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

  • Canada
    • 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.
Behavioral: Digital Education Group
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

University of British Columbia

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

Keywords

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.

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