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 (see Fig. 2) is consistent with National Comprehensive Cancer Network recommendations (32) 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 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 (22) 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.
Implementation of Care to Quit
Intervention Phase: Implementation
The implementation intervention has been developed following the Theoretical Domains Framework (29) via patient surveys, staff surveys, a pilot study and consensus processes (33), and prior unpublished work (Sherwood, Tzelepis, Day & Paul et al, unpublished).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 (34).
Stage 1 (3 months): Building staff capability and motivation and identifying champions
Individual or small group outreach visits (35, 36) with oncologists, physicians and lead cancer nurses (two visits per person over two months) will be delivered by a behavioural scientist with smoking cessation expertise, and ideally a clinician e.g. oncologist and a Quitline counsellor. The visits will be interactive (37), 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: 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. Quitline referral pathways will be developed within each site.
Sites will be supported with a suite of evidence-based implementation strategies tailored to the needs of the individual site. Implementation strategies include: i) feedback (38) 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 (23) 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.
Staff will be invited to complete surveys online (or print if preferred by the site) at the beginning of each study phase (baseline, intervention, follow-up) to collect process measures data, experiences with and perceptions of the Care to Quit intervention and provision of smoking cessation care.
Sample size
The trial will recruit 2160 smokers (40 per site per 6 months over three years for each of nine sites). This sample size will provide approximately 80% power to detect a difference of 7% in smoking cessation (i.e. during the baseline phase 7% of those who were smokers or recent quitters at recruitment will achieve 6 months prolonged abstinence, while during the intervention phase 14% of those who are still smoking at diagnosis will achieve 6 months abstinence) at an alpha level of 0.05, assuming an intra-cluster correlation of 0.01 and a worst-case scenario of cluster autocorrelation equal to zero. This sample also provides over 90% power to detect each of the differences previously stated for the secondary outcomes.
Randomisation
At each intervention ‘step’, 3 sites will be selected at random to commence the intervention. Centres will be randomly allocated to ‘step’ i.e. time of commencement of the intervention phase, by an independent statistician. For pragmatic reasons, three sites will be treated as their own cluster due to the concern for contamination if sites participated in the intervention at different times.
Blinding
Participants, interviewers conducting the CATIs and data analysts will be blinded to the intervention phase. Because of the nature of the intervention, it is not possible to blind clinicians at participating sites or trial investigators to the sites’ allocation to ‘step’ i.e. time of commencement of the intervention phase once randomised. Participants will be blinded to treatment allocation.
Data Management
All data will be entered electronically via e-case report form using Research Electronic Data Capture (REDCap) tools (60) hosted at Hunter New England Local Health District NSW on a secure server. REDcap is a secure, web-based application designed to support data capture for research studies. The lead investigator (and/or delegate) and trial coordinator will conduct ongoing data checking and cleaning. Participant personal details will be accessed, used, and stored according to relevant legislations. Access to external health data (e.g., Quitline, health records) will only occur with the consent of the participant in accordance with protocols of relevant external agencies.
The current study is a trial of a non-invasive clinician delivered smoking cessation support intervention. Clinicians will be trained in support strategies. These strategies will be delivered within the context of standard patient consultations. It does not involve administration of medicine or experimental therapeutic devices. In light of this an independent data safety monitoring board will not be convened.
Evaluation
Statistical Methods
Independent and blinded statisticians from the CReDITSS Unit at the Hunter Medical Research Institute, Australia, supervised by CI Barker, will conduct analyses of the primary and secondary outcomes.
Logistic regression within a generalised linear mixed models framework will be used to model the primary and secondary outcome measures. All models will adjust for time using a fixed effect that describes the phase of the study (pre-intervention and each of the 3 steps). Variation between sites will be accounted for using a random effect for site and repeated measures on sites will be accounted for using a random effect for time within site. To estimate the intervention effect, a variable indicating when the intervention was active for a given site and time will be included in the models. As the timing of the 7 month CATI for some participants overlaps with intervention commencement, the analyses of 6 months abstinence will include a 6 month offset to the coding of the intervention indicator variable to allow the full effect of the intervention to be in place before estimating its effect.
There are no plans for interim analyses.
Cost Effectiveness Evaluation
Using a health services perspective, incremental cost-effectiveness ratios will be calculated from the cost per person quit in the intervention phase (i.e., self-reported, 6-month abstinence from smoking) compared to usual care in the pre-intervention phase. Costs for the delivery of the intervention (e.g. clinician training, smoking cessation resources, NRT/pharmacotherapy where appropriate) will be derived directly from trial data and added to the costs of clinician time (e.g. oncology nurses) in usual care. Exploratory, modelled analyses will examine the potential impacts of smoking cessation (intervention versus usual care) on the cost per quality adjusted life year saved, using mortality relative risk estimates derived from published studies of survival by post-diagnosis smoking cessation (however these studies are likely subject to confounding by indication for quitting and as such modelled results based on these data will be interpreted cautiously). Modelled analyses will include estimates of the health-system costs of cancer (61) and health state utilities for cancer survivors (62). Sensitivity analyses will address potential variation in costs and the survival benefits due to smoking cessation.
Qualitative Evaluation
A nested qualitative study will be conducted. All interviews (key informants and Quitline counsellors) will be audio recorded, transcribed, and a general inductive approach will be taken to the analysis (63). Interviews will be guided by semi-structured interview guides.
Key Informant Interviews
Semi-structured interviews will be conducted with n=45 staff participants (n=5 per site). Potential participants will be purposively selected at each timepoint (baseline, intervention, follow-up) to be invited for interview. Potential participants will be identified by the site principal investigator in consultation with the research team and advised by the principal investigator that they will be contacted by the research team with an invitation to participate in an interview. Eligible participants will include cancer services directors, heads of departments, directors of cancer nursing and team leaders. Interviews will explore the perceived role of system-level factors (e.g. staffing, leadership, technology, infrastructure) which can affect implementation. The interviews will also evaluate the method of multiple outreach visits in identifying and motivating an interdisciplinary group of champions. Participants will have the option of reviewing the interview transcript and editing their responses prior to analysis.
Quitline Counsellor Interviews
Interviews will evaluate the experience of delivering counselling to study participants among Quitline staff. It is anticipated that semi-structured individual and/or group in-depth interviews will be conducted with Quitline counsellors to enable data collection to reach saturation and for key themes to be identified (64). Interviews will explore their experience of delivering counselling and its strengths and weaknesses from their perspective. Interviews will be conducted face to face, via telephone or videoconference depending on practicality and participant preference. Participants will have the option of reviewing the interview transcript and editing their responses prior to analysis.
Recruitment will be undertaken via email from Quitline managers to all eligible Quitline staff (those that delivered counselling to Care to Quit participants) asking them to participate in an interview. Their participation will be optional.
Harms
Adverse events will be monitored by study sites (hospitals) as per their usual protocols.
Protocol Amendments
Each study site will only be able to start data collection once the relevant Ethics Committee and research governance approval is obtained. In the case of proposed protocol changes, an amendment will be submitted to the Ethics Committees for approval, and the trial coordinating centre will ensure all study staff are provided with new documentation. Any significant protocol changes will be updated on the ANZCTR and reported in the final outcomes paper.
Confidentiality
The trial will be conducted in accordance with applicable Privacy Acts and Regulations. Data that identify any trial participant, will not be revealed to anyone not directly involved in the trial or the clinical care of that participant. An exception is where the trial participant has provided written consent for his/her records to be included in source document verification.
Access to Data
All data will be considered the property of the trial chief investigator who, in consultation with the trial management committee, will be responsible for presentations and publications arising from this trial.
Dissemination Policy
Trial findings will be summarized and provided to participants who have indicated they would like a copy of the results. The trial management committee will be responsible for decisions regarding presentations and publications arising from this trial according to agreed Authorship, Publication and Spokesmanship Guidelines.
Access to data during the trial will be limited to the trial management committee and appropriate regulatory bodies.