Key messages regarding feasibility

  • At the start of this process, there were uncertainties around the feasibility of:

    • Reaching and recruiting the target group (men on active surveillance for prostate cancer)

    • Creating an accessible and acceptable intervention

  • Key feasibility findings:

    • Men on active surveillance for prostate cancer would like additional support and are willing to take part in online and group-based sessions

  • The research activities carried out in the intervention planning and development phases have optimised the acceptability of the proposed intervention.

Background

Prostate cancer prevalence is high in the UK [1] and affects around one in eight men [2]. Treatment options include surgery, radiotherapy and hormone therapy, but for men with localised, low-risk prostate cancer, active surveillance (AS), a pathway that involves monitoring biological markers of the disease for progression, is also an option. AS aims to reduce overtreatment and comes without the unwanted side effects of interventional treatment, such as urinary incontinence and erectile dysfunction [3]. However, research has shown AS may have a negative impact on psychological wellbeing with patients experiencing heightened levels of anxiety [4,5,6], illness uncertainty, hopelessness [7] and distress [8].

Few studies have explored the unmet psychological needs of men on AS and ways in which wellbeing could be improved [9], and to our knowledge, there are no existing interventions available to support men on AS. The limited qualitative evidence suggests men on AS find AS-related information inadequate and inconsistent [9] and experience unmet psychological and emotional needs [9], and spousal support is important for AS acceptance [10]. Furthermore, anxiety and uncertainty are two key reasons men choose to discontinue AS and pursue interventional treatments in the absence of changes to tumour status [11, 12], risking treatment side effects. Research in the area of AS-related psychological wellbeing is vital to ensure patients have the information and tools that will allow them to better cope with this treatment pathway.

Best practice guidance recommends taking a ‘person-based’ approach (PBA) when developing behavioural interventions [13]. The PBA is an established method used to optimise interventions, providing a clear process to ground interventions in the perspectives and psychosocial context of the target user group. The PBA recommends comprehensive qualitative research with the target user group to explore their experiences and create a picture of the challenges they face, and in turn the things that are likely to influence a target behaviour. Exploration of the key beliefs target users hold, for example, about their condition, its management or treatment, is important to gain an understanding of what might facilitate or prevent change. Taking this approach, the target users’ needs and preferences can influence the content, structure and overall design of the intervention, ultimately improving the intervention’s feasibility, acceptability and user engagement [14]. Intervention developers are utilising PBA techniques increasingly [15,16,17]; however, there is a lack of literature providing replicable, worked examples of intervention development using the PBA.

This paper describes four previously published research activities, bringing them together to demonstrate how they contributed to the planning and development process of PROACTIVE, a psycho-educational intervention for men with localised prostate cancer on active surveillance, consisting of parallel group-support and web-based sessions. It aims to describe the methodology needed to plan such an intervention, presenting a demonstration of how to develop an intervention using a PBA. The resulting intervention has been trialled in a feasibility study, the results of which are published elsewhere [18].

Methods

Using the person-based approach to guide PROACTIVE planning

The PBA is flexible and non-prescriptive and can be utilised alongside evidence-based approach methods and theory. The PBA provides an established methodological framework for the intervention planning process [13].The approach consists of two key stages. The first involves gathering information from the target audience to gain an insight into what is wanted and needed, giving the researchers a deeper appreciation of the psychosocial context of the audience. This is an iterative process used to continually refine the intervention to promote acceptability and to encourage adherence and engagement.

The second stage is the creation of ‘key guiding principles’. These consist of (a) key intervention design objectives and (b) key distinctive features of the intervention needed to achieve objectives. These principles aim to keep the design and development process on track by providing the research team with a summary of objectives to be referred to at each stage of the process.

The planning process commenced with a systematic review and meta-analysis of depression and anxiety in PCa. This was an evidence gathering activity aiming to improve understanding about the prevalence and magnitude of psychological distress in men with PCa (not specific to AS).

Using the PBA framework, the following activities were subsequently conducted to facilitate our understanding of psychological distress specific to those on the AS pathway, the interventions that have been trialled previously and the supportive care needs of the target audience:

  • A cross-sectional survey on depression and anxiety in active surveillance

  • A review of existing interventions in the field

  • A qualitative study with the target audience

These components facilitated the creation of key guiding principles and a logic model to guide the intervention development.

Table 1 shows the stages recommended by the PBA for intervention planning and development (columns 1 and 2) alongside an overview of the development of PROACTIVE (column 3) to show how the PBA process was implemented. Each activity will be described in depth in the next section.

Table 1 PBA implementation in PROACTIVE
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Intervention planning

In this section of the paper, we describe the data gathering activities we undertook to consolidate our understanding of the issue (reduced psychological wellbeing in men on AS for PCa), and accumulate ideas about what might be helpful to this population. Table 2 provides an overview of these activities.

Table 2 Data gathering activities and relevance to PROACTIVE planning
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Table 3 Self-care psychological interventions targeting prostate cancer patients
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Table 4 Key findings from the qualitative study
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Intervention design

In this section of the paper, we describe how the data gathered in the ‘Intervention planning’ section was used to design the intervention, and how the creation of the ‘key guiding principles’ and ‘logic model’ facilitated this process.

Key guiding principles

Using the information gathered during the intervention planning phase, the research team developed a set of key guiding principles, in line with the PBA approach. The purpose of this is to summarise the design objectives and how these will be achieved, to facilitate quick and easy reference throughout the planning and development phase to guide and focus the decision making around intervention content and design [13]. Table 5 outlines the three intervention design objectives along with the key features of the intervention designed to address each objective.

Table 5 Key guiding principles
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Developing a logic model

The MRC complex intervention guidelines [38] recommend the development of a logic model to outline the hypothesised causal mechanisms involved in bringing about change in men on AS for PCa. The logic model (Fig. 1) demonstrates how we anticipate the intervention will result in improved psychological wellbeing.

Fig. 1
figure 1

Logic model

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Public and patient involvement.

Three patient and public involvement (PPI) contributors with PCa were involved in the intervention planning and development process. The research team met with the contributors every 4–8 weeks to provide progress updates and gain feedback on ideas and written materials. PPI contributors reviewed and commented on the online and workshop content and were involved in all key decisions. The involvement of the PPI contributors ensured developing study materials were likely to be acceptable, understandable and relevant to the target audience.

Results

The PROACTIVE prototype

The prototype intervention was named PROACTIVE – ‘PROstate ACTIVE surveillance support’. The intervention consisted of two parts:

  1. 1)

    An online programme consisting of six sessions designed to be completed on a weekly basis.

  2. 2)

    A face-to-face group support programme with three sessions, spread across six weeks, held fortnightly and each lasting 60–90 min.

The web-based programme and the group support sessions interlink and are designed to run in parallel over 6 weeks, complementing each other; for example, the online sessions introduce topics that will be further discussed in the following group session, and the online sessions reinforce the information covered in previous group sessions. Figure 2 shows the intervention as a whole over the 6 week time period. See Table 6 for a detailed description of the session content.

Fig. 2
figure 2

The PROACTIVE intervention

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The intervention

Table 6 details the content of each of the web-based and face-to-face group sessions delivered over the 6-week period.

Table 6 The intervention
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Think aloud interviews to refine PROACTIVE

Identified by the PCaSO charity (Prostate Cancer Support Organisation), 2 men with prostate cancer took part in think aloud interviews. This process involved each participant working their way through the PROACTIVE prototype whilst simultaneously speaking aloud their thoughts about the programme. Statements such as ‘can you tell me what you think about this page?’ and ‘can you tell me why you chose that option?’ were used as prompts to elicit participants’ opinions on the intervention. Interviews were audio recorded, and participants’ thoughts and opinions were collated and used to amend the prototype to be used in the feasibility study. Table 7 provides a summary of these changes.

Table 7 Summary of changes from think aloud interviews
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PROACTIVE ready for feasibility study

The amended intervention became the final version for the feasibility study. Figure 3 shows some screenshots from the web-based sessions.

Fig. 3
figure 3

PROACTIVE screenshots

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The feasibility study has been conducted, and the results published elsewhere [18].

Discussion

Summary

This paper demonstrates how we used the PBA to develop an Internet- and group-based psycho-educational behavioural intervention for men on AS for PCa. The process of gathering, understanding and utilising target-user needs and perspectives has long been viewed as essential within the eHealth research community [39,40,41]. Intervention developers in the area of eHealth have undertaken this task in a variety of ways [42, 43]; however, until the publication of the PBA, there was no standardised approach or process to follow. Guided by the PBA, the researchers gained a context-specific understanding of the intervention elements likely to be needed to maximise participant acceptability and engagement.

Each component of our approach (see Table 1) added a valuable contribution to the development process. The systematic review and meta-analysis of depression and anxiety in prostate cancer provided a broad understanding of the prevalence of these conditions in PCa patients, and confirmed the dearth of literature specific to AS. Beginning to fill this gap in the literature, the cross-sectional survey on depression and anxiety in AS allowed us to narrow down the treatment pathway diversity in previous studies and focus on men on AS. Men in this survey displayed significant levels of distress, reinforcing the value of the proposed intervention. Reviewing existing interventions in the field provided a way of seeing what has and has not been successful in the past, and an understanding of the elements that may increase the success of the proposed intervention. The qualitative study gave us the opportunity to explore the supportive care needs of this user group in an in-depth way providing focussed direction for the intervention and a way of identifying any gaps.

Integrating the results from these 4 components we were able to create a set of key guiding principles. The key guiding principles summarised the design objectives and provided focus for decision making. Our logic model provided a visual representation of how the intervention might work, displaying the intervention ingredients and how these translate into the causal mechanisms likely to bring about change.

Armed with the understanding gained from the abovementioned processes, we were able to create the prototype PROACTIVE intervention. The think-aloud interviews provided further clarity, and the minor changes made due to the results of these interviews improved our confidence in the intervention.

This methodological approach is rigorous but flexible. For other interventions, the stages and processes may differ depending on the context of the intervention [15, 16, 44, 45], for example, if there is already a large base of existing qualitative research, new qualitative research may not be necessary.

Strengths, limitations and future research

Treatment for PCa is a rapidly changing and advancing field, for example, medical technology and the accuracy of diagnostic tests continually being improved. For this reason PCa interventions (including PROACTIVE) would need to be updated regularly to stay current and accurate. The advantage of this development process is that it has produced a core product based on a rigorous transparent process with clear guiding principles that can easily be shared, adapted and updated, negating the need to repeatedly start from scratch.

The PBA recommends incorporating behavioural science into the development of interventions by integrating a ‘theory-based’ approach with the PBA processes as best practice. In this instance, this was not possible due to time and resource constraints. Further research conducting theory-based processes, and mapping the findings to the intervention, identifying any gaps, would be beneficial to potentially strengthen the intervention.

Conclusion

This paper outlines the stages we followed using the PBA to develop the PROACTIVE intervention. The planning and development process is key to successful delivery of an appropriate accessible intervention. This meticulous description in a clinical setting using this rigorous but flexible method is a useful demonstration for others developing similar interventions.