End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) and Ghent University, Laarbeeklaan 103, 1090, Brussels, Belgium.
University of British Columbia, Vancouver, Okanagan, Canada.
Trials. 2024 Nov 27;25(1):800. doi: 10.1186/s13063-024-08633-5.
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.
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.
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.
Clinicaltrials.gov: identifier NCT06110312 (2023/10/31).
癌症导航计划旨在为患者及其家属提供支持、教育和赋权，解决诊断、治疗和护理方面的障碍。导航员与人们合作，确保他们能够及时获得服务和资源。虽然这些计划对患有癌症的老年人很有前途，但在欧洲却很少见，而且关于它们的有效性和实施情况的研究也很有限。我们描述了 EU NAVIGATE 随机对照试验的方案，旨在评估（1）NavCare-EU 干预措施的有效性和成本效益，该干预措施旨在在整个疾病轨迹中支持患有癌症的老年人，涵盖支持性、姑息性和临终关怀护理的连续体，以及（2）干预措施的实施过程及其在欧洲不同医疗保健系统中的可行性，以及有效和可持续实施的背景障碍和促进因素，以及实现结果所涉及的机制。
我们将在比利时、爱尔兰、意大利、荷兰、波兰和葡萄牙进行一项多地点实用快速通道随机对照试验，同时进行嵌入式收敛混合方法过程评估。该研究针对的是患有癌症且健康状况正在下降的 70 岁及以上的患者及其亲密的家庭照顾者。试验比较了 NavCare-EU 干预措施加标准护理与单独标准护理。我们将在随机分组前进行基线测量，并在干预组和对照组的 12 周、24 周和 48 周时进行随访测量，并在对照组的 72 周时进行额外测量。主要结局在 24 周时测量，包括（1）老年人的整体健康状况/生活质量，这是 EORTC-QLQ-C30（修订版）中测量健康相关生活质量的 2 项子量表之一，（2）用医疗结果研究社会支持调查（MOS-SSS 量表）测量的社会支持水平。该研究将至少包括 246 名在 24 周时完成整体健康状况/生活质量测量的老年人。
EU NAVIGATE 试验将在欧洲不同的医疗保健系统中跨国家测试针对患有癌症的老年人及其家庭照顾者的导航干预措施的有效性和成本效益及其实施情况。由于连续性和获得卫生、社会和社区保健是患者和照顾者的优先事项，因此该试验具有及时性和迫切性。
Clinicaltrials.gov：标识符 NCT06110312（2023/10/31）。
