eQuoL Effectiveness Study

Официальное название

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

Обзор

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.

Вмешательства

• Другое Psychosocial support trought a web app
  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

Первичные конечные точки

• Patient Activation Measure (PAM) [Срок оценки: From enrollment to the end of the web app testing phase at 6 months]

Критерии участия

Критерии включения

\- Patients (male or female) with a history of cancer diagnosis before the age of 25 years

• Patients aged between 16 and 30 years old as the study aims to primarily target digital natives who are familiar with mobile applications.
• To be in follow-up care, completed follow-up, or lost to follow-up before inclusion at one of the institutions participating in the effectiveness study
• Completed the planned treatment protocol
• Without evidence of active disease and having been off therapy for at least 5 years since the first tumor diagnosis
• Able to login and navigate phone apps
• Sufficient language skills in one of the available study languages
• With a valid informed consent from the patient, or, for patients younger than 18, valid consent from their parent/guardian and valid assent from the patient.

Критерии исключения

Being unable to answer the questions of the study questionnaires (not even with help from another person) because of severe mental sequelae or insufficient mastery of the language used;

● currently in treatment for secondary malignancy or relapse of primary malignancy.-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07541183 · ID 101136549

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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