Breast Cancer FemaleNCT05677737
Women on Breast Cancer Health Belıefs and Screenıng Behavıors
A study testing Education in people with Breast Cancer Female, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2022to 15 Jul 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Being over 18 years old
- Being literate,
- Computer can be used,
- Internet is accessible,
- Not getting breast cancer before,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer Female
- Being tested
- Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | In the study, the women in the experimental group will be trained every two weeks for 6 weeks. Receives: Other: Education |
| Control | No intervention | No intervention will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Cancer Screening Beliefs Scale
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.
Measured: two week
Health Belief Model Scale in Breast Cancer Screening
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.
Measured: Two week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start15 Aug 2022
- Primary completion28 May 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NİHAN TÜRKOĞLU, Ataturk University
- Investigators
- Aslı Sis Çelik, Assoc. Prof., Study chair, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677737
- Sponsor's protocol ID
- nihan25
- Status last verified
- Jul 2023
- First submitted
- 29 Dec 2022
- Last updated
- 19 Jul 2023
- 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 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Educatıon Gıven to Women on Breast Cancer Health Belıefs and Screenıng Behavıors,Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05677737
- Acronym / sponsor ID
- nihan25
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 28 May 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 10 Jan 2023 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: EducationIn the study, the women in the experimental group will be trained every two weeks for 6 weeks. |
| Control | No intervention | –No intervention will be applied to the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -Being over 18 years old
- Being literate,
- Computer can be used,
- Internet is accessible,
- Not getting breast cancer before,
Key exclusion criteria (3 listed)
- Having received training on breast cancer before
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 |
|---|---|---|
| EducationEducational 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. | Other | Experimental |
Primary outcome
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.
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.
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 19 Jul 2023.
- 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.
Aslı Sis Çelik, Assoc. Prof. study chair
Ataturk 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 in people with Breast Cancer Female, run by Ataturk 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 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 19 Jul 2023. 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 Cancer Screening Beliefs Scale (time frame: two week). 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 19 Jul 2023.