Clinical trial NCT06005025: Examination of the Effect of Counselling and Follow-up After Breast Cancer Awareness Education
Official 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'
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Nurse
Education
Counselling
Follow-up
Lead sponsor: Tarsus University
Sponsor class: OTHER
Collaborators: name: Mersin University
First posted: 2023-08-22
Enrollment: 160
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was a prospective, parallel, two-arm (1:1), randomised controlled experimental study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Behaviours for Early Diagnosis of Breast Cancer
timeFrame: 6 months
measure: Counselling
timeFrame: 6 months
measure: Healthy Lifestyle Behaviours
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Gamze Bozkul
Study officials:
affiliation: Mersin University
name: Seher Gürdil Yılmaz, Lecturer Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tarsus University
name: Gamze Bozkul, Res. Ass
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Gülay Altun Uğraş, Assoc.Dr.
role: STUDY_DIRECTOR
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citation: Global Cancer Observatory. https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf , Erişim
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citation: Dell, D. (2020). Breast disorders. In: M.M. Harding, J. Kwong, D. Roberts, D. Hagler, C. Reinisch (Eds.) Lewis's Medical Surcigal Nursing Assesment and Management of Clinical Problems. (11th ed). St. Louis Missouri: Elsevier;1190-1211.
citation: Ozmen V. Breast Cancer in Turkey: Clinical and Histopathological Characteristics (Analysis of 13.240 Patients). J Breast Health. 2014 Apr 1;10(2):98-105. doi: 10.5152/tjbh.2014.1988. eCollection 2014 Apr.