Cancer (Active Cancer, Meaning Not Being Cancer Free), of Any Stage and Involving Any Treatment/Care Regimen; i.e. Curative, Life-extending, or PalliativeEU NAVIGATENCT06110312
International Study to Evaluate a Navigation Program for Older People With Cancer and Their Family Caregivers (EU NAVIGATE Study)
A study testing NavCare-EU in people with Cancer (Active Cancer, Meaning Not Being Cancer Free), of Any Stage and Involving Any Treatment/Care Regimen; i.e. Curative, Life-extending, or Palliative, run by Vrije Universiteit Brussel.
Trial summary
Most people with cancer are older, and this affects millions of Europeans yearly. Integrating high-quality, equitable, and cost-effective care across the continuum of supportive, palliative, and end-of-life care for both patients and family caregivers is highly relevant from a healthcare, prevention, and economic… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer (Active Cancer, Meaning Not Being Cancer Free), of Any Stage and Involving Any Treatment/Care Regimen; i.e. Curative, Life-extending, or Palliative
- What is being tested?
- NavCare-EU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 489 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2023to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Have a cancer diagnosis (active cancer, meaning not being cancer free, of any stage and involving any treatment/care regimen; i.e. curative, life-extending, or palliative), AND
- 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
Who cannot join
- The close family caregiver living with the person with cancer or providing care at least on a weekly basis, and identified as the primary family caregiver by the person with cancer, if present, does not agree to participate in the study (unless participation is explicitly requested by the patient) , OR
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study Protocol for an International Pragmatic Randomised Controlled Trial of the NavCare-EU Intervention for Older People With Cancer and Their Family Caregivers
Most people with cancer are older, and this affects millions of Europeans yearly. Integrating high-quality, equitable, and cost-effective care across the continuum of supportive, palliative, and end-of-life care for both patients and family caregivers is highly relevant from a healthcare, prevention, and economic perspective.
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.
Read more
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:
- To compare the NavCare-EU intervention to care as usual, in terms of its:
- 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
- cost-effectiveness
- 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)
- effectiveness and cost-effectiveness in different health care systems and care regimes in Europe
- 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
- Being tested
- NavCare-EU
- Keywords
- palliative care, supportive care, cancer, family caregiver, older people, community, primary care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavCare-EUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 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. Receives: Behavioral: NavCare-EU |
| control group | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global health status/quality of life of the older person with cancer
Global health status/quality of life of the older person with cancer, measured with 2-item subscale from the EORTC-QLQ-C30 (revised) measuring health-related quality of life.
Measured: Change from baseline at 24 weeks.
Levels of social support of the older person with cancer
Levels of social support of the older person with cancer measured with the Medical Outcomes Study Social Support Survey (MOS)
Measured: Change from baseline at 24 weeks.
Secondary outcomes (2)
Feelings of loneliness of the older person with cancer
Feelings of loneliness (relational and social connectedness, and self-perceived isolation) of the older person with cancer, measured with the 3-item-UCLA Revised Loneliness Scale.
Measured: Change from baseline at 24 weeks.
Caregiver burden of close family caregivers
Caregiver burden of close family caregivers, measured with the Zarit Burden Interview Short Form
Measured: Change from baseline at 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start15 Nov 2023 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer (Active Cancer, Meaning Not Being Cancer Free), of Any Stage and Involving Any Treatment/Care Regimen; i.e. Curative, Life-extending, or PalliativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 489 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dublin, Trinity College, Uniwersytet Jagiellonski, Amsterdam UMC, location VUmc, University of Coimbra, University Ghent, University of British Columbia, Lega Italiana per la Lotta contro i Tumori
- Responsible party
- Principal investigator, Lieve Van den Block, Vrije Universiteit Brussel
- Investigators
- Lieve Van den Block, PhD, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110312
- Sponsor's protocol ID
- 1432023000143
- Other IDs
- 101057361
- Acronym
- EU NAVIGATE
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be made available to third parties upon reasonable request and upon signing a unilateral data sharing agreement
Publications
Van Campe F, Smets T, Beijer Veenman I, Pivodic L, Pesut B, Statema EG, Duggleby W, Van Den Noortgate N, Szczerbinska K, Gomes B, Davies A, Ferraris D, Onwuteaka-Philipsen B, Alfieri S, Van den Block L; EU NAVIGATE Consortium; Chambaere K. 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 Serv Res. 2026 May 21;26(1):987. doi: 10.1186/s12913-026-14717-6.
PubMed 42168981Smets 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.
PubMed 39605055
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol for an International Pragmatic Randomised Controlled Trial of the NavCare-EU Intervention for Older People With Cancer and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT06110312
- Acronym / sponsor ID
- EU NAVIGATE / 1432023000143
- Keywords
- palliative care, supportive care, cancer, family caregiver, older people, community, primary care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 489 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- University of Dublin, Trinity College, Uniwersytet Jagiellonski, Amsterdam UMC, location VUmc, University of Coimbra, University Ghent, University of British Columbia, Lega Italiana per la Lotta contro i Tumori
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most people with cancer are older, and this affects millions of Europeans yearly. Integrating high-quality, equitable, and cost-effective care across the continuum of supportive, palliative, and end-of-life care for both patients and family caregivers is highly relevant from a healthcare, prevention, and economic perspective.
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:
- To compare the NavCare-EU intervention to care as usual, in terms of its:
- 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
- cost-effectiveness
- 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)
- effectiveness and cost-effectiveness in different health care systems and care regimes in Europe
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: NavCare-EUIn 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. |
| control group | No intervention | –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). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Have a cancer diagnosis (active cancer, meaning not being cancer free, of any stage and involving any treatment/care regimen; i.e. curative, life-extending, or palliative), AND
- 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
Key exclusion criteria (9 listed)
- The close family caregiver living with the person with cancer or providing care at least on a weekly basis, and identified as the primary family caregiver by the person with cancer, if present, does not agree to participate in the study (unless participation is explicitly requested by the patient) , OR
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NavCare-EUNavCare-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. | Behavioural | intervention group |
Primary outcome
Global health status/quality of life of the older person with cancer
Time frame: Change from baseline at 24 weeks.
Global health status/quality of life of the older person with cancer, measured with 2-item subscale from the EORTC-QLQ-C30 (revised) measuring health-related quality of life.
Levels of social support of the older person with cancer
Time frame: Change from baseline at 24 weeks.
Levels of social support of the older person with cancer measured with the Medical Outcomes Study Social Support Survey (MOS)
2 secondary outcomes
Feelings of loneliness of the older person with cancer
Time frame: Change from baseline at 24 weeks.
Caregiver burden of close family caregivers
Time frame: Change from baseline at 24 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 42168981Van Campe F, Smets T, Beijer Veenman I, Pivodic L, Pesut B, Statema EG, Duggleby W, Van Den Noortgate N, Szczerbinska K, Gomes B, Davies A, Ferraris D, Onwuteaka-Philipsen B, Alfieri S, Van den Block L; EU NAVIGATE Consortium; Chambaere K. 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 Serv Res. 2026 May 21;26(1):987. doi: 10.1186/s12913-026-14717-6.
- Derived from this study: PubMed 39605055Smets 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be made available to third parties upon reasonable request and upon signing a unilateral data sharing agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lieve Van den Block, PhD principal investigator
Vrije Universiteit Brussel
Questions about this trial
What is this clinical trial studying?
A study testing NavCare-EU in people with Cancer (Active Cancer, Meaning Not Being Cancer Free), of Any Stage and Involving Any Treatment/Care Regimen; i.e. Curative, Life-extending, or Palliative, run by Vrije Universiteit Brussel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lieve Van den Block, PhD (+3224774310, lvdblock@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global health status/quality of life of the older person with cancer (time frame: Change from baseline at 24 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06110312, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.