NCT05211778

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

January 4, 2022

Last Update Submit

January 14, 2022

Conditions

Keywords

EducationPatient SatisfactionMultimediaFree flapHead and neck cancer

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction

    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 Outcomes (1)

  • Perceived quality of medical care

    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.

Study Arms (2)

Control Group

NO INTERVENTION

This group will continue to receive the routine standard of care during their treatment journey.

Digital Education Group

EXPERIMENTAL

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

Interventions

Multimedia education provided to the intervention group via a digital tablet

Digital Education Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsPatient Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Eitan Prisman, MD, FRCSC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 4, 2022

First Posted

January 27, 2022

Study Start

January 8, 2019

Primary Completion

March 26, 2020

Study Completion

June 1, 2022

Last Updated

January 27, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations