Effect of Education on Breast Cancer Fear and Health Beliefs

August 3, 2024 updated by: Nermin Kayar, Kırklareli University

The Effect of Education About Breast Cancer and Breast Self- Examination on Breast Cancer Fear and Health Beliefs: Randomized Controlled Trial

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.

Study Overview

Detailed Description

Before beginning the research, women were informed about the aim, duration, and procedures during the research and they were included in the research after written consent was obtained from women accepting participation. Then pre-test data were collected. The collection of data in the research began on 16 October 2017.

In the first stage of the research, pre-test data were collected using the questionnaire form, Champion Health Belief Model Scale, Champion Breast Cancer Fear Scale, and face-to-face interview method, and women were asked to fill out the forms themselves. After the pre-test data were collected, the women were divided into experimental and control groups using a single-blind randomized method.

In the second stage of the research, women in 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. Training was given in groups of 7-9 people and was completed from 2 April 2018 to 30 April 2018. 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.

In the final stage of the research, a post-test was applied to women in the experiment and control groups six months after the first training. The posttest applied the questionnaire, CHBMS, and CBCFS for a second time. Attempts were made to determine the effect of the training and counseling on breast cancer health beliefs and fear of breast cancer.

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

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ordu, Turkey, 52000
        • Ordu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
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.
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.
No Intervention: Control Group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Champion Health Belief Model Scale
Time Frame: Six mounth
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
Time Frame: Six mounth
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: nermin kayar, nerminkayar@klu.edu.tr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2018

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

August 3, 2024

First Submitted That Met QC Criteria

August 3, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 3, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Nermin KAYAR
  • 2018/B-1838 (Other Grant/Funding Number: Ordu University Scientific Research Projects Coordination Department)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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