Clinical trial · Observational
Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients
Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients Initiating Chemoradiation: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to assess the satisfaction and usability of an interactive and patient-centered mobile application (app), Oleena™, designed to assist head and neck cancer patients undergoing chemoradiation in managing common and distressing symptoms in real-time, as well as to assess the satisfaction and usability of the related HCP web portal. Additional secondary usage and clinical endpoints that would be used to assess intervention efficacy in future trials will be collected.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oleena | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Users' satisfaction
- timeFrame
- End of study - Day 90 +/-10 from first radiotherapy
- description
- Users' (participants and HCPs) level of satisfaction with the symptom management app, which will be assessed via a validated, 4-item scale, Acceptability of Intervention Measures (score range 0-20)
Secondary outcomes (4)
- measure
- Feasibility of the technology enabled symptom management solution
- timeFrame
- Assessed up to 90 days
- description
- The extent to which the symptom management app can be successfully implemented within the Head and Neck Clinic. A series of objective measures (e.g., recruitment, retention, data completion, and app usage rates) will be used to define feasibility in this specific head and neck cancer population.
- measure
- Usability of the technology enabled symptom management solution
- timeFrame
- Day 30 and Day 90 +/-10 from first radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years old * Planned to initiate chemoradiation for locally advanced head and neck cancer at Moffitt Cancer Center * ECOG performance status ≤2 * Able to speak and read US English or Spanish * Able to provide informed consent * Owns a smartphone with an iOS or Android operating systemcompatible with Oleena * Able to access the internet * Willing to use a mobile app for symptom management Exclusion Criteria: * Documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., psychosis, active substance abuse). * A prior cancer diagnosis except for non-melanoma skin cancer. * Currently enrolled in an industry-sponsored clinical trial. * Pregnant women. * Patients undergoing RE-irradiation * Patients who meet the inclusion criteria may be excluded at Investigator's discretion
References
Publications (0)
Data not yet available