Periodic Reporting for period 2 - EU NAVIGATE (Implementation and evaluation of a Navigation Intervention for People with Cancer in Old Age and their Family Caregivers: an international pragmatic randomized controlled trial)
Période du rapport: 2024-03-01 au 2025-08-31
Cancer mostly affects older people. Although older people with cancer are a diverse population, research suggests that cancer and cancer treatments affect them differently than younger people, which may lead to health-related suffering, and poor quality of life and well-being throughout their disease trajectory. This also impacts the family carers.
To sustainably meet the increasing needs for high-quality supportive, palliative, and end-of-life care for older people with cancer and their family within existing EU healthcare systems, navigation interventions hold promise. Navigation interventions aim to support, educate, and empower patients (and in some programs also families), and address individual and community barriers to cancer-related diagnostics, treatment, and care to ensure timely access to needed services and resources. However, in Europe hardly any cancer navigation services have been developed, let alone tested using high-quality research methods.
The EU NAVIGATE project is an interdisciplinary, cross-country and intersectoral project aiming to implement a Navigation Intervention (NavCare-EU) for older people with cancer and their family carers in different health care systems in Europe, and to evaluate its effectiveness and cost effectiveness. NavCare-EU is a person- and family-centered non-pharmacological intervention in which navigators, primarily volunteers and social workers, collaborate with patients and families to improve quality of life and well-being, foster empowerment, and facilitate timely and equitable access to health and social care services and resources as needed, throughout the supportive and palliative care continuum. NavCare-EU is based on the existing and successfully tested Nav-CARE navigation intervention from Canada that had demonstrated feasibility and received positive feedback from clients, indicating benefits such as social support, assistance with navigating healthcare systems, increased knowledge of available services, access to resources, and family respite, contributing to potential improvements in quality of life and well-being.
The effectiveness and cost-effectiveness of NavCare-EU will be evaluated through an international fast-track pragmatic randomized controlled trial (RCT) among cancer patients aged 70 years and older who are in declining health, and their family caregivers, in Belgium, Ireland, Italy, the Netherlands, Poland, and Portugal. We also evaluate the effects of the intervention in specific subgroups based on socio-demographic characteristics that are associated with unequal access to healthcare. An in-depth process evaluation runs alongside the trial to evaluate the implementation process of the intervention, guided by contemporary public health and implementation science frameworks. EU NAVIGATE also conducts a mapping study of existing navigation interventions in Europe and beyond.
To sustainably meet the increasing needs for high-quality supportive, palliative, and end-of-life care for older people with cancer and their family within existing EU healthcare systems, navigation interventions hold promise. Navigation interventions aim to support, educate, and empower patients (and in some programs also families), and address individual and community barriers to cancer-related diagnostics, treatment, and care to ensure timely access to needed services and resources. However, in Europe hardly any cancer navigation services have been developed, let alone tested using high-quality research methods.
The EU NAVIGATE project is an interdisciplinary, cross-country and intersectoral project aiming to implement a Navigation Intervention (NavCare-EU) for older people with cancer and their family carers in different health care systems in Europe, and to evaluate its effectiveness and cost effectiveness. NavCare-EU is a person- and family-centered non-pharmacological intervention in which navigators, primarily volunteers and social workers, collaborate with patients and families to improve quality of life and well-being, foster empowerment, and facilitate timely and equitable access to health and social care services and resources as needed, throughout the supportive and palliative care continuum. NavCare-EU is based on the existing and successfully tested Nav-CARE navigation intervention from Canada that had demonstrated feasibility and received positive feedback from clients, indicating benefits such as social support, assistance with navigating healthcare systems, increased knowledge of available services, access to resources, and family respite, contributing to potential improvements in quality of life and well-being.
The effectiveness and cost-effectiveness of NavCare-EU will be evaluated through an international fast-track pragmatic randomized controlled trial (RCT) among cancer patients aged 70 years and older who are in declining health, and their family caregivers, in Belgium, Ireland, Italy, the Netherlands, Poland, and Portugal. We also evaluate the effects of the intervention in specific subgroups based on socio-demographic characteristics that are associated with unequal access to healthcare. An in-depth process evaluation runs alongside the trial to evaluate the implementation process of the intervention, guided by contemporary public health and implementation science frameworks. EU NAVIGATE also conducts a mapping study of existing navigation interventions in Europe and beyond.
During the Reporting Period 1, we completed the adaptation of the original Canadian Nav-CARE navigation intervention into NavCare-EU for implementation in the six European countries. We have also completed the training of the country trainers, who are training and supporting the navigator coordinators and navigators in each country. Ethics approvals had been obtained in all RCT countries. As planned, the RCT was ongoing. Given these achievements, we are on track to achieving our expected outcomes and wider impacts of the project.
During the Reporting Period 2, we continued conducting the RCT across the six RCT countries. All RCT countries experienced a slower than expected participant recruitment, for which an exhaustive list of contingency strategies in each country was implemented, e.g. 3-to-6-month extension of participant recruitment, expansion of implementation site or region. The participant recruitment period for the trial ended on 31 July 2025. In total, 327 patients were recruited, representing 86% of our targeted number of study participants (taking into account the actual drop-out rate of 37%). Given the trial design, the implementation of the navigation intervention will still continue, alongside the data collection that is foreseen to end by February 2027. Concurrent to the effectiveness/outcome analyses, the implementation of the WPs focusing on the cost-effectiveness evaluation, the process evaluation, and the subgroup analyses remain on track. The main output for WP7 focusing on a report that maps existing navigation interventions in cancer has been completed as planned. An updated version of this report will be submitted around the beginning of 2026. The WPs focusing on project management and coordination, as well as on dissemination, exploitation and communication are being conducted as planned. Given these achievements, we are on track to achieving our expected outcomes and wider impacts of the project.
During the Reporting Period 2, we continued conducting the RCT across the six RCT countries. All RCT countries experienced a slower than expected participant recruitment, for which an exhaustive list of contingency strategies in each country was implemented, e.g. 3-to-6-month extension of participant recruitment, expansion of implementation site or region. The participant recruitment period for the trial ended on 31 July 2025. In total, 327 patients were recruited, representing 86% of our targeted number of study participants (taking into account the actual drop-out rate of 37%). Given the trial design, the implementation of the navigation intervention will still continue, alongside the data collection that is foreseen to end by February 2027. Concurrent to the effectiveness/outcome analyses, the implementation of the WPs focusing on the cost-effectiveness evaluation, the process evaluation, and the subgroup analyses remain on track. The main output for WP7 focusing on a report that maps existing navigation interventions in cancer has been completed as planned. An updated version of this report will be submitted around the beginning of 2026. The WPs focusing on project management and coordination, as well as on dissemination, exploitation and communication are being conducted as planned. Given these achievements, we are on track to achieving our expected outcomes and wider impacts of the project.
EU NAVIGATE has presented its intervention and evaluation models at several international conferences and stakeholder meetings. By the end of the project, EU NAVIGATE aims to advance the state of the art by providing innovative solutions to the complex supportive and palliative care needs experienced by older cancer patients and their families, which is implementable in the real world and in diverse health care systems and contexts. User and stakeholder involvement methods are integrated throughout the whole project (https://www.eunavigate.com/(s’ouvre dans une nouvelle fenêtre)).