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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06718322
Registration number
NCT06718322
Ethics application status
Date submitted
13/11/2024
Date registered
5/12/2024
Date last updated
9/04/2025
Titles & IDs
Public title
PIECES - Towards Large-Scale Adaptation and Tailored Implementation of Primary Cancer Prevention Programs
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Scientific title
Towards Large-Scale Adaptation and Tailored Implementation of Primary Cancer Prevention Programs Across 9 Countries
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Secondary ID [1]
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Project 101104390
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Universal Trial Number (UTN)
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Trial acronym
PIECES
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Focus of Study: Tailored Implementation
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Primary Cancer Prevention Implementation Toolkit (PCP-IT)
Experimental: Local implementation teams - The local implementation teams for this study, referred to as the implementers of the Primary Cancer Prevention Implementation Toolkit (PCP-IT), are the primary users of the toolkit and play a central role in tailoring and implementing cancer prevention interventions. Each team is responsible for selecting and adapting the intervention to meet local needs and developing a tailored implementation plan. Each team is led by an implementation lead, who directly oversees the implementation process and ensures the team effectively uses the PCP-IT to guide their work. In some cases, the implementation lead may also serve as the implementation coordinator. The coordinator's role is to provide higher-level oversight and may involve coordinating multiple implementation teams across various locations, such as hospitals, or focusing on a single team at one site.
Other interventions: Primary Cancer Prevention Implementation Toolkit (PCP-IT)
The PCP-IT is an online implementation support toolkit which 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 which 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 toolkit includes: (1) a repository of PCP 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. https://global.itfits-toolkit.com/
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Competencies in Implementation
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Assessment method [1]
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Participants are asked to rate how skilled they feel in various implementation competencies. Respondents evaluate their skills for each item on a 5-point Likert scale, ranging from not at all to extremely (not at all, slightly, moderately, very, extremely).
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Timepoint [1]
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Month 0, repeated every six months until month 24.
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Secondary outcome [1]
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Organizational Readiness for Implementing Change (ORIC)
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Assessment method [1]
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Participants are asked to indicate how they perceive the readiness of their organization to implement a cancer prevention program. This is assessed using the Organizational Readiness for Implementing Change (ORIC) instrument, which includes 12 items about an organizational readiness to implement a cancer prevention program. Respondents rate their level of agreement with each item on a 5-point Likert scale, ranging from I disagree to I agree (I disagree, I somewhat, disagree, Neither agree nor disagree, I somewhat agree, I agree).
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Timepoint [1]
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Month 0, repeated every six months until month 24.
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Secondary outcome [2]
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Perceived Ease of Use
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Assessment method [2]
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Participants are asked to indicate their agreement with 4 items about how useful they perceive the toolkit to be in their job. This is assessed using the Perceived Ease of Use instrument. Respondents rate their level of agreement with each item on a 7-point Likert scale, ranging from I strongly disagree to I strongly agree (I strongly disagree, I disagree I somewhat, disagree, Neither agree nor disagree, I somewhat agree, I agree, I strongly agree).
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Timepoint [2]
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Month 6, repeated every six months until month 24.
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Secondary outcome [3]
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Perceived Usefulness
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Assessment method [3]
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Participants are asked to indicate their agreement with 4 items about how easy they think it is to work with the toolkit. This is assessed using the Perceived Usefulness instrument. Respondents rate their level of agreement with each item on a 7-point Likert scale, ranging from I strongly disagree to I strongly agree (I strongly disagree, I disagree I somewhat, disagree, Neither agree nor disagree, I somewhat agree, I agree, I strongly agree).
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Timepoint [3]
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Month 6, repeated every six months until month 24.
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Secondary outcome [4]
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Satisfaction with the PCP-IT
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Assessment method [4]
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Participants are asked to rate their satisfaction with the toolkit using a Visual Analogue Scale (VAS). Respondents provide a score reflecting their satisfaction with specific modules or components of the toolkit. The VAS ranges from 0 to 10, where 0 represents no satisfaction, 5 represents neutral, and 10 represents extreme satisfaction.
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Timepoint [4]
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Month 6, repeated every six months until month 24.
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Secondary outcome [5]
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Perceived impact of the PCP-IT
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Assessment method [5]
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Participants are asked to rate the extent to which they think the toolkit has contributed to various implementation steps using a Visual Analogue Scale (VAS). The VAS ranges from 0 to 10, where 0 represents non-existent, 5 represents somewhat, and 10 represents very much.
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Timepoint [5]
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Month 6, repeated every six months until month 24.
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Secondary outcome [6]
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Behavioral Intention
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Assessment method [6]
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Participants are asked to indicate their agreement with 4 items about their intention or likelihood of using the toolkit in the future. This is assessed using the Behavioral Intention instrument. Respondents rate their level of agreement with each item on a 7-point Likert scale, ranging from I strongly disagree to I strongly agree (I strongly disagree, I disagree I somewhat, disagree, Neither agree nor disagree, I somewhat agree, I agree, I strongly agree).
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Timepoint [6]
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Month 6, repeated every six months until month 24.
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Eligibility
Key inclusion criteria
* User of the PCP-IT, involved in implementation of PCP programs.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* None.
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Study design
Purpose of the study
Other
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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The University of Queensland - St Lucia
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Recruitment postcode(s) [1]
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- St Lucia
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Recruitment outside Australia
Country [1]
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Albania
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State/province [1]
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Tirana
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Germany
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State/province [2]
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Berlin
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Germany
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Hannover
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Germany
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Heidelberg
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Ireland
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State/province [5]
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Limerick
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Italy
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State/province [6]
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Florence
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Netherlands
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State/province [7]
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Utrecht
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Spain
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State/province [8]
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Barcelona
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Ukraine
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State/province [9]
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Kyiv
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Country [10]
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United Kingdom
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State/province [10]
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Stirling
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Funding & Sponsors
Primary sponsor type
Other
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Name
Hidde van der Ploeg
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Helse Bergen Hospital Trust
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Stichting Trimbos-Instituut
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Other collaborator category [3]
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Other
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Name [3]
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Hannover Medical School
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Other collaborator category [4]
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Other
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Name [4]
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Universiteti i Tiranes
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Other collaborator category [5]
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Other
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Name [5]
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Public Health Center of MOH of Ukraine
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Other collaborator category [6]
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Other
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Name [6]
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German Cancer Research Center
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Other collaborator category [7]
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Other
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University of Stirling
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Other
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University of Limerick
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Other
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The University of Queensland
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Other
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Institut Català d'Oncologia
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Other
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Istituto per lo Studio, la Prevenzione e la Rete Oncologica
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Other
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Institut d'Investigació Biomèdica de Bellvitge
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Other collaborator category [13]
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Other
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Dreamedsoft Solutions
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Other
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German Network for Tobacco Free Healthcare Services
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06718322
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Trial related presentations / publications
Vis C, Schuurmans J, Aouizerate B, Atipei Craggs M, Batterham P, Buhrmann L, Calear A, Cerga Pashoja A, Christensen H, Dozeman E, Duedal Pedersen C, Ebert DD, Etzelmueller A, Fanaj N, Finch TL, Hanssen D, Hegerl U, Hoogendoorn A, Mathiasen K, May C, Meksi A, Mustafa S, O'Dea B, Oehler C, Piera-Jimenez J, Potthoff S, Qirjako G, Rapley T, Rosmalen J, Sacco Y, Samalin L, Skjoth MM, Tarp K, Titzler I, Van der Eycken E, van Genugten CR, Whitton A, Zanalda E, Smit JH, Riper H. Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial. J Med Internet Res. 2023 Feb 3;25:e41532. doi: 10.2196/41532. 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Femke van Nassau, PhD
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Address
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Amsterdam UMC
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Fax
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Email
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Contact person for public queries
Name
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Rixt Smit, MSc
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Address
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Phone
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+31621247582
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06718322
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