Clinical trial NCT06385587: Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients
Official title: Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients Initiating Chemoradiation: A Pilot Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Head and Neck Cancer
Lead sponsor: Aptar Digital Health
Sponsor class: INDUSTRY
First posted: 2024-04-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Users' satisfaction
timeFrame: End of study - Day 90 +/-10 from first radiotherapy
Secondary outcomes:
measure: Feasibility of the technology enabled symptom management solution
timeFrame: Assessed up to 90 days
measure: Usability of the technology enabled symptom management solution
timeFrame: Day 30 and Day 90 +/-10 from first radiotherapy
measure: Appropriateness of the recommendations
timeFrame: After 15 and then 30 patients have reached Day 30 and then Day 90
measure: Semi-structured exit interviews
timeFrame: End of study - Day 90 +/-10 from first radiotherapy
Other outcomes:
measure: Symptom burden will be measured using the NIH PRO-CTCAE measurement system, which includes validated scales for individual toxicities
timeFrame: Baseline, Day 30 and Day 90 +/-10 from first radiotherapy
measure: Quality of life will be measured using the previously validated FACT-G scale
timeFrame: Baseline, Day 30 and Day 90 +/-10 from first radiotherapy
measure: Treatment adherence
timeFrame: Assessed up to 90 days
measure: Health-economic outcome
timeFrame: Assessed up to 90 days
measure: Complaints, alleged deficiencies or malfunctions of the device reported
timeFrame: Assessed up to 90 days
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Amir Alishahi, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: