobile Application

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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]

Citations

1. withpower.com withpower.com/trial/phase-mucositis-2016-378c5

Vibrent Smartphone Mobile Application · Info for Participants This trial is testing a smartphone app called VibrentTM to help people with head and neck cancer manage pain from radiation sores.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28965209/

Feasibility of a Mobile Application to Enhance Swallowing ... Feasibility of a Mobile Application to Enhance Swallowing Therapy for Patients Undergoing Radiation-Based Treatment for Head and Neck Cancer.

3. 2024.sci-hub.box 2024.sci-hub.box/6541/4d460785e0cc2e016d503eb4f4901209/starmer2017.pdf

Feasibility of a Mobile Application to Enhance Swallowing ... Our primary outcome of interest in this investigation was whether the VibrentTM mobile application would be used by patients undergoing radiation therapy.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/86/NCT03832686/Prot_SAP_000.pdf

Protocol version 9/Version date 8/June/2021 Investigation ... No medical risks are expected to result from the use/implementation of the VibrentTM mobile application. The risk associated for all ...

5. advancesradonc.com advancesradonc.com/article/S2452-1094(16)00014-2/fulltext

Use of mobile device technology to continuously collect ... A substantial percentage of patients used mobile devices to continuously report symptoms throughout a course of radiation therapy for head and neck cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9943039/

Mobile applications in radiation oncology—current choices ... The current scientific literature provides some evidence for helpful apps in the field of radiation oncology, with a clear emphasis on apps for patients.

7. hncvirtualcoach.com hncvirtualcoach.com/en/faq

FAQ Head & Neck Cancer Virtual Coach is a mobile application to provide support for patients with head and neck cancer (HNC) who need or want to complete ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5506718/

Use of mobile device technology to continuously collect ... The purpose of this study is to evaluate the feasibility of using mobile device technology to continuously collect patient-reported symptoms for head and neck ...

9. d-nb.info d-nb.info/1299031684/34

Mobile applications in radiation oncology—current choices ... Side effects were usually evaluated concerning the irradi- ated area, e.g., swallowing difficulties, dryness of mouth, skin reaction, and ...