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

August 7, 2024 updated by: Gamze BOZKUL, Tarsus University

The Effect of Counselling and Follow-up After Breast Cancer Awareness Education on Early Diagnosis and Healthy Lifestyle Behaviours: 'Reduce Risks, Increase Life Chances'

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Mersin, Turkey, 33400
        • Gamze Bozkul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Behaviours for Early Diagnosis of Breast Cancer
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tarsus University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mersin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seher Gürdil Yılmaz, Lecturer Dr., Mersin University
  • Principal Investigator: Gamze Bozkul, Res. Ass, Tarsus University
  • Study Director: Gülay Altun Uğraş, Assoc.Dr., Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TU-BOZKUL-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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