Breast CarcinomaNCT06706141
The Effect of Breast Cancer and Breast Self-Examination
A study testing PowerPoint presentation. in people with Breast Carcinoma, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Background: Somali women face extremely high mortality and incidence rates for breast cancer (BC). One of the suggested techniques for screening for breast cancer early detection is breast self-examination, or BSE. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- PowerPoint presentation.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Turkish and Somali instructors work together at the faculty and students are given education in Turkish. If students are successful in one year of Turkish preparation, they can then continue to the department of their choice. The population of the research consisted of 500 female students over the age of 18 studying at the Recep Tayyip Erdoğan Faculty of Health Sciences in Mogadishu, Somalia.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breast Cancer and Breast Self-Examination Health Education on Awareness, Beliefs and Practices Given to Female Students at the Faculty of Health Sciences of a University in Mogadishu, Somalia
Background: Somali women face extremely high mortality and incidence rates for breast cancer (BC). One of the suggested techniques for screening for breast cancer early detection is breast self-examination, or BSE. Studies have revealed that Somalian women, however, lack sufficient understanding and practice about BC and BSE. In this study, female students at a university in Mogadishu, Somalia, had their knowledge, attitudes, health beliefs, and BSE practices evaluated with reference to the effects of health belief model-based health education addressing BC and BSE.
Methods: It was conducted as a randomized controlled study on 86 female university students in Mogadishu, Somalia, between September 2021 and June 2022. Randomization was used to assign participants to the intervention group (n = 43) and control group (n = 43). Data were gathered using two instruments: a self-administered questionnaire was the first tool used to gather information on individuals\' sociodemographic and level of awareness about BC and BSE. The health belief model scale is the second instrument. A validated checklist and a modified structured questionnaire were used to gather data. Subsequently, the students in the experimental group took part in the three 90-minute training sessions that made up the program. The control group did not receive any intervention. Three months later, further student data were gathered. Data analysis was performed using IBM-SPSS software version 20, descriptive and inferential statistical tests (T-test, chi-square, repeated measures).
- Conditions
- Breast Carcinoma
- Being tested
- PowerPoint presentation.
- Keywords
- Awareness, Belief, Breast cancer, Breast self-examination, Health education, Students, Somalia
- Medical subject headings
- Breast Neoplasms, Breast Self-Examination, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PowerPoint presentation.Behavioural
Also called The messages on breast self-examination, health belief models, breast cancer awareness, confidence for BSE, and perceived barriers/benefits for BSE were presented in a PowerPoint presentation.
The training included topics such as breast anatomy; breast cancer incidence in Somalia, mortality, morbidity rates; breast cancer risk factors, importance of screening methods; The messages on breast self-examination, health belief models, breast cancer awareness, confidence for BSE, and perceived barriers/benefits for BSE were presented in a PowerPoint presentation. The procedure for performing breast self-examination was described using the English edition of Bristol-Myers Squibb Oncology. In the movie, BSE was made simpler with schematics showing the breast area that needed to be covered. Simple directions on which fingers to use and how to move them over the breast were provided. After the film, the emphasis shifted to helping students gain more self-assurance in their ability to accurately complete each BSE step. Students were encouraged to use proper palpation technique to find lumps by performing a breast examination on a silicone breast model.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group received various interventions such as group education based on the health belief model, individual counseling, and brochures on screening. The training was given by two study team members in the faculty's conference hall, in the form of a presentation, discussion, and question-answer sessions, with the experimental group divided into two groups, lasting approximately 90 minutes. It was completed in 3 sessions with breaks every 30 minutes. For training hours, free hours when students did not have classes were chosen. For each training group, a member of the study team first gave a presentation on breast cancer and breast screening behaviors and BSE (30 minutes). Then, a film was shown on the BSE practice recommended by the World Health Organization (20 minutes) and training was given on how to perform correct and effective BSE on the breast model (20 minutes). Receives: Behavioral: PowerPoint presentation. |
| Control Group | No intervention | The intervention group within the control group received health education on early diagnosis and prevention of breast cancer once the program was finished for them and all data had been gathered for both groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
post intervention
After the training, a post-test was administered to the experimental and control groups. Data were collected with "Sociodemographic Questionnaire", "Champion's health Belief Model Scale". Sociodemographic Questionnaire: This survey includes questions such as the age of the students, the education level of the mother and father, family income level, and family history of breast cancer. There were also 7 questions about students' breast cancer and breast self-examination. Champion's health Belief Model Scale: The 42-item Champion Health Belief Model Scale (CHBMS) was refined in subsequent research (1993, 1997, 1999) and was created by Victoria Champion in 1984 to assess women's attitudes and beliefs regarding breast cancer and breast self-examination. CHBMS has 6 subscales.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Oct 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blind, randomized, controlled pretest-posttest experimental design was used for this research.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylul Yesilyurt, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706141
- Sponsor's protocol ID
- Recep Tayyip Erdoğan Faculty
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I don\'t want to share
Publications
Altunkurek SZ, Hassan Mohamed S. Determine knowledge and belief of Somalian young women about breast cancer and breast self-examination with champion health belief model: a cross-sectional study. BMC Med Inform Decis Mak. 2022 Dec 8;22(1):326. doi: 10.1186/s12911-022-02065-4.
PubMed 36482433Yang S, Li P, Yu L, Liu N, Wang J, Guo P, Zhang X, Zhang W. Breast Cancer Awareness Based on Health Information Literacy and Influential Factors among Female Nursing Students in China. J Cancer Educ. 2022 Jun;37(3):546-554. doi: 10.1007/s13187-020-01844-9.
PubMed 32876864Andrew Tong JW, Hee MQ. The impact of an online educational game on breast cancer awareness among university female students, Malaysia: a pilot study. BMC Cancer. 2023 Oct 6;23(1):947. doi: 10.1186/s12885-023-11427-8.
PubMed 37803291Altunkurek SZ, Yesilyurt E, Hassan Mohamed S. The Effect of Breast Cancer and Breast Self-Examination Health Education on Awareness, Beliefs, and Practices of Female Students at the Faculty of Health Sciences of a University in Somalia. Breast J. 2026;2026(1):e8854280. doi: 10.1155/tbj/8854280.
PubMed 41885785
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breast Cancer and Breast Self-Examination Health Education on Awareness, Beliefs and Practices Given to Female Students at the Faculty of Health Sciences of a University in Mogadishu, Somalia
- ClinicalTrials.gov ID
- NCT06706141
- Acronym / sponsor ID
- Recep Tayyip Erdoğan Faculty
- Conditions
- Breast Carcinoma
- Keywords
- Awareness, Belief, Breast cancer, Breast self-examination, Health education, Students, Somalia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Somali women face extremely high mortality and incidence rates for breast cancer (BC). One of the suggested techniques for screening for breast cancer early detection is breast self-examination, or BSE. Studies have revealed that Somalian women, however, lack sufficient understanding and practice about BC and BSE. In this study, female students at a university in Mogadishu, Somalia, had their knowledge, attitudes, health beliefs, and BSE practices evaluated with reference to the effects of health belief model-based health education addressing BC and BSE.
Methods: It was conducted as a randomized controlled study on 86 female university students in Mogadishu, Somalia, between September 2021 and June 2022. Randomization was used to assign participants to the intervention group (n = 43) and control group (n = 43). Data were gathered using two instruments: a self-administered questionnaire was the first tool used to gather information on individuals\' sociodemographic and level of awareness about BC and BSE. The health belief model scale is the second instrument. A validated checklist and a modified structured questionnaire were used to gather data. Subsequently, the students in the experimental group took part in the three 90-minute training sessions that made up the program. The control group did not receive any intervention. Three months later, further student data were gathered. Data analysis was performed using IBM-SPSS software version 20, descriptive and inferential statistical tests (T-test, chi-square, repeated measures).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A single-blind, randomized, controlled pretest-posttest experimental design was used for this research.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: PowerPoint presentation.The experimental group received various interventions such as group education based on the health belief model, individual counseling, and brochures on screening. The training was given by two study team members in the faculty's conference hall, in the form of a presentation, discussion, and question-answer sessions, with the experimental group divided into two groups, lasting approximately 90 minutes. It was completed in 3 sessions with breaks every 30 minutes. For training hours, free hours when students did not have classes were chosen. For each training group, a member of the study team first gave a presentation on breast cancer and breast screening behaviors and BSE (30 minutes). Then, a film was shown on the BSE practice recommended by the World Health Organization (20 minutes) and training was given on how to perform correct and effective BSE on the breast model (20 minutes). |
| Control Group | No intervention | –The intervention group within the control group received health education on early diagnosis and prevention of breast cancer once the program was finished for them and all data had been gathered for both groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Turkish and Somali instructors work together at the faculty and students are given education in Turkish. If students are successful in one year of Turkish preparation, they can then continue to the department of their choice. The population of the research consisted of 500 female students over the age of 18 studying at the Recep Tayyip Erdoğan Faculty of Health Sciences in Mogadishu, Somalia.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PowerPoint presentation.Also: The messages on breast self-examination, health belief models, breast cancer awareness, confidence for BSE, and perceived barriers/benefits for BSE were presented in a PowerPoint presentation.The training included topics such as breast anatomy; breast cancer incidence in Somalia, mortality, morbidity rates; breast cancer risk factors, importance of screening methods; The messages on breast self-examination, health belief models, breast cancer awareness, confidence for BSE, and perceived barriers/benefits for BSE were presented in a PowerPoint presentation. The procedure for performing breast self-examination was described using the English edition of Bristol-Myers Squibb Oncology. In the movie, BSE was made simpler with schematics showing the breast area that needed to be covered. Simple directions on which fingers to use and how to move them over the breast were provided. After the film, the emphasis shifted to helping students gain more self-assurance in their ability to accurately complete each BSE step. Students were encouraged to use proper palpation technique to find lumps by performing a breast examination on a silicone breast model. | Behavioural | Experimental Group |
Primary outcome
post intervention
Time frame: 3 months
After the training, a post-test was administered to the experimental and control groups. Data were collected with "Sociodemographic Questionnaire", "Champion's health Belief Model Scale". Sociodemographic Questionnaire: This survey includes questions such as the age of the students, the education level of the mother and father, family income level, and family history of breast cancer. There were also 7 questions about students' breast cancer and breast self-examination. Champion's health Belief Model Scale: The 42-item Champion Health Belief Model Scale (CHBMS) was refined in subsequent research (1993, 1997, 1999) and was created by Victoria Champion in 1984 to assess women's attitudes and beliefs regarding breast cancer and breast self-examination. CHBMS has 6 subscales.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Results publication: PubMed 36482433Altunkurek SZ, Hassan Mohamed S. Determine knowledge and belief of Somalian young women about breast cancer and breast self-examination with champion health belief model: a cross-sectional study. BMC Med Inform Decis Mak. 2022 Dec 8;22(1):326. doi: 10.1186/s12911-022-02065-4.
- Results publication: PubMed 32876864Yang S, Li P, Yu L, Liu N, Wang J, Guo P, Zhang X, Zhang W. Breast Cancer Awareness Based on Health Information Literacy and Influential Factors among Female Nursing Students in China. J Cancer Educ. 2022 Jun;37(3):546-554. doi: 10.1007/s13187-020-01844-9.
- Results publication: PubMed 37803291Andrew Tong JW, Hee MQ. The impact of an online educational game on breast cancer awareness among university female students, Malaysia: a pilot study. BMC Cancer. 2023 Oct 6;23(1):947. doi: 10.1186/s12885-023-11427-8.
- Derived from this study: PubMed 41885785Altunkurek SZ, Yesilyurt E, Hassan Mohamed S. The Effect of Breast Cancer and Breast Self-Examination Health Education on Awareness, Beliefs, and Practices of Female Students at the Faculty of Health Sciences of a University in Somalia. Breast J. 2026;2026(1):e8854280. doi: 10.1155/tbj/8854280.
- WHOLink provided by the sponsor.
- International Agency for Research on Cancer'na (IARC)Link provided by the sponsor.
- Global Cancer Observatory (2022)Link provided by the sponsor.
- Individual participant dataSharing planned: No. I don\'t want to share
Related trials for Breast Carcinoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PowerPoint presentation. in people with Breast Carcinoma, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
post intervention (time frame: 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 NCT06706141, which also lists 4 linked publications.
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 10 Dec 2024.