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

NCT06718322 | Enrolling By Invitation

• 1 other identifier: Project 101104390
• Study Type: interventional
• Target: 100
• Locations: 9 countries
• Sites: 11

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

Conditions

Focus of Study: Tailored Implementation

Keywords

PIECES; Tailored implementation; Implementation support; PCP-IT; Primary Cancer Prevention

Outcome Measures

Primary Outcomes (1)

• Competencies in Implementation

  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).

  Month 0, repeated every six months until month 24.

Secondary Outcomes (6)

• Organizational Readiness for Implementing Change (ORIC)

  Month 0, repeated every six months until month 24.

• Perceived Ease of Use

  Month 6, repeated every six months until month 24.

• Perceived Usefulness

  Month 6, repeated every six months until month 24.

• Satisfaction with the PCP-IT

  Month 6, repeated every six months until month 24.

• Perceived impact of the PCP-IT

  Month 6, repeated every six months until month 24.

Study Arms (1)

Local implementation teams

EXPERIMENTAL

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: Primary Cancer Prevention Implementation Toolkit (PCP-IT)

Interventions

Primary Cancer Prevention Implementation Toolkit (PCP-IT) OTHER

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/

Local implementation teams

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Hidde van der Ploeg: lead
• Helse Bergen Hospital Trust: collaborator
• Stichting Trimbos-Instituut: collaborator
• Hannover Medical School: collaborator
• Universiteti i Tiranes: collaborator
• Public Health Center of MOH of Ukraine: collaborator
• German Cancer Research Center: collaborator
• University of Stirling: collaborator
• University of Limerick: collaborator
• The University of Queensland: collaborator
• Institut Català d'Oncologia: collaborator
• Istituto per lo Studio, la Prevenzione e la Rete Oncologica: collaborator
• Institut d'Investigació Biomèdica de Bellvitge: collaborator
• Dreamedsoft Solutions: collaborator
• German Network for Tobacco Free Healthcare Services: collaborator

Study Sites (11)

Universiteti i Mjekesise Tirane

Tirana, Albania

Location

The University of Queensland

Saint Lucia, Australia

Location

German Network for Tobacco Free Healthcare Services

Berlin, Germany

Location

Hannover Medical School

Hanover, Germany

Location

German Cancer Research Center (DFKZ)

Heidelberg, Germany

Location

University of Limerick

Limerick, Ireland

Location

ISPRO

Florence, Italy

Location

Trimbos Instituut

Utrecht, Netherlands

Location

Catalan Institute of Oncology

Barcelona, Spain

Location

State Institution Public Health Center of the Ministry of Health of Ukraine

Kyiv, Ukraine

Location

University of Stirling

Stirling, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 36735287 BACKGROUND

• 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.

  PMID: 26264453 BACKGROUND

• 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.

  PMID: 24410955 BACKGROUND

Related Links

• Project Website

Study Officials

• Femke van Nassau, PhD

  Amsterdam UMC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: December 5, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2024-10

Locations

AU (1); NL (1); IE (1); AL (1); DE (3); IT (1); UA (1); ES (1); GB (1)