- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05488743
Smoking Prevention Program in Poland
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).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Lower Silesia
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Wroclaw, Lower Silesia, Poland, 50-367
- Wroclaw Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Students from Tyniec Mały
- 7th and 8th graders of the elementary school
- Parental consent
- Students consent
Exclusion Criteria:
- Lack of parental consent
- Lack of students consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
7th and 8th grade students (children age 12-15 years) from the elementary school
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking intention
Time Frame: 2 months
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Change in smoking intention among elementary school students after program completion (score based on survey results).
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2 months
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Knowledge of negative consequences of smoking
Time Frame: 2 months
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Change in knowledge about adverse effects of smoking after program completion (score based on survey results).
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2 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Łukasz Moskal, MD, Wroclaw Medical University
- Principal Investigator: Konrad Reszka, MD, Wroclaw Medical University
- Principal Investigator: Urszula Staszek-Szewczyk, MD, PhD, Wroclaw Regional Comprehensive Cancer Center, Department of Brachytherapy
- Principal Investigator: Jagoda Łaba, MD, Wroclaw Medical University
- Principal Investigator: Krzysztof Szewczyk, MD, PhD, Wroclaw Medical University, Department of Oncology, Division of Surgical Oncology
Publications and helpful links
General 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.
- Kaleta 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Smoking Prevention
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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