Oral CancerNCT06711848
Testing and Comparing the Impacts of Mhealth-Based and Web-Based Education on Oral Cancer
A study testing A web-based educational intervention on oral cancer and A mobile health app-based educational intervention on oral cancer in people with Oral Cancer and Health Education, Community, run by University of Rwanda at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer, Health Education, Community, Digital Intervention
- What is being tested?
- A web-based educational intervention on oral cancer and A mobile health app-based educational intervention on oral cancer
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 5 Jan 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 4 countries
Nigeria2 sites
University of Ibadan
Ibadan, Oyo State
Afeez Salami, BDS, +2347060636389, asalami@puthisastra.edu.kh
Akinyele Adisa, BDS, +2348037252207
Usmanu Danfodiyo University
Sokoto, Sokoto State
Jimoh Amzat, BSc, MA, MSc, PhD, +2348034339221, jimoh.amzat@udusok.edu.ng
Jimoh Amzat, BSc, MA, MSc, PhD
India1 site
Saveetha University
Tamil Nadu
Karthikeyan Ramalingam, BDS, MDS, +918290996783, karthikeyanr.sdc@saveetha.com
Karthikeyan Ramalingam, BDS, MDS
Rwanda1 site
University of Rwanda
Kigali, Kigali
Peace Uwambaye, BSc, MPH, PhD, +250788505856, upeace1602@gmail.com
Kehinde Kanmodi, BDS, MPH, PhD
Sri Lanka1 site
University of Peradeniya
Peradeniya
Ruwan Jayasinghe, BDS, MSc, +94777373689, ruwanja@dental.pdn.ac.lk
Ruwan Jayasinghe, BDS, MSc
About this study
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
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.
Read more
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.
- Conditions
- Oral Cancer, Health Education, Community, Digital Intervention, MHealth Application, MHealth Intervention
- Being tested
- A web-based educational intervention on oral cancer, A mobile health app-based educational intervention on oral cancer
- Keywords
- mobile health, application, website, impact, knowledge, oral cancer, public health, intervention
- Medical subject headings
- Mouth Neoplasms, Health Education, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A web-based educational intervention on oral cancerBehavioural
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 cancerBehavioural
This intervention will involve administering education, via a mhealth application prototype, on the meaning, risks, clinical features, prevention, treatment, and supports on oral cancer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: A mobile health app-based educational intervention on oral cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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).
Measured: 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)
Measured: 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).
Measured: At the end of educational intervention at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start5 Jan 2025 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rwanda
- Sponsor type
- University, hospital or other
- Collaborators
- University of Peradeniya, University of Ibadan, Usmanu Danfodiyo University, Saveetha University
- Responsible party
- Principal investigator, Kehinde Kazeem Kanmodi, University of Rwanda
- Investigators
- Kehinde Kanmodi, BDS, MPH, Principal investigator, University of RwandaPeace Uwambaye, BSC, MPH, PhD, Study director, University of RwandaAfeez Salami, BDS, Study director, University of IbadanBello Almu, BSC, MSc, MPP, Study director, Usmanu Danfodiyo UniversityKarthikeyan Ramalingam, BDS, MDS, Study director, Saveetha UniversityYovanthi Jayasinghe, BSc, PGD, Study director, University of PeradeniyaTimothy Aladelusi, BDS, MSc, Study director, University of IbadanAkinyele Adisa, BDS, Study director, University of Ibadan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711848
- Sponsor's protocol ID
- No 595/CMHS IRB/2024
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06711848
- Acronym / sponsor ID
- No 595/CMHS IRB/2024
- Conditions
- Oral Cancer, Health Education, Community, Digital Intervention, MHealth Application, MHealth Intervention
- Keywords
- mobile health, application, website, impact, knowledge, oral cancer, public health, intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of RwandaUniversity, hospital or other
- Collaborators
- University of Peradeniya, University of Ibadan, Usmanu Danfodiyo University, Saveetha University
- Study start
- 5 Jan 2025 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: A web-based educational intervention on oral cancerA web-based educational intervention on oral cancer will be administered to this group. |
| mHealth-based Intervention Group | Experimental | Behavioral: A mobile health app-based educational intervention on oral cancerAn app-based educational intervention on oral cancer will be administered to this group. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A web-based educational intervention on oral cancerThis intervention will involve administering education, via a website, on the meaning, risks, clinical features, prevention, treatment, and supports on oral cancer. | Behavioural | Web-based Intervention Group |
| A mobile health app-based educational intervention on oral cancerThis intervention will involve administering education, via a mhealth application prototype, on the meaning, risks, clinical features, prevention, treatment, and supports on oral cancer. | Behavioural | mHealth-based Intervention Group |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kehinde Kanmodi, BDS, MPH principal investigator
University of Rwanda
Peace Uwambaye, BSC, MPH, PhD study director
University of Rwanda
Afeez Salami, BDS study director
University of Ibadan
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A web-based educational intervention on oral cancer and A mobile health app-based educational intervention on oral cancer in people with Oral Cancer and Health Education, Community, run by University of Rwanda at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Nigeria, India, Rwanda, Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kehinde K Kanmodi, BDS, MPH (+2347032329156, kanmodikehinde@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.