- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07676812
The Effect of Animation Video and Training Booklet Designed on Breast Cancer (Breast Cancer)
The Effect of Animation Video and Training Booklet Designed on Breast Cancer in Palestinian Women on Screening Methods
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 Overview
Status
Conditions
Detailed Description
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).
- An animated video and educational booklet containing the same information about breast cancer and screening will be developed.
- The script, characters, and story will be prepared in accordance with the information and objectives.
- The opinions of experts will be sought.
- If any changes are made to the animated video and educational booklet based on expert opinions, they will be revised accordingly.
- A pilot study will be conducted to test the data collection tools.
- If necessary, based on feedback received after the pilot study, changes will be made to the animated video, educational booklet, and Breast Cancer and Screening Program Information Test, and their final versions will be finalized.
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 will include questions about women's demographic information, health status, and family history of breast cancer.
- The Breast Cancer and Screening Program Information Test will include: 1) Information and awareness about breast cancer risk factors, symptoms, primary prevention, and secondary prevention; 2) Information on performing self-breast examination (SBE), undergoing clinical breast examination (CBE), and having a mammogram according to the screening program; 3) Questions to assess women's behaviors regarding performing SBE, undergoing CBE, and having a mammogram.
- Animated Video; 1) Information on breast cancer risk factors, symptoms and signs, primary prevention, and secondary prevention; 2) A scenario will be prepared based on information about performing a Self-Breast Examination (SBE), undergoing a Clinical Breast Examination (CBE), and having a mammogram according to the screening program, and an animated video will be created.
- Educational Booklet; 1) Information on breast cancer risk factors, symptoms, primary prevention, and secondary prevention; 2) An educational booklet will be created containing information on performing a Self-Breast Examination (SBE), undergoing a Clinical Breast Examination (CBE), and having a mammogram according to the screening program.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- who could read and write Arabic,
- women between 40 and 69 years of age,
- who own a smartphone or laptop computer.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Animated Video Education Group
Participants in this arm will receive breast cancer and screening education through an animated educational video designed to improve knowledge, awareness, and screening intentions.
|
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.
|
|
Experimental: Booklet group
Participants in this arm will receive breast cancer and screening education through an online booklet designed to improve knowledge, awareness, and screening intentions.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge about Breast Cancer and Screening
Time Frame: Baseline and immediately post-intervention then after 1 month and after 3 months
|
Assessment of participants' knowledge regarding breast cancer, risk factors, prevention methods, and breast cancer screening before and after the educational intervention.
|
Baseline and immediately post-intervention then after 1 month and after 3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Acharya, A., Ashrafian, H., Cunningham, D., Ruwende, J., Darzi, A., & Judah, G. (2022). Evaluating the impact of a novel behavioural science informed animation upon breast cancer screening uptake: protocol for a randomised controlled trial. BMC Public Health, 22(1). https://doi.org/10.1186/s12889-022-13781-x Al Eker O, Imam A, Elissa K. Unveiling health disparities in Palestine: a qualitative study of stakeholders' perspectives. Int J Equity Health. 2025 Apr 16;24(1):102. doi: 10.1186/s12939-025-02449-8. PMID: 40241084; PMCID: PMC12001633. Ali, D. O., Shaheen, A., & Badrasawi, M. (2025, April 22). Impact of the Israeli Occupation on Palestinian Women Health, Narrative review. https://journals.najah.edu/journal/pmpj/first-online/article/2499/ Alkhaldi M, Coghlan R, Miller S, Basuoni AA, Tanous O, Asi YM. State Accountability for the Good Health of Palestinians Has Failed: What Can the Global Health Community Do Next? Health Hum Rights. 2022 Jun;24(1):77-84. PMID: 35747282; PMCID: PMC9212828. Al-Tell, M., Natour, N., & Younes, D. (2019). Barriers to Breast Cancer Screening among Palestinian Women in Nablus Region, North-ern West Bank. Palestinian Medical and Pharmaceutical Journal (Pal. Med. Pharm. J.), 5(2). https://doi.org/10.59049/2790-0231.1061 American College of Obstetricians and Gynecologists. (2017). Breast cancer risk assessment and screening in average-risk women (Practice Bulletin No. 179). Obstetrics & Gynecology, 130(5), e1-e16. https://doi.org/10.1097/AOG.0000000000002158 (Erişim Tarihi 20.6.2025) Bekdemir Ak, Ö. (2024). Meme kanseri taramasında farkındalık ve davranış oluşturmaya yönelik hazırlanan video ve cep telefonu uygulamasının etkinliğinin değerlendirilmesi. İstanbul Üniversitesi-Cerrahpaşa Lisansüstü Enstitüsü, Doktora Tezi. Bu Bshait MS, Almaqhawi A. Quality Assessment of YouTube Videos As Information Source for Breast Self-Examination. Cureus. 2024 Sep 26;16(9):e70227. doi: 10.7759/cureus.70227. PMID: 39463531; PMCID: PMC11512166. Elshami, M
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Skin Diseases
- Breast Diseases
- Skin and Connective Tissue Diseases
- Breast Neoplasms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Diagnostic Techniques and Procedures
- Diagnosis
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Health Services
- Health Care Facilities Workforce and Services
- Preventive Health Services
- Diagnostic Services
- Health Surveys
- Surveys and Questionnaires
- Public Health Practice
- Mass Screening
Other Study ID Numbers
- 2025/592
- 16/1921/2025 (Other Identifier: Palestine Ministry of Health)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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