Real-world rehabilitation for children and young adults with cancer in Italy (ReWori)
Real World Pediatric Oncology Rehabilitation in Italy (ReWori) Study Protocol: Prognostic Factors of Functional Abilities in Children, Adolescents and Young Adults With Cancer Undergoing Rehabilitation
This project will follow children and young adults with cancer in Italy to see how their physical and motor abilities change while they receive usual physiotherapy or neuropsychomotor rehabilitation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 249 (estimated) |
| Ages | 0 Months to 24 Years |
| Sex | All |
| Sponsor | Associazione Italiana Ematologia Oncologia Pediatrica Academic / other |
| Locations | 13 sites (Bergamo, Italia and 12 other locations) |
| Trial ID | NCT07368582 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, observational registry that will collect real-world, longitudinal data on functional abilities in patients aged 0–24 receiving routine physiotherapy or neuropsychomotor rehabilitation across AIEOP centers in Italy. Participants receive usual rehabilitation care and are evaluated on functional outcomes and health-related quality of life at regular intervals, typically monthly, using standardized tools such as the FAAP-O when available. The study documents the types of rehabilitation practices used, rehabilitation needs, and changes in motor performance across different stages of treatment and recovery. Data will be pooled across participating hospitals and rehabilitation centers to describe typical care pathways and outcome trajectories in everyday clinical settings.
Who should consider this trial
Good fit: Children, adolescents, and young adults aged 0–24 with a cancer diagnosis who are referred to rehabilitation services at participating Italian AIEOP hospitals or affiliated rehabilitation centers and who provide consent are ideal candidates.
Not a fit: Patients who cannot attend regular rehabilitation visits, who decline consent, or whose medical condition prevents standard physiotherapy may not receive direct benefit from participation.
Why it matters
Potential benefit: If successful, the project could clarify common rehabilitation pathways and help target therapies to preserve or improve mobility and quality of life for children and young adults with cancer.
How similar studies have performed: Previous research on general physical activity in pediatric oncology suggests some benefit, but high-quality multicenter evidence for targeted physiotherapy or neuropsychomotor rehabilitation is limited, making this larger standardized effort relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of cancer, * Children, adolescents and young adults aged between 0 and 24 years old, * Children, adolescents and young adults at any stage of treatment and off therapy, * Children, adolescents and young adults referred to the Rehabilitation Service of AIEOP centres and Rehabilitation Centres that provide rehabilitation care for paediatric and young adult cancer patients involved in the study. Exclusion Criteria: * Failure to sign the consent/assent form for participation in the study by the subject and/or by the person exercising parental authority.
Where this trial is running
Bergamo, Italia and 12 other locations
- Ospedale Papa Giovanni XXIII USS Oncoematologia Pediatrica — Bergamo, Italia, Italy (Recruiting)
- Istituto Ortopedico Rizzoli Bologna Servizio di Assistenza Infermieristica, Tecnica e della Riabilitazione (SAITER)" — Bologna, Italy (Recruiting)
- AS dell'Alto Adige comprensorio di Bolzano Dipartimento di Pediatria — Bolzano, Italy (Not_yet_recruiting)
- IRCCS Eugenio Medea Associazione "La Nostra Famiglia" — Bosisio Parini, Italy (Recruiting)
- IRCCS Eugenio Medea Associazione "La Nostra Famiglia" — Brindisi, Italy (Withdrawn)
- A.O.U. Policlinico Vittorio Emanuele U.O.C. Ematologia ed Oncologia Pediatrica con TMO — Catania, Italy (Recruiting)
- IRCCS Eugenio Medea Associazione "La Nostra Famiglia" — Conegliano, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria "Anna Meyer" IRCCS - SOC Professioni tecnico sanitarie e della riabilitazione — Florence, Italy (Recruiting)
- Fondazione IRCCS Istituto Nazionale Tumori S.C. Pediatrica Oncologica Milano — Milan, Italy (Active_not_recruiting)
- Azienda Ospedale Università di Modena Dipartimento Materno Infantile, Unità Operativa complessa di Pediatria ad indirizzo oncoematologico — Modena, Italy (Withdrawn)
- IRCCS Ospedale Pediatrico "Bambino Gesù" Dipartimento Ematologia Oncologia e medicina trasfusionale — Roma, Italy (Not_yet_recruiting)
- AOU Città della Salute e della Scienza di Torino — Torino, Italy (Recruiting)
- IRCCS Materno Infantile "Burlo Garofolo" Dipartimento Pediatrico S.C. Onco-ematologia Pediatrica SS Trapianto di Midollo — Trieste, Italy (Recruiting)
Study contacts
- Principal investigator: Francesca Rossi Rossi, Master's degree — AOU Città della Salute e della Scienza di Torino - Ospedale Infantile Regina Margherita
- Study coordinator: AIEOP Clinical trial office AIEOP Clinical trial office
- Email: studiclinici@aieop.org
- Phone: +390512144667
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.