Testing and Comparing the Impacts of Mhealth-Based and Web-Based Education on Oral Cancer

NCT ID: NCT06711848

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-05

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Cancer Health Education, Community Digital Intervention MHealth Application MHealth Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Web-based Intervention Group

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

Group Type EXPERIMENTAL

A web-based educational intervention on oral cancer

Intervention Type BEHAVIORAL

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

mHealth-based Intervention Group

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

Group Type EXPERIMENTAL

A mobile health app-based educational intervention on oral cancer

Intervention Type BEHAVIORAL

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

Interventions

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A web-based educational intervention on oral cancer

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

Intervention Type BEHAVIORAL

A mobile health app-based educational intervention 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Peradeniya

OTHER

Sponsor Role collaborator

University of Ibadan

OTHER

Sponsor Role collaborator

Usmanu Danfodiyo University

OTHER

Sponsor Role collaborator

Saveetha University

OTHER

Sponsor Role collaborator

University of Rwanda

OTHER

Sponsor Role lead

Responsible Party

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Kehinde Kazeem Kanmodi

Honorary Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kehinde Kanmodi, BDS, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rwanda

Peace Uwambaye, BSC, MPH, PhD

Role: STUDY_DIRECTOR

University of Rwanda

Afeez Salami, BDS

Role: STUDY_DIRECTOR

University of Ibadan

Bello Almu, BSC, MSc, MPP

Role: STUDY_DIRECTOR

Usmanu Danfodiyo University

Karthikeyan Ramalingam, BDS, MDS

Role: STUDY_DIRECTOR

Saveetha University

Yovanthi Jayasinghe, BSc, PGD

Role: STUDY_DIRECTOR

University of Peradeniya

Timothy Aladelusi, BDS, MSc

Role: STUDY_DIRECTOR

University of Ibadan

Akinyele Adisa, BDS

Role: STUDY_DIRECTOR

University of Ibadan

Jimoh Amzat, BSC, MA, MSc, PhD

Role: STUDY_DIRECTOR

Usmanu Danfodiyo University

Ruwan Jayasinghe, BDS, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Peradeniya

Locations

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Saveetha University

Tamil Nadu, , India

Site Status

University of Ibadan

Ibadan, Oyo State, Nigeria

Site Status

Usmanu Danfodiyo University

Sokoto, Sokoto State, Nigeria

Site Status

University of Rwanda

Kigali, Kigali, Rwanda

Site Status

University of Peradeniya

Peradeniya, , Sri Lanka

Site Status

Countries

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India Nigeria Rwanda Sri Lanka

Central Contacts

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Kehinde K Kanmodi, BDS, MPH

Role: CONTACT

+2347032329156

Peace Uwambaye, BSc, MPH, PhD

Role: CONTACT

+250788505856

Facility Contacts

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Karthikeyan Ramalingam, BDS, MDS

Role: primary

+918290996783

Karthikeyan Ramalingam, BDS, MDS

Role: backup

Afeez Salami, BDS

Role: primary

+2347060636389

Akinyele Adisa, BDS

Role: backup

+2348037252207

Afeez Salami, BDS

Role: backup

Akinyele Adisa, BDS

Role: backup

Timothy Aladelusi, BDS, MSc

Role: backup

Jimoh Amzat, BSc, MA, MSc, PhD

Role: primary

+2348034339221

Jimoh Amzat, BSc, MA, MSc, PhD

Role: backup

Bello Almu, BSc, MPP, MSc

Role: backup

Peace Uwambaye, BSc, MPH, PhD

Role: primary

+250788505856

Kehinde Kanmodi, BDS, MPH, PhD

Role: backup

Peace Uwambaye, BSc, MPH, PhD

Role: backup

Ruwan Jayasinghe, BDS, MSc

Role: primary

+94777373689

Ruwan Jayasinghe, BDS, MSc

Role: backup

Yovanthi Jayasinghe, BSc, PGD

Role: backup

Other Identifiers

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No 595/CMHS IRB/2024

Identifier Type: -

Identifier Source: org_study_id