Clinical trial NCT06110312: International Study to Evaluate a Navigation Program for Older People With Cancer and Their Family Caregivers (EU NAVIGATE 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Keywords: palliative care
supportive care
cancer
family caregiver
older people
community
primary care
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: University of Dublin, Trinity College
name: Uniwersytet Jagiellonski
name: Amsterdam UMC, location VUmc
name: University of Coimbra
name: University Ghent
name: University of British Columbia
name: Lega Italiana per la Lotta contro i Tumori
First posted: 2023-10-31
Enrollment: 489
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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-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


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

Primary outcomes:
measure: Global health status/quality of life of the older person with cancer
timeFrame: Change from baseline at 24 weeks.
measure: Levels of social support of the older person with cancer
timeFrame: Change from baseline at 24 weeks.
Secondary outcomes:
measure: Feelings of loneliness of the older person with cancer
timeFrame: Change from baseline at 24 weeks.
measure: Caregiver burden of close family caregivers
timeFrame: Change from baseline at 24 weeks.
Other outcomes:
measure: Global health status/quality of life of the older person with cancer
timeFrame: Change from baseline at 48 weeks.
measure: Levels of social support of the older person with cancer
timeFrame: Change from baseline at 48 weeks.
measure: Feelings of loneliness of the older person with cancer
timeFrame: Change from baseline at 48 weeks.
measure: Caregiver burden of close family caregivers
timeFrame: Change from baseline at 48 weeks.
measure: Symptoms or problems experienced
timeFrame: Change from baseline at 24 weeks.
measure: well-being of older people
timeFrame: Change from baseline at 24 weeks.
measure: Knowledge of resources and services and confidence in decision making and communicating those decisions
timeFrame: Change from baseline at 24 weeks.
measure: Health status
timeFrame: Change from baseline at 24 weeks.
measure: Health and social care services and resource use
timeFrame: Change from baseline at 24 weeks.
measure: positive aspects of caregiving of close family caregivers (measured with PAC scale)
timeFrame: Change from baseline at 24 weeks.
Locations:
Study officials:
affiliation: Vrije Universiteit Brussel
name: Lieve Van den Block, PhD
role: PRINCIPAL_INVESTIGATOR
References: