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

Active, not recruiting

• Conditions: Head and Neck Cancer

• Registration Number: NCT06385587
• Lead Sponsor: Aptar Digital Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-24
• Study First Posted: 2024-04-26
• Study Start: 2024-06-06
• Status Verified: 2024-07
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-05-30
• Study Completion: 2025-09-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Users' satisfaction	End of study - Day 90 +/-10 from first radiotherapy	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 Outcome Measures

Name	Time	Method
Feasibility of the technology enabled symptom management solution	Assessed up to 90 days	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.
Usability of the technology enabled symptom management solution	Day 30 and Day 90 +/-10 from first radiotherapy	The extent to which participants can use the symptom management app to manage their symptoms with efficiency and satisfaction and will be measured using the system usability scale (SUS) (score range 0-100)
Appropriateness of the recommendations	After 15 and then 30 patients have reached Day 30 and then Day 90	Participating providers will rate the appropriateness of the recommendations provided by the Oleena app through a brief electronic survey
Semi-structured exit interviews	End of study - Day 90 +/-10 from first radiotherapy	The first twenty (20) study participants exiting the study will gauge their overall perceptions regarding the intervention and identify any potential barriers and facilitators that may affect intervention implementation

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States