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

Breast Cancer Clinical Trial

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'

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06005025
• Other study ID #: TU-BOZKUL-003
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2024
• Source: Tarsus University
• Contact: Gülay Altun UGRAS, Assoc. Dr.
• Phone: 03243610001
• Email: gulaltun[@]mersin.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 1, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Counselling
• Education
• Follow-up
• Nurse

Intervention

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.

Locations

Country	Name	City	State
Turkey	Gamze Bozkul	Mersin

Sponsors (2)

Lead Sponsor	Collaborator
Tarsus University	Mersin University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

De Cicco P, Catani MV, Gasperi V, Sibilano M, Quaglietta M, Savini I. Nutrition and Breast Cancer: A Literature Review on Prevention, Treatment and Recurrence. Nutrients. 2019 Jul 3;11(7):1514. doi: 10.3390/nu11071514. — View 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.

Global Cancer Observatory. https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf , Erisim

Gui Y, Pan Q, Chen X, Xu S, Luo X, Chen L. The association between obesity related adipokines and risk of breast cancer: a meta-analysis. Oncotarget. 2017 May 13;8(43):75389-75399. doi: 10.18632/oncotarget.17853. eCollection 2017 Sep 26. — View Citation

Guo W, Fensom GK, Reeves GK, Key TJ. Physical activity and breast cancer risk: results from the UK Biobank prospective cohort. Br J Cancer. 2020 Mar;122(5):726-732. doi: 10.1038/s41416-019-0700-6. Epub 2020 Jan 10. — View Citation

Niehoff NM, Nichols HB, Zhao S, White AJ, Sandler DP. Adult Physical Activity and Breast Cancer Risk in Women with a Family History of Breast Cancer. Cancer Epidemiol Biomarkers Prev. 2019 Jan;28(1):51-58. doi: 10.1158/1055-9965.EPI-18-0674. Epub 2018 Oct 17. — View 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. — View Citation

Promoting Cancer Early Diagnosis. https://www.who.int/activities/promoting-cancer-early-diagnosis

Skouroliakou M, Grosomanidis D, Massara P, Kostara C, Papandreou P, Ntountaniotis D, Xepapadakis G. Serum antioxidant capacity, biochemical profile and body composition of breast cancer survivors in a randomized Mediterranean dietary intervention study. Eur J Nutr. 2018 Sep;57(6):2133-2145. doi: 10.1007/s00394-017-1489-9. Epub 2017 Jun 20. — View Citation

Sonkaya Z.I, Günay O. The impact of education given to obese and preobese university students according to the health promotion model on nutrition and physical activities. Cukurova Medical Journal. 2020;45(3):795-806.

Walker SN, Sechrist KR, Pender NJ. The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behaviours for Early Diagnosis of Breast Cancer	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
Primary	Counselling	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
Primary	Healthy Lifestyle Behaviours	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