NCT06706141

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
Last Updated

December 10, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

November 17, 2024

Last Update Submit

December 5, 2024

Conditions

Keywords

AwarenessBeliefBreast cancerBreast self-examinationHealth educationStudentsSomalia

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Study Arms (2)

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).

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.

Interventions

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.

Also known as: 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.
Experimental Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale students
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Ankara, Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 36482433BACKGROUND
  • 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.

    PMID: 32876864BACKGROUND
  • 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.

    PMID: 37803291BACKGROUND

Related Links

MeSH Terms

Conditions

Breast NeoplasmsBreast Self-ExaminationHealth Education

Interventions

Health Belief Model

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSelf-ExaminationHealth BehaviorBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

Models, TheoreticalInvestigative TechniquesModels, Psychological

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A single-blind, randomized, controlled pretest-posttest experimental design was used for this research.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, Yüksek Lisans

Study Record Dates

First Submitted

November 17, 2024

First Posted

November 26, 2024

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

December 10, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

I don\'t want to share

Locations