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IRCT20211119053105N1 IRCT 2021-12-15 Esfahan University of Medical Sciences The effect of educational intervention on breast cancer screening behaviors in women Designing, implementation and evaluation of educational intervention related to breast cancer screening behaviors in middle-aged women 2022-04-21 anticipated 250 Complete https://irct.ir/trial/60083 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, a simple randomization method will be used. The randomization scale will be cluster. First, one of the two Isfahan health centers will be randomly assigned to the intervention group and the other to the control group.Then,5 centers will be selected randomly from the comprehensive health centers ,which were their subsets, and among the women who were covered by these centers, considering the inclusion and exclusion criteria and the agreement to participate in the study, 125 people will be opted using convenience sampling method and will enter into the study for each of the intervention and control groups. N/A Breast Cancer. Intervention 1: Intervention group: The intervention will be performed in the following steps: 1- describing the objectives of the study to the participants and obtaining their consent 2- Creating a communication channel (Whats App) to send questionnaires and programs, training packages and reminders Programs 3- Justifying the intervention group regarding the conditions and manner of holding online training sessions, sending the link to enter the sessions via SMS, sending training packages, etc. 4- Providing the necessary instructions regarding the installation of the required programs (for participation in online training classes) on the mobile phone, tablet or laptop of the participant or a family member who lives with him. 5- If necessary, by assigning a specific day and time with the presence of the person participating in the health center, the mentioned programs will be installed on his mobile phone or tablet by the research group.6- Starting educational intervention programs by the participating in 60-80 minute online sessions once a week. These sessions will be held in Skyroom and the presence and absence of people in the sessions will be done in the same way. Sending text, audio and video files and messages reminding sessions and linking classes will be done via SMS and WhatsApp channel. The duration of the intervention is 8 weeks and is as follows, Week 1: Teaching how to work with Skyroom, holding an online session on a trial basis to identify and resolve possible problems of participants in joining the class and fully justify people about holding upcoming sessions,Week 2: Implementation of the intervention to reduce the level of concerns in middle-aged women about breast cancer screening behaviors, consists of holding a training session by a mental health expert, showing a video, discussion with clarification, using muscle relaxation techniques, commitment of participants to decrease their worries about performing breast cancer screening behaviors. Week 3: Implementing an intervention aimed at improving the level of stress management among middle-aged women regarding breast cancer screening behaviors, including holding training session by a mental health expert, recording stress on a daily basis by participants, practicing problem-solving skills, introducing free counseling centers in the city, recording stress reduction goals, introducing active support groups and sports centers, as well as teaching yoga and meditation to participants. Week 4: Implementing an intervention aimed at improving the motivation of middle-aged women to perform breast cancer screening behaviors, including holding a training session by a mental health expert and midwife, playing a role, introducing participants who have successful experiences in screening behaviors, giving verbal encouragement , inviting and interviewing women who have developed breast cancer due to lack of screening behavior as well as Providing participants an incentives to engage in screening behaviors.Week 5: Implementing an intervention aimed at empowering middle-aged women to perform breast cancer self-care, including holding a training session in which a lecture and discussion were included by a midwife or doctor, sending training files on self-care in virtual channels, introducing and interviewing women who were able to discover the mass due to screening, practicing for setting goals, self-monitoring their presence, and considering personal punishment and encouragement for participants' failure or achievement of goals.Week 6: Implementation of the intervention with the aim of improving the level of information search to perform breast cancer screening behaviors, including holding a training session in which lectures and questions and answers by midwives and health education and health promotion experts were included, introducing valid sources, sites and databases for receiving information about breast cancer and ways to prevent it and the positive experience of participants in the field of information search.Week 7: Intervention with the aim of strengthening the support system of the intervention group to perform breast cancer screening behaviors, including holding a training session for women and their husbands to enhance emotional and non-emotional support and a separate training session for midwives of selected health centers to enhance information support as well as providing successful experiences by spouses and staff, forming self-help and support groups,Week 8: Answering questions, repeating topics as needed and updating trainings and sending additional files, getting feedback from participants. Intervention 2: Control group: For this group, the following will be done: 1- describing the objectives of the study to the participants and obtaining their consent 2- Creating a communication channel (Whats app) to send questionnaires 3- Provide routine care and advice in comprehensive health centers in the field of prevention and performance of breast cancer screening behaviors 4- Providing educational content to all members of the control group after completing the study. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participants' data will remain confidential to the researcher due to the given assurance at the beginning of the study.
public Banafsheh Tavakoli
Department of Health Education and Health Promotion, School of Health, Isfahan University of Medical Sciences, Hezar Jarib Street
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3228 tavakoli.bfsh@gmail.com Esfahan University of Medical Sciences scientific Hosein Shahnazi
Department of Health Education and Health Promotion, School of Health, Isfahan University of Medical Sciences, Hezar Jarib Street
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3243 h_shahnazi@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Middle-aged women who have not had two breast cancer screening methods, including mammography or clinical breast examination, for at least the past two years. Minimum literacy No history of malignant breast disease in the person or close relatives Owning a laptop, mobile phone or tablet with the ability to access the Internet and install software Consent to participate in the study 40 years 59 years Female Pregnant and breastfeeding women History of participating in training sessions related to breast cancer screening C50 Malignant neoplasm of breast Early detection Early detection Intervention group: The intervention will be performed in the following steps: 1- describing the objectives of the study to the participants and obtaining their consent 2- Creating a communication channel (Whats App) to send questionnaires and programs, training packages and reminders Programs 3- Justifying the intervention group regarding the conditions and manner of holding online training sessions, sending the link to enter the sessions via SMS, sending training packages, etc. 4- Providing the necessary instructions regarding the installation of the required programs (for participation in online training classes) on the mobile phone, tablet or laptop of the participant or a family member who lives with him. 5- If necessary, by assigning a specific day and time with the presence of the person participating in the health center, the mentioned programs will be installed on his mobile phone or tablet by the research group.6- Starting educational intervention programs by the participating in 60-80 minute online sessions once a week. These sessions will be held in Skyroom and the presence and absence of people in the sessions will be done in the same way. Sending text, audio and video files and messages reminding sessions and linking classes will be done via SMS and WhatsApp channel. The duration of the intervention is 8 weeks and is as follows, Week 1: Teaching how to work with Skyroom, holding an online session on a trial basis to identify and resolve possible problems of participants in joining the class and fully justify people about holding upcoming sessions,Week 2: Implementation of the intervention to reduce the level of concerns in middle-aged women about breast cancer screening behaviors, consists of holding a training session by a mental health expert, showing a video, discussion with clarification, using muscle relaxation techniques, commitment of participants to decrease their worries about performing breast cancer screening behaviors. Week 3: Implementing an intervention aimed at improving the level of stress management among middle-aged women regarding breast cancer screening behaviors, including holding training session by a mental health expert, recording stress on a daily basis by participants, practicing problem-solving skills, introducing free counseling centers in the city, recording stress reduction goals, introducing active support groups and sports centers, as well as teaching yoga and meditation to participants. Week 4: Implementing an intervention aimed at improving the motivation of middle-aged women to perform breast cancer screening behaviors, including holding a training session by a mental health expert and midwife, playing a role, introducing participants who have successful experiences in screening behaviors, giving verbal encouragement , inviting and interviewing women who have developed breast cancer due to lack of screening behavior as well as Providing participants an incentives to engage in screening behaviors.Week 5: Implementing an intervention aimed at empowering middle-aged women to perform breast cancer self-care, including holding a training session in which a lecture and discussion were included by a midwife or doctor, sending training files on self-care in virtual channels, introducing and interviewing women who were able to discover the mass due to screening, practicing for setting goals, self-monitoring their presence, and considering personal punishment and encouragement for participants' failure or achievement of goals.Week 6: Implementation of the intervention with the aim of improving the level of information search to perform breast cancer screening behaviors, including holding a training session in which lectures and questions and answers by midwives and health education and health promotion experts were included, introducing valid sources, sites and databases for receiving information about breast cancer and ways to prevent it and the positive experience of participants in the field of information search.Week 7: Intervention with the aim of strengthening the support system of the intervention group to perform breast cancer screening behaviors, including holding a training session for women and their husbands to enhance emotional and non-emotional support and a separate training session for midwives of selected health centers to enhance information support as well as providing successful experiences by spouses and staff, forming self-help and support groups,Week 8: Answering questions, repeating topics as needed and updating trainings and sending additional files, getting feedback from participants Control group: For this group, the following will be done: 1- describing the objectives of the study to the participants and obtaining their consent 2- Creating a communication channel (Whats app) to send questionnaires 3- Provide routine care and advice in comprehensive health centers in the field of prevention and performance of breast cancer screening behaviors 4- Providing educational content to all members of the control group after completing the study Motivation. Timepoint: 1- Before the intervention 2- Three months after the intervention program 3- Six months after the intervention program. Method of measurement: Questionnaire including factors related to the promotion of breast cancer screening behaviors. Social support. Timepoint: 1- Before the intervention 2- Three months after the intervention program 3- Six months after the intervention program. Method of measurement: Questionnaire including factors related to the promotion of breast cancer screening behaviors. Information seeking. Timepoint: 1- Before the intervention 2- Three months after the intervention program 3- Six months after the intervention program. Method of measurement: Questionnaire including factors related to the promotion of breast cancer screening behaviors. Self-care. Timepoint: 1- Before the intervention 2- Three months after the intervention program 3- Six months after the intervention program. Method of measurement: Questionnaire including factors related to the promotion of breast cancer screening behaviors. Stress management. Timepoint: 1- Before the intervention 2- Three months after the intervention program 3- Six months after the intervention program. Method of measurement: Questionnaire including factors related to the promotion of breast cancer screening behaviors. Worry. Timepoint: 1- Before the intervention 2- Three months after the intervention program 3- Six months after the intervention program. Method of measurement: Questionnaire including factors related to the promotion of breast cancer screening behaviors. Breast self-examination behavior. Timepoint: 1- Before the intervention 2- Three months after the intervention program 3- Six months after the intervention program. Method of measurement: Questionnaire including factors related to the promotion of breast cancer screening behaviors. Clinical breast examination behavior. Timepoint: 1-Before the intervention 2- Three months after the intervention program 3- Six months after the intervention program. Method of measurement: Questionnaire including factors related to the promotion of breast cancer screening behaviors. Mammography behavior. Timepoint: 1-Before the intervention 2- Three months after the intervention program 3- Six months after the intervention program. Method of measurement: Questionnaire including factors related to the promotion of breast cancer screening behaviors. Esfahan University of Medical Sciences Approved 2021-11-15 Ethics Committee of Isfahan University of Medical Sciences Building No. 4, Isfahan University of Medical Sciences, Hezar Jarib Street Esfahan Isfehan Iran (Islamic Republic of)