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

Introduction 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 of a community-based smoking cessation intervention for women living in disadvantaged areas on short and medium term cessation rates. Methods Eight districts (clusters of four matched pairs) in Ireland selected by area level 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) or usual care, a one-to-one smoking cessation service delivered by Smoking Cessation Officers. 25 women will be recruited per cluster (97 per arm; 194 in total) in four phases with consent obtained prior to cluster randomisation. Results The outcome measures will assess feasibility and acceptability of trial processes, including randomisation. Biochemically-validated smoking abstinence data for a future definitive intervention will be collected at end of programme (12 weeks), and at six months. WCQ2 incorporates a comprehensive process evaluation. Processes will be assessed against domains of the PRECIS-2 wheel to inform future a definitive trial design. Conclusions Data from this pilot trial will inform the design and sample size for a full cluster RCT. It will provide transferable learning on the systems and implementation strategies needed to support effective design, implementation and evaluation of tailored intervention trials to address behaviour change in disadvantaged communities.