Clinical Research Directory

eQuoL Effectiveness Study

Sponsor: Monica Muraca

Summary

This prospective cohort study aims to evaluate the implementation and impact of the MyCare eQuoL digital tool across nine clinical sites in Europe: Italy, France, Hungary, Germany, Switzerland, Belgium, Slovenia, Spain, and Norway. MyCare eQuoL is an innovative digital tool designed to support Childhood, Adolescent and Young Adult Cancer Survivors (CAYACSs) in self-assessing their supportive care needs. Based on a built-in needs assessment, the tool provides tailored feedback including relevant information, self-management strategies, digital resources, and links to online support. It also generates a personalized needs summary to facilitate more targeted discussions with healthcare professionals. Feedback is customized through a "content suggestion engine" that is based on personal characteristics (e.g. age, sex, country), on the user's needs assessment, and can consider other data types as well, like the survivors' treatment history, or potential late effects. The primary objective of the study is to assess the effectiveness of MyCare eQuoL in improving patient activation among CAYACSs across diverse European healthcare settings. Eligible participants include males and females aged 16-30 who were diagnosed with cancer before age 25, have completed their treatment at least five years prior, are currently disease-free, and have sufficient digital literacy and language proficiency to engage with the app. Exclusion criteria include severe cognitive impairments or ongoing treatment for recurrent or secondary malignancies. The study follows a structured data collection timeline. At T0, eligible survivors are identified and invited to participate through mail or telephone. Informed consent and contact details are collected from those who agree to participate. At T1, after obtaining consent, each participant is assigned a unique study ID and attends a clinical visit (either in-person or virtual). During this visit, baseline demographic and treatment data are recorded in a secure electronic Case Report Form (eCRF). Participants are then trained to use the MyCare eQuoL app, complete the baseline questionnaires, and receive a personalized Care Plan and, where available, a digital Passport. At T2, six months post-intervention, participants receive automated reminders to complete follow-up assessments, including validated questionnaires evaluating changes in activation, quality of life, and satisfaction with the tool. The primary outcome of the study is the change in patient activation, measured by the Patient Activation Measure (PAM) at baseline and after six months. Secondary outcomes include changes in health-related quality of life (EORTC-AYA), patient-reported experience measures (PREMs), and a cost-effectiveness evaluation. To detect a clinically meaningful 4-point difference in PAM scores, with an assumed standard deviation of 20 and Type I and II error rates of 5% and 20%, respectively, the study requires 199 participants. Accounting for a 20% dropout rate, a total of 239 participants will be recruited. Primary outcome analysis will be conducted using multivariable logistic regression, while secondary outcomes will be analysed descriptively. Economic evaluation will include cost analysis, cost-utility analysis, and multi-criteria decision analysis. The study will be conducted in compliance with the principles of Good Clinical Practice (ICH/GCP) and the Declaration of Helsinki. The project will be registered at ClinicalTrials.gov. The research team will ensure adherence to all applicable ethical, legal, and safety regulations at both national and EU levels.

Official title: Conduct and Analysis of the Multi-country Effectiveness Study Within the eQuol Project

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