The core of the project is an international 6-country multisite pragmatic fast-track randomised controlled trial with an embedded process evaluation. The trial will be implemented in Belgium, Ireland, Italy, the Netherlands Poland, and Portugal, and compare the Navigation intervention NavCare-EU in addition to standard care with standard care alone.
In designing the trial we have followed PRECIS-2 guidance for designing clinical pragmatic trials and recommendations of the European Organisation for Research and Treatment of Cancer (EORTC) on clinical trial methodology on older individuals with cancer. A process and implementation evaluation is embedded in the RCT, guided by the UK MRC Framework for complex intervention evaluation and state-of-the-art implementation science frameworks. Before commencing the trial, the original Canadian Nav-Care intervention will be adapted to an EU version, to ensure optimal fit with the EU countries’ contexts (using the new ADAPT guidance for adaptation and re-evaluation of complex interventions in new contexts.
Participants
In each country, we aim to enrol 89 people with cancer who are older (70 years or over) into the trial and randomise to either the intervention arm (immediate start of NavCare-EU intervention in addition to standard care) or the control arm (delayed start of the NavCare-EU intervention after 6 months and standard care until then).
recruitment
Recruitment will run over 12 months. Pragmatic trials typically aim to recruit broader groups of patients from a variety of settings to represent all who may benefit from the intervention should it be implemented in standard care. Hence we will recruit participants from a range of settings and all cancer types.
measurement
The RCT includes a baseline measurement prior to randomisation (T0) and follow-up measurements at 3 months (T1), 6 months (T2, primary study endpoint), 9 months (T3) and 12 months (T4, after completion of the intervention in the intervention arm) in both the intervention group and the control group, and an additional measurement at 18 months (T5) in the control group.
outcomes
The primary outcomes, measured at 6 months (T2) are patient’s health-related quality of life and well-being.
