Head and Neck Cancer
Conditions
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.
Interventions
DEVICEOleena
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.
Sponsors
Aptar Digital Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Users' satisfaction | 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the technology enabled symptom management solution | 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. |
| Usability of the technology enabled symptom management solution | 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) |
| Appropriateness of the recommendations | 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 |
| Semi-structured exit interviews | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Quality of life will be measured using the previously validated FACT-G scale | 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 |
| Treatment adherence | Assessed up to 90 days | Treatments prescribed and received, dosage, duration of treatment, dose reductions, and discontinuation |
| Health-economic outcome | Assessed up to 90 days | The number of unscheduled outpatient visits, unscheduled inpatient hospitalizations and ER admissions related to the targeted symptoms |
| Complaints, alleged deficiencies or malfunctions of the device reported | Assessed up to 90 days | Safety of the device |
Countries
United States
Outcome results
None listed