SmokingNCT05488743
Smoking Prevention Program in Poland
An observational study of Smoking and Smoking Behaviors, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
Smoking Prevention Program is a pilot exploratory study with a standardized curriculum based on the Tobacco Prevention Toolkit from Stanford University and translated into Polish by the members of Students Scientific Association of Oncology at Wroclaw Medical University. Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Smoking, Smoking Behaviors, Smoking (Tobacco) Addiction
- What is being tested?
- educational intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 sitePoland
- Study dates
- 15 Mar 2022to 14 Oct 2022
- Phase
- Observational
- 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 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: The program will be implemented with all 7th and 8th grade students (children age 12-15 years) from the Elementary School in Tyniec Mały.
Who may be able to join
- Students from Tyniec Mały
- 7th and 8th graders of the elementary school
- Parental consent
- Students consent
Who cannot join
- Lack of parental consent
- Lack of students consent
Trial locations and contacts
1 site in 1 country.
Poland1 site
Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, 50-367
About this study
Official title: Youth Smoking Prevention Program in Poland
Smoking Prevention Program is a pilot exploratory study with a standardized curriculum based on the Tobacco Prevention Toolkit from Stanford University and translated into Polish by the members of Students Scientific Association of Oncology at Wroclaw Medical University. The program will assess the effectiveness of a school-based smoking prevention curricula keeping children as never smokers and test the feasibility of engaging medical students and teachers in implementing and evaluating a validated program on smoking prevention within the Polish School System. The research protocols, methods and data collection instruments of a standardized classroom based valid tobacco prevention program from Stanford University will be used for the study. The smoking prevention program is centred on drug resistance, personal self-management and increasing social skills. The program increases knowledge and uses coaching and practice to provide students with the skills to resist social pressures around cigarette use. The secondary outcome of this study is to determine the change in attitudes by Polish Medical Student regarding Cancer Prevention Research. During Smoking Prevention Program workshops, the 5-Session Curriculum for primary schools will be translated, applied and evaluated for polish students.
This community-based pilot will engage medical students, the local school district and the local health authority. The Educational program meets the requirements set by Centers for Disease Control and Prevention (CDC) in Guidelines for School Health Programs to Prevent Tobacco Use and Addiction. Following parental consent, the program will be implemented with all 7th and 8th grade students (children age 12-15 years) from the Elementary School in Tyniec Mały. This project is supported by the Head of Lower Silesian Oncology Center, the Head of Department of Oncology of Wroclaw Medical University, the Health and Social Affairs Department of City of Wroclaw and under the patronage of the Lower Silesia Governor's Office, the Polish Society of Oncology, the Polish Society of Public Health, the Lower Silesian Department of Polish Society of Cardiology and the European Association for Cancer Education (EACE).
Smoking Prevention Program is funded by the READS Grant Program from the American Association for Cancer Education (AACE).
- Conditions
- Smoking, Smoking Behaviors, Smoking (Tobacco) Addiction, E-cigarette Use, Vaping
- Being tested
- educational intervention
- Keywords
- tobacco prevention cancer, smoking prevention, cancer education, educational intervention, cardiovascular diseases prevention, youth
- Medical subject headings
- Smoking, Behavior, Addictive, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionBehavioural
The program consists of five 50-minutes sessions conducted in person as scheduled during weekly class meetings. Educators will conduct workshops with PowerPoint presentations and worksheets dedicated to in-class activities.
| Study group | Role | What they receive |
|---|---|---|
| 7th and 8th grade students (children age 12-15 years) from the elementary school | Not described Receives: Behavioral: educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking intention
Change in smoking intention among elementary school students after program completion (score based on survey results).
Measured: 2 months
Knowledge of negative consequences of smoking
Change in knowledge about adverse effects of smoking after program completion (score based on survey results).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start15 Mar 2022
- Primary completion13 Aug 2022 (estimated)
- Study completion14 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford Reach Lab - Tobacco Prevention Toolkit, American Association for Cancer Education
- Responsible party
- Principal investigator, Łukasz Moskal, MD, Wroclaw Medical University
- Investigators
- Łukasz Moskal, MD, Principal investigator, Wroclaw Medical UniversityKonrad Reszka, MD, Principal investigator, Wroclaw Medical UniversityUrszula Staszek-Szewczyk, MD, PhD, Principal investigator, Wroclaw Regional Comprehensive Cancer Center, Department of BrachytherapyJagoda Łaba, MD, Principal investigator, Wroclaw Medical UniversityKrzysztof Szewczyk, MD, PhD, Principal investigator, Wroclaw Medical University, Department of Oncology, Division of Surgical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488743
- Sponsor's protocol ID
- Smoking Prevention
- Status last verified
- Aug 2022
- First submitted
- 29 Jul 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Birge M, Duffy S, Miler JA, Hajek P. What Proportion of People Who Try One Cigarette Become Daily Smokers? A Meta-Analysis of Representative Surveys. Nicotine Tob Res. 2018 Nov 15;20(12):1427-1433. doi: 10.1093/ntr/ntx243.
PubMed 29126298Kaleta D, Polanska K, Rzeznicki A, Stelmach W, Wojtysiak P. Tobacco use patterns, knowledge, attitudes towards tobacco and availability of tobacco control training among school personnel from a rural area in Poland. Tob Induc Dis. 2017 Jan 11;15:3. doi: 10.1186/s12971-016-0110-y. eCollection 2017.
PubMed 28096794
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Smoking Prevention Program in Poland
- ClinicalTrials.gov ID
- NCT05488743
- Acronym / sponsor ID
- Smoking Prevention
- Conditions
- Smoking, Smoking Behaviors, Smoking (Tobacco) Addiction, E-cigarette Use, Vaping
- Keywords
- tobacco prevention cancer, smoking prevention, cancer education, educational intervention, cardiovascular diseases prevention, youth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Collaborators
- Stanford Reach Lab - Tobacco Prevention Toolkit, American Association for Cancer Education
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 13 Aug 2022 (estimated)
- Study completion
- 14 Oct 2022 (estimated)
- First posted
- 5 Aug 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.
Smoking Prevention Program is a pilot exploratory study with a standardized curriculum based on the Tobacco Prevention Toolkit from Stanford University and translated into Polish by the members of Students Scientific Association of Oncology at Wroclaw Medical University. The program will assess the effectiveness of a school-based smoking prevention curricula keeping children as never smokers and test the feasibility of engaging medical students and teachers in implementing and evaluating a validated program on smoking prevention within the Polish School System. The research protocols, methods and data collection instruments of a standardized classroom based valid tobacco prevention program from Stanford University will be used for the study. The smoking prevention program is centred on drug resistance, personal self-management and increasing social skills. The program increases knowledge and uses coaching and practice to provide students with the skills to resist social pressures around cigarette use. The secondary outcome of this study is to determine the change in attitudes by Polish Medical Student regarding Cancer Prevention Research. During Smoking Prevention Program workshops, the 5-Session Curriculum for primary schools will be translated, applied and evaluated for polish students.
This community-based pilot will engage medical students, the local school district and the local health authority. The Educational program meets the requirements set by Centers for Disease Control and Prevention (CDC) in Guidelines for School Health Programs to Prevent Tobacco Use and Addiction. Following parental consent, the program will be implemented with all 7th and 8th grade students (children age 12-15 years) from the Elementary School in Tyniec Mały. This project is supported by the Head of Lower Silesian Oncology Center, the Head of Department of Oncology of Wroclaw Medical University, the Health and Social Affairs Department of City of Wroclaw and under the patronage of the Lower Silesia Governor's Office, the Polish Society of Oncology, the Polish Society of Public Health, the Lower Silesian Department of Polish Society of Cardiology and the European Association for Cancer Education (EACE).
Smoking Prevention Program is funded by the READS Grant Program from the American Association for Cancer Education (AACE).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7th and 8th grade students (children age 12-15 years) from the elementary school | – | Behavioral: educational intervention |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The program will be implemented with all 7th and 8th grade students (children age 12-15 years) from the Elementary School in Tyniec Mały.
Key inclusion criteria (4 listed)
- Students from Tyniec Mały
- 7th and 8th graders of the elementary school
- Parental consent
- Students consent
Key exclusion criteria (2 listed)
- Lack of parental consent
- Lack of students consent
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 |
|---|---|---|
| educational interventionThe program consists of five 50-minutes sessions conducted in person as scheduled during weekly class meetings. Educators will conduct workshops with PowerPoint presentations and worksheets dedicated to in-class activities. | Behavioural | 7th and 8th grade students (children age 12-15 years) from the elementary school |
Primary outcome
Smoking intention
Time frame: 2 months
Change in smoking intention among elementary school students after program completion (score based on survey results).
Knowledge of negative consequences of smoking
Time frame: 2 months
Change in knowledge about adverse effects of smoking after program completion (score based on survey results).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Background: PubMed 29126298Birge M, Duffy S, Miler JA, Hajek P. What Proportion of People Who Try One Cigarette Become Daily Smokers? A Meta-Analysis of Representative Surveys. Nicotine Tob Res. 2018 Nov 15;20(12):1427-1433. doi: 10.1093/ntr/ntx243.
- Background: PubMed 28096794Kaleta D, Polanska K, Rzeznicki A, Stelmach W, Wojtysiak P. Tobacco use patterns, knowledge, attitudes towards tobacco and availability of tobacco control training among school personnel from a rural area in Poland. Tob Induc Dis. 2017 Jan 11;15:3. doi: 10.1186/s12971-016-0110-y. eCollection 2017.
- World Health Organization. Regional Office for Europe. 2020. Summary results of the global youth tobacco survey in selected countries of the WHO European Region. World Health Organization. Regional Office for Europe.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Łukasz Moskal, MD principal investigator
Wroclaw Medical University
Konrad Reszka, MD principal investigator
Wroclaw Medical University
Urszula Staszek-Szewczyk, MD, PhD principal investigator
Wroclaw Regional Comprehensive Cancer Center, Department of Brachytherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Smoking Behaviors, run by Wroclaw Medical University at 1 site in Poland.
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 9 Aug 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 Poland. 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?
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?
Smoking intention (time frame: 2 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?
On the ClinicalTrials.gov record for NCT05488743, which also lists 2 linked publications.
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 2022.