Back to resultsDigital Patient Education Platform in Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Digital Education Group
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Education, Patient Satisfaction, Multimedia, Free flap, Head and neck cancer
Eligibility Criteria
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
Sites / Locations
- Vancouver General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Digital Education Group
Arm Description
This group will continue to receive the routine standard of care during their treatment journey.
In addition to the standard of care, this group will complete an audiovisual digital education module during their postoperative stay in hospital.
Outcomes
Primary Outcome Measures
Patient Satisfaction
Measured via a 5-point Likert scale from a survey collected on discharge day
Secondary Outcome Measures
Perceived quality of medical care
Measured via a 5-point Likert scale from a survey collected on discharge day
Full Information
NCT ID
NCT05211778
First Posted
January 4, 2022
Last Updated
January 14, 2022
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT05211778
Brief Title
Digital Patient Education Platform in Head and Neck Cancer
Official Title
Post-Operative Patient-Centred Care Education Administration in Head and Neck Cancer Patients - A Digital Platform
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
March 26, 2020 (Actual)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Education, Patient Satisfaction, Multimedia, Free flap, Head and neck cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will continue to receive the routine standard of care during their treatment journey.
Arm Title
Digital Education Group
Arm Type
Experimental
Arm Description
In addition to the standard of care, this group will complete an audiovisual digital education module during their postoperative stay in hospital.
Intervention Type
Behavioral
Intervention Name(s)
Digital Education Group
Intervention Description
Multimedia education provided to the intervention group via a digital tablet
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
Measured via a 5-point Likert scale from a survey collected on discharge day
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.
Secondary Outcome Measure Information:
Title
Perceived quality of medical care
Description
Measured via a 5-point Likert scale from a survey collected on discharge day
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eitan Prisman, MD, FRCSC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Digital Patient Education Platform in Head and Neck Cancer
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