International Study to Evaluate a Navigation Program for Older People With Cancer and Their Family Caregivers (EU NAVIGATE Study) (EU NAVIGATE)

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.

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

Study Overview

• Status: Not yet recruiting
• 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
• Intervention / Treatment: Behavioral: NavCare-EU

• Study Type: Interventional
• Enrollment (Estimated): 489
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lieve Van den Block, PhD; Phone Number: +3224774310; Email: lvdblock@vub.be
• Study Contact Backup: Name: Tinne Smets, PhD; Phone Number: +3224774755; Email: tinne.smets@vub.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	Change from baseline at 24 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Change from baseline at 24 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline at 48 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)	Change from baseline at 48 weeks.
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.	Change from baseline at 48 weeks.
Caregiver burden of close family caregivers	Caregiver burden of close family caregivers, measured with the Zarit Burden Interview Short Form	Change from baseline at 48 weeks.
Symptoms or problems experienced	Symptoms or problems experienced (i.e. as measured by the EORTC-QLQ-C30 symptom subscales and the emotional functioning scale for cancer patients	Change from baseline at 24 weeks.
well-being of older people	well-being of older people (WOOP) (which captures a comprehensive set of well-being domains relevant to older people (broader than health)	Change from baseline at 24 weeks.
Knowledge of resources and services and confidence in decision making and communicating those decisions	Knowledge of resources and services and confidence in decision making and communicating those decisions (measured with the Nav-CARE engagement questionnaire).	Change from baseline at 24 weeks.
Health status	Health status EQ-5D (has traditionally been used as outcome measure in economic evaluations)	Change from baseline at 24 weeks.
Health and social care services and resource use	Health and social care services and resource use (for economic evaluation)	Change from baseline at 24 weeks.
positive aspects of caregiving of close family caregivers (measured with PAC scale)	positive aspects of caregiving of close family caregivers (measured with PAC scale)	Change from baseline at 24 weeks.

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel
• Collaborators: University of British Columbia; University of Coimbra; Amsterdam UMC, location VUmc; University Ghent; University of Dublin, Trinity College; Lega Italiana per la Lotta contro i Tumori; Uniwersytet Jagiellonski
• Investigators: Principal Investigator: Lieve Van den Block, PhD, Vrije Universiteit Brussel

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: palliative care; cancer; primary care; community; supportive care; family caregiver; older people
• Other Study ID Numbers: 1432023000143; 101057361 (Other Grant/Funding Number: Horizon Europe)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: The data can be obtained from the authors of the publication upon reasonable request. Data will be shared with members of universities, scientific research institutions, or clearly separate and independent research departments of public institutions or non- profit organisations. Data may be used for scientific research only (commercial use of data will not be permitted).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No