Clinical trial · Observational
Smartphone Pain App for Assessing Oral Mucositis Pain in Patients
Smartphone Pain App for Assessing Oral Mucositis Pain in Patients Receiving Head and Neck Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerometer | Device | — | UNRESOLVED |
| OM Pain App | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- OM Pain Smartphone Application
- description
- This study examines whether the smartphone OM Pain App is a feasible and valid tool to assess pain from radiation-induced oral mucositis.
- interventionNames
- Device: OM Pain App
- Device: Accelerometer
Primary outcomes (11)
- measure
- The number of subjects who comply with the compulsory four-time daily pain entries.
- timeFrame
- Week 1 during radiation therapy.
- description
- 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.
- measure
- The number of subjects who comply with the compulsory four-time daily pain entries.
- timeFrame
- Week 2 during radiation therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available