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Protocol for the Efficacy, Process, and Economic Evaluation of the CARE-FIT eHealth Intervention Targeting Physical Activity, Sleep, and Stress in Cancer Patients: A Randomised Controlled Trial
ABSTRACT
Background:
Cancer incidence is steadily increasing worldwide. Reduced physical activity (PA), sleep disturbances, and high levels of psychological stress are prevalent within cancer patients. These impairments reduce quality of life and functional recovery and are linked to increased societal costs. Despite this, support to improve PA and sleep quality and reduce psychological stress remains insufficiently integrated into routine oncological care. Healthcare professionals face structural and organisational barriers to providing lifestyle guidance, while patients report unmet supportive care needs. eHealth interventions offer opportunities to deliver tailored lifestyle support. However, evidence on the efficacy, economic outcomes, and implementation of eHealth interventions embedded within routine oncological care remains limited.
Objective:
This study protocol describes the design of a randomised controlled trial that assesses the efficacy of CARE-FIT, a blended eHealth intervention integrated into routine oncological care, targeting PA, sleep quality, and psychological stress. The study consists of an efficacy evaluation, a process evaluation, and both trial- and model-based economic evaluations.
Methods:
A non-blinded, parallel-group, randomised controlled trial was conducted across hospitals, rehabilitation centres, and physiotherapy practices in the Netherlands. Healthcare organisations were stratified and randomised to either the CARE-FIT intervention plus usual care or usual care alone. Adult patients diagnosed with cancer from the time of diagnosis up to 1 year after completion of curative treatment were eligible. Participants receiving CARE-FIT were provided with theory-informed, tailored online advisory sessions and modules and an activity tracker throughout the 12-week intervention period. Healthcare professionals referred patients to the intervention during routine consultations. Outcomes were assessed at baseline, 12 weeks, and 24 weeks. For the efficacy evaluation, primary outcomes included objectively measured PA and self-reported PA, sleep quality, and psychological stress. Secondary outcomes included fatigue and health-related quality of life. Multilevel linear mixed-effects models were used in accordance with the intention-to-treat principle. For the process evaluation, intervention use, appreciation, and implementation experiences among patients and healthcare professionals were assessed. The economic evaluation comprised cost-effectiveness and cost-utility analyses conducted from a societal perspective using both trial-based and model-based approaches, alongside a budget impact analysis.
Results:
Participants were recruited from September 2025 to April 2026 through 41 participating healthcare organisations, including 15 hospital departments, 4 rehabilitation centres, and 22 physiotherapy practices. The study aimed to include 356 participants, with 178 participants in each condition.
Conclusions:
The described trial will provide comprehensive evidence regarding the clinical efficacy, economic outcomes, and implementation of a blended eHealth lifestyle intervention embedded in routine oncological care. By integrating these components within a multicentre design, the study will provide insights into the feasibility and sustainable implementation of lifestyle support for individuals living with and beyond cancer. Clinical Trial: ISRCTN Registry ISRCTN61846887; https://www.isrctn.com/ISRCTN61846887
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.