Women of Reproductive AgeNCT06410573
The Effect Of Self-Breast Examination Training On The Belief Of Breast Health
A study testing Breast Self-Examination and Practice in people with Women of Reproductive Age, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present research was to detect the effect of self-breast examination provided to women between 18 and 49 years of age and practice on the belief of women on their breast health. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women of Reproductive Age
- What is being tested?
- Breast Self-Examination and Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Nov 2022to 1 Mar 2023
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fertility process to continue
- No communication problems
- Not having a disease that will affect perception
Who cannot join
- Having been previously diagnosed with breast cancer or receiving breast cancer treatment
- Being diagnosed with a medical mental illness and receiving treatment for this reason
- Being under active treatment in hospital due to any problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Self-Breast Examination Training Provided To Women Between 18 And 49 Years Of Age And Practice On The Belief Of Breast Health: A Randomized Controlled Study
The aim of the present research was to detect the effect of self-breast examination provided to women between 18 and 49 years of age and practice on the belief of women on their breast health.
Read the detailed description
The aim of this study was to investigate the effect of breast self-examination training and practice on breast health beliefs. The study was a pretest-posttest randomized controlled experimental design. Women in the experimental group of the study will be provided with the training prepared by the researcher. The presentation used in the training will include information about breast cancer, breast cancer screening programs and breast self-examination. In the presentation, the steps of breast self-examination were shown step by step using visual materials. In addition to the slide presentation about breast cancer and breast self-examination, women will be trained on breast self-examination with a breast examination model using the "show first, then do it" training technique, and the accuracy will be confirmed by asking women to do it. By using the model in breast examination, it will be determined what women do right and what they do wrong during the examination. Data will be collected with Personal Information Form and Champion Health Belief Model Scale.
- Conditions
- Women of Reproductive Age
- Being tested
- Breast Self-Examination and Practice
- Keywords
- Neoplasms, Early Detection of Cancer, Breast Neoplasms, health education
- Medical subject headings
- Neoplasms, Breast Neoplasms, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Self-Examination and PracticeBehavioural
In the training, women will be divided into 5 groups and the training will be held in 5 separate sessions in one day. A training program will be completed with 9 women. All trainings will be conducted under the same conditions in the school's training room. Before the training, women will be informed about the training and their permission and consent will be obtained. The training prepared by the researcher will be presented to the women in the experimental group of the study. The presentation used in the training will include information about breast cancer, breast cancer screening programs and breast self-examination. In the presentation, the steps of breast self-examination will be shown step by step using visual materials.
| Study group | Role | What they receive |
|---|---|---|
| Training on Breast Self-Examination | Experimental | In the training, women will be divided into 5 groups and the training will be held in 5 separate sessions in one day. A training program will be completed with 9 women. All trainings will be conducted under the same conditions in the school's training room. Before the training, women will be informed about the training and their permission and consent will be obtained. The training prepared by the researcher will be presented to the women in the experimental group of the study. The presentation used in the training will include information about breast cancer, breast cancer screening programs and breast self-examination. Receives: Behavioral: Breast Self-Examination and Practice |
| Control | No intervention | 1 week follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Self-Examination Training and Breast Health Beliefs
This outcome is assessed with the Champion Health Belief Model Scale. A higher score on the scale indicates an increase in sensitivity and caring, a higher perception of benefits for the perception of benefits, and a higher perception of obstacles for the perception of obstacles.
Measured: 1 month will be followed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start6 Nov 2022
- Primary completion1 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women of Reproductive AgeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410573
- Sponsor's protocol ID
- KaratayUH9
- Status last verified
- May 2024
- First submitted
- 1 Jun 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Self-Breast Examination Training Provided To Women Between 18 And 49 Years Of Age And Practice On The Belief Of Breast Health: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06410573
- Acronym / sponsor ID
- KaratayUH9
- Conditions
- Women of Reproductive Age
- Keywords
- Neoplasms, Early Detection of Cancer, Breast Neoplasms, health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 6 Nov 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 13 May 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.
The aim of the present research was to detect the effect of self-breast examination provided to women between 18 and 49 years of age and practice on the belief of women on their breast health.
Detailed description
The aim of this study was to investigate the effect of breast self-examination training and practice on breast health beliefs. The study was a pretest-posttest randomized controlled experimental design. Women in the experimental group of the study will be provided with the training prepared by the researcher. The presentation used in the training will include information about breast cancer, breast cancer screening programs and breast self-examination. In the presentation, the steps of breast self-examination were shown step by step using visual materials. In addition to the slide presentation about breast cancer and breast self-examination, women will be trained on breast self-examination with a breast examination model using the "show first, then do it" training technique, and the accuracy will be confirmed by asking women to do it. By using the model in breast examination, it will be determined what women do right and what they do wrong during the examination. Data will be collected with Personal Information Form and Champion Health Belief Model Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training on Breast Self-Examination | Experimental | Behavioral: Breast Self-Examination and PracticeIn the training, women will be divided into 5 groups and the training will be held in 5 separate sessions in one day. A training program will be completed with 9 women. All trainings will be conducted under the same conditions in the school's training room. Before the training, women will be informed about the training and their permission and consent will be obtained. The training prepared by the researcher will be presented to the women in the experimental group of the study. The presentation used in the training will include information about breast cancer, breast cancer screening programs and breast self-examination. |
| Control | No intervention | –1 week follow-up. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fertility process to continue
- No communication problems
- Not having a disease that will affect perception
Key exclusion criteria (3 listed)
- Having been previously diagnosed with breast cancer or receiving breast cancer treatment
- Being diagnosed with a medical mental illness and receiving treatment for this reason
- Being under active treatment in hospital due to any problem
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 |
|---|---|---|
| Breast Self-Examination and PracticeIn the training, women will be divided into 5 groups and the training will be held in 5 separate sessions in one day. A training program will be completed with 9 women. All trainings will be conducted under the same conditions in the school's training room. Before the training, women will be informed about the training and their permission and consent will be obtained. The training prepared by the researcher will be presented to the women in the experimental group of the study. The presentation used in the training will include information about breast cancer, breast cancer screening programs and breast self-examination. In the presentation, the steps of breast self-examination will be shown step by step using visual materials. | Behavioural | Training on Breast Self-Examination |
Primary outcome
Breast Self-Examination Training and Breast Health Beliefs
Time frame: 1 month will be followed
This outcome is assessed with the Champion Health Belief Model Scale. A higher score on the scale indicates an increase in sensitivity and caring, a higher perception of benefits for the perception of benefits, and a higher perception of obstacles for the perception of obstacles.
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 13 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Self-Examination and Practice in people with Women of Reproductive Age, run by KTO Karatay 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 3 inclusion and 3 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 13 May 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?
Breast Self-Examination Training and Breast Health Beliefs (time frame: 1 month will be followed). 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 13 May 2024.