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NCT Number: NCT06711848

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

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.

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Key information

Conditions

Oral Cancer Adherence Interventions Behavior Digital Intervention Head and Neck Neoplasms Health Behavior Health Education Health Education, Community Medication Adherence Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Patient Acceptance of Health Care Patient Compliance Stomatognathic Diseases Tooth Diseases Tooth, Impacted Treatment Adherence and Compliance mHealth Application mHealth Intervention

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saveetha University, Tamil Nadu, India

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A web-based educational intervention on oral cancer

Behavioral

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

A mobile health app-based educational intervention on oral cancer

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.

Primary outcomes

  1. Measurement of change in baseline knowledge on oral cancer four weeks post-intervention using a questionnaire

    Time frame: From enrollment to the end of educational intervention at 4 weeks

    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

Secondary outcomes

  1. Measurement of the usability of the intervention tools using an adapted version of the user Mobile Application Rating Scale

    Time frame: At the end of educational intervention at 4 weeks

    This secondary outcome measure will be on the usability of the intervention tools, and this will be done using a questionnaire. Only those participants in the intervention groups will be evaluated on this outcome, and this will be done at post-intervention survey stage.

    This outcome will be measured using a questionnaire. This questionnaire was adapted from a standardised instrument called the "user Mobile Application Rating Scale". This instrument uses diverse Likert scales with a Likert score of 1 representing the extreme negative outcome (lowest rating on the tool's usability) while a score of 5 representing the extreme positive outcome (highest rating on the tool's usability).

  2. Measurement of the uptake of the intervention tools using an adapted version of the user Mobile Application Rating Scale

    Time frame: At the end of educational intervention at 4 weeks

    This secondary outcome measure will be on the uptake of the intervention tools, and this will be done using a questionnaire. Only those participants in the intervention groups will be evaluated on this outcome, and this will be done at post-intervention survey stage.

    This outcome will be measured using a questionnaire. This questionnaire was adapted from a standardised instrument called the "user Mobile Application Rating Scale". This instrument uses diverse Likert scales with a Likert score of 1 representing the extreme negative outcome (lowest rating on the tool's uptake) while a score of 5 representing the extreme positive outcome (highest rating on the tool's uptake)

  3. Measurement of the acceptability of the intervention tools using an adapted version of the user Mobile Application Rating Scale

    Time frame: At the end of educational intervention at 4 weeks

    This secondary outcome measure will be on the acceptability of the intervention tools, and this will be done using a questionnaire. Only those participants in the intervention groups will be evaluated on this outcome, and this will be done at post-intervention survey stage.

    This outcome will be measured using a questionnaire. This questionnaire was adapted from a standardised instrument called the "user Mobile Application Rating Scale". This instrument uses diverse Likert scales with a Likert score of 1 representing the extreme negative outcome (lowest rating on the tool's acceptability) while a score of 5 representing the extreme positive outcome (highest rating on the tool's acceptability).

Study contacts

Contact information is provided by the study sponsor or research team.

Kehinde K Kanmodi, BDS, MPH

CONTACT

[email protected]

+2347032329156

Peace Uwambaye, BSc, MPH, PhD

CONTACT

[email protected]

+250788505856

Sponsors and collaborators

Lead sponsor

University of Rwanda

Other

Collaborators

  • Saveetha University
  • University of Ibadan
  • University of Peradeniya
  • Usmanu Danfodiyo University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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