Study setting

The trial will be conducted in Belgium, Ireland, Italy, the Netherlands, Poland, and Portugal. The selection of countries was based on achieving good variation in healthcare systems characteristics and socio-cultural factors. Within each country, the intervention will be implemented in real practice (see Table 1).

Table 1 Overview of implementation settings, organizations, and type of navigators in the participating countriesEligibility criteria

The recruitment and eligibility criteria are formulated to include people who would typically use the program if it were implemented in current practice, following pragmatic trial principles. The eligibility criteria for the older person with cancer and declining health and for the family caregiver are detailed in Table 2.

Table 2 Inclusion and exclusion criteria for older people with cancer and close family caregiversWho will take informed consent?

Researchers will perform eligibility screening and obtain informed consent before inclusion in the study.

Additional consent provisions for collection and use of participant data and biological specimens

Not applicable. No ancillary study is conducted, and no biological specimens are collected.

Intervention description The NavCare-EU program

Nav-CARE© was developed and successfully tested in Canada by Pesut and Duggleby [7, 12,13,14, 21]. Nav-CARE© is a person- and family-centered navigation intervention, aimed at improving quality of life and wellbeing throughout a client’s trajectory, via the involvement of a navigator. Navigators are volunteers or health care professionals who collaborate with older people, families, and communities to connect them with appropriate resources, information, and others to promote quality of life, support independence and facilitate community connections. A family centric, culturally sensitive, and palliative approach is used. Nav-CARE© was designed to enhance, not replace, professional health and social care in the region where it is implemented and to be responsive to the individual needs and wishes of the clients and their families. Nav-CARE© is a free program. The copyright concerns the need to acknowledge the original developers of the intervention and their expectation the program is implemented with a high level of quality and consistency.

Nav-CARE© was adapted to NavCare-EU within the EU NAVIGATE project, using user and stakeholder engagement following the Adapting interventions to new contexts (ADAPT) guidance [22]. This adaptation process is described in detail elsewhere [15]. The relevant procedures ensured that adaptations did not compromise the functional integrity of the program as a whole, i.e., the extent to which the core functions and processes of the original, evidence-based program are maintained. The program was visualized as a system-based logic model as recommended by the “Integrated assessment of complex health technologies” (INTEGRATE-HTA) guidance [23], addressing all elements of the Template for Intervention Description and Replication (TIDieR) checklist [24]. Figure 1 shows the intervention’s core and discretionary components, how they are expected to work to impact older people’s and family caregivers’ outcomes and which contextual and personal characteristics can influence the implementation of the intervention and its outcomes. This logic model was used to guide the outcome and process evaluation.

Fig. 1

Conceptual model with core components of the NavCare-EU program after adaptation from the Canadian NavCare

Core components of the program (Fig. 1)

Navigators in NavCare-EU are selected, trained, and mentored volunteers (i.e., in Belgium, Ireland, Italy, the Netherlands, and Portugal) or professionals (i.e., social workers in Poland). They collaborate with older people with cancer and their caregivers throughout the continuum of supportive, palliative, and end-of-life care. Their main activities 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 have face-to-face and/or telephone or IT-supported contact with clients and carers, every 2 weeks on average or as needed. Navigators are matched to clients and caregivers by navigator coordinators who are also responsible for championing the program and for networking with and connecting to health and social care professionals and local initiatives in the community.

To support implementation in the six countries, country trainers are appointed, trained, mentored, and coached in each country by international trainers. This team consists of an international trainer and the original developers from Canada. The country trainers and the international trainers meet on a regular basis (monthly or as needed). Training is competency-based, combines online and face-to-face components, and uses a train-the-trainer approach. The international trainer will aid country trainers to implement the intervention in their specific healthcare contexts and address general and country-specific barriers and facilitators.

Discretionary components of the program are those features which are modifiable depending on the context and clients at hand and include adaptations to adhere to countries’ existing laws and regulations, boundaries of navigator roles, provision of additional training if needed depending on the experience of new navigators, safety protocols, and reporting requirements as needed in each site.

Explanation for the choice of comparators

All older persons with cancer participating in the trial will receive what is standard care in each of the participating countries. We have described for each country the current organization of cancer care in terms of laws and regulations, and the current integration of palliative and end-of-life care within oncology regimens (See Supplementary Table 1).

Criteria for discontinuing or modifying allocated interventions

Participants will be informed that they may withdraw participation at any point in the study without negative consequence. Reasons for discontinuing the intervention will be documented by the researcher in REDCap (Research Electronic Data Capture), if participants wish to state them. REDCap is a software for building and managing questionnaires and facilitating electronic data collection and storage [25].

Strategies to improve adherence to interventions

Strategies to improve adherence will include regular feedback sessions with volunteers, allowing us to maintain oversight of the visits and address any deviations from the protocol promptly. We will also monitor volunteer engagement closely to ensure adherence to the intervention. For monitoring adherence, volunteer diaries will be used to track the frequency and content of visits, providing a clear record of whether the intervention is being delivered as intended. This will allow us to assess both the consistency and quality of the visits throughout the trial.

Relevant concomitant care permitted or prohibited during the trial

There are no restrictions regarding concomitant care during the trial outside of the trial arms.

Provisions for post-trial care

Participants in the trial are referred to services or community resources based on needs identified during intervention visits or after the trial. After the trial, implementation organizations may allow volunteers to continue supporting patients as part of normal practice, if both agree.

Outcomes

All outcomes are assessedat baseline (T0), 12 weeks (T1), 24 weeks (T2), and 48 weeks (T3) for group 1, andat baseline (T0), 12 weeks (T1), 24 weeks (T2), 48 weeks (T3), and 72 weeks (T4) for group 2 (Fig. 2). We will use established and validated measures for all outcomes. All outcomes are continuous variables. Each outcome measure is aggregated as a summary score of multiple items.

Fig. 2Primary outcomes

The study has two co-primary outcomes; change from baseline at 24 weeks in [1] global health status/quality of life of the older person with cancer, assessed on a 2-item subscale from the EORTC Core Quality of Life questionnaire (EORTC-QLQ-C30 revised) measuring health-related quality of life [26], and (2) the level of social support measured with the Medical Outcomes Study Social Support Survey (MOS-SSS) [27] (see Table 3). Both primary outcomes will be reported by the older person with cancer.

Table 3 Constructs measured in the study and corresponding instruments*

The NavCare-EU intervention will be considered effective if the estimated effect on at least one of the outcomes is considered statistically significant (p < 0.025) and clinically relevant (≥ 10 points mean difference).

Secondary outcomes

The secondary outcome for the older person with cancer is change from baseline at 24 weeks in feelings of loneliness, measured with the 3-item-UCLA Revised Loneliness Scale [28]. A secondary outcome for the close family caregivers (if present) is change from baseline at 24 weeks in caregiver burden measured with the Zarit Burden Interview Short Form [29].

Tertiary or exploratory outcomes

As presented in Table 3, we will collect and analyze tertiary or exploratory outcomes for older people with cancer and their family caregivers. Measures for the cost-effectiveness evaluation of the intervention will also be collected.

Other socio-demographic and clinical measures

We will assess sociodemographic and clinical information of the older person with cancer and the family caregivers (Table 3).

Participant timeline (Figs. 2 and 3)Fig. 3

SPIRIT figure of study enrollment, interventions, and assessments

Potentially eligible patients and their close family caregivers (if present) are identified and referred to the researcher by professionals and organizations, or by self-referral. For all patients (and family caregivers) who are potentially eligible, researchers will perform eligibility screening and ask the patients and family caregivers for informed consent before inclusion in the study. After inclusion, participants will take part in the baseline measurements. Immediately after the baseline measurement, participants are randomized to either group 1 or group 2. Group 1 will start with the navigation intervention as soon as possible and group 2 will start the navigation 24 weeks after randomization. Participants in both groups will have a follow-up measurement at 12 weeks, 24 weeks (primary outcome), and 48 weeks after randomization, and group 2 will have an additional follow-up measurement 72 weeks after randomization.

Sample size

To achieve at least 80% power to detect a mean difference between groups of 10 points in patient’s global health status/quality of life (considered the smallest clinically relevant difference in the mean score of EORTC QLQ-C30) [30] using an analysis of covariance (ANCOVA) adjusted for baseline global health status/quality of life, at the two-sided 2.5% significance level assuming a standard deviation of 25 points [30] and a correlation of 0.3 between baseline and 24 weeks, a total sample size of 220 clients is needed with a balanced design (allocation ratio 1:1). Taking into account the partially nested study design (there is a cluster effect of navigators in the intervention group), 115 patients in the control group and 131 patients in the intervention group (246 in total) is most efficient, assuming on average 1.5 patients per navigator in Belgium (Flanders), Ireland, Italy, the Netherlands, and Portugal (recruiting 5/6 of all patients), and 10 patients per navigator in Poland (recruiting 1/6 of all patients), and an intra-cluster correlation (ICC) of 0.10. An ICC of 0.1 was chosen as a conservative estimate as there is currently no empirical data to support an exact estimate of the ICC.

We will continue randomization until 246 patients have completed the primary endpoint at 24 weeks, with a predetermined maximum sample size set at 489 patients (229 subjects in the control group and 260 subjects in the intervention group). This maximum sample size will allow for a drop-out rate of 50% (17.5% due to mortality, 32.5% due to other reasons) [7, 12, 13]. The sample size calculation was performed using SAS software (version 9.4) and is based on the methods of Moerbeek and Wong [31].

Recruitment

We will recruit participants from a range of settings where patients from the target population receive care/support, i.e., hospitals, community, or volunteer organizations. The recruitment strategies per country are aimed to achieve enrolment of the targeted sample size and to recruit a diverse sample, e.g., in terms of age, gender, cancer diagnoses, or cancer care regimen (curative or non-curative/no treatment).

Depending on the recruitment setting, potentially eligible older persons with cancer and their close family caregivers (if present) will be identified via different professionals and organizations following ethical and informed consent procedures. Referral can be done by health or social care professionals following in-person contact or by self-referral (in all countries except Ireland). All researchers will be trained to ensure all research procedures as outlined in the research protocol are followed.

Recruitment is expected to run over 12 months or until the targeted sample size is achieved.