Oral MucositisNCT02727062
Smartphone Pain App for Assessing Oral Mucositis Pain in Patients
An observational study of Oral Mucositis, run by Stuart Wong at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- OM Pain App and Accelerometer
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2018to 21 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a single-arm, clinical trial for patients with tumors involving the oral cavity, oropharynx, or unknown primary.
Who may be able to join
- 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.
Show all 10Show fewer
- Zubrod Score/Eastern Cooperative Oncology Group (ECOG) Performance status < 2.
- Age ≥ 18 years.
- Concurrent enrollment on interventional trial is allowed.
- English-speaking and literate.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Smartphone Pain App for Assessing Oral Mucositis Pain in Patients Receiving Head and Neck Radiation Therapy
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.
Read the 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.
- Conditions
- Oral Mucositis
- Being tested
- OM Pain App, Accelerometer
- Keywords
- head and neck cancer, smartphone application, OM Pain App
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OM Pain AppDevice
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.
AccelerometerDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OM Pain App; Device: Accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 11 post-radiation therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start13 Feb 2018
- Primary completion21 Aug 2019
- Study completion21 Aug 2019
Why it stopped: Funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stuart Wong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stuart Wong, Medical College of Wisconsin
- Investigators
- Stuart J Wong, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727062
- Sponsor's protocol ID
- PRO0026427
- Status last verified
- Aug 2024
- First submitted
- 29 Mar 2016
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Pain App for Assessing Oral Mucositis Pain in Patients Receiving Head and Neck Radiation Therapy
- ClinicalTrials.gov ID
- NCT02727062
- Acronym / sponsor ID
- PRO0026427
- Conditions
- Oral Mucositis
- Keywords
- head and neck cancer, smartphone application, OM Pain App
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Stuart WongUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 21 Aug 2019 (actual)
- Study completion
- 21 Aug 2019 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OM Pain Smartphone Application | – | Device: OM Pain App, Device: AccelerometerThis study examines whether the smartphone OM Pain App is a feasible and valid tool to assess pain from radiation-induced oral mucositis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a single-arm, clinical trial for patients with tumors involving the oral cavity, oropharynx, or unknown primary.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OM Pain AppEach 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. | Device | OM Pain Smartphone Application |
| AccelerometerEach 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). | Device | OM Pain Smartphone Application |
Primary outcome
The number of subjects who comply with the compulsory four-time daily pain entries.
Time frame: Week 1 during radiation therapy.
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.
The number of subjects who comply with the compulsory four-time daily pain entries.
Time frame: Week 2 during radiation therapy.
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.
The number of subjects who comply with the compulsory four-time daily pain entries.
Time frame: Weekly 3 during radiation therapy.
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.
The number of subjects who comply with the compulsory four-time daily pain entries.
Time frame: Week 4 during radiation therapy.
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.
The number of subjects who comply with the compulsory four-time daily pain entries.
Time frame: Week 5 during radiation therapy.
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.
The number of subjects who comply with the compulsory four-time daily pain entries.
Time frame: Week 6 during radiation therapy.
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.
The number of subjects who comply with the compulsory four-time daily pain entries.
Time frame: Week 7 during radiation therapy.
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.
The number of subjects who comply with the compulsory four-time daily pain entries.
Time frame: Week 8 post-radiation therapy.
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.
The number of subjects who comply with the compulsory four-time daily pain entries.
Time frame: Week 9 post-radiation therapy.
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.
The number of subjects who comply with the compulsory four-time daily pain entries.
Time frame: Week 10 post-radiation therapy.
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.
The number of subjects who comply with the compulsory four-time daily pain entries.
Time frame: Week 11 post-radiation therapy.
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.
Results and safety
The study was stopped early (reason given: Funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart J Wong, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Mucositis, run by Stuart Wong at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects who comply with the compulsory four-time daily pain entries. (time frame: Week 1 during radiation therapy.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.