Periodic Reporting for period 1 - 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: 2022-09-01 au 2024-02-29
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 caregivers 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 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. These factors contribute to potential improvements in quality of life and wellbeing. The main activities of navigators focus on addressing the needs, quality of life, and wellbeing of patients and family caregivers, the provision of information and psychosocial support, and ensuring people can connect to and access necessary services or resources. Above all, navigators are trained to ask the question ‘What is most important to you today?’ and work alongside patients and families to help them accomplish that.
The effectiveness and cost-effectiveness of NavCare-EU will be evaluated through an international pragmatic randomized controlled trial (RCT) among 489 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 will 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 will also conduct a mapping study of existing navigation interventions in Europe, United States and Canada.
Our project’s methodology is rooted in the integration of not only medical sciences, but also social sciences and humanities to enhance the methodologies used, increase usability of the results and hence the societal impact of the research. It combines medical and social science approaches by supplementing a pragmatic randomised controlled trial with mixed-method approaches to intervention adaptation, implementation and evaluation.
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 caregivers 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 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. These factors contribute to potential improvements in quality of life and wellbeing. The main activities of navigators focus on addressing the needs, quality of life, and wellbeing of patients and family caregivers, the provision of information and psychosocial support, and ensuring people can connect to and access necessary services or resources. Above all, navigators are trained to ask the question ‘What is most important to you today?’ and work alongside patients and families to help them accomplish that.
The effectiveness and cost-effectiveness of NavCare-EU will be evaluated through an international pragmatic randomized controlled trial (RCT) among 489 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 will 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 will also conduct a mapping study of existing navigation interventions in Europe, United States and Canada.
Our project’s methodology is rooted in the integration of not only medical sciences, but also social sciences and humanities to enhance the methodologies used, increase usability of the results and hence the societal impact of the research. It combines medical and social science approaches by supplementing a pragmatic randomised controlled trial with mixed-method approaches to intervention adaptation, implementation and evaluation.
During Months 1-18, we completed our work to standardize and adapt the original Canadian Nav-CARE navigation intervention into the NavCare-EU intervention for implementation in six European countries, including Belgium, Ireland, Italy, the Netherlands, Poland, and Portugal. 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 is currently ongoing, and we are currently in the implementation phase of the intervention and the recruitment phase for patients and family caregivers. 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)).