Head and Neck CancerNCT05211778
Digital Patient Education Platform in Head and Neck Cancer
A study testing Digital Education Group in people with Head and Neck Cancer, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Digital Education Group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2019to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Digital Education Group
- Keywords
- Education, Patient Satisfaction, Multimedia, Free flap, Head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Education GroupBehavioural
Multimedia education provided to the intervention group via a digital tablet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Digital Education Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Measured via a 5-point Likert scale from a survey collected on discharge day
Measured: 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
Measured via a 5-point Likert scale from a survey collected on discharge day
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start8 Jan 2019
- Primary completion26 Mar 2020
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eitan Prisman, University of British Columbia
- Investigators
- Eitan Prisman, MD, FRCSC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211778
- Sponsor's protocol ID
- H16-01039
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Patient-Centred Care Education Administration in Head and Neck Cancer Patients - A Digital Platform
- ClinicalTrials.gov ID
- NCT05211778
- Acronym / sponsor ID
- H16-01039
- Conditions
- Head and Neck Cancer
- Keywords
- Education, Patient Satisfaction, Multimedia, Free flap, Head and neck cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This group will continue to receive the routine standard of care during their treatment journey. |
| Digital Education Group | Experimental | Behavioral: Digital Education GroupIn addition to the standard of care, this group will complete an audiovisual digital education module during their postoperative stay in hospital. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Education GroupMultimedia education provided to the intervention group via a digital tablet | Behavioural | Digital Education Group |
Primary outcome
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
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eitan Prisman, MD, FRCSC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Education Group in people with Head and Neck Cancer, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.