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Smartphone Pain App for Assessing Oral Mucositis Pain in Patients

NCT02727062 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2024-08-09

No results posted yet for this study

Summary

This research is being done to evaluate whether or not the Oral Mucositis (OM) Pain App (a smartphone application) is a feasible and valid tool to assess 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.

Conditions

  • Oral Mucositis

Interventions

DEVICE

OM Pain App

Each study participant will be issued an Android smartphone, or he or she may use his/her own compatible device (whether or not it has an active data service) to which the OM Pain App will be downloaded and installed. Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels. Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.

DEVICE

Accelerometer

Each patient will be issued an accelerometer and will be encouraged to wear it continuously during the study period (weekly during radiation therapy and four weeks following radiation therapy).

Sponsors & Collaborators

  • Stuart Wong

    lead OTHER

Principal Investigators

  • Stuart J Wong, MD · Medical College of Wisconsin

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-13
Primary Completion
2019-08-21
Completion
2019-08-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02727062 on ClinicalTrials.gov