University StudentsEarly DiagnosiNCT06112158
The Effect of Web-Assisted Peer Education for Early Diagnosis of Breast Cancer on Health Beliefs, Knowledge Levels and Breast Self-Examination in University Students
A study testing Education Intervention in people with University Students and Breast Self-examination, run by Esra ÖZER at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the effect of web-supported peer education on health beliefs, knowledge levels and breast self-examination in university students. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- University Students, Breast Self-examination, Health Education
- What is being tested?
- Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2024to 30 Jun 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Young women who do not have any diagnosis of cancer or breast cancer
- who have no communication barriers
- who are not pregnant or breastfeeding
- who volunteer to participate in the study
Who cannot join
- Participants with a previous cancer diagnosis
- CHCMM training and who were absent for more than two sessions in the intervention group
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Medipol Unıversty
Ankara, 06000
Esra Özer, Asisst. Prof., +905433630475, esra.ozer@ankaramedipol.edu.tr
Yeşim Çetinkaya, Lecturer
About this study
The aim of this study was to examine the effect of web-supported peer education on health beliefs, knowledge levels and breast self-examination in university students.
Read the detailed description
In line with the general purpose of the study, an experimental design will be used in the study. The population of this study consists of female students of Ankara Medipol University. Considering that there may be dropouts from the study in line with the determined sample size, 200 students (intervention; n=100, control; n=100) who were excluded from the exclusion criteria and who agreed to participate in the study were planned to constitute the study group.
Hypotheses of the Research Between the experimental group and the control group, which received peer education on breast cancer and Breast Self-Examination (BSE); H1a1: There is a difference in terms of the sensitivity subscale score average. H1b1: There is a difference in terms of the mean score of the seriousness/importance subscale.
H1c1: There is a difference in terms of the average score of the benefit perception subscale.
H1d1: There is a difference in terms of the average score of the obstacle perception subscale.
H1e1: There is a difference in terms of the mean score of the trust subscale. H1f1: There is a difference in terms of the health motivation subscale score average.
H2a1: There is a difference in terms of the average knowledge score. H3a1: There is a difference in terms of performing breast self-examination.
- Being tested
- Education Intervention
- Keywords
- Breast self-examination, Health Education, University students, Breast cancer
- Medical subject headings
- Breast Self-Examination, Health Education, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education InterventionBehavioural
The BSE training program for the early diagnosis of breast cancer will be offered to students in two ways: face-to-face and via web support.
Content of training Session 1: Topics such as the structure of the breast, the definition of breast cancer, its prevalence, risk factors and symptoms Session 2: Teaching the importance of early diagnosis in breast cancer, the importance and benefits of BSE, the technique of performing BSE, the obstacles to the application of BSE.
Session 3: Teaching the risk factors that cause breast cancer. Session 4: Discussion of case reports of patients diagnosed with breast cancer. Supporting education with web support
| Study group | Role | What they receive |
|---|---|---|
| Education Intervention | Experimental | The BSE training program for the early diagnosis of breast cancer will be offered to students in two ways: face-to-face and via web support.
While the training program prepared by the researchers was applied to the intervention group, it was planned that no application would be applied to the nonınterventıon group.
In this study, the training period was determined in two ways:
First; In face-to-face training, each training is planned as four sessions of 45 minutes. Each session is planned with a different purpose and application.
Latter; The system will continue to be open during the training provided through web support and face-to-face training, but the system will be closed to access immediately after the face-to-face training is completed. Receives: Behavioral: Education Intervention |
| nonıntervention Group | No intervention | Until the research is finalized, no intervention will be made. After the research is finalized, the system will be opened to the nonınterventıon group and the university in general to contribute to their knowledge and awareness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Breast Cancer Information Test
Questions from 1 to 12 on the scale; general knowledge about breast cancer; Questions 13 to 20 contain information about the treatability of breast cancer. It also consists of 20 questions that can be answered as "true" or "false". 1 point for each correct answer given; 0 points are given for incorrect answers and blank items. As the score obtained from the scale increases, the level of knowledge also increases.
Measured: four months
Champion Health Belief Model Scale
It is used to determine women's beliefs and attitudes about breast cancer and breast self-examination. Each sub-dimension of the scale is evaluated separately. Champion Health Belief Model Scale (CHBMS) has 6 subscales and is a 5-point Likert type. "Perception of sensitivity" (3 items), "perception of seriousness" (7 items), "perception of benefit" (4 items), "perception of obstacle" (11 items), "trust" (10 items), "Health" regarding breast cancer It has sub-dimensions "motivation" (7 items). The total score of the scale is not calculated. Receiving a low score on the "obstacle perception" subscale and a high score on other subscales shows that women have positive attitudes and beliefs about breast cancer and breast self-examination practices.
Measured: four months
Breast self-examination proficiency rating instrument-BSEPRI
This form was used to assess women's ability to perform breast self-examination according to the appropriate stages and their ability to find breast masses. In the form, there are 10 statements including the stages of performing CHBM. Each stage of the examination that is performed correctly is given 10 points, and 0 points are given for incorrect or non-performed stages. Accordingly, a minimum of 0 and a maximum of 100 points are obtained from the form. A score of 90 and above indicates that "CHCMM is performed correctly" and a score of 80 and below indicates that "CHCMM is not performed correctly".
Measured: four months
Secondary outcomes (1)
Semi-structured Interview Form
"Can you tell us about how the training has changed your life?", "What has this training added to your knowledge about breast cancer and CHCMM?", "What are the beneficial aspects of this training?" and "What are the aspects of this training that need to be improved?".
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start13 Mar 2024
- Primary completion30 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for University StudentsStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esra ÖZER
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Medipol University
- Responsible party
- Sponsor-investigator, Esra ÖZER, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112158
- Sponsor's protocol ID
- AMU-SBF-EO-131
- Acronym
- Early Diagnosi
- Status last verified
- Mar 2024
- First submitted
- 27 Oct 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-Assisted Peer Education for Early Diagnosis of Breast Cancer on Health Beliefs, Knowledge Levels and Breast Self-Examination in University Students
- ClinicalTrials.gov ID
- NCT06112158
- Acronym / sponsor ID
- Early Diagnosi / AMU-SBF-EO-131
- Keywords
- Breast self-examination, Health Education, University students, Breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Esra ÖZERUniversity, hospital or other
- Collaborators
- Ankara Medipol University
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 1 Nov 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.
The aim of this study was to examine the effect of web-supported peer education on health beliefs, knowledge levels and breast self-examination in university students.
Detailed description
In line with the general purpose of the study, an experimental design will be used in the study. The population of this study consists of female students of Ankara Medipol University. Considering that there may be dropouts from the study in line with the determined sample size, 200 students (intervention; n=100, control; n=100) who were excluded from the exclusion criteria and who agreed to participate in the study were planned to constitute the study group.
Hypotheses of the Research Between the experimental group and the control group, which received peer education on breast cancer and Breast Self-Examination (BSE); H1a1: There is a difference in terms of the sensitivity subscale score average. H1b1: There is a difference in terms of the mean score of the seriousness/importance subscale.
H1c1: There is a difference in terms of the average score of the benefit perception subscale.
H1d1: There is a difference in terms of the average score of the obstacle perception subscale.
H1e1: There is a difference in terms of the mean score of the trust subscale. H1f1: There is a difference in terms of the health motivation subscale score average.
H2a1: There is a difference in terms of the average knowledge score. H3a1: There is a difference in terms of performing breast self-examination.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups with randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Education Intervention | Experimental | Behavioral: Education InterventionThe BSE training program for the early diagnosis of breast cancer will be offered to students in two ways: face-to-face and via web support. While the training program prepared by the researchers was applied to the intervention group, it was planned that no application would be applied to the nonınterventıon group. In this study, the training period was determined in two ways: First; In face-to-face training, each training is planned as four sessions of 45 minutes. Each session is planned with a different purpose and application. Latter; The system will continue to be open during the training provided through web support and face-to-face training, but the system will be closed to access immediately after the face-to-face training is completed. |
| nonıntervention Group | No intervention | –Until the research is finalized, no intervention will be made. After the research is finalized, the system will be opened to the nonınterventıon group and the university in general to contribute to their knowledge and awareness. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Young women who do not have any diagnosis of cancer or breast cancer
- who have no communication barriers
- who are not pregnant or breastfeeding
- who volunteer to participate in the study
Key exclusion criteria (2 listed)
- Participants with a previous cancer diagnosis
- CHCMM training and who were absent for more than two sessions in the intervention group
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 InterventionThe BSE training program for the early diagnosis of breast cancer will be offered to students in two ways: face-to-face and via web support. Content of training Session 1: Topics such as the structure of the breast, the definition of breast cancer, its prevalence, risk factors and symptoms Session 2: Teaching the importance of early diagnosis in breast cancer, the importance and benefits of BSE, the technique of performing BSE, the obstacles to the application of BSE. Session 3: Teaching the risk factors that cause breast cancer. Session 4: Discussion of case reports of patients diagnosed with breast cancer. Supporting education with web support | Behavioural | Education Intervention |
Primary outcome
Comprehensive Breast Cancer Information Test
Time frame: four months
Questions from 1 to 12 on the scale; general knowledge about breast cancer; Questions 13 to 20 contain information about the treatability of breast cancer. It also consists of 20 questions that can be answered as "true" or "false". 1 point for each correct answer given; 0 points are given for incorrect answers and blank items. As the score obtained from the scale increases, the level of knowledge also increases.
Champion Health Belief Model Scale
Time frame: four months
It is used to determine women's beliefs and attitudes about breast cancer and breast self-examination. Each sub-dimension of the scale is evaluated separately. Champion Health Belief Model Scale (CHBMS) has 6 subscales and is a 5-point Likert type. "Perception of sensitivity" (3 items), "perception of seriousness" (7 items), "perception of benefit" (4 items), "perception of obstacle" (11 items), "trust" (10 items), "Health" regarding breast cancer It has sub-dimensions "motivation" (7 items). The total score of the scale is not calculated. Receiving a low score on the "obstacle perception" subscale and a high score on other subscales shows that women have positive attitudes and beliefs about breast cancer and breast self-examination practices.
Breast self-examination proficiency rating instrument-BSEPRI
Time frame: four months
This form was used to assess women's ability to perform breast self-examination according to the appropriate stages and their ability to find breast masses. In the form, there are 10 statements including the stages of performing CHBM. Each stage of the examination that is performed correctly is given 10 points, and 0 points are given for incorrect or non-performed stages. Accordingly, a minimum of 0 and a maximum of 100 points are obtained from the form. A score of 90 and above indicates that "CHCMM is performed correctly" and a score of 80 and below indicates that "CHCMM is not performed correctly".
1 secondary outcome
Semi-structured Interview Form
Time frame: four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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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.
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 Intervention in people with University Students and Breast Self-examination, run by Esra ÖZER 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 4 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: status not confirmed, as of the sponsor's last update on 15 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Breast Cancer Information Test (time frame: four months). The study lists 3 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 15 Mar 2024.