NCT05488743

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2022

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

July 29, 2022

Last Update Submit

August 4, 2022

Conditions

Keywords

tobacco prevention cancersmoking preventioncancer educationeducational interventioncardiovascular diseases preventionyouth

Outcome Measures

Primary Outcomes (2)

  • Smoking intention

    Change in smoking intention among elementary school students after program completion (score based on survey results).

    2 months

  • Knowledge of negative consequences of smoking

    Change in knowledge about adverse effects of smoking after program completion (score based on survey results).

    2 months

Study Arms (1)

7th and 8th grade students (children age 12-15 years) from the elementary school

Behavioral: educational intervention

Interventions

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.

7th and 8th grade students (children age 12-15 years) from the elementary school

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Students from Tyniec Mały
  • th and 8th graders of the elementary school
  • Parental consent
  • Students consent

You may not qualify if:

  • Lack of parental consent
  • Lack of students consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

Location

Related 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.

    PMID: 29126298BACKGROUND
  • 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.

    PMID: 28096794BACKGROUND

Related Links

MeSH Terms

Conditions

SmokingBehavior, AddictiveVaping

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

BehaviorCompulsive BehaviorImpulsive Behavior

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 5, 2022

Study Start

March 15, 2022

Primary Completion

August 13, 2022

Study Completion

October 14, 2022

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations