The goal of this clinical trial is to validate the use of innovative tele-rehabilitation (TR) models in terms of efficiency and effectiveness in a pilot cohort of subjects with central and peripheral chemotherapy-induced neurotoxicity. Participants will be randomized (with an allocation ratio of 1:1) into the experimental group (TRUST\_ME - 15 sessions of motor and cognitive activities delivered at home through a TR approach using the Maia platform) and Treatment as Usual (15 sessions of multimedia content of educational/rehabilitation activities delivered via telemedicine platfom). It expected that the TR system to be considered acceptable in terms of efficiency (usability and acceptability of the technologies) and clinically effective, with positive impacts on both quality of life and central and peripheral functioning in these patients.
Adult subjects (>18 years old) with central and/or peripheral neurotoxic sequelae following a history of cancer treated with chemotherapeutic agents (Cisplatin and Taxanes), in accordance with the criteria of the International Cognitive Cancer Task Force (Wefel et al., 2011. 10.1016/S1470-2045(10)70294-1)
agreement to participate with the signature of the informed consent form;
Ongoing chemotherapy treatment;
Pre-existing neurological or psychiatric comorbidities (e.g., epilepsy, post-stroke disability, neurodegenerative diseases, genetically based polyneuropathy);
Severe visual or hearing impairments that could interfere with the use of technology;
Severe cognitive impairment (Mini-Mental State Examination score <18);
Parallel
RICORDO-DTx system
DeviceParticipants with will undergo a cognitive enhancement program using the Astir RICORDO-DTx system (http://www.ricordo-dtx.com), which allows for the personalization of rehabilitative content based on the needs of the target population and can be delivered remotely.
HOMING system
DeviceParticipants will also undergo motor rehabilitation sessions focused on improving balance, gait, and muscular endurance using the HOMING system (https://www.tecnobody.com/homing).
Home-based training program
DeviceSubjects will view videos on Tablet. The treatment will be provided via a digital medicine platform on a mobile device (tablet).
Changes in Activation level of Patients measured by Patient Activation Measure 13 (PAM13; Hibbard et al., 2004)
PAM13 is a 13-item scale that assesses a person's underlying knowledge, skills and confidence integral to managing his or her health and healthcare. PAM13 total score ranging from 0 to 100. Higher values represent a better outcome. Specifically, individuals in the lowest activation level do not yet understand the importance of their role in managing their health and have significant knowledge gaps and limited self-management skills. Individuals in the highest activation level are proactive with their health, have developed strong self- management skills, and are resilient in times of stress or change.
Change in Functional Assessment of Cancer Therapy-Cognitive Function - FACT-Cog (Fardell et al., 2022. 10.1002/pon.5928);
FACT-Cog is a 37 item self-report tool on 5-point Likert scale to assess perceived cognitive function in adult cancer patients with chemotherapy-induced cognitive problems
Change in EORTC CIPN-20 questionnaire (Postam et al., 2005).
EORTC CIPN-20 is a 20-item self-report questionnaire to assess patients' experience of symptoms and functional limitations related to chemotherapy-induced peripheral neuropathy;
Change in Patient Health Engagement Scale (PHE) (Graffigna et al., 2017)
Patient Health Engagement Scale (PHE-s) is a validated tool designed to measure a person's level of engagement in managing their own health, based on the Patient Health Engagement (PHE) Model.
Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment (MoCA; Santangelo et al., 2015)
MoCA is a screening test for global cognitive functioning. It includes tasks involving several domains: visuospatial/executive function tests, naming, selective and sustained attention, language, abstraction, memory and orientation. High scores are indicative of better general cognitive performance.
Changes in brain morphometry as detected by Magnetic Resonance Imaging Examination.
T1-3D MPRAGE, FLAIR 3D and T2 will be collected to test changes in brain morphometry
Changes in structural connectivity as detected by Magnetic Resonance Imaging Examination.
DWI sequences will be collected to detect changes in structural connectivity
Changes in functional connectivity as detected by Magnetic Resonance Imaging Examination.
Resting-State fMRI (Multi echo - Multi-Band) and EPI-T2\* images will be collected for the assessment of brain activity at rest and functional connectivity.
Changes in muscle tissue inflammation as detected by Magnetic Resonance Imaging Examination.
T2 mapping (T2 SE multi-echo) will be collected to measure change in inflammation
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Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
Astir s.r.l.
Collaborator
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