PIECES - Towards Large-Scale Adaptation and Tailored Implementation of Primary Cancer Prevention Programs

A range of modifiable factors are associated with cancer incidence among the population of the European Union (EU) and beyond. These include: 1) tobacco smoking and exposure to second-hand smoke, 2) alcohol consumption, 3) poor physical activity, 4) HPV infection, 5) sun exposure, and 6) poor diet. Various Primary Cancer Prevention (PCP) programs are currently available to address these risk factors with proven effectiveness. Decision-makers and implementers face the challenge of: 1) selecting appropriate and suitable programs, 2) tailoring the programs to the local context and consulting stakeholders, and 3) developing a tailored plan (i.e., strategies) for effectively implementing the selected and adapted PCP program. The lack of guidance and support for this complex and time-consuming process leads to two undesired outcomes: 1) the selection of ineffective or poorly adapted PCP programs, and 2) the application of ineffective implementation strategies that do not target local and context-dependent barriers to implementation. These scenarios are likely to reduce the effectiveness of primary cancer prevention programs in real-world settings, leading to inefficiencies and failing to prevent new cancer cases.

The PIECES project involves the development and evaluation of an online implementation support toolkit (the Primary Cancer Prevention Implementation Toolkit (PCP-IT)). The PCP-IT aims to support implementation teams in improving the implementation of primary cancer prevention programs (PCPs). The PCP-IT builds upon the theory-base and the proven to be effective ItFits tool. The PCP-IT encompasses a total of six modules. The modules are designed to guide implementers through the process of selecting and adapting PCP programs, identifying and addressing barriers, and developing and applying tailored implementation strategies. The core resources contributing to the generative mechanisms of the toolkit include: 1) a repository of primary cancer prevention programs, 2) a repository of determinants of practice, 3) a repository of implementation strategies, 4) stakeholder consultation at all stages, 5) an online community of implementation practitioners, and 6) structured stepped process flows, instructions, examples and worksheets for working with the materials.

In the PIECES study, a multi-site case comparison design is chosen to generate in-depth knowledge about the performance and working mechanisms of the PCP-IT. Similarities, differences, and patterns across the cases (i.e. different implementation settings) will be investigated using a Realist Evaluation approach. A pre/post-test measure will be applied to descriptively assess implementation outcomes. A time horizon of two years is selected to assess change over time.

The PCP-IT will be used in various countries and implementation settings, aiming for a rich representation of healthcare systems (Spain, the Netherlands, Albania, the United Kingdom, Ireland, Italy, Ukraine, Germany (3 settings), and Australia).

Within each implementation site, different types of participants with specific roles can be distinguished:

1. implementation coordinator: oversees the implementation process and can coordinate one or multiple implementation teams. 2. implementation lead: oversees the implementation process of one implementation team and is part of that team. This person is responsible for working through the PCP-IT with their implementation team. It is possible that the implementation coordinator and implementation lead is the same person. 3. implementation core team: the implementation team consists of the toolkit users who are the group responsible for selecting and adapting the PCP, as well as developing a tailored implementation plan. 4. service deliverers: the team/persons responsible for the actual implementation of the selected PCP and tailored implementation strategies.

The PCP-IT will be evaluated through various levels of evalution, with a primary focus on evaluating the use of the PCP-IT and implementation outcomes of the PCP programs.

1. PCP-IT: evaluating the use of the PCP-IT by the implementation teams. 2. PCP implementation: evaluating implementation outcomes of the implemented PCP programs 3. PCP impact: evaluating the impact of the implemented PCP programs (in terms of changes in behaviour the PCP program is targeting) (conducted if feasible).

The primary focus of the evaluation study will be on evaluating the use of the PCP-IT (level 1) and the implementation outcomes of the PCP program (level 2). Level 3 evaluation, which involves evaluating the impact of the implemented PCP programs on targeted behavior changes, is not part of the central evaluation study. However, implementation sites are encouraged to conduct level 3 evaluations if resources such as time and funding permit. While level 3 evaluation is not critically necessary from a research perspective-since PCP programs included in the PCP-IT repository have already demonstrated effectiveness-it is important from a monitoring perspective. Conducting level 3 evaluations can for example help implementation sites to:

* Assess whether the adapted PCP programs are achieving the desired outcomes * Provide ongoing feedback to refine and improve the programs, ensuring the programs remain effective and relevant * Show stakeholders, including funders and participants, that the programs are making a tangible difference, thereby justifying continued support and investment.

For this third level of evaluation, the specific details and ethical approvals are managed by each local implementation site. However, recommendations grounded in previous research are provided to guide the process and help maintain consistency across sites.

• Organizational Readiness for Implementing Change (ORIC) [Time frame: Month 0, repeated every six months until month 24.]
• Perceived Ease of Use [Time frame: Month 6, repeated every six months until month 24.]
• Perceived Usefulness [Time frame: Month 6, repeated every six months until month 24.]
• Satisfaction with the PCP-IT [Time frame: Month 6, repeated every six months until month 24.]
• Perceived impact of the PCP-IT [Time frame: Month 6, repeated every six months until month 24.]
• Behavioral Intention [Time frame: Month 6, repeated every six months until month 24.]