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

NCT ID: NCT06005025

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-03-15

Brief Summary

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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

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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.

Conditions

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Breast Cancer Nurse Education Counselling Follow-up

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was a prospective, parallel, two-arm (1:1), randomised controlled experimental study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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

Study Groups

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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.

Group Type EXPERIMENTAL

Reminder message

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mersin University

OTHER

Sponsor Role collaborator

Tarsus University

OTHER

Sponsor Role lead

Responsible Party

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Gamze BOZKUL

Principal Investigator (Research Assistant)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seher Gürdil Yılmaz, Lecturer Dr.

Role: PRINCIPAL_INVESTIGATOR

Mersin University

Gamze Bozkul, Res. Ass

Role: PRINCIPAL_INVESTIGATOR

Tarsus University

Gülay Altun Uğraş, Assoc.Dr.

Role: STUDY_DIRECTOR

Mersin University

Locations

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Gamze Bozkul

Mersin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 31919405 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29088874 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30333218 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31277273 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28634625 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 3644262 (View on PubMed)

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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 28331652 (View on PubMed)

Other Identifiers

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TU-BOZKUL-003

Identifier Type: -

Identifier Source: org_study_id

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