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

Last updated: October 15, 2025
Sponsor: Aptar Digital Health
Overall Status: Completed

Phase

N/A

Condition

Head And Neck Cancer

Nasopharyngeal Cancer

Human Papilloma Virus (Hpv)

Treatment

Oleena

Clinical Study ID

NCT06385587
ADH-OL-Study-01-23
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years old

  • Planned to initiate chemoradiation for locally advanced head and neck cancer atMoffitt 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

Exclusion Criteria:

  • Documented or observable psychiatric or neurological disorders that would interferewith 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'sdiscretion

Study Design

Total Participants: 33
Treatment Group(s): 1
Primary Treatment: Oleena
Phase:
Study Start date:
June 06, 2024
Estimated Completion Date:
September 25, 2025

Connect with a study center

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

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