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

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.

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.