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

NCT06385587 | Completed

• 1 other identifier: ADH-OL-Study-01-23
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Feasibility of the technology enabled symptom management solution

  Assessed up to 90 days

• Usability of the technology enabled symptom management solution

  Day 30 and Day 90 +/-10 from first radiotherapy

• Appropriateness of the recommendations

  After 15 and then 30 patients have reached Day 30 and then Day 90

• Semi-structured exit interviews

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

Other Outcomes (5)

• Symptom burden will be measured using the NIH PRO-CTCAE measurement system, which includes validated scales for individual toxicities

  Baseline, Day 30 and Day 90 +/-10 from first radiotherapy

• Quality of life will be measured using the previously validated FACT-G scale

  Baseline, Day 30 and Day 90 +/-10 from first radiotherapy

• Treatment adherence

  Assessed up to 90 days

Interventions

Oleena DEVICE

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aptar Digital Health: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Amir Alishahi, MD, PhD, MPH

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 26, 2024
• Study Start: June 6, 2024
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (1)