International Study to Evaluate a Navigation Program for Older People With Cancer and Their Family Caregivers (EU NAVIGATE Study)
NCT ID: NCT06110312
Last Updated: 2023-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
489 participants
INTERVENTIONAL
2023-11-15
2026-05-31
Brief Summary
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EU NAVIGATE is an interdisciplinary, cross-country, and intersectoral project funded by the European Union. The overall aim of the study is to evaluate the effectiveness and cost-effectiveness of a patient and family navigation intervention (NavCare-EU) for older people with cancer and declining health and their family caregivers in different healthcare systems in Europe. Nav-Care EU is a person- and family-centered non-pharmacological intervention in which navigators collaborate with patients and families to improve quality of life and improve levels of social support, 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(c) intervention from Canada.
Effectiveness and cost-effectiveness will be evaluated through an international 6-country multisite pragmatic fast-track randomised controlled trial (RCT) with an embedded mixed methods process evaluation to compare the NavCare-EU intervention in addition to standard care with the provision of standard care alone. The RCT and process evaluation will be conducted in Belgium (Flanders), Ireland, Italy, the Netherlands, Poland, and Portugal. Participants are people with cancer and declining health, who are aged 70 years and older, as well as their close family caregivers.
Specific objectives are:
1\. To compare the NavCare-EU intervention to care as usual, in terms of its:
1. Effectiveness on (1) global health status/quality of life, and the levels of social support (two co-primary outcomes); and on feelings of loneliness of older persons with cancer across the continuum of supportive, palliative, and end-of-life care; (2) family caregiver burden
2. cost-effectiveness
3. effects on different subgroups defined by characteristics known to affect health equity and equitable access, i.e., gender, age, socioeconomic status, extent of social support and living situation, and geographical location (rural vs. urban)
4. effectiveness and cost-effectiveness in different health care systems and care regimes in Europe
2\. To evaluate the implementation processes of the NavCare-EU intervention and the feasibility of its integration in different health care systems and care regimens in Europe, the contextual barriers and facilitators for effective and sustainable implementation, and the mechanisms involved in reaching the outcomes in each country, as perceived by patients, family caregivers, and other care providers
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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intervention group
In EU NAVIGATE, participants in the intervention group will receive a navigation intervention (also called NavCare-EU), alongside any usual care. Navcare-EU is a person- and family-centered navigation intervention, aimed at supporting older people with cancer throughout the care and illness continuum, via the involvement of a patient/family navigator. Navigators focus on connecting clients to social supports, both formal and informal, advocating for clients in meeting their quality-of-life goals, resourcing by identifying needs and negotiating access to meeting those needs, and engaging clients in what is most meaningful to them. Navigators are selected, trained, and mentored volunteers or professionals. NavCare-EU is based on the existing and successfully tested Nav-CARE(c) intervention from Canada.
NavCare-EU
NavCare-EU is a person- and family-centered intervention in which navigators collaborate with older persons and their close family caregivers across the continuum of supportive, palliative, and end-of-life care,. NavCare-EU is based on the existing and successfully tested Nav-CARE intervention from Canada. Navigators focus on connecting clients to social supports, both formal and informal, advocating for clients in meeting their quality-of-life goals, resourcing by identifying needs and negotiating access to meeting those needs, and engaging clients in what is most meaningful to them. Navigators are selected, trained, and mentored volunteers or professionals. NavCare-EU is based on the existing and successfully tested Nav-CARE(c) intervention from Canada.
control group
Participants in the control group will receive what is usual care in each of the participating countries for 24 weeks (primary trial outcome). After 24 weeks, they will also receive the navigation intervention (NavCare-EU) (fast-track RCT).
No interventions assigned to this group
Interventions
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NavCare-EU
NavCare-EU is a person- and family-centered intervention in which navigators collaborate with older persons and their close family caregivers across the continuum of supportive, palliative, and end-of-life care,. NavCare-EU is based on the existing and successfully tested Nav-CARE intervention from Canada. Navigators focus on connecting clients to social supports, both formal and informal, advocating for clients in meeting their quality-of-life goals, resourcing by identifying needs and negotiating access to meeting those needs, and engaging clients in what is most meaningful to them. Navigators are selected, trained, and mentored volunteers or professionals. NavCare-EU is based on the existing and successfully tested Nav-CARE(c) intervention from Canada.
Eligibility Criteria
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Inclusion Criteria
* Aged 70 years or over, AND
* Have declining or deteriorating health using the Clinical Frailty Scale, AND
* Live at home (own home or home of the family caregiver) (or discharged home if recruited in hospital), AND
* Live within the catchment area of the navigation programme/service
* Aged 18 years or over , AND
* Lives with the person with cancer OR provides care at least on a weekly basis, AND
* Identified as primary family caregiver by the older person with cancer
Exclusion Criteria
* Lives in a care or nursing home, or is incarcerated, OR
* Currently receives care from a formally recognized community-based multidisciplinary or specialist palliative care team, OR
* Is unable to provide informed consent or has difficulties understanding the information about the study , OR
* Has a psychiatric condition (i.e. schizophrenia, bipolar disorder, or major depressive disorder) OR has an active substance abuse disorder OR
* Is not able to participate in data collection in the country's language
For close family caregiver (if present)
* Is unable to provide informed consent or has difficulties understanding the information about the study, OR
* Is not able to participate in data collection in the country's language
70 Years
ALL
No
Sponsors
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University of Dublin, Trinity College
OTHER
Uniwersytet Jagiellonski
UNKNOWN
Amsterdam UMC, location VUmc
OTHER
University of Coimbra
OTHER
University Ghent
OTHER
University of British Columbia
OTHER
Lega Italiana per la Lotta contro i Tumori
OTHER
Vrije Universiteit Brussel
OTHER
Responsible Party
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Lieve Van den Block
Professor of ageing and palliative care
Principal Investigators
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Lieve Van den Block, PhD
Role: PRINCIPAL_INVESTIGATOR
Vrije Universiteit Brussel
Central Contacts
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References
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Smets T, Pivodic L, Miranda R, Van Campe F, Vinckier C, Pesut B, Duggleby W, Davies AN, Lavan A, May P, Gomes B, Furlan de Brito M, Rodrigues V, Szczerbinska K, Kijowska V, Baranska I, De Buyser S, Ferraris D, Alfieri S, Scacciati B, Du Cheyne H, Chambaere K, Gilissen J, van der Plas AGM, Pasman RH, Onwuteaka-Philipsen BD; EU NAVIGATE; Van den Block L. 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. Trials. 2024 Nov 27;25(1):800. doi: 10.1186/s13063-024-08633-5.
Other Identifiers
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101057361
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1432023000143
Identifier Type: -
Identifier Source: org_study_id