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Swallowing Exercise from Home for Swallowing Difficulty in Head and Neck Cancer Patients
N/A
Waitlist Available
Led By Jana Rieger, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 weeks post-baseline
Awards & highlights
Study Summary
This trial will test whether a mobile health system with sEMG biofeedback can help people with dysphagia (trouble swallowing) due to head and neck cancer treatment adhere to a home-based swallowing exercise program.
Eligible Conditions
- Head and Neck Cancers
- Swallowing Difficulty
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 weeks post-baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks post-baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the MD Anderson Dysphagia Inventory (MDADI)
Percent adherence to recommended number of exercises
Secondary outcome measures
The Health Questionnaire (EuroQoL EQ-5D)
Three-Day Dietary Intake Record
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mobile health systemExperimental Treatment1 Intervention
Participants will complete swallowing exercises using a mobile health system with surface electromyography (sEMG) biofeedback.
Group II: Pen and PaperActive Control1 Intervention
Participants will complete swallowing exercises using printed materials and diary for tracking.
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Who is running the clinical trial?
University of AlbertaLead Sponsor
886 Previous Clinical Trials
384,760 Total Patients Enrolled
Alberta Cancer FoundationOTHER
17 Previous Clinical Trials
5,615 Total Patients Enrolled
Jana Rieger, PhDPrincipal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
65 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your skin under the chin is irritated or has open wounds.You have a history of cognitive delay, which means you may have experienced difficulties with thinking and learning.You have a history of stroke or a serious head injury that required medical attention.You are allergic to silver.You have difficulty swallowing due to previous treatment for squamous cell carcinoma in the throat.You have previously undergone treatment for head and neck cancer, such as surgery, radiation therapy, or chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Pen and Paper
- Group 2: Mobile health system
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is the maximum threshold for this research endeavor?
"Affirmative. According to information on clinicaltrials.gov, this experiment is actively recruiting participants. It was posted on October 27th 2021 and its most recent update was recorded on October 28th 2022. The study requires 60 patients from a single medical centre for enrolment."
Answered by AI
Are there still openings in this clinical venture?
"Affirmative. The information accessible on clinicaltrials.gov demonstrates that this research endeavour, which was published on October 27th 2021, is actively enlisting patients for participation. Approximately 60 persons must be recruited from one trial site."
Answered by AI
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