Clinical trial NCT05488743: Smoking Prevention Program in Poland
Official title: Youth Smoking Prevention Program in Poland
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
Collaborators: name: Stanford Reach Lab - Tobacco Prevention Toolkit
name: American Association for Cancer Education
First posted: 2022-08-05
Enrollment: 180
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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).


Eligibility criteria: 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

Primary outcomes:
measure: Smoking intention
timeFrame: 2 months
measure: Knowledge of negative consequences of smoking
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Wroclaw Medical University
state: Lower Silesia
Study officials:
affiliation: Wroclaw Medical University
name: Łukasz Moskal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wroclaw Medical University
name: Konrad Reszka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wroclaw Regional Comprehensive Cancer Center, Department of Brachytherapy
name: Urszula Staszek-Szewczyk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wroclaw Medical University
name: Jagoda Łaba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wroclaw Medical University, Department of Oncology, Division of Surgical Oncology
name: Krzysztof Szewczyk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.