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

Study Overview
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Brief Summary
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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.

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

Conditions
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Oropharynx Cancer

Intervention / Treatment
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* Device: Mobili-T/Noona


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly diagnosed Oropharyngeal cancer patients<br>Newly diagnosed oropharyngeal cancer patients will be enrolled into the study. Patients will receive both mobile health systems and be asked to complete swallowing exercises and report symptoms daily for a period of 6 months. Following completion of the study, this group will be interviewed individually to gain insight into the user experience of using both systems | Device: Mobili-T/Noona<br>* Use of two mobile health systems over a period of 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |