Implementation and evaluation of a Navigation Intervention for People with Cancer in Old Age and their Family Caregivers: an international pragmatic randomized controlled trial

Background: Most people who have cancer are older people, affecting millions of Europeans each year. Providing high-quality, equitable, and cost-effective care across the continuum of supportive, palliative, end-of-life, and survivorship care for both patients and their frequently overburdened family caregivers is highly relevant from an economic, a healthcare and a prevention perspective. Aims: The EU NAVIGATE project is an interdisciplinary, cross-country and intersectoral project aiming to evaluate the effectiveness and cost-effectiveness of a Navigation Intervention (NavCare-EU) for older people with cancer and their family caregivers in different health care systems in Europe. Concept and methods: NavCare-EU is a person- and family-centered non-pharmacological intervention in which navigators 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. Effectiveness and cost-effectiveness will be evaluated through an international pragmatic randomized controlled trial among 532 cancer patients aged 70 years and older and their family caregivers. Robust mixed-method subgroup analyses and in-depth process and implementation evaluations are also included. Impact: EU NAVIGATE will 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.