NCT06543147

Brief Summary

The study was conducted to determine the effect of breast cancer and breast self-examination (BSE) education on breast cancer fear and health beliefs. The main questions it aims to answer are: H1: Breast cancer and BSE training given to women will affect the health beliefs of women. H2: Breast cancer and BSE training given to women will affect the fear of breast cancer among women. H3: Breast cancer and BSE training given to women will affect the information and behaviour in relation to breast cancer screening among women. Researchers divided participants into experimental and control groups to examine the effects of breast cancer and breast self-examination education on breast cancer fear and health beliefs. The experimental group received education about breast cancer and breast self-examination and was reminded to perform breast self-examination by phone for six months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

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

March 17, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

August 3, 2024

Last Update Submit

August 3, 2024

Conditions

Keywords

Breast self examinationhealth belief modelbreast cancerbreast cancer fear

Outcome Measures

Primary Outcomes (2)

  • Champion Health Belief Model Scale

    The CHBMS consists of 6 subscales and 42 items; susceptibility perception of the perceived individual risks of catching breast cancer (3 items), seriousness perception about the perceived degree of individual threat from breast cancer (7 items), benefits perception expressing advantages related to BSE (4 items), barriers perception about perceived obstacles related to BSE (11 items), confidence expressing perceived individual competence in the ability to identify an abnormal breast mass during BSE (10 items) and health motivation subscale (7 items). Each subscale is evaluated separately and total points including the whole scale are not calculated. Women receiving low points for the barrier subscale and high points from the other subscales show positive attitudes and beliefs related to breast cancer and BSE

    Six mounth

  • Champion Breast Cancer Fear Scale

    Items on the scale investigate emotions like fear, upset, tension, irritation, restlessness, and worry and situations like depression or increased heart rate when breast cancer is considered. The scale contains 8 items and has a five-point Likert response. Responses to the scale are "definitely disagree" 1 point, "disagree" 2 points, "undecided" 3 points, "agree" 4 points and "completely disagree" 5 points. The lowest points that can be obtained from the scale is 8 with the highest points of 40. High points show high levels of fear about breast cancer. For definition of fear levels to breast cancer low levels of fear are 8-15 points, moderate levels of fear are 16-23 points and high levels of fear are 24-40 points.

    Six mounth

Study Arms (2)

experimental group

EXPERIMENTAL

There are 79 female participants in this group. After the pre-test, participants in the experimental group were given breast cancer and breast self-examination training. After the training, they were reminded to do breast self-examination by phone for six months. The post-test was administered six months later.

Other: breast cancer and breast self- examination education

Control Group

NO INTERVENTION

There are 80 female participants in this group. A pre-test was applied to the participants in the control group. The participants in the experimental group were given an intervention for six months, while the participants in the control group were not. A post-test was applied after six months. Based on the principle of sufficient and accurate care, women in the control group were given training about breast cancer and BSE in groups of 7-9 people after posttest data were collected and given brochures at the end of training

Interventions

The experimental group were given education about breast cancer and BSE. Slide presentations used during training provided information about breast anatomy and physiology, breast cancer symptoms and risk factors, early diagnosis methods for breast cancer and breast cancer screening programs, and barriers to breast cancer screening programs were discussed. In addition to slide presentations about breast cancer and BSE, women were also given BSE training on a breast examination mannequin and given brochures after training. The training lasted 40-50 minutes. After women in the experimental group were given training, they were called by telephone once per month until 6 months and reminded about doing BSE.

experimental group

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 20 years old
  • not having a history of breast cancer
  • not being in the lactation process
  • not having a communication barrier
  • volunteering to participate in the study

You may not qualify if:

  • having a history of breast cancer
  • having a communication barrier
  • being in the lactation process
  • not volunteering to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Ordu, 52000, Turkey (Türkiye)

Location

Related Publications (2)

  • Karayurt O, Dramali A. Adaptation of Champion's Health Belief Model Scale for Turkish women and evaluation of the selected variables associated with breast self-examination. Cancer Nurs. 2007 Jan-Feb;30(1):69-77. doi: 10.1097/00002820-200701000-00013.

    PMID: 17235224BACKGROUND
  • Champion VL, Skinner CS, Menon U, Rawl S, Giesler RB, Monahan P, Daggy J. A breast cancer fear scale: psychometric development. J Health Psychol. 2004 Nov;9(6):753-62. doi: 10.1177/1359105304045383.

MeSH Terms

Conditions

Health EducationBreast Self-ExaminationBreast Neoplasms

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorSelf-ExaminationNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • nermin kayar

    nerminkayar@klu.edu.tr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Administering a pre-test to the participants in the experimental and control groups. After the pre-test, the participants in the experimental group were given breast cancer and breast self-examination training, brochure distribution, and reminders of breast self-examination by phone for six months. They administered a post-test to the participants in the experimental and control groups six months later.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, Msc., Lecturer

Study Record Dates

First Submitted

August 3, 2024

First Posted

August 7, 2024

Study Start

March 17, 2018

Primary Completion

October 1, 2018

Study Completion

April 30, 2019

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Clinical data are not publicly available due to privacy laws. Questions regarding data can be directed to the corresponding author.

Locations