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

NCT06005025 | Completed

• 1 other identifier: TU-BOZKUL-003
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Nurse; Education; Counselling; Follow-up

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

REMİNDER MESSAGE

EXPERIMENTAL

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

CONTROL GROUP

NO INTERVENTION

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.

Interventions

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.

REMİNDER MESSAGE

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarsus University: lead
• Mersin University: collaborator

Study Sites (1)

Gamze Bozkul

Mersin, 33400, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 31919405 BACKGROUND

• 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.

  PMID: 29088874 BACKGROUND

• 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.

  PMID: 30333218 BACKGROUND

• 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.

  PMID: 31277273 BACKGROUND

• 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.

  PMID: 28634625 BACKGROUND

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

  PMID: 3644262 BACKGROUND

• Sonkaya Z.İ, 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.

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28331652 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Seher Gürdil Yılmaz, Lecturer Dr.

  Mersin University

  PRINCIPAL INVESTIGATOR

• Gamze Bozkul, Res. Ass

  Tarsus University

  PRINCIPAL INVESTIGATOR

• Gülay Altun Uğraş, Assoc.Dr.

  Mersin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Firstly, the names of the personnel will be listed alphabetically. A number will be written opposite each personnel and the number of 160 personnel will be determined from the total number of administrative personnel with high risk level by randomisation generated by an independent researcher in the computer environment. The sequence number of the personnel determined by randomisation will be divided into group A (study) and group B (control) in the computer environment and the information showing that they are assigned to group A and B according to the randomisation table will be placed in an opaque envelope. This envelope will be kept by the coordinator researcher and when the staff is approached for training, it will be learnt which group the staff is in. Since all personnel will be trained, the personnel will be blinded. The data will be computerised by the researcher and a biostatistician independent of the research will blind the groups unknowingly
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Research Assistant)

Model Details: The study was a prospective, parallel, two-arm (1:1), randomised controlled experimental study.

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 22, 2023
• Study Start: April 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 15, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)