Overview of the intervention planning process

Figure 2 provides an overview of the intervention planning process, which was based on an integrated evidence-, theory- and person-based approach.24,25,26 The person-based approach draws on qualitative research with target users to ensure that interventions are grounded in a detailed understanding of the user and their psychosocial context. This enables interventions to be accessible, acceptable, persuasive and motivating.24

Fig. 2 The key elements of the Renewed intervention planning process, which began with a rapid scoping review of the literature (panel 1). The results of the scoping review then informed the guiding principles (panel 2), behavioural analysis (panel 3), and logic model (panel 4). In turn, these informed the prototype of renewed (panel 5), which was then refined in two qualitative optimisation studies, the first with patients (panel 6) and the second with NHS and cancer charity workers (panel 7) Full size image

When creating Renewed, we were able to adapt two of our existing digital interventions: POWeR+ for weight management41 and Healthy Paths for distress management.42 Intervention planning for Renewed therefore focussed on creating content to support physical activity and healthy eating, plus an introduction to raise motivation and guide users in choosing which healthy changes would suit them best.

Intervention planning first drew on the existing evidence base through a rapid scoping review of barriers and facilitators to the success of interventions that aim to improve QoL in cancer survivors. Review findings informed the development of ‘guiding principles’,24 theory-based ‘behavioural analysis’27 and ‘logic modelling’.43 Guiding principles are part of the person-based approach to intervention planning and draw on existing evidence to identify key needs of target users’, which can be used to identify intervention components necessary to meet users’ needs.24 Theory-based behavioural analysis27 and logic modelling43 were employed to provide a comprehensive description of the intervention and its potential mechanisms of action.

The intervention development team included six PPI representatives who were survivors of breast, prostate or colon cancer, two experts in the area of cancer survivorship research, one expert in cancer survivorship services and research, two health psychologists, seven research psychologists, two general practitioners (GPs), one human–computer interaction researcher and a physical activity expert. Regular meetings with all members of the intervention development team (including PPI members) were used to discuss and agree the intervention plan and prototype materials.

The planning of Renewed began in December 2015 with a rapid scoping review. Searches were conducted from December 2015 to January 2016; the review findings informed the intervention’s Guiding Principles in March 2016. We began writing intervention content in April 2016 and by July 2016 we had created a prototype website. We then began optimising Renewed, which continued until the September of 2017, this began with qualitative optimisation study 1 (with patients), followed by optimisation study 2 (with healthcare practitioners and cancer charity workers), followed by final in-house testing of the website to ensure that all navigation and emails worked as intended before entering into our RCT evaluation. During the period of optimisation, we wrote and programmed all the email content for Renewed and also completed the behavioural analysis and logic model.

Rapid scoping review

The timetable for intervention development demanded a rapid review of the literature, so a rapid scoping review was conducted.39,44 Rapid scoping reviews aim to efficiently map key findings in a particular area, allowing exploration of a large breadth of research, without following all the steps involved in systematic reviews, such as appraising the quality of each included study,39 they are therefore ideally suited to inform intervention development where a broad view of the literature is needed quickly. Our review aimed to identify potential barriers and facilitators to the success of interventions aiming to improve QoL in cancer survivors. This included literature that would provide a detailed understanding of target users’ needs. A rapid scoping review allowed the inclusion of a range of study designs (e.g. qualitative studies of cancer survivors’ experiences) that would be useful for addressing our aims, unlike traditional systematic reviews that tend to focus on RCT evidence to answer narrower questions about efficacy.39 We followed the five core steps set out by Arskey and O’Malley for rapid scoping reviews (identifying the research question, identifying relevant studies, study selection, charting the data and collating and reporting the results). We did not follow the optional sixth step (seeking expert consensus from various sources on the findings of the review to help refine them) as our timetable for intervention development did not allow this, although we did seek feedback from our PPI and expert development group, who were happy with our findings. We also conducted a qualitative synthesis that explored components of digital interventions for cancer survivors, which might influence uptake, acceptably, feasibility and effectiveness (reported elsewhere17—see Supplementary Table 1 for summary).

Searches were conducted in the Cochrane Library, DARE (1996–March 2015—when DARE stopped publication), Ovid MEDLINE (1996–November 2015) and PsycINFO (1996–November 2015), Box 1 outlines the search strategy and Fig. 3 provides a PRISMA flowchart. Originally, we limited searches to the past 20 years (as we had limited time). We found that more recent studies included more relevant interventions (for example, digital interventions were rare in the 90s). Further papers were identified by experts in the team and from reference lists of identified studies. We screened the search results for references that met the following criteria: qualitative or quantitative studies or reviews that reported experiences of cancer survivors or evaluations of interventions for cancer survivors who had completed primary treatment for breast, colorectal or prostate cancer, with needs relating to QoL (Fig. 1). We only read papers that were published in English, we did not review the grey literature or contact authors to search for additional papers. Data items were extracted (study date, design, intervention, potential barriers/facilitators) to a preliminary table to allow discussion between the team of barriers/factors, which could inform the Guiding Principles, Behavioural Analysis and Logic Model. A final table was produced that provided an overview of potential barriers and facilitators to the success of interventions, which aim to improve QoL in cancer survivors (see ‘Results’ section). We followed the PRISMA guidelines for reporting scoping reviews45 (see Supplementary Table 1 for checklist).

Fig. 3 A PRISMA flow diagram for the rapid scoping review. The first row shows the identification of potentially relevant literature, the second row describes the screening and the third row shows the number of papers assessed for eligibility and the number of full text papers read in full. The fourth row shows the number of studies included Full size image

Guiding principles

In line with our person-based approach, we developed brief ‘Guiding Principles’, which outlined what Renewed needed to contain in order to meet target users’ needs and maximise engagement.24 Drawing on our understanding of target users from our rapid scoping review, we identified key behavioural issues, needs or challenges that the intervention needed to address. We then formulated intervention ‘design objectives’ (i.e. what the intervention needed to include to meet users’ needs) and ‘key intervention features’, which intended to address each objective.

Behavioural analysis

The behavioural analysis involved using evidence from the review and expert consultation (with the multi-disciplinary team, including PPI) to identify potential barriers to each target behaviour (physical activity, diet and using the intervention). Intervention components that would address each barrier were then selected and coded using the Taxonomy of Behaviour Change Techniques,34 behavioural theory (BCW32) and implementation theory (NPT33) to provide a clear description of the digital intervention and enable comparison with other interventions. The BCW is a theoretical framework that provides an overview of intervention functions used in complex interventions to target key influences on behaviour.32 NPT highlights factors that are necessary for an intervention to be successfully implemented.33 Mapping onto these theoretical frameworks also allowed us to check that we had not missed any crucial potential barriers to intervention success.

Logic model

A logic model was developed based on findings from the rapid review and behavioural analysis, which outlined a testable model of the proposed mechanisms of action of the Renewed intervention (i.e. how the intervention is thought to work).27,43

Prototype intervention

Once the intervention planning had progressed sufficiently, we built a prototype of Renewed. An introductory session was designed to build motivation for engaging with behavioural changes, after this users could access the rest of Renewed: Getting Active (to increase physical activity), Eat for Health (to support a healthy diet based on increasing fruit, vegetables and whole grains and limiting saturated fats, sugar, alcohol, red and processed meats), Healthy Paths (support with feelings of distress, loss or fear of recurrence),42 and POWeR+ (for weight loss41). Table 4 outlines the intervention content.

Table 4 An overview of the Renewed digital intervention for patients Full size table

As human support can boost the effects of digital interventions,46 we wanted to test whether providing brief support could boost the effects of Renewed. The Renewed intervention therefore also needed to include a facility for participants to contact their ‘Supporter’. Renewed users will be offered three 10-min appointments (face-to-face/by telephone) with their Supporter. Support is based on the CARE (Congratulate, Ask, Reassure, Encourage) approach (detailed elsewhere47), designed to boost autonomous motivation and engagement by listening to participants and helping them to decide what they want to do, rather than giving advice. We developed online training to show Supporters how to use CARE (Table 5 provides an overview).

Table 5 Overview of prototype online Supporter Training Full size table

Intervention optimisation overview

After building the prototype of Renewed and the supporter training, we took a person-based approach to intervention optimisation.24 This involved conducting qualitative interviews with cancer survivors to identify intervention modifications needed to maximise engagement with the intervention and behaviour change. We also conducted focus groups with potential Supporters (cancer charity and NHS workers) to explore who might be most appropriate to provide support alongside Renewed and to identify barriers to implementation. These studies are described below and the COREQ checklist for both qualitative studies can be found in Supplementary Table 3.

Ethical approvals for both qualitative optimisation studies were gained from the University of Southampton (ref no. 191936) and NHS ethics committees (ref no. 17658). Written informed consent was obtained from all individual participants included in this manuscript.

Qualitative optimisation study 1—with cancer survivors

Thirty-two people who had completed treatment for breast, colorectal or prostate cancer in the past 10 years were recruited from GP practices in the South of England (see Table 6 for sample characteristics). Each participant took part in three qualitative think-aloud interviews, where they used Renewed while saying what they were thinking aloud. This enabled us to gauge immediate reactions to intervention content. Next, semi-structured interview questions explored what participants liked, disliked and thought should be changed within Renewed. Interviews were transcribed and used to inform intervention modifications. This process involved recording in a table all positive and negative perceptions of the intervention, to identify changes necessary to improve how acceptable, persuasive, motivating and likely to change behaviour the intervention was.40 When deciding whether to implement an intervention change, we considered whether each barrier was mentioned by more than one participant, whether the barrier was critical to behaviour change and whether the change was in line with Renewed’s Guiding Principles.40 We prioritised implementing changes that were viewed as crucial to behaviour change. Lower priority changes were made if they were quick and easy to implement. Occasionally, it was obvious that a potential intervention modification was essential even if negative feedback came from a single participant, as it would be very likely to influence behaviour change. At other times, more participant views were needed to decide whether a change was required. Potential changes were discussed within team meetings and agreed changes implemented. This was an iterative process whereby 3–5 participants were interviewed, feedback was tabulated and discussed, changes made to the intervention and then further interviews conducted. We continued this process until no further important required modifications were identified—a particular type of saturation specific to intervention development.40

Table 6 Characteristics of cancer survivors in qualitative optimisation study 1 Full size table

Qualitative optimisation study 2—with potential Supporters

Seven focus groups explored possible Supporters’ perceptions of potentially supporting cancer survivors using Renewed and the online training. Five focus groups were conducted with GP practice staff (nurses, GPs, healthcare assistants, N = 21; see Supplementary Box 2 for focus group schedule). Two focus groups were conducted with staff and volunteers from two cancer charities (N = 10) (charity names have been removed to protect the identities of the participants). Table 7 provides an overview of the participants who attended each focus group. Participant feedback was recorded in a table (as described in optimisation study 1) and informed modifications to the training; we continued until reaching saturation (as described in optimisation study 1). The data also helped us identify the most suitable supporters of Renewed to use in our trial.

Table 7 Focus group participant characteristics in qualitative optimisation study 2 Full size table

Box 1 Search strategy for rapid scoping review Search strategy • Combinations of terms for cancer or cancer survivorship, or rehabilitation (intervention or programme or self-management or self-management or health education or self-care or self-care or self-monit* or self monit* or surviv*), • Quality of life (quality of life) • Methodology (review or synthesis or meta-ethnography qualitative or grounded or interview or focus group* or ethnograph* or phenomenol* or view* or experience*). • Interventions (intervention or programme or self-management or self-management or health education or self-care or self-care or self-monit* or self monit*) • Technologies (internet or online or digital or web or e-health or computer or technolog* or telecommunication* or multimedia or PC or website or www or cellular phone or cell phone or mobile or smartphone or smart phone or electronic or ehealth or mhealth or m-health or telemedicine or text messag* or email or telehealth or teletherap* or telemonit*)

Reporting summary

Further information on research design is available in the Nature Research Reporting Summary linked to this article.