NCT06711848

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

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
4 countries

5 active sites

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

November 18, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 5, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 18, 2024

Last Update Submit

November 28, 2024

Conditions

Keywords

mobile healthapplicationwebsiteimpactknowledgeoral cancerpublic healthintervention

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 INTERVENTION

This is the control group (arm). No educational intervention on oral cancer will be administered to this group.

Web-based Intervention Group

EXPERIMENTAL

A web-based educational intervention on oral cancer will be administered to this group.

Behavioral: A web-based educational intervention on oral cancer

mHealth-based Intervention Group

EXPERIMENTAL

An app-based educational intervention on oral cancer will be administered to this group.

Behavioral: A mobile health app-based educational intervention on oral cancer

Interventions

This intervention will involve administering education, via a website, on the meaning, risks, clinical features, prevention, treatment, and supports on oral cancer.

Web-based Intervention Group

This intervention will involve administering education, via a mhealth application prototype, on the meaning, risks, clinical features, prevention, treatment, and supports on oral cancer.

mHealth-based Intervention Group

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (5)

Saveetha University

Tamil Nadu, India

Location

University of Ibadan

Ibadan, Oyo State, Nigeria

Location

Usmanu Danfodiyo University

Sokoto, Sokoto State, Nigeria

Location

University of Rwanda

Kigali, Kigali, Rwanda

Location

University of Peradeniya

Peradeniya, Sri Lanka

Location

MeSH Terms

Conditions

Mouth NeoplasmsHealth EducationTooth, Impacted

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorTooth Diseases

Study Officials

  • Kehinde Kanmodi, BDS, MPH

    University of Rwanda

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY DIRECTOR
  • Ruwan Jayasinghe, BDS, MSc

    University of Peradeniya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kehinde K Kanmodi, BDS, MPH

CONTACT

Peace Uwambaye, BSc, MPH, PhD

CONTACT

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

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.

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.

Locations