- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05211778
Digital Patient Education Platform in Head and Neck Cancer
January 14, 2022 updated by: Eitan Prisman, University of British Columbia
Post-Operative Patient-Centred Care Education Administration in Head and Neck Cancer Patients - A Digital Platform
Head and neck cancer is a disease that has a particular propensity for treatment-related morbidity.
It is hypothesized that patients who are more involved in their care in hospital and who are actively provided with more treatment-related education may report increased satisfaction and have improved overall outcomes.
The investigators aim to determine whether delivery of patient-centred education in a multimedia format via a digital platform has an impact on overall satisfaction and perceived quality of medical care.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- Vancouver General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients aged 19 years old or above
- Patients seen in outpatient clinic who are scheduled to undergo reconstructive head and neck surgeries for a confirmed oral or oropharyngeal cancer diagnosis.
Exclusion Criteria:
- Patients who are unable to use a digital tablet
- Patients who do not speak or read English
- Individuals unable to understand the purpose, methods and conduct of this study
- Patients unwilling to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
This group will continue to receive the routine standard of care during their treatment journey.
|
|
|
Experimental: Digital Education Group
In addition to the standard of care, this group will complete an audiovisual digital education module during their postoperative stay in hospital.
|
Multimedia education provided to the intervention group via a digital tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Satisfaction
Time Frame: From date of surgery until the date of discharge. The number of days patients will remain in hospital after surgery can range from 7-14 days.
|
Measured via a 5-point Likert scale from a survey collected on discharge day
|
From date of surgery until the date of discharge. The number of days patients will remain in hospital after surgery can range from 7-14 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived quality of medical care
Time Frame: From date of surgery until the date of discharge. The number of days patients will remain in hospital after surgery can range from 7-14 days.
|
Measured via a 5-point Likert scale from a survey collected on discharge day
|
From date of surgery until the date of discharge. The number of days patients will remain in hospital after surgery can range from 7-14 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eitan Prisman, MD, FRCSC, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2019
Primary Completion (Actual)
March 26, 2020
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
January 4, 2022
First Submitted That Met QC Criteria
January 14, 2022
First Posted (Actual)
January 27, 2022
Study Record Updates
Last Update Posted (Actual)
January 27, 2022
Last Update Submitted That Met QC Criteria
January 14, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H16-01039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.