Oropharynx CancerNCT05368025
Staying Connected: a Mobile Health Study With the Noona® and Mobili-T® Systems
An observational study of Oropharynx Cancer, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oropharynx Cancer
- What is being tested?
- Mobili-T/Noona
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- 17 Feb 2022to 26 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Newly diagnosed Oropharyngeal Cancer patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Staying Connected: a Mobile Health Study for Remote Monitoring of Dysphagia Exercises and Patient-reported Outcome Measures
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
- Being tested
- Mobili-T/Noona
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobili-T/NoonaDevice
Use of two mobile health systems over a period of 6 months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Mobili-T/Noona |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 month post surgery
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: Up to 6 months, calculated from date of enrollment until the date of study completion or patient exit interview, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start17 Feb 2022
- Primary completion1 Dec 2022
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jana Rieger, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368025
- Sponsor's protocol ID
- Pro00094960
- Status last verified
- Oct 2023
- First submitted
- 15 Feb 2022
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staying Connected: a Mobile Health Study for Remote Monitoring of Dysphagia Exercises and Patient-reported Outcome Measures
- ClinicalTrials.gov ID
- NCT05368025
- Acronym / sponsor ID
- Pro00094960
- Conditions
- Oropharynx Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed Oropharyngeal cancer patients | – | Device: Mobili-T/NoonaNewly 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newly diagnosed Oropharyngeal Cancer patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobili-T/NoonaUse of two mobile health systems over a period of 6 months | Device | Newly diagnosed Oropharyngeal cancer patients |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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.
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.
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.
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.
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
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jana Rieger, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharynx Cancer, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The MD Anderson Dysphagia Inventory (MDADI) to assess dysphagia severity in those with a history of HNC (time frame: pre-operative). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.