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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
5/12/2024

Titles & IDs
Public title
PIECES - Towards Large-Scale Adaptation and Tailored Implementation of Primary Cancer Prevention Programs
Scientific title
Towards Large-Scale Adaptation and Tailored Implementation of Primary Cancer Prevention Programs Across 9 Countries
Secondary ID [1] 0 0
Project 101104390
Universal Trial Number (UTN)
Trial acronym
PIECES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Focus of Study: Tailored Implementation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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/
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Competencies in Implementation
Timepoint [1] 0 0
Month 0, repeated every six months until month 24.
Secondary outcome [1] 0 0
Organizational Readiness for Implementing Change (ORIC)
Timepoint [1] 0 0
Month 0, repeated every six months until month 24.
Secondary outcome [2] 0 0
Perceived Ease of Use
Timepoint [2] 0 0
Month 6, repeated every six months until month 24.
Secondary outcome [3] 0 0
Perceived Usefulness
Timepoint [3] 0 0
Month 6, repeated every six months until month 24.
Secondary outcome [4] 0 0
Satisfaction with the PCP-IT
Timepoint [4] 0 0
Month 6, repeated every six months until month 24.
Secondary outcome [5] 0 0
Perceived impact of the PCP-IT
Timepoint [5] 0 0
Month 6, repeated every six months until month 24.
Secondary outcome [6] 0 0
Behavioral Intention
Timepoint [6] 0 0
Month 6, repeated every six months until month 24.

Eligibility
Key inclusion criteria
* User of the PCP-IT, involved in implementation of PCP programs.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* None.

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The University of Queensland - St Lucia
Recruitment postcode(s) [1] 0 0
- St Lucia
Recruitment outside Australia
Country [1] 0 0
Albania
State/province [1] 0 0
Tirana
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Germany
State/province [3] 0 0
Hannover
Country [4] 0 0
Germany
State/province [4] 0 0
Heidelberg
Country [5] 0 0
Ireland
State/province [5] 0 0
Limerick
Country [6] 0 0
Italy
State/province [6] 0 0
Florence
Country [7] 0 0
Netherlands
State/province [7] 0 0
Utrecht
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona
Country [9] 0 0
Ukraine
State/province [9] 0 0
Kyiv
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Stirling

Funding & Sponsors
Primary sponsor type
Other
Name
Hidde van der Ploeg
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Helse Bergen Hospital Trust
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Stichting Trimbos-Instituut
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Hannover Medical School
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Universiteti i Tiranes
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Public Health Center of MOH of Ukraine
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
German Cancer Research Center
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
University of Stirling
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
University of Limerick
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Institut d'Investigació Biomèdica de Bellvitge
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
German Network for Tobacco Free Healthcare Services
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
The University of Queensland
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Dreamedsoft Solutions
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Catalan Institute of Oncology, Barcelona
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Istituto per lo Studio, la Prevenzione e la Rete Oncologica
Address [14] 0 0
Country [14] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06718322
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.
Public notes

Contacts
Principal investigator
Name 0 0
Femke van Nassau, PhD
Address 0 0
Amsterdam UMC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rixt Smit, MSc
Address 0 0
Country 0 0
Phone 0 0
+31621247582
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06718322