Care to Quit: An intervention for people with cancer who smoke

Care to Quit Intervention ‘Ask, Advise, Act/Help’ (as per state-based recommendations) All patients who smoke tobacco or have recently quit and who are receiving anti-cancer therapies at the study centres will be eligible to receive cessation care from clinic staff. The ‘Ask Advise Help’ model is consistent with National Comprehensive Cancer Network recommendations for evidence-based cessation support for cancer patients: Ask: Assess and record smoking status (current smoker or recent quitter); Advise: Give a personalised description of the specific benefits of smoking abstinence during and after treatment; endorse use of evidence-based support (telephone counselling and pharmacotherapy); Act/Help: Offer referral to Quitline or other local cessation support service (including education around the benefits of Quitline); prescribe, provide or advise on pharmacotherapy options (nicotine replacement therapy (NRT) or varenicline) which are safe during treatment; and monitor progress. The above components of the cessation care model are the staff behaviours that our implementation intervention (described below) aims to target. A description of how these will be measured is provided in secondary outcomes (provision of smoking cessation care). The model is relevant for current smokers and people who have recently quit smoking, including access to NRT for as a relapse prevention strategy. As people with cancer are likely to report abstinence when in fact they are still smoking it is important to ensure all recent quitters have evidence-based forms of cessation support ready at hand. The roles of oncologists, physicians, nurses, radiation therapists, hospital pharmacists and other relevant staff in the delivery of ‘Ask Advise Help’ will be tailored by the site staff to reflect the local context as part of the intervention process. Pre-existing skills, expertise and experience relevant to provision of smoking cessation care will differ across staff. Implementation of Care to Quit Intervention Phase: Implementation The implementation intervention has been developed following the Theoretical Domains Framework (TDF). The TDF is a validated comprehensive framework for identifying barriers and enablers to behaviour change and includes 14 theoretical domains. We used this framework in preliminary work that included patient surveys, staff surveys, a pilot study and consensus processes, and prior unpublished work (Sherwood, Tzelepis, Day & Paul et al, unpublished). The strategies also address the need to adapt intervention content to the contexts being encountered. Further detail is provided in a separate manuscript (Tait et al, unpublished) describing intervention development using the TDF and APEASE criteria (affordability, practicability, effectiveness and cost effectiveness, acceptability, side effects/safety and equity). The overall duration of intervention implementation for the cessation care model is 12 months. Stage 1 (3 months): Building staff capability and motivation and identifying champions Small group and individual outreach visits with oncologists, physicians and lead cancer nurses will be delivered by a behavioural scientist with smoking cessation expertise, and ideally a clinician e.g. oncologist and a Quitline counsellor. At least one small group visit (30 minutes) and one individual visit per person identified by research team and sites as integral to implementation (e.g. head of department, senior staff member; one hour) will be conducted across Stage 1. The trainers’ specific backgrounds and expertise will be reported in the trial outcome paper. The visits will be interactive, use behavioural principles and incorporate the use of brief persuasive videos from discipline-relevant opinion leaders. The visits will address: i) the evidence of cessation benefits specific to the types of patients the oncologist sees; ii) evidence for multi-session specialist telephone support (i.e. Quitline) including how counselling is now tailored to support people with cancer; iii) evidence regarding cessation pharmacotherapy during cancer treatment; iv) suggested scripts and modelling of brief interactions for succinctly discussing cessation benefits and endorsing Quitline; v) sensitive timing and framing of stop smoking messages and vi) reviewing recent consultations and managing challenging cases. Stage 2 (9 months): Identifying and implementing cessation care models/pathways During stage 1 an inter-disciplinary team interested in championing smoking cessation care will be identified and invited to form an interprofessional, multi-disciplinary team of project champions at each cancer centre. The team will be supported by regular teleconferences with the researchers to identify how to implement ‘Ask Advise Help’ within existing patient pathways. Researchers will work collaboratively with sites to develop within each site. Sites will be supported (for the duration of Stage 2) with a suite of evidence-based implementation strategies tailored to the needs of the individual site. Implementation strategies include: i) feedback of current rates of care using data collected in the baseline phase, ii) evidence-informed training for staff not involved in stage 1 (delivered via multiple formats such as face to face and existing online Quit and health departmental training, with refreshers and updates at regular intervals), and iii) educational tools for use with patients. The method of providing pharmacotherapy will vary as not all centres are able to provide this directly to outpatients. Where the medication cannot be supplied directly to the patient (e.g. using a hospital pharmacist-led or nurse-led approach), a prescription can be written by the treating doctor. Referral to the patient’s GP for prescription of pharmacotherapy may also occur. Ongoing support will be provided to sites to support adherence to the collaborative and tailored models developed. Staff will be invited to complete surveys online (or print if preferred by the site) at each study phase (baseline, intervention, post-intervention) to collect process measures data, experiences with and perceptions of the Care to Quit intervention and provision of smoking cessation care. Due to the stepped-wedge design of the trial, sites will enter intervention and follow-up periods at varying timepoints. Sites 1-3 will enter intervention at 6 months post baseline, sites 4-6 at 13 months post baseline and sites 7-9 at 19 months post baseline. Staff surveys will therefore occur at varying timepoints from baseline across sites. The intervention period questionnaires will be completed mid-intervention period (i.e. 6 months post beginning of intervention period) for each cluster of sites (i.e. 13 months post baseline for sites 1-3, 19 months post baseline for sites 4-6 and 25 months post baseline for sites 7-9). The post-intervention period questionnaires will be completed at the beginning of the post-intervention period (19 months post baseline for sites 1-3, 25 months post baseline for sites 4-6 and 28 months post baseline for sites 7-9). As the support provided at Stage 1 and 2 will be delivered following assessment of site need (including current procedures, existing staff skills and experience) and tailored accordingly, further details of intervention dose (i.e. consultations, meetings, training materials provided) and mode of delivery (e.g., individual vs group, powerpoint presentations, videos) will be provided in the trial outcome paper. Project records will be used to document staff attendance at meetings and training. The delivery of smoking cessation support to patients will be implemented as part of routine care and tailored to site. Therefore, this may occur individually face to face at outpatient clinics, via telephone and/or telehealth and the amount or ‘dose’ of the support will differ.