NCT06385587Completed
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 · Last updated 20 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 33 (actual)
- First submitted
- 12 Apr 2024
- Start date
- 6 Jun 2024
- Primary completion date
- 25 Sept 2025
- Lead sponsor
- Aptar Digital Health
- Diseases
- Head and neck cancer
- NCT number
- NCT06385587
What you commit to
- Study type: Observational
- Participants enrolled: 33
- From 6 Jun 2024 to the primary completion date, 25 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing RE-irradiation
Other illness
- 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.
Other
- Currently enrolled in an industry-sponsored clinical trial.
- Pregnant women.
- Patients who meet the inclusion criteria may be excluded at Investigator's discretion
Who the study is looking for
- ≥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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.