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Completed

NCT Number: NCT06005025

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

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.

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Key information

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gamze Bozkul

Mersin, 33400, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reminder message

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Tarsus University

Other

Collaborators

  • Mersin University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2023
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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