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Completed

NCT Number: NCT05368025

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

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.

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Key information

Conditions

Oropharynx Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobili-T/Noona

Device

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

Primary outcomes

  1. The MD Anderson Dysphagia Inventory (MDADI) to assess dysphagia severity in those with a history of HNC

    Time frame: pre-operative

    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.

  2. The MD Anderson Dysphagia Inventory (MDADI) to assess dysphagia severity in those with a history of HNC

    Time frame: 1 month post-surgery

    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. The MD Anderson Dysphagia Inventory (MDADI) to assess dysphagia severity in those with a history of HNC

    Time frame: 3 months post-surgery

    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.

  4. The MD Anderson Dysphagia Inventory (MDADI) to assess dysphagia severity in those with a history of HNC

    Time frame: 6 months post-surgery

    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.

  5. The Health Questionnaire (EuroQoL EQ-5D) will assess health status in terms of five dimensions of health

    Time frame: pre-operative

    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. The Health Questionnaire (EuroQoL EQ-5D) will assess health status in terms of five dimensions of health

    Time frame: 1 month post-surgery

    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.

  7. The Health Questionnaire (EuroQoL EQ-5D) will assess health status in terms of five dimensions of health

    Time frame: 3 months post-surgery

    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.

  8. The Health Questionnaire (EuroQoL EQ-5D) will assess health status in terms of five dimensions of health

    Time frame: 6 months post-surgery

    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.

  9. Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients

    Time frame: pre-operative

    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

  10. Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients

    Time frame: 1 month post-surgery

    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

  11. Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients

    Time frame: 3 months post-surgery

    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

  12. Edmonton Symptom Assessment Scale is a questionnaire used to rate the intensity of nine common symptoms experienced by cancer patients

    Time frame: 6 months post-surgery

    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

  13. 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

    Time frame: 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.

  14. 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

    Time frame: 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.

  15. 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

    Time frame: 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.

  16. 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

    Time frame: 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.

  17. Patient demographics including age, gender, T-stage, date of surgery

    Time frame: pre-operative

    Patient demographics including age, gender, T-stage, date of surgery: these variables will be entered into the Noona clinician portal by the research nurse

  18. ER admissions related to aspiration pneumonia or dehydration

    Time frame: 6 month post surgery

    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

Secondary outcomes

  1. Adherence to exercise using Mobili-T system

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

    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

  2. Targets met when using Mobili-T system

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

    Targets met: The daily percentage of exercise targets that the participant completes is automatically logged in the clinician portal.

  3. Top three dysphagia symptoms reported on a weekly basis

    Time frame: 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, 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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 10, 2022
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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