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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-06

Study Completion Date

2025-09-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Oleena

Oleena™ is a software medical device for patients and their healthcare team which digitalizes some aspects of their supportive care, allows remote monitoring by healthcare professionals (HCP) and supports the management of targeted symptoms in adult cancer patients while they are being actively treated for their cancer.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No