Childhood Cancer Survivors

In France today, it is estimated that one in 850 people aged between 20 and 45 has been cured of cancer in childhood. Some descriptive studies have established that cancer diagnosis and treatment can affect psychological health, with an increased risk of depression, post-traumatic stress, anxiety and suicidal risk. A French study published by our team in 2015 and 2020 also showed that, as adults, 40% of former pediatric cancer patients experienced symptoms of anxiety, a rate significantly higher than that of the general French population (25%). While it is well established that it is essential to detect the onset of anxiety-depressive disorders and, if necessary, to set up conventional psychological treatment (CPT), few studies have sought to show the benefit of complementing this conventional CPT with mind-body therapies (MBT) in the post-cancer pediatric setting. This project aims to determine the benefit of mind-body therapies (hypnosis and relaxation) as a complement to conventional psychological treatment (CPT) in the management of anxiety in children, adolescents and young adults in remission from pediatric cancer or leukemia.

This study will look at whether motivational sessions (including regular calls with a trained health coach) in combination with time-restricted eating (TRE) is an effective way to achieve weight loss and lower cardiometabolic risk in adult survivors of childhood cancer. The researchers will look at how effective this intervention is compared to the usual approach, which is to review educational materials and measure weight once a month. This study will not provide treatment for any disease or cancer.

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.

The goal of the Cardiovascular Health Equity Through Food (CHEF) program is to make it easier for participants and families to cook and eat healthy foods during and following childhood cancer treatment with the long-term goal of supporting heart health.

Advances in pediatric cancer treatment have led to significant improvements in survival rates, where 5-year survival now exceeds 85%. Despite improved survival, children and adolescents who survive cancer often face significant short- and long-term psychosocial and physical late effects. Children undergoing cancer treatment often experience prolonged school absence, which disrupts their academic development and impedes critical socio-emotional growth during formative school years, with lasting consequences into adulthood. Together, these challenges underscore the need for targeted interventions that support educational continuity, promote school activity, and foster psychosocial well-being. The SchoolCare Intervention aims to reduce school absence experienced by children diagnosed with cancer during their treatment trajectory. The intervention introduces school navigation support in combination with the use of telepresence robots (TPRs) and a teleteaching program. TPRs enable the children to attend school remotely, when they are not able to attend physically. The study is designed to investigate the effectiveness of the intervention throughout a period of eight months for school-aged children (i.e., 5-17 years) who are diagnosed with cancer. The investigators hypothesize that telepresence robots will increase school attendance among children and adolescents diagnosed with cancer, representing our primary outcome (H1). Additionally, the investigators explore secondary outcomes by hypothesizing that the intervention will improve the social well-being of these children and adolescents (H2) and enhance their academic level (H3). By focusing on both school attendance and broader psychosocial and academic effects, this study will provide a comprehensive evaluation of the telepresence robot intervention and its potential to support educational continuity and well-being for children with cancer.

In recent decades, the survival rate of children with cancer has increased significantly thanks to personalized treatments and the adoption of international therapeutic protocols. However, along with this increase in survival, side effects related to these treatments on various organs and systems have been observed. Among the most widely used chemotherapeutic agents in pediatric age, anthracyclines play a crucial role in the treatment of various forms of neoplasms (both haematological such as acute lymphoblastic leukemia or lymphomas, and solid tumors such as sarcomas). However, in addition to their excellent antineoplastic effect, they are burdened by the potential for cardiotoxicity. This cardiotoxicity manifests clinically with left ventricular systolic dysfunction and arrhythmias. At the moment, international guidelines recommend long-term cardiac follow-up evaluations for this group of patients, even after treatment has concluded.The methods used in the cardiac follow-up of patients undergoing anthracycline therapy include echocardiography, cardiac magnetic resonance imaging, tests to assess endothelial function, and measurements of the biomarkers troponin and atrial natriuretic peptide. These methods can assess anthracycline-induced cardiac and endothelial damage once it has already occurred, but they cannot predict its onset nor can they study its pathogenesis. Furthermore, to date, no information is available regarding the possibility of using "endothelial-mesenchymal transition" biomarkers as predictors of the onset of anthracycline-induced cardiac damage. This study analyzes these biomarkers as predictive tools for cardiac damage. Specifically, plasma levels of Serpin 3, THBS1, TGFbeta1, HIF1a, extracellular ICAM1, troponin, proBNP, fibrinogen, von Willebrand factor, and endothelin will be measured in patients treated with anthracycline. The concentrations of these biomarkers will be compared with the results of the echocardiogram and with the treatments performed in order to identify any relationships. Furthermore, plasma levels of Serpin 3, THBS1, TGFbeta1, HIF1a, extracellular ICAM1, troponin, proBNP, fibrinogen, von Willebrand factor, and endothelin will also be measured in a population of healthy subjects in order to obtain data on a possible relationship between the biomarkers and the anthracycline therapies performed.

Clinical levels of fear of cancer recurrence (FCR) affect up to 59% of adult cancer survivors. Family caregivers experience equal or greater levels of FCR, which has been linked to lower quality of life and increased distress. FCR can be addressed in cancer survivors with brief interventions. However, none of these interventions have been tested with parents of childhood cancer survivors. This is an urgent gap: the survival rates of childhood cancer have increased more rapidly than for adult cancers, resulting in a growing population of childhood cancer survivors who, along with their families, need support. The goals of this pilot study are to demonstrate 1) that a newly adapted intervention of FORT (Parent-FORT) is feasible (i.e., participant recruitment, attendance and participation) and acceptable (i.e., parent satisfaction of the intervention) for a larger study, and 2) the clinical implications of Parent-FORT on fear of cancer recurrence (FCR) and quality of life in parents of childhood cancer survivors. Parents will be randomly assigned to participate in the Parent-FORT intervention immediately or a three-month waitlist control group. They will complete a questionnaire package before and after the intervention, as well as at a three month follow up. This study will help bridge an important gap in bringing evidence-based care to parents who have never been offered help before for their FCR.

Children living beyond cancer (CBC) represent a unique and growing population of young people in need of long-term clinical support. Studies suggest that 11-44% of CBC experience chronic pain, negatively impacting a wide range of child biopsychosocial outcomes and creating high financial burden for their families and society. Often comorbid with pain, one of the most chronic and disturbing side effects reported by CBC are sleep disturbances, and in particular, difficulties initiating and maintaining sleep. Indeed, \>50% of CBC report some form of sleep disturbance even 9 to 15 years after the cancer diagnosis. Much attention has been paid to sleep and pain as independent constructs within pediatric oncology, yet Belgian data is lacking. Additionally, little is known about how these domains interact with one another and subsequent indications for prevention and intervention. Although evidence shows an interrelationship between pain and sleep in adult and pediatric populations, this interrelationship is understudied in childhood cancer patients and CBC. (Chronic) pain may serve as a modifiable target for interventions to improve sleep quality and vice versa, and understanding this relationship is crucial for providing comprehensive care to CBC. Therefore, this cross-sectional case-control study aims to explore the differences in pain and sleep disturbances in CBC compared to healthy age- and sex-matched healthy controls, as well as the interrelationship between both outcomes.

This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer. * The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal. * The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.

Advances in the medical treatment of childhood acute lymphoblastic leukemia (ALL) have resulted in 5-year survival rates above 90%- however, the success is not without consequences. Childhood ALL survivors experience markedly impaired physical capacity - reducing their opportunity to engage in everyday activities including leisure activities, sports, and school - affecting their quality of life. Furthermore, Childhood ALL survivors have markedly increased risk of chronic medical conditions including cardiometabolic diseases - that can be prevented through an active lifestyle. Thus, it is imperative to develop novel interventions that can mitigate these treatment-related late-effects. In this RCT, including 82 childhood ALL survivors (10-21 years-old), we will investigate a 26-week online exercise intervention combined with access to a lifestyle physical activity webpage, and health consultations on cardiorespiratory fitness (primary outcome) markers of metabolic syndrome, and physical activity habits. While other pilot studies have investigated the effects of exercise for childhood ALL survivors, this study is the first RCT internationally to investigate the effects of online exercise combined with education through an app and health counselling for childhood ALL survivor. Using this approach, we are geographically able to reach every survivor in our targeted population, thereby, minimizing logistic challenges like travel distances. This study has the potential to radically change the way physical rehabilitation is approached in childhood ALL survivors - Potentially changing the workflow of health professionals from referring only survivors with specific deficits to local physiotherapy to referring all survivors to an exercise program tailored to their needs. By improving the children's general physical capacity, we can give the children the required tools to re-enter everyday life activities, including school physical education, leisure activities, and sports earlier after treatment has ended - ultimately minimizing the social complications of treatment. This study will also answer the government´s call to digitalize 30% of rehabilitation by the 2030.

Ovarian function impairment affects the quality of life of the survivors of paediatric cancer by impacting fertility, bone quality and mental and cognitive health. The objective of this project is to evaluate the impact of low-intermediate dose alkylating agents associated or not with ovarian cryopreservation technique on ovarian function in female survivors of paediatric cancer. We propose to identify new epigenetic markers in order to predict the risk of premature ovarian insufficiency. The project will be led by a national multi-disciplinary team (paediatric oncologists, gynaecologists, endocrinologists). Paediatric cancer clinical data (therapy, fertility preservation, ...) will be extracted from the Paediatrics Late Effects database and additional data will be collected during PRINCESS fertility evaluation. Through translational and multi-disciplinary approaches, results should improve quality of life and fertility preservation in female survivors of paediatric cancer by developing new personalised screening tools for premature ovarian insufficiency.