Implementation and evaluation of a navigation program for people with cancer in old age and their family caregivers: study protocol for the EU NAVIGATE International Pragmatic Randomized Controlled Trial
Tinne Smets,
Lara Pivodic,
Rose Miranda,
Fien Van Campe,
Chelsea Vinckier,
Barbara Pesut,
Wendy Duggleby,
Andrew N. Davies,
Amanda Lavan,
Peter May,
Barbara Gomes,
Maja Furlan de Brito,
Vitor Rodrigues,
Katarzyna Szczerbińska,
Violetta Kijowska,
Ilona Barańska,
Stefanie De Buyser,
Davide Ferraris,
Sara Alfieri,
Bianca Scacciati,
Helena Du Cheyne,
Kenneth Chambaere,
Joni Gilissen,
Annicka G.M. van der Plas,
Roeline H. Pasman,
Bregje D. Onwuteaka-Philipsen,
on behalf of EU NAVIGATE,
Lieve Van den Block
Affiliations
Tinne Smets
End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) and Ghent University
Lara Pivodic
End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) and Ghent University
Rose Miranda
End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) and Ghent University
Fien Van Campe
End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) and Ghent University
Chelsea Vinckier
End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) and Ghent University
Barbara Pesut
University of British Columbia
Wendy Duggleby
Faculty of Nursing, University of Alberta
Andrew N. Davies
School of Medicine, Trinity College Dublin
Amanda Lavan
School of Medicine, Trinity College Dublin
Peter May
School of Medicine, Trinity College Dublin
Barbara Gomes
Faculty of Medicine, University of Coimbra
Maja Furlan de Brito
Faculty of Medicine, University of Coimbra
Vitor Rodrigues
Faculty of Medicine, University of Coimbra
Katarzyna Szczerbińska
Medical Faculty, Laboratory for Research On Aging Society, Jagiellonian University Medical College
Violetta Kijowska
Medical Faculty, Laboratory for Research On Aging Society, Jagiellonian University Medical College
Ilona Barańska
Medical Faculty, Laboratory for Research On Aging Society, Jagiellonian University Medical College
Stefanie De Buyser
Biostatistics Unit, Faculty of Medicine and Health Sciences, Ghent University
Davide Ferraris
Lega Italiana per la Lotta contro i Tumori di Milano, LILT Milano Monza Brianza
Sara Alfieri
Clinical Psychology Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori
Bianca Scacciati
Clinical Psychology Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori
Helena Du Cheyne
Department of Public Health and Primary Care, Ghent University
Kenneth Chambaere
End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) and Ghent University
Joni Gilissen
Department of Public Health and Primary Care, Ghent University
Annicka G.M. van der Plas
Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Expertise Center for Palliative Care Amsterdam UMC
Roeline H. Pasman
Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Expertise Center for Palliative Care Amsterdam UMC
Bregje D. Onwuteaka-Philipsen
Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Expertise Center for Palliative Care Amsterdam UMC
on behalf of EU NAVIGATE
Lieve Van den Block
End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) and Ghent University
Abstract Background Cancer navigation programs aim to support, educate, and empower patients and families, addressing barriers to diagnostics, treatment, and care. Navigators engage with people to ensure timely access to services and resources. While promising for older people with cancer, these programs are scarce in Europe, and research on their effectiveness and implementation is limited. We describe the protocol of the EU NAVIGATE randomized controlled trial, aimed to evaluate (1) effectiveness and cost-effectiveness of NavCare-EU, an intervention that aims to support older people with cancer throughout their illness trajectory, spanning the continuum of supportive, palliative, and end-of-life care, and (2) the intervention’s implementation processes and feasibility of its integration into different health care systems in Europe, contextual barriers and facilitators for effective and sustainable implementation, and mechanisms involved in reaching the outcomes. Methods We will conduct a multisite pragmatic fast-track randomized controlled trial with embedded convergent mixed-method process evaluation in Belgium, Ireland, Italy, Netherlands, Poland, and Portugal. The study targets people with cancer and declining health, 70 years or older, and their close family caregivers. The trial compares the NavCare-EU intervention plus standard care with standard care alone. We will perform a baseline measurement prior to randomization and follow-up measurements at 12 weeks, 24 weeks, and 48 weeks in intervention and control group, and an additional measurement at 72 weeks in the control group. Primary outcomes, measured at 24 weeks are (1) the older person’s global health status/quality of life, a 2-item subscale from EORTC-QLQ-C30 (revised) measuring health-related quality of life, (2) level of social support measured with Medical Outcomes Study Social Support Survey (MOS-SSS scale). The study will include at least 246 older persons with completed global health status/quality of life at 24 weeks. Discussion The EU NAVIGATE trial will cross-nationally test the effectiveness and cost-effectiveness of a navigation intervention for older people with cancer and their family caregivers, and its implementation in different health care systems in Europe. As continuity and access to health, social, and community care is a priority for patients and caregivers, the trial is timely and critically needed. Trial registration Clinicaltrials.gov: identifier NCT06110312 (2023/10/31).
