Testicular NeoplasmsNCT05056688
Effect of Online Education Given to Young Adults on Testicular Cancer Health Beliefs and Behaviors
A study testing Testicular Model BSE/TSE Training Set in people with Testicular Neoplasms, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial summary
Aim: One of the cheapest, easiest and most effective ways to detect testicular cancer early is to resort to early detection screening methods associated with health beliefs about testicular cancer, and the second is to self-examine the testicles. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Testicular Neoplasms
- What is being tested?
- Testicular Model BSE/TSE Training Set
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2021to 28 Sep 2022
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being 18-35 years old,
- Being literate,
- Computer can be used,
- Being able to access the Internet,
- Not having a testicular diagnosis before,
- Deciding to participate in the research.
Who cannot join
- Being outside the age range of 18-35,
- To be diagnosed with testicular cancer before
Trial locations and contacts
1 site in 1 country.
About this study
Aim: One of the cheapest, easiest and most effective ways to detect testicular cancer early is to resort to early detection screening methods associated with health beliefs about testicular cancer, and the second is to self-examine the testicles. In the country, there are a limited number of studies on the health beliefs and early diagnosis behaviors of young adult men for testicular cancer. For this reason, the study was conducted to determine the effect of online education given to young adults on testicular cancer health beliefs and behavior.
Material and method: The research was conducted as a randomized controlled experimental study. The study population consisted of 768 individuals who applied to Family Health Centers affiliated to Agri Provincial Health Directorate between April 2021 and June 2022, and the sample of the research consisted of 90 individuals selected from the population using the improbable random sampling method. "Descriptive Feature Form", "Champion's Health Belief Model Scale in Testicular Cancer Screenings" were used to collect data. In the analysis of data; percentile distribution, chi-square, Fisher-Freeman-Halton Exact test, t-test in independent groups, Repeated Measures ANOVA Test, Friedman Test, One Way ANOVA test, Kruskall Wallis test, and post hoc analyzes (Bonferroni, Games Howell, Dunn) were used.
- Conditions
- Testicular Neoplasms
- Being tested
- Testicular Model BSE/TSE Training Set
- Keywords
- Health Belief Model, Health Behavior, Education, Distance, Testicular Neoplasms
- Medical subject headings
- Testicular Neoplasms, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testicular Model BSE/TSE Training SetDiagnostic test
The investigators will use the Testicular Model BSE/TSE Trainer to transform individuals' routine testicular self-examination into behavior.
| Study group | Role | What they receive |
|---|---|---|
| Application of training set to experimental group | Experimental | Testicular Model BSE/TSE Training Set Receives: Diagnostic Test: Testicular Model BSE/TSE Training Set |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Giving training to the experimental group for 6 weeks with an interval of 2 weeks.
Individuals in the experimental and control group were evaluated with "Champion's Health Belief Model Scale in Testicular Cancer Screening". The effect of the training given to people in the online training group, which cannot be given to the control group, was changed at the end of 16 weeks with the mid-test "Champion's Health Belief Model Scale in Testicular Cancer Screening". A minimum of 26 points and a maximum of 130 points are obtained from Champion's Health Belief Model Scale in Testicular Cancer Screenings. The sub-dimensions of the scale are evaluated separately and there is no total score.
Measured: Four monts
Collection of the final test
The mid-test for individuals in the experimental and control group was evaluated by the "Champion's Health Belief Model Scale in Testicular Cancer Screening". The effect of training given to those who could not be given to the control group in the online training group was replaced by the "Champion's Health Belief Model Scale in Testicular Cancer Screening" final test 3 months after training. A minimum of 26 points and a maximum of 130 points are obtained from Champion's Health Belief Model Scale in Testicular Cancer Screenings. The sub-dimensions of the scale are evaluated separately and there is no total score.
Measured: Three monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start30 Apr 2021
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular NeoplasmsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the study, 90 individuals, including 1 experimental and 1 control group, were included in the study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Salih YILDIRIM, Agri Ibrahim Cecen University
- Investigators
- Mehmet Salih YILDIRIM, Ph. D, Principal investigator, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056688
- Sponsor's protocol ID
- AICUNI-YILDIRIM-001
- Status last verified
- Oct 2022
- First submitted
- 12 Sep 2021
- Last updated
- 10 Oct 2022
- 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 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Online Education Given to Young Adults on Testicular Cancer Health Beliefs and Behaviors
- ClinicalTrials.gov ID
- NCT05056688
- Acronym / sponsor ID
- AICUNI-YILDIRIM-001
- Conditions
- Testicular Neoplasms
- Keywords
- Health Belief Model, Health Behavior, Education, Distance, Testicular Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 24 Sep 2021 (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.
Aim: One of the cheapest, easiest and most effective ways to detect testicular cancer early is to resort to early detection screening methods associated with health beliefs about testicular cancer, and the second is to self-examine the testicles. In the country, there are a limited number of studies on the health beliefs and early diagnosis behaviors of young adult men for testicular cancer. For this reason, the study was conducted to determine the effect of online education given to young adults on testicular cancer health beliefs and behavior.
Material and method: The research was conducted as a randomized controlled experimental study. The study population consisted of 768 individuals who applied to Family Health Centers affiliated to Agri Provincial Health Directorate between April 2021 and June 2022, and the sample of the research consisted of 90 individuals selected from the population using the improbable random sampling method. "Descriptive Feature Form", "Champion's Health Belief Model Scale in Testicular Cancer Screenings" were used to collect data. In the analysis of data; percentile distribution, chi-square, Fisher-Freeman-Halton Exact test, t-test in independent groups, Repeated Measures ANOVA Test, Friedman Test, One Way ANOVA test, Kruskall Wallis test, and post hoc analyzes (Bonferroni, Games Howell, Dunn) were used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In the study, 90 individuals, including 1 experimental and 1 control group, were included in the study.
| Arm | Type | Receives |
|---|---|---|
| Application of training set to experimental group | Experimental | Diagnostic Test: Testicular Model BSE/TSE Training SetTesticular Model BSE/TSE Training Set |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being 18-35 years old,
- Being literate,
- Computer can be used,
- Being able to access the Internet,
- Not having a testicular diagnosis before,
Key exclusion criteria (2 listed)
- Being outside the age range of 18-35,
- To be diagnosed with testicular 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 |
|---|---|---|
| Testicular Model BSE/TSE Training SetThe investigators will use the Testicular Model BSE/TSE Trainer to transform individuals' routine testicular self-examination into behavior. | Diagnostic test | Application of training set to experimental group |
Primary outcome
Giving training to the experimental group for 6 weeks with an interval of 2 weeks.
Time frame: Four monts
Individuals in the experimental and control group were evaluated with "Champion's Health Belief Model Scale in Testicular Cancer Screening". The effect of the training given to people in the online training group, which cannot be given to the control group, was changed at the end of 16 weeks with the mid-test "Champion's Health Belief Model Scale in Testicular Cancer Screening". A minimum of 26 points and a maximum of 130 points are obtained from Champion's Health Belief Model Scale in Testicular Cancer Screenings. The sub-dimensions of the scale are evaluated separately and there is no total score.
Collection of the final test
Time frame: Three monts
The mid-test for individuals in the experimental and control group was evaluated by the "Champion's Health Belief Model Scale in Testicular Cancer Screening". The effect of training given to those who could not be given to the control group in the online training group was replaced by the "Champion's Health Belief Model Scale in Testicular Cancer Screening" final test 3 months after training. A minimum of 26 points and a maximum of 130 points are obtained from Champion's Health Belief Model Scale in Testicular Cancer Screenings. The sub-dimensions of the scale are evaluated separately and there is no total score.
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 10 Oct 2022.
- 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.
Mehmet Salih YILDIRIM, Ph. D principal investigator
Agri Ibrahim Cecen 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 Testicular Model BSE/TSE Training Set in people with Testicular Neoplasms, run by Agri Ibrahim Cecen 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 6 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 10 Oct 2022. 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?
Giving training to the experimental group for 6 weeks with an interval of 2 weeks. (time frame: Four monts). 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 10 Oct 2022.