Prostate CancerNCT05428098
The Effect of the Educatıon and Counselıng of Prostatectomy Patıents
A study testing education in people with Prostate Cancer and Surgery, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The research was planned as a randomized controlled experimental study. This study is planned to be conducted in the Urology clinic of a university hospital located in the south of Turkey. The population of the research will be the patients admitted to the urology clinic for prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Surgery, Nursing Caries
- What is being tested?
- education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2022to 10 Jan 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years or older,
- Being literate,
- Being able to understand and speak Turkish and not have a hearing impairment,
- Agreeing to participate in the research.
Who cannot join
- Development of any complications during the surgical intervention,
- Having any psychiatric disorder that will reduce the ability to comprehend and understand,
- Having other concomitant cancer,
- Having metastases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of educatıon and counselıng gıven to patıents patıent wıth Prostatectomy on qualıty of lıfe
The research was planned as a randomized controlled experimental study. This study is planned to be conducted in the Urology clinic of a university hospital located in the south of Turkey. The population of the research will be the patients admitted to the urology clinic for prostatectomy. The sample of the study will consist of patients who meet the criteria for participation in the study and volunteer to participate in the study. Evaluation of the research data will be done with the SPSS package program.
- Conditions
- Prostate Cancer, Surgery, Nursing Caries
- Being tested
- education
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationOther
Oral and written education according to the life model
| Study group | Role | What they receive |
|---|---|---|
| experiment group | Experimental | In addition to standard care, patients will be given discharge training, planned within the framework of the Life model, one day before discharge. It is planned that the discharge training will be given by the researcher in the patient's room and by providing an accompanying person. Written training material will be delivered to the patients for their re-use after the training. Receives: Other: education |
| control group | No intervention | standard care will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of traınıng and counselıng gıven after prostatectomy on qualıty of lıfe
It will be measured with SF-12. Measurement will be made before and after the application. It is evaluated between 0 and 100 points, with a higher score representing better health.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start10 Jul 2022
- Primary completion25 Oct 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Deniz Dogan, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428098
- Sponsor's protocol ID
- 5312256941
- Status last verified
- Aug 2023
- First submitted
- 15 Jun 2022
- Last updated
- 9 Aug 2023
- 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 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of educatıon and counselıng gıven to patıents patıent wıth Prostatectomy on qualıty of lıfe
- ClinicalTrials.gov ID
- NCT05428098
- Acronym / sponsor ID
- 5312256941
- Conditions
- Prostate Cancer, Surgery, Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 10 Jul 2022 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 22 Jun 2022 (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 research was planned as a randomized controlled experimental study. This study is planned to be conducted in the Urology clinic of a university hospital located in the south of Turkey. The population of the research will be the patients admitted to the urology clinic for prostatectomy. The sample of the study will consist of patients who meet the criteria for participation in the study and volunteer to participate in the study. Evaluation of the research data will be done with the SPSS package program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group | Experimental | Other: educationIn addition to standard care, patients will be given discharge training, planned within the framework of the Life model, one day before discharge. It is planned that the discharge training will be given by the researcher in the patient's room and by providing an accompanying person. Written training material will be delivered to the patients for their re-use after the training. |
| control group | No intervention | –standard care will be applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18 years or older,
- Being literate,
- Being able to understand and speak Turkish and not have a hearing impairment,
- Agreeing to participate in the research.
Key exclusion criteria (4 listed)
- Development of any complications during the surgical intervention,
- Having any psychiatric disorder that will reduce the ability to comprehend and understand,
- Having other concomitant cancer,
- Having metastases.
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 |
|---|---|---|
| educationOral and written education according to the life model | Other | experiment group |
Primary outcome
Effect of traınıng and counselıng gıven after prostatectomy on qualıty of lıfe
Time frame: six months
It will be measured with SF-12. Measurement will be made before and after the application. It is evaluated between 0 and 100 points, with a higher score representing better health.
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 9 Aug 2023.
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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 education in people with Prostate Cancer and Surgery, run by Cukurova 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 4 inclusion and 4 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 9 Aug 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?
Effect of traınıng and counselıng gıven after prostatectomy on qualıty of lıfe (time frame: six months). 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 9 Aug 2023.