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Not yet recruiting NCT06711848

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

No phase Interventional Oral Cancer Health Education, Community Digital Intervention MHealth Application

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A web-based educational intervention on oral cancer, A mobile health app-based educational intervention on oral cancer.
Who it may be relevant to
Registry conditions: Oral Cancer, Health Education, Community, Digital Intervention, MHealth Application. Basic parameters: 18 years — 39 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India, Nigeria, Rwanda, Sri Lanka
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Interventions

  • Behavioral 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.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • 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]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Nigeria · 2 centers
  • University of Ibadan — Ibadan
  • Usmanu Danfodiyo University — Sokoto
India · 1 center
  • Saveetha University — Tamil Nadu
Rwanda · 1 center
  • University of Rwanda — Kigali
Sri Lanka · 1 center
  • University of Peradeniya — Peradeniya

Identifiers

NCT: NCT06711848 · No 595/CMHS IRB/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗