An interventional study of Animated Educational Video on Breast Cancer and Screening and Educational booklet on Breast Cancer and Screening, in Breast Cancer and Breast Cancer Screening, sponsored by Istanbul University. Not yet recruiting. Open to female participants aged 40 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Istanbul University · Not applicable, Interventional, and Screening
Aim of the Study This study aims to evaluate the effect of an animated video and educational booklet developed to inform Palestinian women aged 40-69 about breast cancer and screening programs on their level of knowledge about breast cancer and screening methods.
The breast cancer screening program in Palestine includes monthly self-examination, clinical breast examination, and mammography.
This study will be conducted in two phases. In the first phase, the animated video and educational booklet will be developed, and in the second phase, the level of knowledge and participation in screening programs will be evaluated after the educational intervention.
Type of research: This is a randomized controlled experimental study. The study will be conducted with two intervention groups. Women who receive education through the animated video will form Intervention Group I, while women who receive education through the educational booklet will form Intervention Group II. The study will evaluate the effectiveness of the intervention in increasing the knowledge of women who received education through an animated video and an educational booklet about breast cancer, performing self-breast examinations, undergoing clinical breast examinations, and participating in breast cancer screening programs that include mammograms. This study will be conducted on Palestinian women and will target women with different levels of education.
This study is based on a randomized controlled trial design and will compare the pre-, interim, and post-test results for women in both groups (animation video group and educational booklet group) in terms of breast cancer, breast cancer screening program information, and behavior change. It will be evaluated whether animation videos or educational booklets are more effective in increasing knowledge and behavior.
Location and Timing of the Study: The study will be conducted in the West Bank of Palestine between September 2025 and December 2026.
Research Population and Sample: The research population will consist of women aged 40-69 living in the West Bank of Palestine. Since this study was designed as a randomized controlled trial, a power analysis was conducted to determine the number of participants to be included in each group. In this context, the G*Power (3.1.19.7) program was used to calculate the sample size. Using Cohen's standard effect sizes, the power analysis determined that a total of 128 participants (64 in each group) were needed to achieve 80% power at an effect size of 0.5, a 0.05 error rate, and a 0.95 confidence interval.
Participants were volunteers who could read and write Arabic, were between 40 and 69 years of age, did not have breast cancer, and did not have a history of benign breast diseases such as breast cysts, fibroadenoma, or hyperplasia, no family history of breast cancer, no history of self-breast examination, no participation in breast cancer screening programs, and who own a smartphone or laptop computer.
Women who meet the inclusion criteria will be divided into two groups: Intervention Group I, which will be trained using an animated video, and Intervention Group II, which will be trained using an educational booklet, using a simple random allocation method. To enhance the reliability of the study and ensure an equal distribution of the sample between the two groups, a program that generates random numbers will be used, and the sample will be randomly selected via the www.randomizer.org website. Women will be divided into two groups (in a 1:1 ratio).
Women diagnosed with breast cancer during the study, women working in the healthcare sector (doctors, midwives, or nurses), pregnant and breastfeeding women, and women who do not watch the animated video or read the educational booklet within one week of receiving the educational materials will be excluded.
Research Context Palestinians have been living under constant Israeli occupation and attacks since 1948, and the situation has worsened since the war began on October 7, 2023. The recent war has led to further restrictions and deliberate obstruction of access to health centers and hospitals by Israeli occupiers (Ali et al., 2025). Therefore, the universe will consist of women who come to the Murabitat Charity Association in the Palestinian Governorate of Qalqilya. The sample will be selected from women who meet the inclusion criteria. To facilitate the research and better reach women, an animated video will be published on the YouTube platform (as a private video), meaning only those with the link will be able to watch it, and it will not appear in search results. The educational booklet will be sent via a WhatsApp group in PDF format and will be password-protected, so only those with the password will be able to view it. Data collection tools will be managed online via WhatsApp or Zoom, ensuring accessibility and security under local political and logistical constraints.
Study Hypotheses H1: Using educational animated videos about breast cancer has a positive effect on participants' knowledge about breast cancer and the importance of screening programs.
H2: Using an informative educational booklet about breast cancer has a positive effect on participants' knowledge about breast cancer and the importance of screening programs.
H3: Using an educational animated video about breast cancer increases participants' participation rates in breast cancer screening programs.
H4: Using an informative educational booklet on breast cancer increases the participation rate of female participants in breast cancer screening programs.
H5: Using an educational animation video on breast cancer and screening programs increases women's knowledge about breast cancer and their participation rate in screening programs more than using an educational booklet.
Educational intervention and evaluation In a study examining the content of YouTube videos as a source of information for breast examination, it was found that although the quality of these videos was quite good, they were not sufficiently reliable in terms of the reliability of health information and the quality of information (Bu Bshait and Almaqhawi, 2024). Therefore, a new educational video will be developed from scratch. The video will provide high reliability, accuracy, and fluency based on evidence-based guidelines and will be aligned with the guidelines of the World Health Organization (WHO, 2024), the Palestinian Ministry of Health (MOH, 2024), the Royal College of Obstetricians and Gynaecologists (RCOG, 2011), and the American College of Obstetricians and Gynecologists (ACOG, 2017).
Women participating in the study will be randomly selected and their written consent will be obtained via Google forms before the study begins. They will then be divided into two groups on the WhatsApp platform, and the "Introductory Information Form" and "Breast Cancer and Screening Program Information Test" will be sent online prior to the first follow-up intervention. Subsequently, animated videos and educational booklets will be distributed to both groups randomly. The Breast Cancer and Screening Program Knowledge Test will be sent to the women again one month and three months after the intervention for follow-up and evaluation purposes. This study aims to determine the short- and long-term effectiveness of the animated video and educational booklet on women's knowledge and behavior regarding breast cancer and screening.
Data collection tools used in the study The data collection tools will include an "Identification Information Form," a "Breast Cancer and Screening Program Information Test," an "Animation Video," and an "Educational Booklet."
The "Information Form," "Breast Cancer and Screening Program Information Test," "Animation Video," and "Educational Booklet" will be written in Turkish and Arabic and, after their linguistic validity has been checked, will be sent to experts (breast disease specialists, midwives, and academics) their content validity will be determined, and the final version of the data collection tools will be created based on the experts' opinions. The questions in the "Information Form," "Breast Cancer and Screening Program Knowledge Test" will be evaluated according to criteria such as relevance to the subject, clarity of questions, fluency of expression, and suitability for general culture. All suggestions will be considered, and if necessary, changes will be made to the "Informative Information Form," "Breast Cancer and Screening Program Knowledge Test," "Animation Video," and "Educational Booklet." After the pilot study is conducted with 14 women (who will not be included in the study), the internal consistency of the questionnaire will be evaluated using Cronbach's alpha coefficient, and if the values are between 0.70 and 0.95, these results will be considered sufficient.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 128 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Exclusion Criteria:
Participants in this arm will receive breast cancer and screening education through an animated educational video designed to improve knowledge, awareness, and screening intentions.
Other: Animated Educational Video on Breast Cancer and Screening
Participants in this arm will receive breast cancer and screening education through an online booklet designed to improve knowledge, awareness, and screening intentions.
Other: Educational booklet on Breast Cancer and Screening,
Women participating in the study will be randomly selected and their written consent will be obtained via Google forms before the study begins. They will then be divided into two groups on the WhatsApp platform, and the "Introductory Information Form" and "Breast Cancer and Screening Program Information Test" will be sent online prior to the first follow-up intervention. Subsequently, animated video will be distributed to both groups randomly. The Breast Cancer and Screening Program Knowledge Test will be sent to the women again one month and three months after the intervention for follow-up and evaluation purposes. This study aims to determine the short- and long-term effectiveness of the animated video and educational booklet on women's knowledge and behavior regarding breast cancer and screening.
Women participating in the study will be randomly selected and their written consent will be obtained via Google forms before the study begins. They will then be divided into two groups on the WhatsApp platform, and the "Introductory Information Form" and "Breast Cancer and Screening Program Information Test" will be sent online prior to the first follow-up intervention. Subsequently, educational booklets will be distributed to both groups randomly. The Breast Cancer and Screening Program Knowledge Test will be sent to the women again one month and three months after the intervention for follow-up and evaluation purposes. This study aims to determine the short- and long-term effectiveness of the animated video and educational booklet on women's knowledge and behavior regarding breast cancer and screening.
Knowledge about Breast Cancer and Screening
Assessment of participants' knowledge regarding breast cancer, risk factors, prevention methods, and breast cancer screening before and after the educational intervention.
Time frame: Baseline and immediately post-intervention then after 1 month and after 3 months
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared to protect participant confidentiality and privacy. The data are collected for academic research purposes only and are subject to institutional ethical approval restrictions.
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Istanbul University