Clinical trial NCT05368025: Staying Connected: a Mobile Health Study With the Noona® and Mobili-T® Systems
Official title: Staying Connected: a Mobile Health Study for Remote Monitoring of Dysphagia Exercises and Patient-reported Outcome Measures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oropharynx Cancer
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 65
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed Oropharyngeal Cancer patients

Brief summary: Mobile health applications are an attractive technological solution that facilitates access to care for patients conveniently and efficiently. Research has shown that remote mHealth delivery has improved patient reported outcomes of disease severity. While such outcomes have traditionally been collected at one point in time within a clinical setting, the potential exists to now gather patient perspectives remotely. Additionally, when combined with a mobile health device, mHealth apps can objectively monitor a treatment plan.

Before implementing a new technology, it is important to investigate how digital health technologies are best integrated into clinical workflows, and how more than one technology can work together to streamline the process. Additionally, it is important to understand the relative benefits of each system from a user perspective and identify how combined data can benefit clinical workflows. Therefore, the purposes of this project are to demonstrate how two technology companies can work together to assess the feasibility of implementing two related systems into one care pathway.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of head and neck cancer;
* Will be receiving treatment for head and neck cancer (e.g., +/-surgery, +/- radiation therapy, +/- chemotherapy);
* The primary site of their cancer is the oropharynx, as this is the subgroup of patients known to experience dysphagia.

Exclusion Criteria:

* Have a history of cognitive delay,
* History of stroke or traumatic brain injury.
* Have a beard that they are not willing to shave or partially shave (as the device adheres under the chin, on the surface of the skin).
* Have an implanted electronic device of any kind, including cardiac pacemakers or similar assistive devices, electronic infusion pumps, and implanted stimulators
* Have irritated skin or skin with open wounds under the chin;
* Have an allergy to silver.

Primary outcomes:
measure: The MD Anderson Dysphagia Inventory (MDADI) to assess dysphagia severity in those with a history of HNC
timeFrame: pre-operative
measure: The MD Anderson Dysphagia Inventory (MDADI) to assess dysphagia severity in those with a history of HNC
timeFrame: 1 month post-surgery
measure: The MD Anderson Dysphagia Inventory (MDADI) to assess dysphagia severity in those with a history of HNC
timeFrame: 3 months post-surgery
measure: The MD Anderson Dysphagia Inventory (MDADI) to assess dysphagia severity in those with a history of HNC
timeFrame: 6 months post-surgery
measure: The Health Questionnaire (EuroQoL EQ-5D) will assess health status in terms of five dimensions of health
timeFrame: pre-operative
measure: The Health Questionnaire (EuroQoL EQ-5D) will assess health status in terms of five dimensions of health
timeFrame: 1 month post-surgery
measure: The Health Questionnaire (EuroQoL EQ-5D) will assess health status in terms of five dimensions of health
timeFrame: 3 months post-surgery
measure: The Health Questionnaire (EuroQoL EQ-5D) will assess health status in terms of five dimensions of health
timeFrame: 6 months post-surgery
measure: Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients
timeFrame: pre-operative
measure: Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients
timeFrame: 1 month post-surgery
measure: Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients
timeFrame: 3 months post-surgery
measure: Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients
timeFrame: 6 months post-surgery
measure: Edmonton-33 is a patient reported outcomes measurement scale that was created by patients to measure the main functional areas of concern for patients with head and neck cancer
timeFrame: pre-operative
measure: Edmonton-33 is a patient reported outcomes measurement scale that was created by patients to measure the main functional areas of concern for patients with head and neck cancer
timeFrame: 1 month post-surgery
measure: Edmonton-33 is a patient reported outcomes measurement scale that was created by patients to measure the main functional areas of concern for patients with head and neck cancer
timeFrame: 3 months post-surgery
measure: Edmonton-33 is a patient reported outcomes measurement scale that was created by patients to measure the main functional areas of concern for patients with head and neck cancer
timeFrame: 6 months post-surgery
measure: Patient demographics including age, gender, T-stage, date of surgery
timeFrame: pre-operative
measure: ER admissions related to aspiration pneumonia or dehydration
timeFrame: 6 month post surgery
Secondary outcomes:
measure: Adherence to exercise using Mobili-T system
timeFrame: Up to 6 months, calculated from date of enrollment until the date of study completion or patient exit interview, whichever came first
measure: Targets met when using Mobili-T system
timeFrame: Up to 6 months, calculated from date of enrollment until the date of study completion or patient exit interview, whichever came first
measure: Top three dysphagia symptoms reported on a weekly basis
timeFrame: Up to 6 months, calculated from date of enrollment until the date of study completion or patient exit interview, whichever came first
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Jana Rieger, PhD
role: PRINCIPAL_INVESTIGATOR
References: