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

NCT05368025 | Completed DMC FDA Device

• 1 other identifier: Pro00094960
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharynx Cancer

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (3)

• Adherence to exercise using Mobili-T system

  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

  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

  Up to 6 months, calculated from date of enrollment until the date of study completion or patient exit interview, whichever came first

Study Arms (1)

Newly diagnosed Oropharyngeal cancer patients

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

Interventions

Mobili-T/Noona DEVICE

Use of two mobile health systems over a period of 6 months

Newly diagnosed Oropharyngeal cancer patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Newly diagnosed Oropharyngeal Cancer patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jana Rieger, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: May 10, 2022
• Study Start: February 17, 2022
• Primary Completion: December 1, 2022
• Study Completion: May 26, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)