Examination of the Effect of Counselling and Follow-up After Breast Cancer Awareness Education

August 7, 2024 updated by: Gamze BOZKUL, Tarsus University

The Effect of Counselling and Follow-up After Breast Cancer Awareness Education on Early Diagnosis and Healthy Lifestyle Behaviours: 'Reduce Risks, Increase Life Chances'

The aim of the study was to examine the effect of counselling and follow-up after education on the risks and prevention methods of breast cancer on early diagnosis behaviours and healthy lifestyle behaviours. The population of the study will consist of female administrative staff working at Mersin University. The sample of the study will consist of 160 people. A total of 160 personnel determined by randomisation will be divided into group A (study) and group B (control) formed by the independent researcher in the computer environment. All participants will be given a one-hour training on breast cancer and will be practised with a model as well as a presentation. Group A will be counselled for 6 months after the training and a reminder message will be sent via SMS on Monday every week as "Check your modifiable risk factors for breast cancer" and their feedback will be received. In group B, no additional application will be made except for the training. The data of the study will be collected before and 6 months after the training by using the Descriptive Characteristics Form, Breast Cancer Early Diagnosis Behaviours Form, Counselling Form and Healthy Lifestyle Behaviours Scale II. The data obtained from the study will be analysed in a computer environment. Number, percentage, mean and standard deviation will be used as descriptive statistics in the evaluation of the data.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was a prospective, parallel, two-arm (1:1), randomised controlled experimental study. The aim of the study was to examine the effect of counselling and follow-up after education on the risks and prevention methods of breast cancer on early diagnosis behaviours and healthy lifestyle behaviours. The population of the study will consist of female administrative staff working at Mersin University. The sample of the study will consist of 160 people with an effect size of 0.23, 80% power maximum 5% type 1 error and drop out rate of 10%. The sample determined by randomisation A total of 160 personnel in the group will be divided into group A (study) and group B (control) formed by the independent researcher in the computer environment. All participants will be given one-hour training on breast cancer, modifiable and non-modifiable risk factors for breast cancer, symptoms of breast cancer, screening programmes and breast self-examination. Group A will be counselled for 6 months after the training and a reminder message will be sent via SMS on Monday every week as "Check your Changeable Risk Factors for Breast Cancer" and their feedback will be received. In group B, no additional application will be made except for the training. The data of the study will be collected before and 6 months after the training by using the Descriptive Characteristics Form, Breast Cancer Early Diagnosis Behaviours Form, Counselling Form and Healthy Lifestyle Behaviours Scale II. The data obtained from the study will be analysed in a computer environment. Number, percentage, mean and standard deviation will be used as descriptive statistics in the evaluation of the data.

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

  • Turkey
      • Mersin, Turkey, 33400
        • Gamze Bozkul

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:

  • 35 years and older,
  • No visual impairment and no physical problems that would prevent breast self-examination,
  • Not previously diagnosed with breast cancer,
  • Accepted to participate in the research,
  • Female administrative staff working at Mersin University

Exclusion Criteria:

  • 35 and under,
  • Visually impaired and have a physical problem that would prevent them from performing breast self-examination,
  • Previously diagnosed with breast cancer,
  • Willing did not agree to participate in the research,
  • Female administrative staff not working at Mersin University

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CONTROL GROUP
All participants will be given one-hour training on breast cancer, modifiable and non-modifiable risk factors for breast cancer, symptoms of breast cancer, screening programmes and breast self-examination. In addition to the presentation, breast self-examination will be applied one-to-one with a breast examination model. There will be no additional practice outside the training.
Experimental: REMİNDER MESSAGE
All participants will be given one-hour training on breast cancer, modifiable and non-modifiable risk factors for breast cancer, symptoms of breast cancer, screening programmes and breast self-examination. In addition to the presentation, breast self-examination will be applied one-to-one with a breast examination model. This group will be counselled for 6 months after the training and a reminder message will be sent via SMS on Monday every week as "Check your modifiable risk factors for breast cancer" and their feedback will be received.
Other: Reminder message
Experimental group will be counselled for 6 months after the training and a reminder message will be sent via SMS on Monday every week as "Check your modifiable risk factors for breast cancer" and their feedback will be received.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behaviours for Early Diagnosis of Breast Cancer
Time Frame: 6 months
Breast Cancer Early Diagnosis Behaviours Form: It is a form consisting of 5 questions about the frequency of early diagnosis behaviours such as breast self-examination, clinical breast examination and mammography.
6 months
Counselling
Time Frame: 6 months
Counselling Form: This is a 5-question form that includes information on the subject consulted, the number of consultations, what was recommended in the consultation, the status of referral to a health institution after the consultation and what the outcome was if referred to a health institution.
6 months
Healthy Lifestyle Behaviours
Time Frame: 6 months
Healthy Lifestyle Behaviours Scale II; The scale consists of six subscales under the titles of 'health responsibility', 'physical activity', 'nutrition', 'spiritual development', 'interpersonal relationships' and 'stress management'. The higher score obtained from the scale indicates more appropriate lifestyle behaviour.
6 months

Collaborators and Investigators

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

Sponsor

Tarsus University

Collaborators

Mersin University

Investigators

  • Principal Investigator: Seher Gürdil Yılmaz, Lecturer Dr., Mersin University
  • Principal Investigator: Gamze Bozkul, Res. Ass, Tarsus University
  • Study Director: Gülay Altun Uğraş, Assoc.Dr., Mersin University

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.

General Publications

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)

April 1, 2023

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

March 15, 2024

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TU-BOZKUL-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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