Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients (SYMTECH01)

Aptar Digital Health

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Device: Oleena

Study type: Observational

Funder types: Industry

Identifiers

NCT06385587

ADH-OL-Study-01-23

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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