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
|Condition or disease||Intervention/treatment||Phase|
|Oral Mucositis||Other: OM Pain App||Not Applicable|
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|
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.
- 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.
- 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.
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
|Contact: Medical College of Wisconsin Cancer Center Clinical Trials Officefirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Stuart J Wong, MD||Medical College of Wisconsin|