Breast CancerNCT06371508
Breast Cancer and Breast Self-examination Education
A study testing Education based on breast cancer and breast examination in people with Breast Cancer and Breast Self-Examination, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
According to a news published by the World Health Organization (WHO); More than 2.3 million cases of breast cancer occur each year, making it the most common cancer among adults. In 95% of all countries, breast cancer is the first or second cause of female cancer death. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Breast Self-Examination
- What is being tested?
- Education based on breast cancer and breast examination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to read and write,
- Having no history of breast cancer,
- No communication barriers,
- Not pregnant or lactating,
- Those who are willing and agree to participate in the research.
Who cannot join
- Having a mental illness,
- Those who wish to withdraw from any part of the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breast Cancer and Breast Self-examination Education Given to Women on Breast Cancer Fear and Breast Examination Skills
According to a news published by the World Health Organization (WHO); More than 2.3 million cases of breast cancer occur each year, making it the most common cancer among adults. In 95% of all countries, breast cancer is the first or second cause of female cancer death. In 2020, 2.3 million women worldwide were diagnosed with breast cancer and 685,000 deaths occurred. In Turkey, breast cancer ranks first among the most common cancer types in women, and the number of breast cancer cases in women in 2020 was recorded as 74 638. As a result of this situation, WHO (2023) published the Global Breast Cancer Initiative Framework to save 2.5 million lives from breast cancer by 2040. This published framework includes health promotion for early detection, timely diagnosis and comprehensive management of breast cancer.
One of the most effective ways to reduce breast cancer mortality and morbidity rate is early diagnosis. It is important to determine early diagnosis and signs and symptoms of cancer before they appear. Early diagnosis of breast cancer is possible with breast self-examination (BSE), clinical breast examination and mammography. Breast self-examination is an important examination method in terms of detecting changes in breast tissue and preventing subsequent complications. It is also an easy-to-apply, cheap and non-invasive method. In Turkey, it is recommended that women regularly perform breast self-examination every month after the age of 20, women between the ages of 20 and 40 should have a clinical breast examination every two years, and women between the ages of 40 and 69 should have a clinical breast examination every year and have a mammogram every two years.
There are studies showing that fear of breast cancer has a positive and negative impact on early diagnosis behaviors. Champion et al. (2004) stated that women with moderate breast cancer fear had a high rate of early detection behavior, whereas low and high fear levels had a negative effect on behavior. In the study conducted by Yavan et al. (2010) on 188 women, 2% of the women. They found that 3 of them had regular BSE and 78.7% of them had never had a mammography. In addition, 85% of the women included in the study stated that they had a fear of breast cancer due to a family history of breast cancer, being diagnosed with breast cancer, and the presence of risk factors. Study results show that fear of breast cancer affects screening results. Therefore, aim in the study is; To determine the effect of breast cancer and BSE training given to women on breast cancer fear and BSE skills.
- Conditions
- Breast Cancer, Breast Self-Examination
- Being tested
- Education based on breast cancer and breast examination
- Keywords
- breast self examination, breast cancer, education, fear
- Medical subject headings
- Breast Neoplasms, Breast Self-Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education based on breast cancer and breast examinationBehavioural
Training for the intervention group will be provided with a 40-45 minute training organized by one of the researchers.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Women in the experimental group of the research will be given training content prepared by the researcher. The training presentation content will include information about breast cancer, breast cancer screening programs and breast self-examination. Receives: Behavioral: Education based on breast cancer and breast examination |
| Control group | No intervention | Women in the control group will not be given any training and only their current information will be determined. Additionally, their awareness on this issue will be raised as they participate in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Champion Breast Cancer Fear Scale Change
Breast Cancer Fear Scale; Champion et al. The scale developed by (2004) is an 8-item, one-dimensional, five-point Likert type measurement tool. The measurement tool was adapted to Turkish culture by Seçginli (2012). The items in the scale are scored by the participants as "strongly disagree" 1 point, "disagree" 2 points, "undecided" 3 points, "agree" 4 points, "completely agree" 5 points. The lowest score from the scale is 8 and the highest score is 40. As the scores from the scale increase, the level of breast cancer fear increases. 8-15 points from the scale indicate "low level of fear", 16-23 points indicate "medium level fear", and 24-40 points indicate "high level fear".
Measured: pre-intervention, 1 month after intervention
Breast Self Examination Checklist Success Score
Breast self-examination proficiency rating instrument-BSEPRI was developed by Robin Wood in 1994. In the study, the form will be used to evaluate women's ability to perform breast self-examination according to appropriate stages and their ability to detect breast masses. There are 10 statements in the form that include the stages of performing BSE. 10 points are given for each stage of the examination that is completed correctly, and 0 points are given for any stage that is incorrectly performed or not performed. Accordingly, a minimum of 0 and a maximum of 100 points are taken from the form. A BSE score of 90 or above indicates that the BSE was performed correctly, and a score of 80 or below indicates that the BSE was not performed correctly.
Measured: pre-intervention, 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Feb 2024
- Primary completion15 May 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Hamlaci Baskaya, Sakarya University
- Investigators
- Yasemin Hamlacı Başkaya, Phd., Study director, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371508
- Sponsor's protocol ID
- 14042024
- Status last verified
- Nov 2024
- First submitted
- 14 Apr 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breast Cancer and Breast Self-examination Education Given to Women on Breast Cancer Fear and Breast Examination Skills
- ClinicalTrials.gov ID
- NCT06371508
- Acronym / sponsor ID
- 14042024
- Conditions
- Breast Cancer, Breast Self-Examination
- Keywords
- breast self examination, breast cancer, education, fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to a news published by the World Health Organization (WHO); More than 2.3 million cases of breast cancer occur each year, making it the most common cancer among adults. In 95% of all countries, breast cancer is the first or second cause of female cancer death. In 2020, 2.3 million women worldwide were diagnosed with breast cancer and 685,000 deaths occurred. In Turkey, breast cancer ranks first among the most common cancer types in women, and the number of breast cancer cases in women in 2020 was recorded as 74 638. As a result of this situation, WHO (2023) published the Global Breast Cancer Initiative Framework to save 2.5 million lives from breast cancer by 2040. This published framework includes health promotion for early detection, timely diagnosis and comprehensive management of breast cancer.
One of the most effective ways to reduce breast cancer mortality and morbidity rate is early diagnosis. It is important to determine early diagnosis and signs and symptoms of cancer before they appear. Early diagnosis of breast cancer is possible with breast self-examination (BSE), clinical breast examination and mammography. Breast self-examination is an important examination method in terms of detecting changes in breast tissue and preventing subsequent complications. It is also an easy-to-apply, cheap and non-invasive method. In Turkey, it is recommended that women regularly perform breast self-examination every month after the age of 20, women between the ages of 20 and 40 should have a clinical breast examination every two years, and women between the ages of 40 and 69 should have a clinical breast examination every year and have a mammogram every two years.
There are studies showing that fear of breast cancer has a positive and negative impact on early diagnosis behaviors. Champion et al. (2004) stated that women with moderate breast cancer fear had a high rate of early detection behavior, whereas low and high fear levels had a negative effect on behavior. In the study conducted by Yavan et al. (2010) on 188 women, 2% of the women. They found that 3 of them had regular BSE and 78.7% of them had never had a mammography. In addition, 85% of the women included in the study stated that they had a fear of breast cancer due to a family history of breast cancer, being diagnosed with breast cancer, and the presence of risk factors. Study results show that fear of breast cancer affects screening results. Therefore, aim in the study is; To determine the effect of breast cancer and BSE training given to women on breast cancer fear and BSE skills.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Education based on breast cancer and breast examinationWomen in the experimental group of the research will be given training content prepared by the researcher. The training presentation content will include information about breast cancer, breast cancer screening programs and breast self-examination. |
| Control group | No intervention | –Women in the control group will not be given any training and only their current information will be determined. Additionally, their awareness on this issue will be raised as they participate in the study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to read and write,
- Having no history of breast cancer,
- No communication barriers,
- Not pregnant or lactating,
- Those who are willing and agree to participate in the research.
Key exclusion criteria (2 listed)
- Having a mental illness,
- Those who wish to withdraw from any part of the research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education based on breast cancer and breast examinationTraining for the intervention group will be provided with a 40-45 minute training organized by one of the researchers. | Behavioural | Experimental group |
Primary outcome
Champion Breast Cancer Fear Scale Change
Time frame: pre-intervention, 1 month after intervention
Breast Cancer Fear Scale; Champion et al. The scale developed by (2004) is an 8-item, one-dimensional, five-point Likert type measurement tool. The measurement tool was adapted to Turkish culture by Seçginli (2012). The items in the scale are scored by the participants as "strongly disagree" 1 point, "disagree" 2 points, "undecided" 3 points, "agree" 4 points, "completely agree" 5 points. The lowest score from the scale is 8 and the highest score is 40. As the scores from the scale increase, the level of breast cancer fear increases. 8-15 points from the scale indicate "low level of fear", 16-23 points indicate "medium level fear", and 24-40 points indicate "high level fear".
Breast Self Examination Checklist Success Score
Time frame: pre-intervention, 1 month after intervention
Breast self-examination proficiency rating instrument-BSEPRI was developed by Robin Wood in 1994. In the study, the form will be used to evaluate women's ability to perform breast self-examination according to appropriate stages and their ability to detect breast masses. There are 10 statements in the form that include the stages of performing BSE. 10 points are given for each stage of the examination that is completed correctly, and 0 points are given for any stage that is incorrectly performed or not performed. Accordingly, a minimum of 0 and a maximum of 100 points are taken from the form. A BSE score of 90 or above indicates that the BSE was performed correctly, and a score of 80 or below indicates that the BSE was not performed correctly.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin Hamlacı Başkaya, Phd. study director
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education based on breast cancer and breast examination in people with Breast Cancer and Breast Self-Examination, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Champion Breast Cancer Fear Scale Change (time frame: pre-intervention, 1 month after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.