Background Tobacco use is the leading preventable cause of morbidity, mortality and health inequalities in Ireland. The ‘We Can Quit2’ (WCQ2) programme is a new smoking cessation intervention for women living in disadvantaged areas, previously developed and examined in promising feasibility research conducted by members of our team with the Irish Cancer Society.
Aims To conduct a cluster randomised pilot study which will determine the feasibility and acceptability of trial processes in evaluating a community-based smoking cessation intervention (WCQ2), including randomisation of districts, recruitment and data collection in both the intervention and usual care arms, for women who smoke, and are living in disadvantaged areas of Ireland, to inform the sample size estimates and design of a future definitive trial.
Design Pilot two-arm cluster randomised controlled study comparing the WCQ2 smoking cessation programme with usual care (HSE standard smoking cessation services). This is a pragmatic pilot study of a complex intervention and is a small-scale version of the future definitive trial.
Four work packages (WPs) are planned. WP1 is the design, set up and analysis of the pilot trial involving 194 women (97 per arm) in four districts. The primary outcome is biochemically-validated abstinence of smoking at the end of programme (12 weeks) with secondary outcomes including continuous validated abstinence at 6 months. WP2 focuses on trial implementation and a process evaluation. WP3 is a cost activity analysis that involves a micro costing of the intervention and a preliminary analysis of the cost-effectiveness of the intervention to inform a decision of whether to undertake a full RCT. WP4 will develop strategies to optimise recruitment and dissemination of findings to trial stakeholders to inform knowledge exchange and future research.
Research Team The proposal is submitted by an experienced team of researchers from Ireland and the UK led by Professor Catherine Hayes at Trinity College Dublin and including experts in: trial design, statistics, process evaluation, behaviour change, smoking cessation, cost-effectiveness analysis and cancer prevention. Collaborators are drawn from a range of relevant agencies and include members of the public. An independent Trials Steering Committee will support the study.
