Clinical trial NCT02727062: Smartphone Pain App for Assessing Oral Mucositis Pain in Patients
Official title: Smartphone Pain App for Assessing Oral Mucositis Pain in Patients Receiving Head and Neck Radiation Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Oral Mucositis
Keywords: head and neck cancer
smartphone application
OM Pain App
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: OVERVIEW: This is a single-arm, observational, 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.

OM PAIN APP (DESCRIPTION): The Oral Mucositis (OM) PAIN APP (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 OBSERVATION: 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 accelerometer during 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.

Eligibility 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 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.

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.

Primary outcomes:
measure: The number of subjects who comply with the compulsory four-time daily pain entries.
timeFrame: Week 1 during radiation therapy.
measure: The number of subjects who comply with the compulsory four-time daily pain entries.
timeFrame: Week 2 during radiation therapy.
measure: The number of subjects who comply with the compulsory four-time daily pain entries.
timeFrame: Weekly 3 during radiation therapy.
measure: The number of subjects who comply with the compulsory four-time daily pain entries.
timeFrame: Week 4 during radiation therapy.
measure: The number of subjects who comply with the compulsory four-time daily pain entries.
timeFrame: Week 5 during radiation therapy.
measure: The number of subjects who comply with the compulsory four-time daily pain entries.
timeFrame: Week 6 during radiation therapy.
measure: The number of subjects who comply with the compulsory four-time daily pain entries.
timeFrame: Week 7 during radiation therapy.
measure: The number of subjects who comply with the compulsory four-time daily pain entries.
timeFrame: Week 8 post-radiation therapy.
measure: The number of subjects who comply with the compulsory four-time daily pain entries.
timeFrame: Week 9 post-radiation therapy.
measure: The number of subjects who comply with the compulsory four-time daily pain entries.
timeFrame: Week 10 post-radiation therapy.
measure: The number of subjects who comply with the compulsory four-time daily pain entries.
timeFrame: Week 11 post-radiation therapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Stuart J Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: