Clinical trial NCT06718322: PIECES - Towards Large-Scale Adaptation and Tailored Implementation of Primary Cancer Prevention Programs
Official title: Towards Large-Scale Adaptation and Tailored Implementation of Primary Cancer Prevention Programs Across 9 Countries
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Focus of Study: Tailored Implementation
Keywords: PIECES
Tailored implementation
Implementation support
PCP-IT
Primary Cancer Prevention
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Helse Bergen Hospital Trust
name: Stichting Trimbos-Instituut
name: Hannover Medical School
name: Universiteti i Tiranes
name: Public Health Center of MOH of Ukraine
name: German Cancer Research Center
name: University of Stirling
name: University of Limerick
name: The University of Queensland
name: Institut Català d'Oncologia
name: Istituto per lo Studio, la Prevenzione e la Rete Oncologica
name: Institut d'Investigació Biomèdica de Bellvitge
name: Dreamedsoft Solutions
name: German Network for Tobacco Free Healthcare Services
First posted: 2024-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study evaluates an implementation intervention targeting professionals implementing a cancer prevention program. The intervention is an online toolkit that supports implementers in selecting and adapting an evidence-based cancer prevention program and developing a tailored implementation plan.
Primary purpose: OTHER

Brief summary: The PIECES project aims to evaluate the Primary Cancer Prevention Implementation Toolkit (PCP-IT), an online implementation support toolkit that aids implementation teams in improving the implementation of primary cancer prevention programs (PCPs).

The primary aim of the PIECES study is to support and learn from the process of selecting, adapting, and implementing existing evidence-based programs to improve implementation outcomes and by that, improve the reach and effectiveness of primary cancer prevention programmes in real-world settings.

The study objectives are:

1. To assess whether the PCP-IT is usable and if implementation teams are satisfied with the tool;
2. To assess what works for whom in using the PCP-IT for selecting, adapting, and implementing PCP programs;
3. To assess whether the PCP-IT is feasible and effective in improving acceptability, adoption, penetration, and sustainable implementation of the PCP programs.

The PCP-IT will be used by various implementation settings across 9 countries (8 European countries and Australia). A multi-site case comparison design is used to generate in-depth knowledge about the performance and working mechanisms of the PCP-IT. Similarities, differences, and patterns across the different implementation sites will be investigated using a Realist Evaluation approach.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* User of the PCP-IT, involved in implementation of PCP programs.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Competencies in Implementation
timeFrame: Month 0, repeated every six months until month 24.
Secondary outcomes:
measure: Organizational Readiness for Implementing Change (ORIC)
timeFrame: Month 0, repeated every six months until month 24.
measure: Perceived Ease of Use
timeFrame: Month 6, repeated every six months until month 24.
measure: Perceived Usefulness
timeFrame: Month 6, repeated every six months until month 24.
measure: Satisfaction with the PCP-IT
timeFrame: Month 6, repeated every six months until month 24.
measure: Perceived impact of the PCP-IT
timeFrame: Month 6, repeated every six months until month 24.
measure: Behavioral Intention
timeFrame: Month 6, repeated every six months until month 24.
Other outcomes:
Locations:
city: Tirana
country: Albania
facility: Universiteti i Mjekesise Tirane
city: St Lucia
country: Australia
facility: The University of Queensland
city: Berlin
country: Germany
facility: German Network for Tobacco Free Healthcare Services
city: Hannover
country: Germany
facility: Hannover Medical School
city: Heidelberg
country: Germany
facility: German Cancer Research Center (DFKZ)
city: Limerick
country: Ireland
facility: University of Limerick
city: Florence
country: Italy
facility: ISPRO
city: Utrecht
country: Netherlands
facility: Trimbos Instituut
city: Barcelona
country: Spain
facility: Catalan Institute of Oncology
city: Kyiv
country: Ukraine
facility: State Institution Public Health Center of the Ministry of Health of Ukraine
city: Stirling
country: United Kingdom
facility: University of Stirling
Study officials:
affiliation: Amsterdam UMC
name: Femke van Nassau, PhD
role: STUDY_CHAIR
References:
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citation: Padek M, Colditz G, Dobbins M, Koscielniak N, Proctor EK, Sales AE, Brownson RC. Developing educational competencies for dissemination and implementation research training programs: an exploratory analysis using card sorts. Implement Sci. 2015 Aug 12;10:114. doi: 10.1186/s13012-015-0304-3.
citation: Shea CM, Jacobs SR, Esserman DA, Bruce K, Weiner BJ. Organizational readiness for implementing change: a psychometric assessment of a new measure. Implement Sci. 2014 Jan 10;9:7. doi: 10.1186/1748-5908-9-7.