Head and Neck CancerSYMTECH01NCT06385587
Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients
An observational study of Head and Neck Cancer, run by Aptar Digital Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Oleena
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2024to 25 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Oleena
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: End of study - Day 90 +/-10 from first radiotherapy
Secondary outcomes (4)
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.
Measured: 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)
Measured: 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
Measured: 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
Measured: End of study - Day 90 +/-10 from first radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start6 Jun 2024
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptar Digital Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amir Alishahi, MD, PhD, MPH, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385587
- Sponsor's protocol ID
- ADH-OL-Study-01-23
- Acronym
- SYMTECH01
- Status last verified
- Oct 2025
- First submitted
- 12 Apr 2024
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients Initiating Chemoradiation: A Pilot Study
- ClinicalTrials.gov ID
- NCT06385587
- Acronym / sponsor ID
- SYMTECH01 / ADH-OL-Study-01-23
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Aptar Digital HealthIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- ≥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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OleenaOleena™ 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. | Device | – |
Primary outcome
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)
4 secondary outcomes
Feasibility of the technology enabled symptom management solution
Time frame: Assessed up to 90 days
Usability of the technology enabled symptom management solution
Time frame: Day 30 and Day 90 +/-10 from first radiotherapy
Appropriateness of the recommendations
Time frame: After 15 and then 30 patients have reached Day 30 and then Day 90
Semi-structured exit interviews
Time frame: End of study - Day 90 +/-10 from first radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Alishahi, MD, PhD, MPH principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Aptar Digital Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Users' satisfaction (time frame: End of study - Day 90 +/-10 from first radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.