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CompletedNCT06005025Updated Aug 9, 2024

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

An interventional study of Reminder message in Breast Cancer, Nurse and Education, sponsored by Tarsus University. Completed at 1 site in Turkey. Open to female participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by Tarsus University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2023, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
35 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 160 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Tarsus University is the lead sponsor of 78 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    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.

    Other: Reminder message

  • No intervention
    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.

Interventions

  • OtherReminder 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Gamze Bozkul
    Mersin, 33400, Turkey
08

References and documents

Publications

  • 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. PubMed 31919405 ↗
  • 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. PubMed 29088874 ↗
  • 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. PubMed 30333218 ↗
  • 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. PubMed 31277273 ↗
  • 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. PubMed 28634625 ↗
  • Walker SN, Sechrist KR, Pender NJ. The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81. PubMed 3644262 ↗
  • 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.
  • Global Cancer Observatory. https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf , Erişim
  • Promoting Cancer Early Diagnosis. https://www.who.int/activities/promoting-cancer-early-diagnosis
  • 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.
  • 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. PubMed 28331652 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06005025
Lead sponsor
Tarsus University
Collaborators
Mersin University
Responsible party
Gamze BOZKUL (Principal Investigator (Research Assistant), Tarsus University) — Principal investigator
First posted
Aug 22, 2023
Start date
Apr 1, 2023
Primary completion
Feb 1, 2024
Completion
Mar 15, 2024
Last update
Aug 9, 2024

Study contacts

Seher Gürdil Yılmaz, Lecturer Dr.
principal investigator · Mersin University
Gamze Bozkul, Res. Ass
principal investigator · Tarsus University
Gülay Altun Uğraş, Assoc.Dr.
study director · Mersin University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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