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We Can Quit2 (WCQ2): a community-based intervention on smoking cessation for women living in disadvantaged areas of Ireland—study protocol for a pilot cluster randomised controlled trial

Hayes, Catherine; Ciblis, Aurelia; Darker, Catherine; Dougall, Nadine; Vance, Joanne; O�Connell, Nicola; Dobbie, Fiona; Loudon, Kirsty; Burke, Emma; Devane, Declan; Bauld, Linda


Catherine Hayes

Aurelia Ciblis

Catherine Darker

Joanne Vance

Nicola O�Connell

Fiona Dobbie

Kirsty Loudon

Emma Burke

Declan Devane

Linda Bauld


Tobacco use is the leading cause of preventable death in Ireland with almost 6000 smokers dying each year from smoking-related diseases. The ‘We Can Quit2’ (WCQ2) study is a pilot pragmatic two-arm, parallel-group, cluster randomised trial that aims to explore the feasibility and acceptability of trial processes including recruitment and to estimate parameters to inform sample size estimates needed for an effectiveness trial. This future trial will assess the effectiveness of a community-based smoking cessation intervention for women living in disadvantaged areas on short- and medium-term cessation rates.

Four matched pairs of districts (eight clusters) selected by area level of deprivation, geographical proximity, and eligibility for free medical services will be randomised to receive either WCQ (behavioural support + access to Nicotine Replacement Therapy (NRT)) delivered over 12 weeks by trained Community Facilitators (CFs) or to a form of usual care, a one-to-one smoking cessation service delivered by Smoking Cessation Officers from Ireland’s national health service, the Health Service Executive (HSE). Within each cluster, 24–25 women will be recruited (97 per arm; 194 in total) in 4 phases with consent obtained prior to cluster randomisation. The outcome measures will assess feasibility and acceptability of trial processes, including randomisation. Outcome data for a future definitive intervention (biochemically validated smoking abstinence) will be collected at end of programme (12 weeks) and at 6 months. WCQ2 has an embedded process evaluation using both qualitative and quantitative methods. This will be conducted (semi-structured client and CF interviews, intervention delivery checklist, and diary) to explore acceptability of trial processes, intervention fidelity, trial context, and implementation. Trial processes will be assessed against domains of the PRECIS-2 wheel to inform a future definitive trial design.

Data from this pilot trial will inform the design and sample size for a full cluster randomised trial to determine the effectiveness of an intervention tailored to disadvantaged women in improving smoking cessation rates. It will provide transferable learning on the systems and implementation strategies needed to support effective design of future pragmatic community-based trials which address health promotion interventions for women in disadvantaged communities.

Journal Article Type Article
Acceptance Date Oct 1, 2019
Online Publication Date Nov 23, 2019
Publication Date 2019-12
Deposit Date Jul 21, 2020
Publicly Available Date Jul 21, 2020
Journal Pilot and Feasibility Studies
Print ISSN 2055-5784
Publisher BMC
Peer Reviewed Peer Reviewed
Volume 5
Article Number 138 (2019)
Keywords Smoking cessation, Women and smoking, Community-based intervention, Social and health inequalities, Cluster randomised controlled trial, Feasibility study, Pilot trial, PRECIS-2, Process evaluation
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We Can Quit2 (WCQ2): a community-based intervention on smoking cessation for women living in disadvantaged areas of Ireland—study protocol for a pilot cluster randomised controlled trial (844 Kb)

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Copyright Statement
© The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.

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