An interventional study of A web-based educational intervention on oral cancer and A mobile health app-based educational intervention on oral cancer in Oral Cancer, Health Education, Community and Digital Intervention, sponsored by University of Rwanda. Not yet recruiting at 5 sites in 4 countries. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by University of Rwanda · Not applicable, Interventional, and Prevention
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.
446 studies on the registry are indexed under Mouth Neoplasms; 130 are open to participants now.
This study's planned enrollment of 75 is above the median of 60 across 313 interventional studies indexed under Mouth Neoplasms.
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Exclusion Criteria:
This is the control group (arm). No educational intervention on oral cancer will be administered to this group.
A web-based educational intervention on oral cancer will be administered to this group.
Behavioral: A web-based educational intervention on oral cancer
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
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.
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
Time frame: From enrollment to the end of educational intervention at 4 weeks
Measurement of the usability of the intervention tools using an adapted version of the user Mobile Application Rating Scale
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).
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
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)
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
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).
Time frame: At the end of educational intervention at 4 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
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This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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University of Rwanda