Testing and Comparing the Impacts of Mhealth-Based and Web-Based Education on Oral Cancer
A Comparative Analysis of the Effectiveness, Usability, Uptake, and Acceptability of an Educational Website and a Mobile Health Application Prototype in Improving Knowledge on Oral Cancer
1 other identifier
interventional
75
4 countries
5
Brief Summary
Introduction: Oral cancer is a malignant neoplastic disease affecting the lip, oral cavity (mouth) and/or the oropharynx. Despite the intense and diverse public health interventions on oral cancer prevention, the global prevalence rates of oral cancer and its major risk factors are still very high. Hence, oral cancer is an issue of serious global health importance. Aim: To test and compare the effectiveness, usability, uptake, and acceptability of an educational website and a mobile health application prototype on oral cancer in improving oral cancer knowledge among university students. Methods: This study will adopt a randomised control trial design, and it will be conducted among 75 first-year bachelor's degree students from five universities across two continents: University of Rwanda (Rwanda, Africa), Usmanu Danfodiyo University (Nigeria, Africa), University of Peradeniya (Sri Lanka, Asia), University of Ibadan (Nigeria), and Saveetha University (India, Aisa). The study participants will be in three groups (Group 1, Group 2, and Group 3). The participants in Group 1 will be the control group (n = 25 participants; 5 participants from each university); that is the group that will not receive an educational intervention. However, those in Group 2 (n = 25 participants; 5 participants from each university) will receive a web-based educational intervention on oral cancer while those in Group 3 (n = 25 participants; 5 participants from each university) will receive an app-based educational intervention on oral cancer. Pretest survey and posttest survey will be done for all participants. The data collected will be statistically analysed using the Statistical Package for Social Sciences (SPSS) version 28 software. Descriptive statistics will be done for all variables while inferential statistics (analysis of variance) will be done to test for associations between variables of interest. Conclusion: The findings of this study will determine the effectiveness, usability, uptake, and acceptability of the tested digital intervention tools.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2024
CompletedFirst Posted
Study publicly available on registry
December 2, 2024
CompletedStudy Start
First participant enrolled
January 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedDecember 2, 2024
November 1, 2024
3 months
November 18, 2024
November 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement of change in baseline knowledge on oral cancer four weeks post-intervention using a questionnaire
This primary outcome measure will be a change in knowledge on oral cancer at four weeks after the delivery of the intervention, and this will be done using a questionnaire. All participants in both the control and intervention groups will be evaluated at baseline and at endline. This outcome will be measured using a questionnaire. This questionnaire was developed by the investigators. The questionnaire will obtain assess the participants' knowledge of oral cancer through the use of 10 multiple choice questions
From enrollment to the end of educational intervention at 4 weeks
Secondary Outcomes (3)
Measurement of the usability of the intervention tools using an adapted version of the user Mobile Application Rating Scale
At the end of educational intervention at 4 weeks
Measurement of the uptake of the intervention tools using an adapted version of the user Mobile Application Rating Scale
At the end of educational intervention at 4 weeks
Measurement of the acceptability of the intervention tools using an adapted version of the user Mobile Application Rating Scale
At the end of educational intervention at 4 weeks
Study Arms (3)
Control Group
NO INTERVENTIONThis is the control group (arm). No educational intervention on oral cancer will be administered to this group.
Web-based Intervention Group
EXPERIMENTALA web-based educational intervention on oral cancer will be administered to this group.
mHealth-based Intervention Group
EXPERIMENTALAn app-based educational intervention on oral cancer will be administered to this group.
Interventions
This intervention will involve administering education, via a website, on the meaning, risks, clinical features, prevention, treatment, and supports on oral cancer.
This intervention will involve administering education, via a mhealth application prototype, on the meaning, risks, clinical features, prevention, treatment, and supports on oral cancer.
Eligibility Criteria
You may qualify if:
- being a first-year bachelor degree student of either University of Rwanda (Rwanda), University of Peradeniya (Sri Lanka), Usmanu Danfodiyo University (Nigeria), University of Ibadan (Nigeria), or Saveetha University (India)
- being within the age range of 18 to 39 years
- having a personal smartphone
- willingness to participate in the study
You may not qualify if:
- being a member of staff or a visitor or a non-first year bachelor degree student of University of Rwanda (Rwanda), University of Peradeniya (Sri Lanka), Usmanu Danfodiyo University (Nigeria), University of Ibadan (Nigeria), or Saveetha University (India)
- being a student of a tertiary institution not selected for the study
- being below the age of 18 years or above the age of 39 years.
- not having a personal smartphone
- not willing to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rwandalead
- University of Peradeniyacollaborator
- University of Ibadancollaborator
- Usmanu Danfodiyo Universitycollaborator
- Saveetha Universitycollaborator
Study Sites (5)
Saveetha University
Tamil Nadu, India
University of Ibadan
Ibadan, Oyo State, Nigeria
Usmanu Danfodiyo University
Sokoto, Sokoto State, Nigeria
University of Rwanda
Kigali, Kigali, Rwanda
University of Peradeniya
Peradeniya, Sri Lanka
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kehinde Kanmodi, BDS, MPH
University of Rwanda
- STUDY DIRECTOR
Peace Uwambaye, BSC, MPH, PhD
University of Rwanda
- STUDY DIRECTOR
Afeez Salami, BDS
University of Ibadan
- STUDY DIRECTOR
Bello Almu, BSC, MSc, MPP
Usmanu Danfodiyo University
- STUDY DIRECTOR
Karthikeyan Ramalingam, BDS, MDS
Saveetha University
- STUDY DIRECTOR
Yovanthi Jayasinghe, BSc, PGD
University of Peradeniya
- STUDY DIRECTOR
Timothy Aladelusi, BDS, MSc
University of Ibadan
- STUDY DIRECTOR
Akinyele Adisa, BDS
University of Ibadan
- STUDY DIRECTOR
Jimoh Amzat, BSC, MA, MSc, PhD
Usmanu Danfodiyo University
- PRINCIPAL INVESTIGATOR
Ruwan Jayasinghe, BDS, MSc
University of Peradeniya
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Honorary Research Fellow
Study Record Dates
First Submitted
November 18, 2024
First Posted
December 2, 2024
Study Start
January 5, 2025
Primary Completion
March 31, 2025
Study Completion
April 30, 2025
Last Updated
December 2, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Start date: 05 June 2025 End date: 05 May 2035
- Access Criteria
- Only the anonymised IPD documents will be shared and such can be shared upon reasonable request.
The names, and any other personal information that could potentially identify the participants will not appear in any reports or publications. The participants will be assigned a unique study identifying number (or pseudonym) which will be recorded only on a link document. This link document will be stored separately on the U-drive from both the person identifiable consent forms and the pseudo-anonymised data. Any participant that wishes to withdraw would email the researcher without giving a reason. As soon as the last date allowed for withdrawal has passed the coding (link) document will be securely destroyed and the data rendered non-person identifiable. Withdrawal is not possible after this point. The consent form will be stored for up to 10 years on the U-drive of the principal investigators, separate to other study data, as it is an important document. This is in case other scientists wish to raise questions about the results that need checking again.