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

Aptar Digital Health33 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Head and Neck Cancer

Interventions

OleenaDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Outcomes

Primary Outcomes

Users' satisfaction

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)

Time frame: End of study - Day 90 +/-10 from first radiotherapy

Secondary Outcomes

Feasibility of the technology enabled symptom management solution

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.

Time frame: Assessed up to 90 days

Usability of the technology enabled symptom management solution

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)

Time frame: Day 30 and Day 90 +/-10 from first radiotherapy

Appropriateness of the recommendations

Participating providers will rate the appropriateness of the recommendations provided by the Oleena app through a brief electronic survey

Time frame: After 15 and then 30 patients have reached Day 30 and then Day 90

Semi-structured exit interviews

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

Time frame: End of study - Day 90 +/-10 from first radiotherapy

Data from ClinicalTrials.gov

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