UnknownNot Applicable

Environmental Assessment of Secondhand Smoke Exposure in Private Settings and Outdoor Settings in Europe

Spain1,080 participantsStarted 2017-02-01

Plain-language summary

This is a European study which is part of a larger research project (TackSHS project) funded by the European Union's Horizon 2020 Research and Innovation Programme (Grant Agreement 681040) and led by the Catalan Institute of Oncology. The main goal of the study is to assess the environmental levels of secondhand smoke (SHS) in non-regulated settings such as private and outdoor settings of 12 European countries (Bulgaria, France, Germany, Greece, Ireland, Italy, Latvia, Poland, Portugal, Romania, Spain and the United Kingdom) representing geographical, legislative (country-specific smoke-free policies) and cultural variations across Europe. This is a multi-country cross-sectional study based on objective environmental measurements of SHS levels. Private settings studied are homes and cars and outdoors settings are terraces of hospitality venues, children playgrounds and entrances of primary school buildings. A total of 1,080 environmental measures of airborne nicotine will be collected. 20 environmental measures will be collected from homes and each of the outdoor settings for the 12 countries involved in the study (960 samples). Regarding cars, 60 environmental measurements will be collected in two countries (Spain and the UK) (120 samples), which have been selected taking into account differences in smoke-free legislation. Further information about SHS exposure will be collected for each setting through brief questionnaires or forms. Medians and interquartile ranges of nicotine concentrations will be calculated by country for each setting studied. Nicotine concentrations will be compared using non-parametric tests according to country, socioeconomic status and other determinants of exposure for each setting.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Homes: * non-smoking volunteers living in different homes with at least one smoker * participants living in more deprived neighborhoods (lower than 20th percentile of the SES distribution) or participants living in wealthier neighborhoods (above than 80th percentile of the SES distribution) Cars: * volunteers who travel in a car for at least 30min/day * profiles of participants: 10 daily-smoking volunteers that usually smoke within their car; 10 daily-smoking volunteers that do not smoke within their car; and 10 non-smoking volunteers. Outdoor settings: * there should be at least five adults present at the moment of the measurement start * the settings should be located in more deprived neighborhoods (lower than 20th percentile of the SES distribution) or in wealthier neighborhoods (above than 80th percentile of the SES distribution) * playgrounds with slides, swings or other similar playing equipment and located outdoors (for children playgrounds) * terraces with at least one wall or roof, placed in cafeterias, bars or night pubs (for terraces) Exclusion Criteria: * volunteers with literacy level or language skills preventing them from understanding the study documents

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SHS exposure in private and outdoor settings

Timeframe: Passive sampling (homes and cars): 1 week in homes and 24 hours in cars; active sampling (outdoor settings): 30 minutes

Trial details

NCT IDNCT03150186

SponsorInstitut Català d'Oncologia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-03-01

View on ClinicalTrials.gov More Second Hand Tobacco Smoke trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.