Status:
NOT_YET_RECRUITING
International Study to Evaluate a Navigation Program for Older People With Cancer and Their Family Caregivers (EU NAVIGATE Study)
Lead Sponsor:
Vrije Universiteit Brussel
Collaborating Sponsors:
University of Dublin, Trinity College
Uniwersytet Jagiellonski
Conditions:
Cancer (Active Cancer, Meaning Not Being Cancer Free), of Any Stage and Involving Any Treatment/Care Regimen; i.e. Curative, Life-extending, or Palliative
Eligibility:
All Genders
70+ years
Phase:
NA
Brief 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-o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
489 Patients enrolled
Trial Details
Trial ID
NCT06110312
Start Date
November 15 2023
End Date
May 1 2026
Last Update
October 31 2023
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