Staying Connected: a Mobile Health Study With the Noona® and Mobili-T® Systems

Oropharynx Cancer Clinical Trial

Official title:

Staying Connected: a Mobile Health Study for Remote Monitoring of Dysphagia Exercises and Patient-reported Outcome Measures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05368025
• Other study ID #: Pro00094960
• Status: Completed
• Start date: February 17, 2022
• Est. completion date: May 26, 2023

Study information

• Verified date: October 2023
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 26, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Oropharyngeal Neoplasms
• Oropharynx Cancer

Intervention

Device:
• Mobili-T/Noona
Use of two mobile health systems over a period of 6 months

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The MD Anderson Dysphagia Inventory (MDADI) to assess dysphagia severity in those with a history of HNC	The MD Anderson Dysphagia Inventory (MDADI) is a validated and reliable self-administered questionnaire that was specifically designed for patients with a history of HNC. MDADI consists of 20 questions and results in 4 subscales: global, emotional, functional and physical. Although no gold standard questionnaire exists for HNC patients, a recent systematic review revealed that MDADI was one of the most frequently utilized and thoroughly tested instruments for symptom-specific HNC measures. While all subscores will be reported for demographic purposes, only the composite score will be used for statistical analyses.	pre-operative
Primary	The MD Anderson Dysphagia Inventory (MDADI) to assess dysphagia severity in those with a history of HNC	The MD Anderson Dysphagia Inventory (MDADI) is a validated and reliable self-administered questionnaire that was specifically designed for patients with a history of HNC. MDADI consists of 20 questions and results in 4 subscales: global, emotional, functional and physical. Although no gold standard questionnaire exists for HNC patients, a recent systematic review revealed that MDADI was one of the most frequently utilized and thoroughly tested instruments for symptom-specific HNC measures. While all subscores will be reported for demographic purposes, only the composite score will be used for statistical analyses.	1 month post-surgery
Primary	The MD Anderson Dysphagia Inventory (MDADI) to assess dysphagia severity in those with a history of HNC	The MD Anderson Dysphagia Inventory (MDADI) is a validated and reliable self-administered questionnaire that was specifically designed for patients with a history of HNC. MDADI consists of 20 questions and results in 4 subscales: global, emotional, functional and physical. Although no gold standard questionnaire exists for HNC patients, a recent systematic review revealed that MDADI was one of the most frequently utilized and thoroughly tested instruments for symptom-specific HNC measures. While all subscores will be reported for demographic purposes, only the composite score will be used for statistical analyses.	3 months post-surgery
Primary	The MD Anderson Dysphagia Inventory (MDADI) to assess dysphagia severity in those with a history of HNC	The MD Anderson Dysphagia Inventory (MDADI) is a validated and reliable self-administered questionnaire that was specifically designed for patients with a history of HNC. MDADI consists of 20 questions and results in 4 subscales: global, emotional, functional and physical. Although no gold standard questionnaire exists for HNC patients, a recent systematic review revealed that MDADI was one of the most frequently utilized and thoroughly tested instruments for symptom-specific HNC measures. While all subscores will be reported for demographic purposes, only the composite score will be used for statistical analyses.	6 months post-surgery
Primary	The Health Questionnaire (EuroQoL EQ-5D) will assess health status in terms of five dimensions of health	The Health Questionnaire (EuroQoL EQ-5D) will be administered. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. The 5 areas that it measures include: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.	pre-operative
Primary	The Health Questionnaire (EuroQoL EQ-5D) will assess health status in terms of five dimensions of health	The Health Questionnaire (EuroQoL EQ-5D) will be administered. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. The 5 areas that it measures include: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.	1 month post-surgery
Primary	The Health Questionnaire (EuroQoL EQ-5D) will assess health status in terms of five dimensions of health	The Health Questionnaire (EuroQoL EQ-5D) will be administered. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. The 5 areas that it measures include: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.	3 months post-surgery
Primary	The Health Questionnaire (EuroQoL EQ-5D) will assess health status in terms of five dimensions of health	The Health Questionnaire (EuroQoL EQ-5D) will be administered. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. The 5 areas that it measures include: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.	6 months post-surgery
Primary	Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients	Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath	pre-operative
Primary	Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients	Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath	1 month post-surgery
Primary	Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients	Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath	3 months post-surgery
Primary	Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients	Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath	6 months post-surgery
Primary	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	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.	pre-operative
Primary	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	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.	1 month post-surgery
Primary	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	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.	3 months post-surgery
Primary	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	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.	6 months post-surgery
Primary	Patient demographics including age, gender, T-stage, date of surgery	Patient demographics including age, gender, T-stage, date of surgery: these variables will be entered into the Noona clinician portal by the research nurse	pre-operative
Primary	ER admissions related to aspiration pneumonia or dehydration	admissions related to aspiration pneumonia or dehydration: these will be entered into the Noona system by the research nurse, who will access Connect Care at the end of the 6-month period for each patient to record any such events	6 month post surgery
Secondary	Adherence to exercise using Mobili-T system	Adherence. Daily adherence logs are automatically collected by the Mobili-T system. Daily adherence as a percent of trials completed of those prescribed (e.g., 70/72*100) will be used to calculate average weekly adherence for each participant	Up to 6 months, calculated from date of enrollment until the date of study completion or patient exit interview, whichever came first
Secondary	Targets met when using Mobili-T system	Targets met: The daily percentage of exercise targets that the participant completes is automatically logged in the clinician portal.	Up to 6 months, calculated from date of enrollment until the date of study completion or patient exit interview, whichever came first
Secondary	Top three dysphagia symptoms reported on a weekly basis	Top three dysphagia symptoms reported on a weekly basis, where dysphagia symptoms include: coughing or choking, voice quality; food/liquid through nose; food/liquid out of mouth; watery eyes; food going down the wrong way; pain when swallowing; food felt stuck in throat; food felt stuck in cheeks; food in mouth after eating; long time to eat; reflux.	Up to 6 months, calculated from date of enrollment until the date of study completion or patient exit interview, whichever came first