Smartphone Pain App for Assessing Oral Mucositis Pain in Patients

NCT02727062 | Terminated DMC FDA Device

• 1 other identifier: PRO0026427
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

head and neck cancer; smartphone application; OM Pain App

Outcome Measures

Primary Outcomes (11)

• The number of subjects who comply with the compulsory four-time daily pain entries.

  The study coordinator will download data and check the equipment weekly for proper functioning and compliance. Patients will be interviewed weekly to assure the device is functioning correctly and that data is being recorded.

  Week 1 during radiation therapy.

• The number of subjects who comply with the compulsory four-time daily pain entries.

  The study coordinator will download data and check the equipment weekly for proper functioning and compliance. Patients will be interviewed weekly to assure the device is functioning correctly and that data is being recorded.

  Week 2 during radiation therapy.

• The number of subjects who comply with the compulsory four-time daily pain entries.

  The study coordinator will download data and check the equipment weekly for proper functioning and compliance. Patients will be interviewed weekly to assure the device is functioning correctly and that data is being recorded.

  Weekly 3 during radiation therapy.

• The number of subjects who comply with the compulsory four-time daily pain entries.

  The study coordinator will download data and check the equipment weekly for proper functioning and compliance. Patients will be interviewed weekly to assure the device is functioning correctly and that data is being recorded.

  Week 4 during radiation therapy.

• The number of subjects who comply with the compulsory four-time daily pain entries.

  The study coordinator will download data and check the equipment weekly for proper functioning and compliance. Patients will be interviewed weekly to assure the device is functioning correctly and that data is being recorded.

  Week 5 during radiation therapy.

• The number of subjects who comply with the compulsory four-time daily pain entries.

  The study coordinator will download data and check the equipment weekly for proper functioning and compliance. Patients will be interviewed weekly to assure the device is functioning correctly and that data is being recorded.

  Week 6 during radiation therapy.

• The number of subjects who comply with the compulsory four-time daily pain entries.

  The study coordinator will download data and check the equipment weekly for proper functioning and compliance. Patients will be interviewed weekly to assure the device is functioning correctly and that data is being recorded.

  Week 7 during radiation therapy.

• The number of subjects who comply with the compulsory four-time daily pain entries.

  The study coordinator will download data and check the equipment weekly for proper functioning and compliance. Patients will be interviewed weekly to assure the device is functioning correctly and that data is being recorded.

  Week 8 post-radiation therapy.

• The number of subjects who comply with the compulsory four-time daily pain entries.

  The study coordinator will download data and check the equipment weekly for proper functioning and compliance. Patients will be interviewed weekly to assure the device is functioning correctly and that data is being recorded.

  Week 9 post-radiation therapy.

• The number of subjects who comply with the compulsory four-time daily pain entries.

  The study coordinator will download data and check the equipment weekly for proper functioning and compliance. Patients will be interviewed weekly to assure the device is functioning correctly and that data is being recorded.

  Week 10 post-radiation therapy.

• The number of subjects who comply with the compulsory four-time daily pain entries.

  The study coordinator will download data and check the equipment weekly for proper functioning and compliance. Patients will be interviewed weekly to assure the device is functioning correctly and that data is being recorded.

  Week 11 post-radiation therapy.

Study Arms (1)

OM Pain Smartphone Application

This study examines whether the smartphone OM Pain App is a feasible and valid tool to assess pain from radiation-induced oral mucositis.

Device: OM Pain App; Device: Accelerometer

Interventions

OM Pain App DEVICE

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.

OM Pain Smartphone Application

Accelerometer DEVICE

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).

OM Pain Smartphone Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a single-arm, clinical trial for patients with tumors involving the oral cavity, oropharynx, or unknown primary.

You may qualify if:

• Patients must have histologically confirmed malignancy (including non-squamous cell histologies and unknown primary tumors).
• Patient must be undergoing a course of radiation therapy (RT) (with or without chemotherapy) including oral cavity and/or oropharynx to a dose of at least 50 Gy (SBRT is not allowed).
• Prior definitive course of RT is allowed.
• Physical exam demonstrating no preexisting mucositis.
• Ability to complete the questionnaire.
• No current oral infection or ongoing toxicity from prior radiotherapy.
• Zubrod Score/Eastern Cooperative Oncology Group (ECOG) Performance status \< 2.
• Age ≥ 18 years.
• Concurrent enrollment on interventional trial is allowed.
• English-speaking and literate.

You may not qualify if:

• Nasopharyngeal cancer
• Paranasal sinus tumors
• Laryngeal cancer
• Pregnant or lactating women are ineligible as treatment involves unforeseeable risks to the participant and to the embryo or fetus.

Sponsors & Collaborators

• Stuart Wong: lead

Study Sites (1)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Stomatitis; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Study Officials

• Stuart J Wong, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Medicine, Division of Hematology/Oncology

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 4, 2016
• Study Start: February 13, 2018
• Primary Completion: August 21, 2019
• Study Completion: August 21, 2019
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)