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Completed

NCT Number: NCT06385587

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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Users' satisfaction

    Time frame: 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 outcomes

  1. Feasibility of the technology enabled symptom management solution

    Time frame: 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.

  2. Usability of the technology enabled symptom management solution

    Time frame: 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)

  3. Appropriateness of the recommendations

    Time frame: 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

  4. Semi-structured exit interviews

    Time frame: 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

Other outcomes

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

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

    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.

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

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

    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

  3. Treatment adherence

    Time frame: Assessed up to 90 days

    Treatments prescribed and received, dosage, duration of treatment, dose reductions, and discontinuation

  4. Health-economic outcome

    Time frame: Assessed up to 90 days

    The number of unscheduled outpatient visits, unscheduled inpatient hospitalizations and ER admissions related to the targeted symptoms

  5. Complaints, alleged deficiencies or malfunctions of the device reported

    Time frame: Assessed up to 90 days

    Safety of the device

Sponsors and collaborators

Lead sponsor

Aptar Digital Health

Industry

Registry information

Official study title

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

Acronym: SYMTECH01

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 26, 2024
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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