Evaluation of the effect of educational interventions on preventive behaviors of oral cancer based on the Theory of Planned Behavior among people aged 15 years and more: A cluster randomized controlled trial

Evaluation of the effect of educational interventions on preventive behaviors of oral cancer based on the Theory of Planned Behavior

Cluster randomized controlled trial, with parallel groups, single blind, people aged 15 years and more living in Tehran, two intervention groups, simple randomization using Excel software, 400 people, participated in study in 2022

The health centers in two low-advantaged and very low-advantaged areas of Tehran located in five districts covered by Tehran University of Medical Sciences, which have the necessary criteria for better implementation of study will be selected, and from these centers, 20 centers will be randomly selected, and in each center, 20 people will be selected by simple random sampling. Data will be collected using structured interviewer-administered questionnaire of Theory of Planned Behavior, which will be again completed one and three months after the intervention. The data will be entered into STATA software with special codes, so that the analyzer is not informed about the clusters and groups.

Inclusion criteria: Age of 15 years and more; Living in low-advantaged or very low-advantaged area of Tehran; Absence of physical and mental disabling diseases; Agreement to sign the informed consent form Exclusion criteria: Non-Iranian citizens; Unwillingness to participate in face-to-face educational sessions; Unwillingness to work with virtual social networks; Inability to use smartphone applications

Intervention group 1 (control group): Education on oral cancer prevention using lecture presentation and pamphlet based on the Theory of Planned Behavior, Intervention group 2: Education on oral cancer prevention using smartphone based on the Theory of Planned Behavior

Preventive behaviors of oral cancer; Knowledge about oral cancer

This study will be performed using simple cluster random sampling. Based on the socio-economic development index, the city of Tehran is divided into five areas of advantaged, relatively-advantaged, semi-advantaged, low-advantaged, and very low-advantaged. The city of Tehran has 22 districts, of which the advantaged area includes four districts (1, 2, 3, 6), the relatively-advantaged area includes two districts (5, 7), the semi-advantaged area includes six districts (4, 8, 11, 13, 21, 22), the low-advantaged area includes five districts (9, 10, 12, 14, 20), and the very low-advantaged area includes five districts (15, 16, 17, 18, 19). Two areas of low- and very low-advantaged will be selected according to the research goal. Then, the list of health centers in these two areas will be extracted based on their locations in the districts covered by Tehran University of Medical Sciences, including districts 10, 15, 16, 17, and 19, which include 100 centers. Next, among the health centers located in these districts, the centers which have capability to implement study better will be selected based on the criteria such as activeness of the center, cooperation of the center, sufficient number of clients, amount of participation of covered people, and facilities of the center including appropriate space and place for education. The list of selected health centers that are considered as clusters will be prepared, and from these selected centers, 20 centers will be randomly selected, of which 10 centers will be allocated to intervention group 1 (control) and 10 centers to intervention group 2 by simple randomization using Excel software. Then, according to the sample size of 400 people, in each of the 20 health centers, 20 people will be selected, in such a way that the list of people covered by these centers will be prepared, and 20 of them will be selected by simple random sampling and invited to participate in the study, and if people do not have willing to participate in the study, alternative people from the prepared list will be also selected by simple random sampling.

The data will be entered into STATA software with special codes, so that the analyzer is not informed about the clusters and groups.