The Effect of Breast Cancer and Breast Self-Examination

NCT ID: NCT06706141

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Carcinoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Awareness Belief Breast cancer Breast self-examination Health education Students Somalia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A single-blind, randomized, controlled pretest-posttest experimental design was used for this research.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group

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).

Group Type EXPERIMENTAL

PowerPoint presentation.

Intervention Type BEHAVIORAL

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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eylul Yesilyurt

RN, Yüksek Lisans

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Health Sciences

Ankara, Ankara, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 36482433 (View on PubMed)

Yang 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.

Reference Type BACKGROUND
PMID: 32876864 (View on PubMed)

Andrew 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.

Reference Type BACKGROUND
PMID: 37803291 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Recep Tayyip Erdoğan Faculty

Identifier Type: -

Identifier Source: org_study_id