Trial Title:
International Study to Evaluate a Navigation Program for Older People With Cancer and Their Family Caregivers (EU NAVIGATE Study)
NCT ID:
NCT06110312
Condition:
Cancer (Active Cancer, Meaning Not Being Cancer Free), of Any Stage and Involving Any Treatment/Care Regimen; i.e. Curative, Life-extending, or Palliative
Conditions: Keywords:
palliative care
supportive care
cancer
family caregiver
older people
community
primary care
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
NavCare-EU
Description:
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.
Arm group label:
intervention group
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 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:
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
Criteria for eligibility:
Criteria:
For older person with cancer
Inclusion criteria
- 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
Exclusion criteria
- 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
For close family caregiver (if present)
Inclusion criteria
- 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
- 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
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 15, 2023
Completion date:
May 2026
Lead sponsor:
Agency:
Vrije Universiteit Brussel
Agency class:
Other
Collaborator:
Agency:
University of Dublin, Trinity College
Agency class:
Other
Collaborator:
Agency:
Uniwersytet Jagiellonski
Agency class:
Other
Collaborator:
Agency:
Amsterdam UMC, location VUmc
Agency class:
Other
Collaborator:
Agency:
University of Coimbra
Agency class:
Other
Collaborator:
Agency:
University Ghent
Agency class:
Other
Collaborator:
Agency:
University of British Columbia
Agency class:
Other
Collaborator:
Agency:
Lega Italiana per la Lotta contro i Tumori
Agency class:
Other
Source:
Vrije Universiteit Brussel
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06110312
