- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06112158
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 (Early Diagnosi)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey, 06000
- Recruiting
- Ankara Medipol Unıversty
-
Contact:
- Esra Özer, Asisst. Prof.
- Phone Number: +905433630475
- Email: esra.ozer@ankaramedipol.edu.tr
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Sub-Investigator:
- Yeşim Çetinkaya, Lecturer
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Participants with a previous cancer diagnosis
- CHCMM training and who were absent for more than two sessions in the intervention group
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Education Intervention
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. |
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 |
No Intervention: nonıntervention Group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
four months
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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".
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four months
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Champion Health Belief Model Scale
Time Frame: four months
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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.
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four months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Semi-structured Interview Form
Time Frame: four months
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"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?".
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four months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMU-SBF-EO-131
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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