Women on Breast Cancer Health Belıefs and Screenıng Behavıors

July 18, 2023 updated by: NİHAN TÜRKOĞLU, Ataturk University

The Effect of Educatıon Gıven to Women on Breast Cancer Health Belıefs and Screenıng Behavıors,Randomized Controlled Trial

Method: It was conducted in a randomized controlled experimental type. The population of the study consisted of 2426 women over the age of 20 living in a family health center in Erzurum between October 2021 and September 2022. The sample of the study consisted of 252 women with 0.05 margin of error and 95% confidence level, according to the sample size calculation formula used in cases where the universe is known. Within the framework of the exclusion criteria of the study, 52 women were excluded from the study and 200 women were included in the randomization.

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

Persons in the experimental group will be trained 6 times with an interval of 2 weeks via an online platform (zoom, etc.). No training will be given to the control group, and the post-test data will be collected by re-administering the two groups with the mid-test created via Google forms and containing the scales immediately after the training, and the "Health Belief Model Scale in Breast Cancer Screening" and "Breast Cancer Screening Beliefs Scale" two months later.

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.
165

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
    • Yakutiye
      • Erzurum, Yakutiye, Turkey, 25240
        • Ataturk Unıversity

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

-Being over 18 years old

  • Being literate,
  • Computer can be used,
  • Internet is accessible,
  • Not getting breast cancer before,

Exclusion Criteria:

  • Having received training on breast cancer before

    • Having a history of breast cancer in first degree relatives
    • Those who did not attend all of the online trainings in the experimental group

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
Experimental: Experimental
In the study, the women in the experimental group will be trained every two weeks for 6 weeks.
Other: Education

Educational program; It will be applied to the individuals in the experimental group for an average of 40 minutes in a time period they are suitable through the online platform prepared for the individuals in the experimental group in a three-month period. The literature will be scanned and appropriate educational materials will be created, and videos will be used to support education.

Educational program During the first interview, the individuals in the experimental group will be introduced to the online platform, their entrance will be provided, they will be informed about how to follow the trainings, and sample applications will be made.

Six main topics will be covered in the training program and will be completed every two weeks in three months.
No Intervention: Control
No intervention will be applied to the control group.

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
Breast Cancer Screening Beliefs Scale
Time Frame: two week
Breast Cancer Screening Beliefs Questionnaire: The scale was developed by Kwok et al. (2010) in 2010 to determine women's breast cancer screening beliefs. Turkish adaptation, reliability, and validity of the scale were performed by Türkoğlu and Sis Çelik in 2021. The scale has three sub scales including Attitudes towards General Health Checkups, Knowledge and Perceptions about Breast Cancer, and Perceived Barriers to Mammographic Screening. Cronbach's alpha internal coefficients were found to range between 0.76 and 0.87 in the sub-scales of the original scale. The scores to be obtained from the scale range between 0 and 100. Mean scores of 65 and over in the sub-scales indicate that screening beliefs increase positively, knowledge level increases, and barriers to mammography screening decrease.
two week
Health Belief Model Scale in Breast Cancer Screening
Time Frame: Two week
This policy was first established by Champion in 1984 in the Health Belief Model base building. The scale has 8 dimensions: sensitivity, caring, health motivation, BSE barriers, benefits, self-efficacy, mammography benefits and barriers. Necessary components were tested, with the scale's caring and health motivation being revised in 1993, refinement in 1999, and BSE benefits, barriers, and self-efficacy dimensions revised again in 1997 (Champion, 1993; Champion and Scott, 1997; Champion, 1999; Champion, 1984) . Turkish validity and reliability were performed by Gözüm and Aydın in 2004. The scale includes subsections of "sensitivity", "caring", "health motivation", "BSE benefits", "BSE barriers", "BSE self-efficacy". The scale is a Likert-type scale scored from 1 to 5. A score closer to 5 means that caring, health motivation, BSE benefits, BSE barriers and BSE self-efficacy are perceived to be high.
Two week

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.
Ataturk 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.
  • Study Chair: Aslı Sis Çelik, Assoc. Prof., Ataturk University

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.
August 15, 2022

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.
May 28, 2023

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.
July 15, 2023

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).
December 29, 2022

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.
December 29, 2022

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.
January 10, 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.
July 19, 2023

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.
July 18, 2023

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.
July 1, 2023

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.
  • nihan25

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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