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Smartphone Pain App for Assessing Oral Mucositis Pain in Patients Receiving Head and Neck Radiation Therapy

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ClinicalTrials.gov Identifier: NCT02727062
Recruitment Status : Recruiting
First Posted : April 4, 2016
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Stuart Wong, Medical College of Wisconsin

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.

Condition or disease Intervention/treatment Phase
Oral Mucositis Other: OM Pain App Not Applicable

Detailed Description:

OVERVIEW: This is a single-arm, interventional, supportive care clinical trial for patients with tumors involving the oral cavity, oropharynx, or unknown primary expecting to receive at least a 50 Gy dose of definitive radiation therapy. This will generate preliminary data to test the feasibility, validity and the clinical usefulness of the smartphone pain App in recording and reporting radiation-induced oral mucositis pain.

OM PAIN APP (DESCRIPTION): The Oral Mucositis (OM) Pain App (the App) is a smartphone application that was designed to permit patients to key in pain severity, using a visual analog 0-10 scale. The App is programed with an alarm to prompt the patient to record pain severity at prescribed intervals daily and through spontaneous patient input. Data collected on each patient's smartphone can be backed up wirelessly to a central server where the data can be analyzed remotely or data can be viewed on the device. The software is capable of generating a time-weighted measure of pain, total area under the pain cure (AUC), a summary measure that integrates serial assessments of a patient's pain over the duration of the study.

DAILY INTERVENTION: 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. Data recording will not commence until radiation starts. Because symptoms of mucositis do not commence typically until the third week of radiation therapy, and no sooner than week 2, recordings from week 1 will be used for baseline data. Recording of data will cease four weeks after the end of radiation therapy at which time mucositis symptoms typically start to resolve and pain symptoms substantially abate.

ACCELEROMETER: Each patient will be issued an accelerometer and will be encouraged to wear it continuously during the study period. To help determine whether decline in physical activity is associated with severity of pain, physical activity will be assessed directly with accelerometers (activity monitor). Participants will wear an accelerometerduring sleep and waking hours, but not while bathing, starting one week prior to the start radiation therapy. Accelerometer output data will be obtained in 1-minute epochs that will be then summed to provide raw daily average activity units, which will be subsequently divided by 1000 for clarity. Data will by synced weekly by the study coordinator to a computer connected to a central server.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Smartphone Pain App for Assessing Oral Mucositis Pain in Patients
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : February 13, 2019
Estimated Study Completion Date : September 12, 2019

Arm Intervention/treatment
Experimental: 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.
Other: 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.

Each patient will be issued an accelerometer and will be encouraged to wear it continuously during the study period.




Primary Outcome Measures :
  1. Feasibility (measured by adequate enrollment and compliance) [ Time Frame: 12 weeks ]
    The primary objective is to demonstrate that this mobile technology application is feasible. This will be assessed by weekly administered compliance questionnaires assessing patient perception of ease of use, burden of use, and technical hindrances.


Secondary Outcome Measures :
  1. Validity [ Time Frame: 12 weeks ]
    We will compare pain scores from the OM Pain App, as determined by area under the curve (AUC) measurement, in patients at high risk for severe oral mucositis (radiation plus concurrent chemo--RT/CT) versus patients at low risk for severe oral mucositis (radiation alone--RT). Because patients with severe oral mucositis experience worse pain than patients with mild mucositis, RT/CT patient would be expected to have significantly higher AUC than patients who receive RT alone. The validity of the OM Pain App will also be tested by comparing a standardized pain assessment tool (Brief Pain Inventory-BPI) and the OM Pain App to discriminate pain in subgroups determined by severity of pain scores, dose of radiation, and anatomic site of disease.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically confirmed malignancy (including non-squamous cell histologies and unknown primary tumors).
  • Patient must be undergoing a course of 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. (See Section 5 regarding mucositis evaluation and WHO grade.)
  • Ability to complete the questionnaire.
  • No current oral infection or ongoing toxicity from prior radiotherapy.
  • Zubrod/ECOG Performance status < 2.
  • Age ≥ 18 years.
  • Concurrent enrollment on interventional trial is allowed.
  • English-speaking and literate.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727062


Contacts
Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office 414-805-8900 cccto@mcw.edu

Locations
United States, Wisconsin
Froedtert Hospital and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office    414-805-8900    cccto@mcw.edu   
Sponsors and Collaborators
Stuart Wong
Investigators
Principal Investigator: Stuart J Wong, MD Medical College of Wisconsin

Responsible Party: Stuart Wong, Associate Professor, Department of Medicine, Division of Hematology/Oncology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02727062     History of Changes
Other Study ID Numbers: PRO0026427
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stuart Wong, Medical College of Wisconsin:
pain
radiation
head and neck cancer
smartphone pain app
OM Pain App

Additional relevant MeSH terms:
Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases