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

Head and Neck Cancer Clinical Trial

— SYMTECH01  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06385587
• Other study ID #: ADH-OL-Study-01-23
• Status: Not yet recruiting
• Start date: May 3, 2024
• Est. completion date: September 27, 2025

Study information

• Verified date: April 2024
• Source: Aptar Digital Health
• Contact: Amir Alishahi, MD, PhD, MPH
• Phone: (813) 745-1127
• Email: Amir.Alishahi[@]moffitt.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 27, 2025
• Est. primary completion date: December 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aptar Digital Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Treatment adherence	Treatments prescribed and received, dosage, duration of treatment, dose reductions, and discontinuation	Assessed up to 90 days
Other	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
Other	Complaints, alleged deficiencies or malfunctions of the device reported	Safety of the device	Assessed up to 90 days
Primary	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	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
Secondary	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
Secondary	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
Secondary	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