BackgroundTobacco 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.Methods/designFour 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.DiscussionData 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.Trial registrationConcurrent to publication. Controlled trials ISRCTN74721694.

is an open access, peer-reviewed online journal that encompasses all aspects of tobacco use, prevention and cessation that can promote a tobacco free society. The aim of the journal is to foster, promote and disseminate research involving tobacco use, prevention, policy implementation at a regional, national or international level, disease development-progression related to tobacco use, tobacco use impact from the cellular to the international level and finally the treatment of tobacco attributable disease through smoking cessation.

Introduction We Can Quit” (WCQ) is community-based stop-smoking program delivered by trained community facilitators, based on the socio-ecological framework and developed using a Community-based Participatory Research approach, targeting women living in socioeconomically disadvantaged (SED) areas of Ireland. Aims and Methods The We Can Quit2 (WCQ2) pilot trial assessed the feasibility of WCQ. A pragmatic cluster randomized controlled trial with a process evaluation WCQ2, was conducted in four matched pairs of SED districts (8–10 000 women per district). Districts were independently randomized to WCQ (group support + nicotine replacement therapy), or to individual support delivered by health professionals. Participants were adult women smokers interested in quitting, who were living or working in trial districts. Recruitment of districts and 194 women in four waves (49 women per wave); retention at 12 weeks and 6 months; fidelity to intervention delivery and acceptability of trial-related processes were assessed. Validated smoking abstinence at 12-week and 6-month post-intervention was recorded, missing data assumed as continued smoking. Results Eight districts were recruited. 125/188 (66.5%) eligible women consented. The 49 women target was reached in wave4. Retention at 12 weeks was (Intervention [I]: 55.4%; Control [C]: 51.7%), at 6 months (I: 47.7%; C: 46.7%). Smoking abstinence at 12 weeks was (I: 23.1%, [95% CI: 14.5 to 34.7]; C: 13%, [95% CI: 6.9 to 24.1]). 83.8% of session activities were delivered. Trial-related processes were acceptable to facilitators. Low literacy was highlighted as a barrier for participants’ acceptability. Conclusions WCQ was feasible to deliver by trained facilitators and indicated a positive direction in abstinence rates. Low literacy will need to be addressed in a future trial design. Implications This pilot trial showed that a stop-smoking intervention tailored to a group of women smokers living in SED areas which was delivered by trained local women within their local communities was feasible. Furthermore, although not formally compared, more WCQ women were abstinent from smoking at the end of treatment. The results are relevant to enhance the design of a fully powered effectiveness trial, and provide important evidence on the barriers to deliver a tailored smoking cessation service to SED women smokers in Ireland.

Tobacco use is the leading cause of preventable death in Ireland with almost 6,000 smokers dying each year from smoking-related diseases. Amongst younger Irish women, smoking rates are considerably higher in those from socially disadvantaged areas compared to women from affluent areas. Women from poorer areas also experience higher rates of lung cancer. To our knowledge, there are no peer reviewed published systematic reviews on the effectiveness of interventions tailored to reduce smoking rates in women from disadvantaged areas. This systematic review protocol will aim to examine the effectiveness of such interventions and to describe trial processes such as recruitment, follow-up and dropout prevention strategies, as well as barriers and enablers of successful implementation.    A systematic review will be conducted of peer-reviewed randomised controlled trials and associated process evaluations of smoking cessation interventions designed for women living in socially disadvantaged areas. If the search returns, less than five studies are review criteria will expand to include quasi-experimental studies. A number of databases of scholarly literature will be searched from inception using a detailed search strategy. Two independent reviewers will screen titles, abstracts and full-text articles to identify relevant studies using a pre-defined checklist based on PICOS. In the case of disagreement, a third reviewer will be consulted. The quality of included studies will be assessed using the ‘Grading of Recommendations Assessment, Development and Evaluation’ (GRADE) criteria. Quantitative data will be extracted and, if comparable, will be assessed using meta-analysis. A narrative meta-synthesis of qualitative data will be conducted.   This review aims to synthesise information from relevant studies on smoking cessation interventions tailored for women from socially disadvantaged areas. The evidence obtained from studies and presented in this review will help guide future research in this area. Registration: This review will be registered with International Prospective Register of Systematic Reviews (PROSPERO).

Background: Smoking poses a serious risk of early preventable death and disease especially for women living with socio-economic disadvantage (SED). A smoking cessation programme ‘We Can Quit’ was developed in Ireland tailored to SED women. The programme includes group-based support delivered by trained lay local women and free nicotine replacement therapy (NRT). The intervention was pilot tested in a cluster randomised controlled trial, ‘We Can Quit 2’. A process evaluation assessed feasibility and acceptability of the programme and trial processes.Methods: Embedded qualitative design using the Medical Research Council’s (MRC) process evaluation framework. Semi-structured interviews with trial participants (N=18) and programme deliverers, the community facilitators (CFs; N=8). Thematic analysis was used for interview transcripts.Results: Results focused on programme and trial operational factors. Peer-modelling, a non-judgemental environment, and CFs supportive role of group support were viewed as facilitative. Potential for broader message diffusion into the social networks of participating women was observed. Free NRT was helpful for cessation. Some participants expressed concerns about NRT side effects. Community pharmacists provided guidance relating to NRT and additional support between programme meetings. Provision of saliva samples proved challenging. Low literacy was a barrier for engagement with programme and trial-related materials. Hypothetical scenarios of direct or indirect observational fidelity assessment for a future definitive trial (DT) were acceptable. Conclusions: The We Can Quit intervention and trial-related processes were feasible and acceptable to participants and Community Facilitators. Any future DT will need to address low literacy.Trial registration: Controlled trials ISRCTN74721694.