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Breast Cancer and Breast Cancer ScreeningBreast CancerNCT07676812

The Effect of Animation Video and Training Booklet Designed on Breast Cancer

A study testing Animated Educational Video on Breast Cancer and Screening and Educational booklet on Breast Cancer and Screening, in people with Breast Cancer and Breast Cancer Screening, run by Istanbul University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 69 years, women onlyHealthy volunteers can take part
What is being tested?
Animated Educational Video on Breast Cancer and Screening and Educational booklet on Breast Cancer and Screening,
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
No sites listed yet
Study dates
30 Aug 2026to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 69 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • who could read and write Arabic,
  • women between 40 and 69 years of age,
  • who own a smartphone or laptop computer.

Who cannot join

  • 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

About this study

Official title: 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.

Read more

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.

Read the 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."

  1. The Information Form will include questions about women's demographic information, health status, and family history of breast cancer.
  2. 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.
  3. 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.
  4. 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.

Being tested
Animated Educational Video on Breast Cancer and Screening, Educational booklet on Breast Cancer and Screening,
Keywords
Breast cancer Breast cancer screening Health education Educational intervention Animated video Online booklet Women's health, Randomized controlled trial
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Animated Educational Video on Breast Cancer and ScreeningOther

    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.

  • Educational booklet on Breast Cancer and Screening,Other

    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.

Study groups in NCT07676812
Study groupRoleWhat they receive
Animated Video Education GroupExperimentalParticipants in this arm will receive breast cancer and screening education through an animated educational video designed to improve knowledge, awareness, and screening intentions.
Receives: Other: Animated Educational Video on Breast Cancer and Screening
Booklet groupExperimentalParticipants in this arm will receive breast cancer and screening education through an online booklet designed to improve knowledge, awareness, and screening intentions.
Receives: Other: Educational booklet on Breast Cancer and Screening,

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and immediately post-intervention then after 1 month and after 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2026
  2. Study start30 Aug 2026 (estimated)
  3. Primary completion30 Aug 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
the groups will 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.
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07676812
Sponsor's protocol ID
2025/592
Other IDs
16/1921/2025
Acronym
Breast Cancer
Status last verified
Jun 2026
First submitted
21 Dec 2025
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Animated Educational Video on Breast Cancer and Screening and Educational booklet on Breast Cancer and Screening, in people with Breast Cancer and Breast Cancer Screening, run by Istanbul University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge about Breast Cancer and Screening (time frame: Baseline and immediately post-intervention then after 1 month and after 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07676812, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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