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

Primary Purpose

Breast Cancer, Nurse, Education

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reminder message
Sponsored by
Tarsus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Gamze BozkulRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

REMİNDER MESSAGE

CONTROL GROUP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2023
Last Updated
September 16, 2023
Sponsor
Tarsus University
Collaborators
Mersin University
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1. Study Identification

Unique Protocol Identification Number
NCT06005025
Brief Title
Examination of the Effect of Counselling and Follow-up After Breast Cancer Awareness Training
Official Title
The Effect of Counselling and Follow-up After Breast Cancer Awareness Training on Early Diagnosis and Healthy Lifestyle Behaviours: 'Reduce Risks, Increase Life Chances'
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tarsus University
Collaborators
Mersin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Nurse, Education, Counselling, Follow-up

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was a prospective, parallel, two-arm (1:1), randomised controlled experimental study.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
REMİNDER MESSAGE
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL GROUP
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Reminder message
Intervention Description
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.
Primary Outcome Measure Information:
Title
Behaviours for Early Diagnosis of Breast Cancer
Description
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
Title
Counselling
Description
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
Title
Healthy Lifestyle Behaviours
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gülay Altun UĞRAŞ, Assoc. Dr.
Phone
03243610001
Ext
14224
Email
gulaltun@mersin.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seher Gürdil Yılmaz, Lecturer Dr.
Organizational Affiliation
Mersin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gamze Bozkul, Res. Ass
Organizational Affiliation
Tarsus University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gülay Altun Uğraş, Assoc.Dr.
Organizational Affiliation
Mersin University
Official's Role
Study Director
Facility Information:
Facility Name
Gamze Bozkul
City
Mersin
ZIP/Postal Code
33400
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gamze Bozkul, Res. Ass.
Phone
(0324) 600 00 33
Email
gamze.bozkul@gmail.com
First Name & Middle Initial & Last Name & Degree
Seher Gürdil Yılmaz, Lecturer Dr.
First Name & Middle Initial & Last Name & Degree
Gülay Altun Uğraş, Assoc. Dr.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31919405
Citation
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Results Reference
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PubMed Identifier
30333218
Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Citation
Global Cancer Observatory. https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf , Erişim
Results Reference
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Citation
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Citation
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Citation
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Results Reference
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Examination of the Effect of Counselling and Follow-up After Breast Cancer Awareness Training

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