ArticleTrials2024
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.
Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06110312 (Study Protocol for an International Pragmatic Randomised Controlled Trial of the NavCare-EU Intervention for Older People With Cancer and Their Family Caregivers), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Study Protocol for an International Pragmatic Randomised Controlled Trial of the NavCare-EU Intervention for Older People With Cancer and Their Family Caregivers
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Longing for continuity: A systematic review and thematic synthesis of qualitative research on the experience of older people living with chronic illness towards the end of life.Social science & medicine (1982) · 2026Pooled it
- Evaluating a Train-the-Trainer program to implement a navigation program for older people with cancer across six European countries, as part of the EU NAVIGATE project: a Kirkpatrick multi-method evaluation.BMC health services research · 2026Article
- Article
- The ESMO/SIOG Cancer in the Elderly Working Group pragmatic strategies for clinical trial designs and endpoints in older adults with cancer.ESMO open · 2026Review
- From the hospital to the community: reshaping the palliative care paradigm.Frontiers in public health · 2026Article
- Systematic adaptation of public health palliative care interventions across settings using ADAPT guidance: Methodological learnings from the EU NAVIGATE project.Palliative medicine · 2025Article
- Adapting, implementing and evaluating a navigation intervention for older people with cancer and their family caregivers in six countries in Europe: the Horizon Europe-funded EU NAVIGATE project.Palliative care and social practice · 2024Article
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Authors and funding
28 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCancer 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.
methodsWe 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 registrationClinicaltrials.gov: identifier NCT06110312 (2023/10/31).
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