Healthy LifestyleNCT06311565
Effects of Education After Colorectal Cancer Screening
A study testing Education in people with Healthy Lifestyle and Education, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of the education given to individuals undergoing colorectal cancer screening on their attitudes, beliefs and healthy lifestyle behaviors. This study was planned to be conducted as a prospective randomized controlled study in a family health center in Istanbul. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle, Education
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2024to 30 Dec 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 50-70 years old,
- Registered at the Family Health Center,
- Able to speak Turkish,
- No diagnosis of psychiatric disease and no history of anxiolytic drug use,
- They will have a Fecal Occult Blood test for the first time,
- Positive result of fecal occult blood test,
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- Faecal occult blood test was positive and had a colonoscopy,
- Those who have not been diagnosed with colorectal cancer as a result of colonoscopy,
- Individuals who volunteer to participate in the research
Who cannot join
- Having had previous colon surgery,
- Individuals with a history of colorectal cancer will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Given to Individuals Undergoing Colorectal Cancer Screening on Attitudes, Beliefs and Healthy Lifestyle Behaviors
The aim of this study is to examine the effect of the education given to individuals undergoing colorectal cancer screening on their attitudes, beliefs and healthy lifestyle behaviors.
This study was planned to be conducted as a prospective randomized controlled study in a family health center in Istanbul. The universe of the research; The sample of individuals registered to the family health center will consist of a total of 70 individuals who meet the inclusion criteria for the study.
Patient Diagnosis Form, Colorectal Cancer Screening Attitude Belief Scale, Healthy Lifestyle Behavior Scale II will be used to collect data. Data will be collected at the first encounter, 1 month later, 3 months later, pre-test and post-test. In the research, individuals will be divided into two groups: intervention (n = 35) and control (n = 35). Training will be provided to the intervention group.
- Conditions
- Healthy Lifestyle, Education
- Being tested
- Education
- Keywords
- colorectal cancer, cancer screening, healthy lifestyle, education
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Individuals in this group will be trained on acquiring healthy lifestyle behaviors to protect against colorectal cancer. Training will be individual, face-to-face and in the form of question and answer. At the end of the training, training brochures prepared by the researchers after taking expert opinions will be distributed to the participants. The training will take approximately 25-30 minutes. The training will take place in the training hall at the family health center.
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | People who have undergone colorectal cancer screening will be given training on colorectal cancer prevention. Training will be carried out face to face and individually. The training will take approximately 25-30 minutes. Receives: Behavioral: Education |
| Control | No intervention | Individuals in this group will be screened for colorectal cancer. However, this group will not be given any training on cancer prevention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer screening attitude belief scale
Scale; It consists of five subscales: relevance and consistency, perception of sensitivity, response effectiveness, cancer anxiety, and social influence. There are 16 items in the scale. The scale is in 5-point Likert style and the answer options for each item are; It is evaluated as "strongly disagree" (1 point), "disagree" (2 points), "don't know" (3 points), "agree" (4 points) and "strongly agree" (5 points).
Measured: Baseline, after one month and after three months
Healthy lifestyle behaviors scale II
The scale consists of 52 items and six factors. These; health responsibility, physical activity, nutrition, spiritual development, interpersonal relationships and stress management. Scale rating is 4-point Likert type. Expressions such as never (1), sometimes (2), often (3), regularly (4) are accepted. The lowest score that can be obtained from the entire scale is 52 and the highest score is 208.
Measured: Baseline, after one month and after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start30 Apr 2024
- Primary completion30 Oct 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies 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
- Randomized controlled ( experimental and control group)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal KARTAL, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311565
- Sponsor's protocol ID
- SBU-ISTANBUL-0001
- Status last verified
- Feb 2025
- First submitted
- 8 Mar 2024
- Last updated
- 4 Feb 2025
- 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 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Individuals Undergoing Colorectal Cancer Screening on Attitudes, Beliefs and Healthy Lifestyle Behaviors
- ClinicalTrials.gov ID
- NCT06311565
- Acronym / sponsor ID
- SBU-ISTANBUL-0001
- Conditions
- Healthy Lifestyle, Education
- Keywords
- colorectal cancer, cancer screening, healthy lifestyle, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 15 Mar 2024 (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 is to examine the effect of the education given to individuals undergoing colorectal cancer screening on their attitudes, beliefs and healthy lifestyle behaviors.
This study was planned to be conducted as a prospective randomized controlled study in a family health center in Istanbul. The universe of the research; The sample of individuals registered to the family health center will consist of a total of 70 individuals who meet the inclusion criteria for the study.
Patient Diagnosis Form, Colorectal Cancer Screening Attitude Belief Scale, Healthy Lifestyle Behavior Scale II will be used to collect data. Data will be collected at the first encounter, 1 month later, 3 months later, pre-test and post-test. In the research, individuals will be divided into two groups: intervention (n = 35) and control (n = 35). Training will be provided to the intervention group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled ( experimental and control group)
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: EducationPeople who have undergone colorectal cancer screening will be given training on colorectal cancer prevention. Training will be carried out face to face and individually. The training will take approximately 25-30 minutes. |
| Control | No intervention | –Individuals in this group will be screened for colorectal cancer. However, this group will not be given any training on cancer prevention. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between 50-70 years old,
- Registered at the Family Health Center,
- Able to speak Turkish,
- No diagnosis of psychiatric disease and no history of anxiolytic drug use,
- They will have a Fecal Occult Blood test for the first time,
Key exclusion criteria (2 listed)
- Having had previous colon surgery,
- Individuals with a history of colorectal cancer will not be included in the study.
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 |
|---|---|---|
| EducationIndividuals in this group will be trained on acquiring healthy lifestyle behaviors to protect against colorectal cancer. Training will be individual, face-to-face and in the form of question and answer. At the end of the training, training brochures prepared by the researchers after taking expert opinions will be distributed to the participants. The training will take approximately 25-30 minutes. The training will take place in the training hall at the family health center. | Behavioural | Education |
Primary outcome
Colorectal cancer screening attitude belief scale
Time frame: Baseline, after one month and after three months
Scale; It consists of five subscales: relevance and consistency, perception of sensitivity, response effectiveness, cancer anxiety, and social influence. There are 16 items in the scale. The scale is in 5-point Likert style and the answer options for each item are; It is evaluated as "strongly disagree" (1 point), "disagree" (2 points), "don't know" (3 points), "agree" (4 points) and "strongly agree" (5 points).
Healthy lifestyle behaviors scale II
Time frame: Baseline, after one month and after three months
The scale consists of 52 items and six factors. These; health responsibility, physical activity, nutrition, spiritual development, interpersonal relationships and stress management. Scale rating is 4-point Likert type. Expressions such as never (1), sometimes (2), often (3), regularly (4) are accepted. The lowest score that can be obtained from the entire scale is 52 and the highest score is 208.
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 4 Feb 2025.
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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 Healthy Lifestyle and Education, run by Istanbul Saglik Bilimleri 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 9 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 4 Feb 2025. 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?
Colorectal cancer screening attitude belief scale (time frame: Baseline, after one month and after three months). 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 4 Feb 2025.