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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05488743
Other study ID # Smoking Prevention
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 15, 2022
Est. completion date October 14, 2022

Study information

Verified date August 2022
Source Wroclaw Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 180
Est. completion date October 14, 2022
Est. primary completion date August 13, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years to 15 Years
Eligibility Inclusion Criteria: - Students from Tyniec Maly - 7th and 8th graders of the elementary school - Parental consent - Students consent Exclusion Criteria: - Lack of parental consent - Lack of students consent

Study Design


Intervention

Behavioral:
educational intervention
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.

Locations

Country Name City State
Poland Wroclaw Medical University Wroclaw Lower Silesia

Sponsors (3)

Lead Sponsor Collaborator
Wroclaw Medical University American Association for Cancer Education, Stanford Reach Lab - Tobacco Prevention Toolkit

Country where clinical trial is conducted

Poland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking intention Change in smoking intention among elementary school students after program completion (score based on survey results). 2 months
Primary Knowledge of negative consequences of smoking Change in knowledge about adverse effects of smoking after program completion (score based on survey results). 2 months
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