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The goal of this observational study is to assess the satisfaction and usability of an interactive and patient-centered mobile application (app), Oleenaâ„¢, 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oleena | Device | Oleenaâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom burden will be measured using the NIH PRO-CTCAE measurement system, which includes validated scales for individual toxicities | 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. | Baseline, Day 30 and Day 90 +/-10 from first radiotherapy |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Amir Alishahi, MD, PhD, MPH | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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) | 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 | 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 | End of study - Day 90 +/-10 from first radiotherapy |
| Quality of life will be measured using the previously validated FACT-G scale | 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 | Baseline, Day 30 and Day 90 +/-10 from first radiotherapy |
| Treatment adherence | Treatments prescribed and received, dosage, duration of treatment, dose reductions, and discontinuation | Assessed up to 90 days |
| Health-economic outcome | The number of unscheduled outpatient visits, unscheduled inpatient hospitalizations and ER admissions related to the targeted symptoms | Assessed up to 90 days |
| Complaints, alleged deficiencies or malfunctions of the device reported | Safety of the device | Assessed up to 90 days |