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

Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients Initiating Chemoradiation: A Pilot Study

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 Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Device: Oleena

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Amir Alishahi, MD, PhD, MPH; Phone Number: (813) 745-1127; Email: Amir.Alishahi@moffitt.org
• Study Contact Backup: Name: Emma Hume; Phone Number: (813) 745-6426; Email: emma.hume@moffitt.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced head and neck cancer initiating chemoradiation. Patients will use Oleena for 90 days from the initiation of the treatment and be instructed to enter symptoms as they occur and receive self-management recommendations via the app. Surveys will be completed by patients at baseline, 30, and 90 days after initiation. A subgroup of patients (20) will be asked to participate in exit interviews with a study team member regarding their experience with the app.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	End of study - Day 90 +/-10 from first radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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	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	End of study - Day 90 +/-10 from first radiotherapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom burden will be measured using the NIH PRO-CTCAE measurement system, which includes validated scales for individual toxicities	The following PRO-CTCAE items will be used: diarrhea, nausea, loss of appetite, vomiting, pain, skin rash, hand-foot syndrome, fatigue, fever, breathing, cough, swallowing difficulties, mucositis, and smell and taste changes.	Baseline, Day 30 and Day 90 +/-10 from first radiotherapy
Quality of life will be measured using the previously validated FACT-G scale	The FACT-G is a 27-item questionnaire that measures four domains of health-related quality of life including physical, social, functional, and emotional well-being with a 7-day recall period	Baseline, Day 30 and Day 90 +/-10 from first radiotherapy
Treatment adherence	Treatments prescribed and received, dosage, duration of treatment, dose reductions, and discontinuation	Assessed up to 90 days
Health-economic outcome	The number of unscheduled outpatient visits, unscheduled inpatient hospitalizations and ER admissions related to the targeted symptoms	Assessed up to 90 days
Complaints, alleged deficiencies or malfunctions of the device reported	Safety of the device	Assessed up to 90 days

Collaborators and Investigators

• Sponsor: Aptar Digital Health
• Investigators: Principal Investigator: Amir Alishahi, MD, PhD, MPH, Moffitt Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 3, 2024
• Primary Completion (Estimated): December 29, 2024
• Study Completion (Estimated): September 27, 2025

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: ADH-OL-Study-01-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No