Co-developing, co-creating, and testing an educational mobile health application prototype on oral cancer: A mixed methods study protocol

Kehinde Kazeem Kanmodi; Ruwan Duminda Jayasinghe; Yovanthi Anurangi Jayasinghe; Afeez Abolarinwa Salami; Success Onuoha; Akinyele Olumuyiwa Adisa; Jimoh Amzat; Karthikeyan Ramalingam; Bello Almu; Timothy Olukunle Aladelusi; Peace Uwambaye; Misheck Julian Nkhata; Lawrence Achilles Nnyanzi

doi:10.12688/f1000research.159649.1

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Study Protocol

Co-developing, co-creating, and testing an educational mobile health application prototype on oral cancer: A mixed methods study protocol

[version 1; peer review: 1 approved with reservations]

Kehinde Kazeem Kanmodi ^1-4, Ruwan Duminda Jayasinghe^2,4-6, Yovanthi Anurangi Jayasinghe⁵, [...] Afeez Abolarinwa Salami^2,3,7,8, Success Onuoha⁴, Akinyele Olumuyiwa Adisa^9,10, Jimoh Amzat^4,11,12, Karthikeyan Ramalingam⁶, Bello Almu¹¹, Timothy Olukunle Aladelusi^7,13, Peace Uwambaye ¹, Misheck Julian Nkhata⁴, Lawrence Achilles Nnyanzi^4,14

Kehinde Kazeem Kanmodi ^1-4, Ruwan Duminda Jayasinghe^2,4-6, [...] Yovanthi Anurangi Jayasinghe⁵, Afeez Abolarinwa Salami^2,3,7,8, Success Onuoha⁴, Akinyele Olumuyiwa Adisa^9,10, Jimoh Amzat^4,11,12, Karthikeyan Ramalingam⁶, Bello Almu¹¹, Timothy Olukunle Aladelusi^7,13, Peace Uwambaye ¹, Misheck Julian Nkhata⁴, Lawrence Achilles Nnyanzi^4,14

PUBLISHED 13 Jan 2025

Author details Author details

¹ Department of Preventive and Community Dentistry, University of Rwanda, Kigali, Kigali, Rwanda
² Faculty of Dentistry, University of Puthisastra, Phnom Penh, Phnom Penh, Cambodia
³ Campaign for Health and Neck Cancer Education (CHANCE) Programme, Cephas Health Research Initiative Inc, Ibadan, Nigeria
⁴ School of Health and Life Sciences, Teesside University, Middlesbrough, England, UK
⁵ Department of Oral Medicine and Periodontology, University of Peradeniya Department of Sociology, Peradeniya, Central Province, Sri Lanka
⁶ Department of Oral Medicine and Periodontology, SIMATS Deemed University, Chennai, Tamil Nadu, India
⁷ Department of Oral and Maxillofacial Surgery, University College Hospital, Ibadan, Oyo, Nigeria
⁸ Department of Public Health Dentistry, Manipal Academy of Higher Education, Manipal, Karnataka, India
⁹ Department of Oral Pathology and Oral Medicine, University College Hospital, Ibadan, Oyo State, Nigeria
¹⁰ Department of Oral Pathology and Oral Medicine, University of Ibadan, Ibadan, Oyo, Nigeria
¹¹ Department of Sociology, Usmanu Danfodiyo University, Sokoto, Sokoto, Nigeria
¹² Department of Sociology, University of Johannesburg, Auckland Park, Gauteng, South Africa
¹³ Department of Oral and Maxillofacial Surgery, University of Ibadan, Ibadan, Oyo, Nigeria
¹⁴ School of Public Health, King Ceasor University, Kampala, Kampala, Uganda

Kehinde Kazeem Kanmodi
Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Ruwan Duminda Jayasinghe
Roles: Data Curation, Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Review & Editing

Yovanthi Anurangi Jayasinghe
Roles: Data Curation, Investigation, Methodology, Project Administration, Resources, Software, Writing – Review & Editing

Afeez Abolarinwa Salami
Roles: Data Curation, Investigation, Methodology, Project Administration, Resources, Writing – Review & Editing

Success Onuoha
Roles: Data Curation, Investigation, Resources, Software

Akinyele Olumuyiwa Adisa
Roles: Data Curation, Investigation, Project Administration, Resources

Jimoh Amzat
Roles: Data Curation, Investigation, Methodology, Project Administration, Resources, Writing – Review & Editing

Karthikeyan Ramalingam
Roles: Investigation, Methodology, Project Administration, Resources, Writing – Review & Editing

Bello Almu
Roles: Data Curation, Funding Acquisition, Investigation, Project Administration, Resources

Timothy Olukunle Aladelusi
Roles: Data Curation, Investigation, Resources

Peace Uwambaye
Roles: Data Curation, Investigation, Project Administration, Resources, Writing – Review & Editing

Misheck Julian Nkhata
Roles: Investigation, Methodology, Resources, Supervision, Writing – Review & Editing

Lawrence Achilles Nnyanzi
Roles: Conceptualization, Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Visualization, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Introduction

Globally, oral cancer is the 15^th deadliest cancer among humans. Diverse health education interventions have played a very significant role in the prevention of oral cancer. Of these interventions, digital interventions, especially mhealth-driven interventions, have been largely underutilized. So far, only two known educative mobile health applications (MHAs) for oral cancer exits; unfortunately, these two applications are not comprehensive and not inclusive for diverse populations. There is a need for a comprehensive and more inclusive MHA that can be used to educate the public about oral cancer.

Objectives

To co-develop, co-create, and test a comprehensive and inclusive MHA that can be used to educate the public about oral cancer.

Methods

The proposed study will be conducted and reported using the PRODUCES (PRoblem, Objective, Design, (end-) Users, Co-creators, Evaluation, Scalability) framework—this framework provides a novel approach which can be used to develop mhealth interventions through participatory action research methodologies. This study will have three parts. The first part will co-develop an eight-sectioned lay educational content on oral cancer through three-round Delphi consultations with thirty subject matter experts in the field of oral cancer and public health. Using the co-developed educational content, the second part of this study will co-create an educative MHA prototype on oral cancer through three-round Delphi consultations with twenty digital communication experts and persons at risk of oral cancer. Lastly, the third part will, through a three-arm, parallel, open-label randomized control trial, test and compare, among seventy-five young adults, the effectiveness, usability, uptake, and acceptability of the co-created MHA prototype on oral cancer against a web-based educational resource on oral cancer.

Conclusion

The outcomes of this study will co-produce and test an inclusive and comprehensive MHA prototype that can be used to educate diverse populations across the world about oral cancer.

Keywords

health education, mhealth, oral cancer, public health, study protocol

Corresponding authors: Kehinde Kazeem Kanmodi, Peace Uwambaye

Competing interests: No competing interests were disclosed.

Grant information: This study is partly funded by Teesside University. Teesside University did not play any influential role in the study design; in the writing of the report; and in the decision to submit the paper for publication.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2025 Kanmodi KK et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Kanmodi KK, Jayasinghe RD, Jayasinghe YA et al. Co-developing, co-creating, and testing an educational mobile health application prototype on oral cancer: A mixed methods study protocol [version 1; peer review: 1 approved with reservations]. F1000Research 2025, 14:67 (https://doi.org/10.12688/f1000research.159649.1) First published: 13 Jan 2025, 14:67 (https://doi.org/10.12688/f1000research.159649.1) Latest published: 13 Jan 2025, 14:67 (https://doi.org/10.12688/f1000research.159649.1)

1. Background

Oral cancer is a malignant neoplastic disease affecting the lip, oral cavity (mouth) and/or the oropharynx (throat).¹ Globally, oral cancer is the commonest head and neck cancer type, and it is the 15^th deadliest and the 16^th most common cancer affecting human beings.^2–6

Oral cancer, if untreated or not properly treated, can lead to metastasis, secondary cancers, and even death. The global burden of oral cancer has doubled within the past three decades, with recent global epidemiological data in 2017 indicating its age-standardised incidence rate, age-standardised mortality rate, and disability-adjusted life years being 4.84 per 100,000 persons, 2.82 per 100,000 persons, and 64.0 per 100,000 person-years, respectively.⁶ Currently, the oral cancer epidemiological burden in several countries exceeds the global average.^6,7 For example, in the UK, the (European) age-standardised incidence rates of oral cavity cancer, oropharyngeal cancer, and outer lip cancer for the year 2019 were 6.0, 5.9, and 0.2 cases per 100,000 persons respectively.⁷ Similarly high rates have also been reported in Brunei, Japan, South Korea, Singapore, Nigeria, Seychelles, Pakistan, Taiwan, Kiribati, and India.⁶ Based on these findings, it can be concluded that the whole world is battling with an oral cancer epidemic.

Several factors have been found to increase the risk of developing oral cancer; these can be categorised into microbial and non-microbial factors.^7,8 The microbial factors are majorly human papillomavirus (HPV), and human immunodeficiency virus (HIV).^7,8 On the other hand, the non-microbial factors include tobacco, alcohol, betel nut (a.k.a. areca nut or betel quid), ultraviolet radiation, hydrochlorothiazide (an antihypertensive), genetic factors, inadequate physical activity, and diets low in fruits and vegetables.^7–9 Of all these risk factors, the four most important ones are betel nut, tobacco, alcohol, and oral HPV infection (an infection which is predominantly contracted through oral sex).^7,9,10

Over the years, diverse public health interventions on oral cancer prevention, including oral screening, public education to raise knowledge and awareness of the disease, tobacco and alcohol cessation programmes, sex education, and HPV vaccination programmes have been introduced into the public health services of several countries to curb the rising trends of oral cancer among their populations.^7,8,11–15 Despite these intense efforts, the global prevalence rates of oral cancer major risk factors (oral sex [a major route of HPV transmission], tobacco use, betel nut use, and alcohol use) are still unacceptably high.^{4,7,9,14,16–18} Based on existing research evidence, about 38% and 20% of the global adult populations have been estimated to have engaged in oral sex and betel nut chewing, respectively, in their lifetime.^14,16,19,20 For tobacco and alcohol use, about 22.8% and 41.7% of the world’s population are estimated to be smoked tobacco users and alcohol users, respectively.^4,17 Based on these afore-stated statistics, it can be asserted that the global public health system may not attain an oral cancer free population in coming decades.

Public health education interventions have been proven to play a very significant role in the prevention of a disease.²¹ Through education, a lot of people can be made aware of the risk factors, signs and symptoms, and preventive and curative measures against oral cancer.^22–24 In several surveys conducted among different world populations, it was found that knowledge on oral cancer was unacceptably low.^24–31 This indicates that more public health efforts are needed globally to increase public knowledge and awareness on the role on oral cancer.

There are diverse public health education strategies that can be adopted to increase knowledge and awareness on oral cancer. These strategies include the use of technology-based, clinic-based, and community-based interventions.^{22–24,32–35} Of all these intervention strategies, technology-based interventions have not been adequately explored.^32–35 Also, of the diverse technology-based intervention options that can be deployed, mobile health application-based intervention seems to be the most promising.^36–40 Also, the adoption of mobile health application-based intervention strategy closely aligns with the United Nations’ Sustainable Development Goals, as well as the commitments of several countries towards the digital transformation of their healthcare system^41–44; hence, such intervention is very promising and timely in the global public health setting.

However, in a recent systematic review, mobile health application-based educational interventions on oral cancer have been documented to effectively improve knowledge about the disease.⁴⁰ In the review, it was also noted that the reviewed mobile health applications lacked sufficient educational content, and only one of them was designed for the use of the general populations.⁴⁰ Additionally, none of the reviewed applications provided adequate educational content on the risk factors, signs and symptoms, and preventive measures concerning oral cancer.⁴⁰ Considering the limitations of these applications, it will be worthwhile if a more comprehensive educational mobile health application for oral cancer is developed.⁴⁰

Pertinently, the development, creation, and testing of an effective health intervention is a very complex process.^45,46 It requires a well-thought-out approach, involving multiple stakeholders, in order to achieve desired outcomes concerning end-user adherence, end-user satisfaction, scalability, and effectiveness.⁴⁵ These stakeholders may include the research team members, subject matter experts, and potential end-users.⁴⁵ Different research designs have been proposed in the literature for the accomplishment of such tasks.^45,47–49 However, of these proposed designs, the PRODUCES (PRoblem, Objective, Design, (end-) Users, Co-creators, Evaluation, Scalability) framework was found to be the most suitable.⁴⁵ The superiority of the PRODUCES framework over other existing frameworks are noteworthy. First, the framework proposes a systematic and iterative approach to health intervention development and co-creation, which therefore ensures scientific rigour in the research process.⁴⁵ Second, this framework encourages stakeholder involvement in the development and co-creation process, which increases the potential for adherence, satisfaction, and effectiveness of the mobile phone-based application among its end-users, after it has been developed.⁴⁵ Third, the framework relies on participatory methodologies. Participatory research methodologies include, but not limited to, action research, participatory action research, and participatory action and reflection research.⁴⁵ Of these methodologies, the participatory action and reflection research methodology has been recommended in the literature for mobile health application co-development and co-creation.⁴⁵ Fourth, the framework provides the opportunity for evaluation of the feasibility, usability, acceptability, and satisfaction of an intervention by stakeholders.⁴⁵ Fifth, and finally, the framework provides room for scalability of a health intervention, including mobile health application prototypes.⁴⁵

1.1 Aim and objectives of the study

Considering the above notes, this study thereby aims to co-develop (with inputs from subject matter experts), co-create (with inputs from digital communication experts and oral cancer at-risk persons), and test, among general populations, an educational mobile health application prototype on oral cancer.

The specific objectives of this study are the following:

Objective 1: To co-develop, with subject matter experts, an educational content for a proposed mobile health application prototype for improving knowledge on oral cancer.

Objective 2: To co-create, with digital communication experts and oral cancer at-risk persons, the proposed mobile health application prototype.

Objective 3: To test the effectiveness, usability, uptake, and acceptability of the co-created mobile health application prototype among a comparable and diverse lay population.

2. Methods

2.1 Study design

The design of this study is based on the PRODUCES (PRoblem, Objective, Design, (end-) Users, Co-creators, Evaluation, Scalability) framework.⁴⁵

2.2 Study procedure

Based on the objectives of this study, the study procedure is divided into three parts, namely: Part 1, Part 2, and Part 3. The schematic flow of the study procedure is depicted in Figure 1.

Figure 1. The schematic flow of the study procedure.

Part 1 will involve the co-development of the educational content of the proposed mobile health application prototype. Part 2 will involve the co-creation of the proposed mobile health application prototype. Part 3 will involve comparative testing of the effectiveness, usability, uptake, and acceptability of the co-created mobile health application prototype.

2.2.1 Part 1: Co-Development of the educational content of the application prototype

This part of the study will be accomplished in two phases: Phase 1 and Phase 2.

2.2.1.1 Phase 1: Development of the pre-review version of the educational content

In this phase, the research team will develop the educational content of the mobile health application prototype using current international, national, and local guidelines/advisory and literature reviews on oral cancer. The educational content will have 8 sections. The information in each section will be presented in sub-sections, in lay terms, and in texts, pictures, charts, and/or audiovisuals. The first section will contain information about the meaning of oral cancer. The second section will contain information on oral cancer risk factors. The third section will contain information on oral cancer signs and symptoms. The fourth section will contain information on measures that can be taken in the prevention of oral cancer. The fifth section will contain information on measures used in the diagnosis of oral cancer. The sixth section will contain information on measures that can be taken in the treatment of oral cancer. The seventh section will contain information on the sources of support (i.e. organisations that provide support) on oral cancer. The eighth section will contain information on the sources of information that were used to develop the educational content on oral cancer.

2.2.1.2 Phase 2: Consultations with subject matter expert on the educational content

After the objective of Phase 1 of this study part has been accomplished, the research team will conduct three rounds of consultations with subject matter experts to provide expert feedback on the developed educational content.

2.2.1.3 Technique

The Delphi technique will be adopted to guide the expert consultation processes. The conduct and reportage of the consultation process will be done in accordance with the Guidance on Conducting and REporting DElphi Studies (CREDES).⁴⁸ The consultations will be done in three rounds.

2.2.1.4 Study participants

The study participants will be subject matter experts, who are persons with academic/clinical/public health experience in oral cancer prevention and management. To be eligible to participate in this study as a subject matter expert, the participant must meet the following criteria:

• Must be an academically/professionally qualified oral and maxillofacial surgeon, oral physician (a.k.a. oral medicine specialist), oral pathologist, health education specialist, general dental practitioner, or a general medical practitioner.
• Must have at least one year of experience in their area of expertise.
• Must be 18 years old or older.
• Must provide informed consent to participate in the study.

Country location, religion, gender, or sexual orientation will not determine eligibility to participate in this study.

2.2.1.5 Sample size

For research involving the development and creation of tools and contents, and content validation, different sample size has proposed. However, for this study part, a minimum sample size of 30 participants, as proposed by Polit & Beck⁵⁰ for a rigorous content review/validation, will be adopted for this study part. For fair representation, this group will include 5 oral and maxillofacial surgeons, 5 oral physicians, 5 oral pathologists, 5 health education specialists, 5 general dental practitioners, and 5 general medical practitioners.

2.2.1.6 Recruitment

Because subject matter experts on oral cancer are scarce personalities, the research team will rely on executive/senior members of two international organisations on oral cancer who will help facilitate the recruitments of subject matter experts in their organisational networks. The two organizations that will be engaged are the following: the Asia-Pacific Oral Cancer Network,⁵¹ and the Consortium for Head and Neck Cancer in Africa (formerly called the International Head and Neck Cancer Working Group).⁵² These two organisations were chosen because both focus on oral cancer prevention and control in the two world regions with the highest burdens of oral cancer and cancer-related deaths.^2–6 Secondly, these two organizations have memberships and networks across Africa, Asia, Europe, and North America.

The research team have identified two executives/senior members (one from each of the above-mentioned organisations) who will serve as gatekeepers and help facilitate the recruitment of the subject matter experts via email. The research team will send an approach email to the two senior members/executive, and they will be asked to invite eligible participants (i.e. subject matter experts) to come forward to participate in the study. The email will contain an invitation message, a participant information sheet, and a consent form. The invitation message (as well as the participant information sheet) will advise the recipients to not directly name other potential participants but rather to inform interested participants to directly contact the research team through the contact details provided in the participant information sheet.

2.2.1.7 Study instrument

The study instruments will be two data collection forms (Questionnaire A and Questionnaire B). Instrument 1 will be used for the first round of the Delphi study while Instrument 2 will be used for the second round. However, no study instrument will be used in the third round of the Delphi consultation, as the round will be a bespoke correspondence to address remnants of comments to be discussed with the subject matter experts.

Since only those subject matter experts that have participated in the first round of the consultation will be invited to participate in the second round, only Questionnaire A will obtain data on the sociodemographic characteristics (quantitative data) of the subject matter experts. In addition to the sociodemographic data that it will collect, Questionnaire A will obtain written comments (qualitative data) concerning the content of each section of the educational content, as well as their ratings (quantitative data) of the relevance of the information presented in each section. Their ratings will be collected using a Likert scale of 1 to 4: 1 (not relevant); 2 (somewhat relevant); 3 (quite relevant); and 4 (highly relevant).⁵⁰ However, Questionnaire B will only collect data from the participating experts on their level of satisfaction (quantitative data) concerning the revised the educational content on oral cancer as well as additional comments on the revised content (qualitative data). The ratings of the participating experts concerning their level of satisfaction will be collected using a Likert scale of 1 to 4: 1 (very dissatisfied); 2 (dissatisfied); 3 (satisfied); and 4 (very satisfied).

2.2.1.8 Consultation rounds

The Delphi consultations will be done via email, and in three rounds. The first round of the consultation will involve the sending the subject matter experts the developed educational content (version 1) and Questionnaire A to collect data on their socio-demographic characteristics, as well as their feedback on the relevance and content of each section of the educational content shared with them.

Only those experts that participated in the first round of the consultation will be engaged in the second round. In the second round, the revised version of the educational content (version 2), an anonymised document containing the actions taken and rebuttals of the research team concerning the feedback that will be provided in the first round of the consultation, and a Questionnaire B will be sent to the participating subject matter experts for their feedback on their satisfaction and content of each section of the revised educational content shared with them.

As the possibility of obtaining comments from fewer experts in the second round is anticipated, the research team will conduct the third round of consultation to ensure all raised comments are finally addressed. This round of consultations may involve back-and-forth correspondence between the research team and the experts to ensure that all compelling queries are addressed.

2.2.1.9 Data analysis and determination of consensus

In this study, only the quantitative data will be analysed while the qualitative data will not be analysed, as the qualitative data will only be used for the revisions of the educational content. Furthermore, since two rounds of quantitative data collection will be conducted in this study part, it implies that two rounds of data analysis will be done.

Since the study did not seek to test associations between variables, the analysis of the obtained quantitative data, which will be information on the sociodemographic characteristics and the ratings on the relevance of each section of the educational content, will be done using descriptive statistics only. For each Delphi study round, the quantitative data analysis will be done using the Statistical Package for Social Sciences (SPSS). The descriptive statistical analysis will include the determination of the frequency, mean, mode, range, and standard deviation of the quantitative data. The frequencies of the sociodemographic characteristics of the participants will give an overview of the portfolio of the engaged subject matter experts while means, modes, ranges, and standard deviations will be used to summarize the Likert score responses of the subject matter experts on their ratings on each section of the educational content. A mean Likert score of 3 or above for each section of the educational content will be considered as a consensus among the subject matter experts; hence, only those sections of the educational content with such scores (i.e. mean Likert score of 3 or above) will be considered appropriate for retention as part of the content.

Notably, the outcomes of each round of the quantitative data analysis will inform what will be done in each round of the revision process of the educational content.

2.2.1.10 Revision of the education content

Since two rounds of qualitative data collection will be conducted in this study part, it implies that two rounds of content revisions content will also be done. These rounds of revisions will be based on the outcomes of each round of the quantitative data analysis, and the comments obtained in each round of consulting the subject matter experts. Based on the quantitative data analysis outcomes, only those sections of the educational content with a mean Likert score of 3 or above will be retained. Thereafter, the comments obtained from the subject matter experts concerning each of those retained sections of the educational content will be used to revise each section of the content, in each round.

2.2.2 Part 3: Co-creation of the application prototype

This study part will involve the co-creation of the mobile health application prototype.

2.2.2.1 Technique

The Delphi technique will be used to accomplish this study part, and the technique will be conducted and reported in accordance with the Guidance on Conducting and REporting DElphi Studies (CREDES).⁴⁸ The Delphi technique will be in three rounds. The first round will be a series of focus group discussions while the second and third rounds will be a survey each.

2.2.2.2 Study participants

The study participants will be: (i) digital communication experts, and (ii) people with oral cancer risk factors (such as alcohol users, tobacco users, and sexually active persons). Only those that are aged 18 years or above, who are using smart phones, and who gave informed consent to participate will be eligible to participate in this study phase.

2.2.2.3 Sample size

For the creation of tools and contents through qualitative approach, a sample size of 10-12 participants was recommended by the PRODUCES framework.⁴⁵ However, for most Delphi studies, the sample size is usually between 6 to 50 participants.^53,54

Considering the above information, a sample size of 20 participants will be adopted for this proposed study part, as it sits well within range of sample for Delphi studies, and it is well above the sample size recommended in the PRODUCES framework.

For fair representation of the study participants, the proposed sample will include 5 digital communication experts, 5 alcohol users, 5 tobacco users, and 5 sexually active persons, totalling 20 participants.

2.2.2.4 Participant recruitment

Due to the peculiarities of the eligibility criteria of the participants in this study part, purposive and snowballing sampling techniques will be used to recruit the study participants.^45,55 Firstly, purposive sampling technique will be used to recruit the first few participants, and this will be done through the aid of the Asia-Pacific Oral Cancer Network and the Consortium for Head and Neck Cancer in Africa. If the required sample of participants could not be recruited through these organizations, then a snowballing technique will be used to recruit other eligible participants through the already identified participants.

2.2.2.5 Study instrument

Three study instruments (Questionnaire C, Questionnaire D, and Questionnaire E) will be used in this study part. Questionnaire C is a questionnaire which will obtain information on the sociodemographic characteristics of the consenting study participants who will be participating in this study part. Questionnaire D is a question guide which will explore the opinions of the participants about their knowledge of oral cancer, to identify their opinions about the roles of an educative mobile health application in oral cancer education, and how an ideal mobile health application on oral cancer should look like. Lastly, Questionnaire E is user Mobile Application Rating Scale—a standardised study instrument—which will obtain information from the participants about their feedback concerning the engagement, functionality, aesthetics, information quality, and subjective quality of the first and second versions of the mobile health application prototype.^56,57

2.2.2.6 Consultation rounds

The Delphi consultations will be done via email, and in the three rounds. After consenting to participate in the study, sociodemographic data of each of the participants will be obtained via using Questionnaire C, after which the first, second, and third rounds of the Delphi consultations will be done consecutively.

The first round of the consultation will involve four sessions of focus group discussion: one session each will be conducted among 5 digital communication experts, 5 sexually active persons, 5 tobacco users, and 5 alcohol users. Each of the session will be conducted online via Microsoft Teams and it will be audio-recorded using a digital audio-recorder. In each focus group discussion, the participants will be asked series of questions, using Questionnaire D, including questions asking them about what they think to be the most important and least important features that should be in the application prototype.

Based on the information obtained in the first round of the consultation, the first version of the mobile health application will be created. After this has been done, the research team will proceed to the second round of consultation where the participants will be sent an email, inviting them to download, through a secured link, the first version of the mobile health application prototype on oral cancer, and engage with the application prototype for a period of one week. After a week, they will be asked to review the shared application prototype, through a survey (using Questionnaire E), based on their experience concerning its engagement, functionality, aesthetics, information quality, and subjective quality. In the survey, they will also be asked to comment on the aspects that can be improved upon in the application prototype.

The third round of the consultation will be a repetition of the second round, but with the second version of the mobile health application prototype, and it will only involve those participants that provided comments on where to improve upon on the application prototype. The second version of the prototype will be a revised version of its first version based on the feedback obtained from the second round of this study part. Also, in the third round of consultation, feedback to the anonymised comments (qualitative data) obtained from them in the previous round will be shared with them.

2.2.2.7 Data analysis and determination of consensus

Both qualitative and quantitative data will be obtained in this study part. The qualitative data will be the data obtained from the first round of the Delphi consultation (transcripts from the audio-recorded focus group discussions) and the written comments obtained in the second and third rounds of consultations concerning the application prototype. Thematic analysis approach, proposed by Braun and Clarke,⁵⁸ will be used for the analysis of all the qualitative data obtained in this study part, and this will be done manually.

However, the quantitative data will be analysed using the SPSS. Descriptive statistical analysis will be done, and this will include the determination of the frequencies, means, modes, ranges, and standard deviations of all variables. The frequencies of the sociodemographic characteristics of the participants will give an overview of their portfolio while means, modes, ranges, and standard deviations will be used to summarise their ratings on the engagement, functionality, aesthetics, information quality, and subjective quality of each version of the application prototype. The questions that will obtain these ratings are in sections B to F of Questionnaire E, and each question has five possible responses tagged “a”, “b”, “c”, “d”, and “e”. A response to “a” will be scored a point of 1, a response to “b” will be scored a point of 2, a response to “c” will be scored a point of 3, a response to “d” will be scored a point of 4, and a response to “e” will be scored a point of 5. For each question in these sections, question responses with a mean score of 3 or above concerning the application prototype will be considered as a consensus among the participants concerning the prototype’s engagement, functionality, aesthetics, information quality, and subjective quality.

2.2.2.8 Application prototype co-creation

The mobile health application prototype will be co-created and improved upon, if recommended by the study participants, using the information obtained from each round of the Delphi consultations. The entire process will occur in three rounds, and it will occur after each round of the consultation. The third version of the prototype (i.e. the revised version of the prototype after the considering feedback from the third round of the Delphi study) will be the version that will be used in the Part 4 of this proposed project.

2.2.3 Part 4:Comparative testing of the effectiveness, usability, uptake, and acceptability of the co-created mobile health application prototype

In this part, the latest version of the mobile health application prototype will be comparatively tested, with a web-based online resource, for its effectiveness, usability, uptake, and acceptability among potential end users.

2.2.3.1 Technique

In the PRODUCES framework, randomised controlled trial study design was recommended as the mainstay for testing the effectiveness of digital interventions, before such interventions are being scaled up for use among a larger population.⁴⁵ Therefore, this study part will adopt a randomised control trial (RCT) study design, and it will be reported in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Also, this proposed RCT has been registered (Name of registry: National Institute of Health’s Clinical Trials Registry [ClinicalTRials.gov]; Registration number: NCT06711848; Registration date: 02 December 2024; URL of the registered trial: https://clinicaltrials.gov/study/NCT06711848?locStr=Rwanda&country=Rwanda&cond=mHealth%20Intervention&rank=1).

2.2.3.2 Study participants

For this part, the study participants will be digitally savvy adults, aged 18 to 39 years, who are non-experts on oral cancer. This population group is considered as the most suitable target population for testing this mobile health application prototype, and this suitability is based on four major considerations that are of clinical and public health relevance. First, there is a rising incidence rate of oral cancer among this population group⁵⁹; hence, they are at-risk population. Second, this population group have the highest rate of the major oral cancer risk factors—tobacco, alcohol, and oral sex¹⁴; this further consolidates the point that they are at-risk population. Third, oral cancer literacy level is low among this age group^14,24; hence, their need to be literate about oral cancer cannot be over-emphasised. Fourth, this population group, unlike the younger (below 18 years of age) and older (above 40 years of age) population groups, are the most digitally savvy group⁶⁰; hence, this population has a high propensity to utilize such interventions unlike other age groups.^61,62

Pertinently, for the ease of comparability, the study participants will be first-year university students as it is assumed that this category of students would not have received any professional training on oral cancer. Only those that are aged 18 years to 39 years and who give informed consent to participate will be eligible to participate in this study part.

2.2.3.3 Arms/Groups

The proposed RCT will have three parallel arms (groups). The first arm (Group 1) will be the control group while the second (Group 2) and third (Group 3) will be the intervention groups. No intervention will be administered to the participants in Group 1. Upon provision of written informed consent, all consenting participants will be assigned to a group (Group 1 or 2 or 3) using a simple random sampling technique, and this will before the study begins.

2.2.3.4 Anticipated outcomes

The following are the outcomes anticipated in this study part:

Primary outcome: this 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.

Secondary outcomes: these will be opinions of the participants on the usability, uptake, and acceptability of the digital intervention packages they have received, 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.

2.2.3.5 The intervention packages

In this proposed RCT, separate digital intervention packages will be delivered to each of the intervention groups:

(i) Group 1: education on oral cancer, for a period of four weeks, via a website.
(ii) Group 2: education on oral cancer, for a period of four weeks, via the mobile health application prototype that will be created in the Part 2 component of this study (see subsection 2.2.2. of the Methods section).

Notably, the educational content in both digital intervention packages will be the same, and it would be developed in the Part 1 component of this study (see subsection 2.2.1. of the Methods section).

2.2.3.6 Labelling

The proposed RCT will be open label, that is, both the investigators and the participants will have knowledge of the intervention types that is being administered to each participant.

2.2.3.7 Sample size

The G*Power version 3.1.9.7. algorithm was used to determine the sample size of this study.⁶³ The effect size used to calculate the sample size was obtained from a randomised controlled trial which reported a mean effect size of 0.43 in the change of oral cancer-related knowledge among its participants.⁶⁴ Using an effect size of 0.43, a significance level (α) of 0.05, a power (1-β) of 0.8, and a group of 3, a total sample size of 57 participants was determined.^63,65,66

Anticipating a drop-out rate of 20%, the total sample size is corrected and rounded up to a minimum of 70 participants.⁶⁴ However, since the study aims to have three groups of participants and 70 is not divisible by 3, the final sample size for this study will be 75 participants, so that a total of 25 participants will be recruited per group.

2.2.3.8 Sampling/Randomization technique

A four-staged multistage sampling technique will be used in the study. The first stage will involve identifying the participating universities: Usmanu Danfodiyo University (Sokoto, Nigeria), University of Peradeniya (Peradeniya, Sri Lanka), University of Rwanda (Kigali, Rwanda), University of Ibadan (Ibadan, Nigeria), and Saveetha Dental College & Hospital (Chennai, India). These five universities are the affiliating institutions of the research team members and ethical clearance has been obtained from these universities to conduct this study part among their student populations.

The second stage will involve choosing a participating department from each of the identified universities through balloting (a form of simple random sampling technique). The third stage will involve selecting 12 study participants (first year bachelor’s degree students) in each of the selected departments via simple random sampling technique. The fourth stage will involve grouping the selected participants into three groups (Group 1, Group 2, and Group 3) using through balloting (a form of simple random sampling technique), with 5 participants in each group in each participating university.

The participants in Group 1 (a total of 25 participants [5 each from the 5 participating university departments]) will be the control group; that is the group that will not receive an educational intervention. However, those in Group 2 (a total of 24 participants [5 each from the 5 participating university departments]) will receive a web-based educational intervention on oral cancer while those in Group 3 (a total of 24 participants [5 each from the 5 participating university departments]) will receive an app-based educational intervention on oral cancer. Notably, the educational contents of both the web-based and app-based interventions will be the same. The sampling/randomization process will be done by the lead author (KKK).

2.2.3.9 Study instrument

The study instrument is a pre-test e-questionnaire (Questionnaire F) and a post-test e-questionnaire (Questionnaire G) which were adapted from previous studies and from the Mobile Health Application Rating Scale. These adapted questionnaires will be reviewed among 10 health education specialists, through patient and public involvement and engagement, before its final use. The pre-test e-questionnaire will obtain information on the sociodemographic characteristics of the participants as well as their baseline knowledge of oral cancer. The post-test e-questionnaire will obtain information on the sociodemographic characteristics of the participants, their endline knowledge of oral cancer, and, if they have received a digital intervention, their opinions on the usability, uptake, and acceptability of the digital intervention package they have received.

2.2.3.10 Data collection

The research team will recruit the first-year students domiciled in the selected departments through email invitation. The email will contain an invitation message, a participant information sheet, and a consent form. After consenting participants have been recruited electronically from each participating institution, they will be randomly assigned to a group (Group 1, Group 2, or Group 3).

All recruited participants will be surveyed at baseline (using Questionnaire F) to evaluate their current knowledge of oral cancer. Thereafter, those participants in Groups 2 and 3 will be sent a link to access an educational website on oral cancer and an educational mobile app prototype on oral cancer, respectively. Group 1, being the control group, will receive no intervention.

Four weeks after the links have been shared, all the recruited participants, in all groups, will be invited to participate in a post-test survey (using Questionnaire G) to evaluate their knowledge of oral cancer. Additionally, those participants in the intervention group will also be asked to evaluate the usability, uptake, and acceptability of the digital intervention package they have received.

2.2.3.11 Data analysis

The collected data will be analysed using SPSS. This software will be used for the descriptive statistical analysis (including the frequency, and where applicable, the mean, mode, range, and standard deviation) and inferential statistical analysis of all independent and dependent variables.

The independent variables include the participants’ age, gender, university name, bachelor’s degree programme name, status on the receipt of mhealth- or website-based educational intervention on oral cancer, and the duration of receipt of mhealth- or website-based educational intervention on oral cancer. The dependent variable is the knowledge scores of the participants on oral cancer.

All variables are on nominal scale, except for the one on knowledge scores which is on a ratio scale. Since this study involves repeated measure of variables among three independent groups (Group 1, Group 2, and Group 3), of which the dependent variable is on a ratio scale; hence, the one-way analysis of variance (ANOVA) test will be used to inferentially test for the mean differences in the change in oral cancer knowledge among the three study groups.^63,67 Also, this statistical test will be used to test the difference between the level of uptake, usability, and acceptability concerning the digital intervention package received by the two intervention groups. For the ANOVA test, a confidence level of 95% and a p-value of <0.05 will be used to determine the level of statistical significance.

2.2.3.12 Reportage and management of adverse events

In the conduct of a randomised control trial, adverse events may occur.⁶⁸ An adverse event refers to “any untoward medical occurrence that may present during treatment with a pharmaceutical product, but which does not necessarily have a causal relationship with this treatment”.⁶⁹ However, in this proposed randomised control trial, digital interventions to educate the participants on oral cancer are the treatments that will be delivered. Because the subject matter of oral cancer is sensitive and may be upsetting, there is a possibility of adverse events, including psychological problems, to occur due to participation in this study. Should this occur, such events will be reported using an adverse events/reactions recording and reporting form. To ensure professional management of such adverse events, the participants will be signposted to the health or support centres of their university.

2.3 Ethical considerations

The conduct of this study will be done in strict compliance with the World Medical Association Guidelines for conducting health research involving human participants.⁷⁰ No participant will be coerced to participate in this study. Also, participation will be strictly voluntary, anonymous, and no obvious harm will be caused to the participants. Written informed consent will be obtained from the participants in the qualitative part of the study while those participants in the quantitative part will be informed that their participation implies consent. Ethical clearance to conduct this study has been obtained from the School of Health and Life Sciences Research Ethics sub-Committee of Teesside University, Middlesbrough, United Kingdom (Approval number: 2024 Mar 20233 Kanmodi; Approval date: 07 March 2024), Institutional Human Ethical Committee of Saveetha Dental College & Hospital, Chennai, India (Approval number: IHEC/SDC/FACULTY/24/OPATH/166; Approval date: 02 August 2024), College of Medicine and Health Sciences’ Institutional Review Board of the University of Rwanda, Kigali, Rwanda (Approval number: 595/CMHS IRB/2024; Approval date: 29 August 2024), Ethics Review Committee of the Faculty of Dental Sciences of the University of Peradeniya, Peradeniya, Sri Lanka (Approval number: ERC/FDS/UOP/I/2024/69; Approval date: 19 November 2024), Ethics Committee of the University of Ibadan and University College Hospital, Ibadan, Nigeria (Approval number: UI/EC/24/0660; Approval date: 17 September 2024), and the State Health Research Ethics Committee of Sokoto State Ministry of Health, Sokoto, Nigeria (Approval number: SMH/1580/V.IV; Approval date: 07 August 2024).

3. Conclusions

Oral cancer remains the leading cause of deaths globally. Despite the utilization of diverse intervention strategies targeting oral cancer prevention and control, the burden of the disease keeps increasing, especially among younger populations. Despite the continual growth and advancement in this present world, digital technologies have been largely underutilized in public health education on oral cancer. Unfortunately, the few available digital interventions of such were not comprehensive and not inclusive. This proposed study, through engagement with diverse stakeholders, will co-develop, co-create, and test a comprehensive and inclusive mobile health application prototype that can be used to educate the lay public about oral cancer. The outcomes of this study will also provide deeper and broader insights on how digital health education interventions can be produced for public health use.

Ethics approval and consent to participate

Institutional ethical clearance to conduct this study was obtained from School of Health and Life Sciences Research Ethics sub-Committee of Teesside University, Middlesbrough, United Kingdom (Approval number: 2024 Mar 20233 Kanmodi; Approval date: 07 March 2024), Institutional Human Ethical Committee of Saveetha Dental College & Hospital, Chennai, India (Approval number: IHEC/SDC/FACULTY/24/OPATH/166; Approval date: 02 August 2024), College of Medicine and Health Sciences’ Institutional Review Board of the University of Rwanda, Kigali, Rwanda (Approval number: 595/CMHS IRB/2024; Approval date: 29 August 2024), Ethics Review Committee of the Faculty of Dental Sciences of the University of Peradeniya, Peradeniya, Sri Lanka (Approval number: ERC/FDS/UOP/I/2024/69; Approval date: 19 November 2024), Ethics Committee of the University of Ibadan and University College Hospital, Ibadan, Nigeria (Approval number: UI/EC/24/0660; Approval date: 17 September 2024), and the State Health Research Ethics Committee of Sokoto State Ministry of Health, Sokoto, Nigeria (Approval number: SMH/1580/V.IV; Approval date: 07 August 2024). Written informed consent will be taken from all participants prior to their participation in this proposed study.

Data availability statement

Underlying data

No underlying data are associated with this article.

Extended data

Figshare repository: “Co-developing, co-creating, and testing an educational mobile health application prototype on oral cancer: A mixed methods study protocol”, https://doi.org/10.6084/m9.figshare.28093925.v1.⁷²

This project contains following dataset:

• Questionnaires A – G:

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC0).

Reporting guidelines

Figshare: SPIRIT checklist for “Co-developing, co-creating, and testing an educational mobile health application prototype on oral cancer: A mixed methods study protocol”, https://doi.org/10.6084/m9.figshare.28089716.v1.⁷¹

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC0).

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