INTRODUCTION
Lung cancer is the most common cancer in the world and Scottish males and females have among the highest rates in the world.1,2 In Scotland lung cancer is the commonest cause of cancer and of cancer death in males and females, and disproportionately affects deprived communities.3 In the UK, lung cancer has one of the lowest survival outcomes of any cancer, with only around 27% of males and 30% of females alive at one year, falling to 7% and 9% at 5 years.4 These figures compare poorly with those of other developed countries, where 5-year survival varies between 11 and 17%.5,6 Lung cancer survival is linked to the stage at diagnosis with much poorer survival for those with more advanced disease.7,8 On the other hand, for early (stage I) disease, treated with surgical resection, 5-year survival rates of up to 90% have been reported.9
In a recent study it was found that nearly all 360 participants newly diagnosed with lung cancer had experienced symptoms prior to diagnosis, and that the median time between onset of symptoms and consultation was 99 days (interquartile range [IQR] 31–381).10 Current UK guidelines recommend referral for investigation after 3 weeks of symptoms, so this study suggests there is potential for more than 75% of patients to be referred earlier if they consulted earlier.11–13 While this ‘perfect’ consulting behaviour may not be achievable, an intervention aiming to reduce the time taken to consult with chest symptoms would appear to be desirable, timely, and consistent with current health policy initiatives in the UK.14 This article describes the development and optimisation of an intervention to reduce the time between onset and first consultation with symptoms that might indicate lung cancer.
Results
Phase 1: Defining the problem, collecting evidence, and developing underlying theory
Phase 1 progressed through five sequential steps led by an expert multidisciplinary group comprising two psychologists, a sociologist, three GPs, a respiratory physician, and a health services researcher. The group had two formal meetings and also worked iteratively on the draft intervention via smaller meetings between members and e-mail contact. The group’s work is summarised in Table 1. In Step 1, the group defined and quantified the essential underlying problem as patient behaviour leading to the late presentation of lung cancer symptoms. In Step 2, they identified the target group most likely to benefit from an intervention as people aged ≥55 years, with a history of 20 pack years or more, who are current smokers or gave up within the past 10 years. In Step 3, the key concepts underlying the causative and sustaining pathways of a delayed lung cancer diagnosis were elucidated. The most informative behavioural and social models from health psychology (for example, the Illness Action Model, Theory of Planned Behaviour, Zola’s triggers: see Table 2) to address each concept were identified. These were then used to develop the construct encapsulating the way in which the concept caused or sustained late diagnosis. This was further mapped on to evidence that supported the theory (Table 2). In Step 4, theory and evidence were mapped on to concrete behaviour change techniques (such as goal setting, action planning, and prompts/cues: see Table 3) to positively impact on the causative and sustaining pathways (Table 3). In Step 5, the potential benefit of the intervention was quantified (Table 1).
Table 1 Developing an intervention: defining and understanding the problem
Table 2 Theories and evidence on how late consultation is caused and sustained
Table 3 Mapping theory and evidence to behaviour change techniques17–35,42
Also accomplished within Step 5 was the synthesis of identified techniques into the first draft of the intervention (Figure 1). In summary, it comprised a nurse consultation (which included physical examination and spirometry) in which the patient was introduced to a home-based self-help manual providing information and behaviour change techniques, and was guided in making ‘if–then’ action and coping plans. The consultation and self-help manual sought to increase the salience and personal relevance of chest symptoms, introduce chest disease prototypes, reinforce the benefits of early intervention in lung cancer and other chest disease, sanction early consultation, tackle barriers to consultation, and develop good personalised action and coping plans.
Figure 1 Progress of intervention development.
Phase 2: Optimising the intervention prior to implementation
To optimise the intervention the study explored its implementation in focus groups with GPs, high-risk patients, and patients with lung cancer. People at high risk of lung cancer (smokers and ex-smokers with and without lung disease, non-smokers with lung disease) and partners of smokers were recruited through two general practices in Northeast Scotland and the Aberdeen British Lung Foundation’s Breath Easy Group. Patients with lung cancer were recruited with assistance from the specialist lung cancer nurses at Aberdeen Royal Infirmary. GPs were approached through the Grampian teaching practices group.
Two focus groups were conducted, one for high-risk patients at a community location (with seven participants), and one for GPs at a health centre in Aberdeen (four participants). Six individual interviews were conducted with patients with lung cancer, mostly in their own homes. In two cases, spouses/partners stayed for the interview.
During focus groups, practice meetings, and interviews, participants were presented with a summary of the intervention. The study explored positive and negative responses, perceived consequences, methods of implementation, barriers and facilitators to implementation, methods to optimise attendance, and possible solutions to negative consequences and barriers. Focus groups and interviews were audiotaped and transcribed. Notes were taken during practice meetings. Data were analysed inductively, to identify unanticipated themes, and deductively, to identify problems with and barriers to the intervention as well as possible solutions.
General comments were positive, such as ‘Excellent idea, it’s got to be done, but a tall task’ (lung cancer patient). Most comments about problems for the intervention could be grouped into three main themes: engaging patients; achieving behavioural change; and the patient–general practice interface.
Engaging patients — ‘the hook’
There were concerns from all three groups that recruitment to the intervention would be difficult and non-attendance rates high. Smokers were thought by the high-risk group to be ‘in denial’, believing ‘it’s not going to affect me [the smokers]’. ‘They don’t apply it [knowledge of the risks of smoking] to themselves.’ ‘I really think it’s the apathy of some people — they don’t want to know.’ One said:
‘Before I stopped smoking, it [the intervention self-help manual] would go in the bin.’ (high-risk group)
There were similar comments from the interviewees with lung cancer:
‘Some people just don’t care about their health’ and ‘might not want to know.’
The GPs commented that many in this group ‘don’t listen to advice’.
The need for a ‘hook’ was emphasised repeatedly:
‘The key thing’s to get people hooked.’
‘Unless it is something really interesting you just stick it to the side.’
‘Something that jumps out of the envelope and punches you on the nose!’
‘What’s in it for me?’
An approach based on striking slogans was thought good:
‘Sell, sell, sell —“nip lung disease in the bud”’, ‘the hard sell has got to be there, [with] impact on the front page.’ (high-risk group).
The nature of the hook was more difficult, but several ideas were generated. The ‘1,2,3’ slogan in the draft intervention self-help manual was applauded:
‘1,2,3 page should be at the front — it pulled me in right away — and it should also be repeated at the back’. (lung cancer patient)
Celebrity endorsement was suggested by members of the high-risk group. Targeted patients should be made to feel they were getting special attention, rather than stigmatised as usual:
‘It’s getting a little bit more attention’, ‘like a lung screening,’ (high-risk group), or being made to feel they were being moved from a ‘non-priority up to a priority’ (GP group). There were differing views on the role of fear. Its use was advocated as a way to make people take notice initially:
‘What would make me want to find out is if it might be cancer — everybody is afraid of cancer I think, and therefore if you get something which will alert you to the fact that you might have cancer then you’d read it — whereas if it was other things you wouldn’t worry that much about them.’
‘It’s a good thing raising anxiety in people that smoke … terrify the buggers that’s what I say!’ (high-risk group)
On the other hand, there were concerns that it may also be counter-productive and that people ‘may be too scared’ (lung cancer group). ‘What they are going to be doing is being scared, if they get symptoms they will ignore it’ (high-risk group).
One strategy suggested by GPs was to tie the intervention in with something else (for example COPD reviews). This was based on previous experience of attempting to implement similar interventions opportunistically on hard-to-reach groups.
Achieving behavioural change
Even once ‘captured’ for a consultation, there were concerns about whether achieving behaviour change was possible. As above, reasons included non-recognition of personal risk, optimistic bias, and apathy. Much of the discussion of possible solutions also followed the above pattern, with emphasis on the need for a ‘hook’ and discussion about whether fear would encourage or hinder action. There were also several other specific ideas and suggestions. There was considerable discussion about the need for support and sanctioning:
‘Support is important — it’s surprising the number of people that have been really worried about something far worse … they need support to go and get the diagnosis.’ (high-risk group).
There was encouragement from the high-risk group for participants to bring a family member, partner, or close friend along to be involved in the intervention. This was also advocated by the GP group, with the proviso that the possibility of conflict between the family member or friend and the participant should be looked for and avoided, as this could be counter-productive. Ideas from both patients and GPs were put forward as a means to prompt self-monitoring of symptoms included calendars, text messaging, postcards, and Post-it ® notes, but with a need for plans to be tailored to individuals. GPs suggested prompts on cigarette lighters so patients were prompted to think about their symptoms ‘every time you light up’. There were several specific recommendations for the self-help manual from both the high-risk group and lung cancer patients. These included keeping it simple, emphasising symptoms are not ‘just because you are older’, provision of a helpline, a sprinkling of benefit messages throughout, and quotes from people who have been through it. Finally, GPs advocated sending the booklet to non-attenders anyway, backed up by telephone calls if possible.
Barriers at the patient–general practice interface
Participants from all groups mentioned potential problems at the patient–general practice interface and made clear that they felt this was a very important part of the explanation for late presentation. The high-risk group was worried that GPs had a negative attitude towards smokers and one said ‘I just think GPs don’t really know [about lung disease].’ There was a need for confidence that GPs would take them seriously. ‘Smokers are beginning to think now wait a minute, are they going to treat me because I am a smoker?’ Patients with lung cancer spoke of the difficulty people can have making appointments: ‘Those who live alone or those who are short of cash … may need help to make appointments … to go to the appointments.’ GPs were concerned that the advice in the booklet should be consistent with what was achievable and not foster expectations that could not be met in practice.
The key solution, agreed by all, was for involvement of the entire general practice team in the process:
‘If recruiting through GP practices, you have got to involve the whole care team — receptionists, doctors, nurses.’ (patient with lung cancer).
Receptionists were the first point of contact for patients, so need to be involved. Triage by practice nurses could bring in delay, so they should be involved too. Indeed, this concept was extended to secondary care too:
‘Everybody has got to be involved: the GPs, the consultants, the hospitals themselves.’ (patient with lung cancer).
The involvement of GPs should be demonstrable as part of the intervention:
‘GP endorsement essential … make it as personal as possible.’ (high-risk group)
Patients with lung cancer felt that advice should be provided on making appointments and exactly what to ask when contacting their general practice. Care was needed to ensure that this wording was in line with what could be implemented in the trial practices. Similarly, but more generally, the wording of recommendations in the booklet should avoid friction between patients and GPs.
Intervention refinement as a result of the focus groups, interviews, and practice meetings
With reference to evidence around the diagnosis of lung cancer, underpinning psychological models, and recent recommendations on mapping behavioural determinants to behavioural change techniques, the study used the data from the focus groups to refine that intervention.36 Changes included:
Simplifying checklists.
Using the identified barriers to generate action and coping plans.
Including messages to sanction and encourage appropriate consultation.
Demonstrating approval of GPs, respiratory physicians, and oncologists for the process.
Incorporating a celebrity endorsement.
Providing action plans and prompts (Post-its, postcards, or text messages) for self-monitoring.
Giving specific advice on what to say when making appointments.
Finally, in two meetings with general practices that had agreed to pilot the intervention, meetings were held with representatives of all staff. These were used to identify potential barriers at the patient–general practice interface and to ensure that the intervention was practically deliverable within these practices. Efforts were also made to minimise the work and disruption for general practices. This required some very minor refinements to account for differences in practice administration systems. None of these changed the final intervention in any material way.
Final intervention
The intervention comprised a self-help manual, nurse consultation, and system of prompts. The key components of the final intervention are:
Referring to a range of lung disease, not only cancer.
Proposing ‘special attention’ rather than fear message.
Endorsement by Liz Dawn, best known for her role as Vera Duckworth in Coronation Street, who has emphysema. Messages to sanction and encourage consultation with chest symptoms from Liz Dawn, local specialists in respiratory medicine and oncology, participants’ GPs, and others with chest disease.
Stories and speech bubble messages from patients about early and late consultation.
Frequent messages about the benefits of early consultation.
A simple checklist of symptoms that need action and when.
Prompts to self-monitoring — monthly postcards, texts, or stickers — to themselves and close others.
If–then action and coping plans based on identified barriers to consultation.
Specific advice on what to say and expect when making appointments.
1,2,3 action plan logo repeated throughout the manual.
The nurse consultation was based on a script produced primarily by the lead health psychologist, the lead research nurse, and the health services researcher for the project. The basis for the script was the intervention self-help manual. The research nurses were advised on what to say as they talked through the manual with the patient. Research nurse training took place over 2 separate days and included nurses simulating consultations with a member of the multidisciplinary team.
The manual was coded independently using a taxonomy of 84 behaviour change techniques to identify the precise techniques used in the intervention. 37 Where there were disagreements about the presence of a technique, discussion followed until agreement was reached. The twelve techniques included in the manual are given in Table 3, with examples, including prompts/cues, action planning, and goal setting.
DISCUSSION
Summary
This study describes the development of an intervention that is feasible and acceptable to potential recipients, and worthy of further evaluation. The experience gathered in this intervention developmental process has clear implications for others seeking to develop similar interventions.
First, considerable care and thought should be expended in the formation of any multidisciplinary group tasked with devising an intervention such as this. The apparent success of the study’s developmental process, it is believed, was based in large part on the sound theoretical underpinning of the intervention elements, which, at the same time, was tempered with the practical experience and insights of clinicians used to working with these patient groups. Second, the theoretical development of the intervention was iterative, with much discussion, questioning, and refinement of individual components before they developed a concrete form. This ensured shared understanding amongst the multidisciplinary group, which was an essential prerequisite for further refinement once the perspectives of end-users were available. Third, once the intervention had been devised, rather than proceeding directly to a pilot exercise that would have required considerable resources, the study explored the theoretical intervention in focus groups with GPs, high-risk patients, and patients with lung cancer, essentially the end-users of the intervention. As a result, the study was able to effect several refinements that are believed to be likely to improve the intervention. The authors suggest that such exploratory piloting may be a more efficient and cost-effective approach than moving straight to a potentially costly practical pilot exercise. Furthermore, the authors believe that this approach provides a template for others wishing to develop complex healthcare interventions.
Strengths and limitations
This study describes the development of an intervention underpinned by evidence, theory, and context, and with care taken over wording, presentation, and delivery. Although apparently comprising separate phases, the process was iterative. There was much refining and revising of ideas before the first draft of the intervention emerged, and once the data from focus groups and interviews had been analysed, the expert group was again able to contribute to the fine tuning of the intervention. An iterative process in intervention development has been used and recommended previously by the researchers.38 Full engagement of a multidisciplinary team with both theoretical and clinical expertise helped to ensure the intervention was grounded both theoretically and in its context of delivery. Formal consultations (qualitative research) with patients and professionals allowed many of the potential strengths and weaknesses of the intervention to be identified, confirmed, and addressed before it was rolled out to patients. Preparatory work with general practices ensured that the potential barriers faced by patients in securing a GP appointment were taken into account. Care was taken to ensure the intervention was attractive and wording was both easy to read and consistent with underlying theory and evidence. Training in delivery with a clear plan for the way the work of the intervention is actually done by the nurses in the consultations, developed with involvement of the nurses themselves, and supported by a training programme. This should help to ensure fidelity in delivery.39 Finally, the specification of the active behaviour change techniques and of the mode of delivery makes it more likely that the intervention is replicable by different investigators as per the WIDER Recommendations to Improve Reporting of the Content of Behaviour Change Interventions.40 A further strength worth highlighting is that the detailed development methods presented here could form a template or structure for others developing complex interventions. The processes engaged in that added strength to the intervention are summarised in Box 1.
Box 1. Summary of processes engaged in to develop the intervention
Full engagement of multidisciplinary team with both theoretical expertise and clinical expertise in general practice, secondary care of chest problems, and behaviour change.
An iterative process where each stage built on previous stages.
Use of evidence about patterns of consultation and delay in lung cancer.
A theoretical basis that drew on a range of disciplines including primary care, sociology, and health psychology.
Use of well-specified active ingredients of behaviour change (behaviour change techniques).
Consultation with patients.
Consultation with health professionals.
Gaining celebrity endorsement.
Developing a workbook with good readability and attractiveness.
Preparatory work with the general practices involved.
Development of a clear plan for the work done by the nurses in the consultations with patients.
Training of the nurses conducting the consultations.
Replicable intervention based on specified behaviour change techniques, mode of delivery, self-help manual, and training script for the person delivering the intervention.
The study had some limitations. The involvement of patients was only as participants in the qualitative research, not as members of the expert group, and the involvement of secondary care practitioners was only as members of the expert group, not as participants in the qualitative research. It is possible that including patients in the expert group may have had benefits, such as helping with the language of the intervention, while interviewing more secondary care practitioners may have revealed more issues for them, such as effects on secondary care workload. The study elected not to select a single psychological theory to underpin their intervention, but rather took elements from several theories (as described in Table 2) that best fitted the empirical evidence. While this approach may be criticised as not being theoretically pure, it draws from recent research grouping constructs from different theories into ‘construct domains’ and identifying behavioural change techniques for each domain.36, 42
Implications for practice and research
This intervention has been carefully designed to accord with the ideas, concerns, and expectations of patients and health professionals in Northeast Scotland. It has a mechanism of action that has the theoretical potential for benefit. Now it requires evaluation.