Real World Pediatric Oncology Rehabilitation in Italy ( ReWori )

NCT07368582 | Recruiting

• 2 other identifiers: REWORIAIEOP
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 13

Brief Summary

This observational study aims to describe changes in the functional abilities of children, adolescents and young adults with cancer who are undergoing physiotherapy or neuropsychomotor rehabilitation. This is real-world study aiming to describe normal rehabilitation pathways in many different hospitals or rehabilitation centres in Italy. The primary research question is: 1\) What are the longitudinal changes in functional abilities among these patients receiving physiotherapy or neuropsychomotor rehabilitation? The secondary research questions are:

1. 1.What types of rehabilitation practices are implemented across AIEOP centres?
2. 2.What are the rehabilitation needs among patients undergoing physiotherapy or neuropsychomotor rehabilitation?
3. 3.How does health-related quality of life differ across the various stages of the rehabilitation pathway? Participants undergoing usual rehabilitation treatment are evaluated on their functional abilities on a monthly basis. If they agree to participate in this study, the main characteristics of the rehabilitation treatment and the monthly evaluation are collected.

Conditions

Pediatric Cancer; Pediatric Cancer Patients; Pediatric Oncology; Rehabilitation; Motor Outcomes; Physical Therapy

Keywords

pediatric oncology; rehabilitation; motor performance; physical therapy; children; adolescents; young adults; exercise

Outcome Measures

Primary Outcomes (3)

• Functional Abilities Assessment in Pediatric Oncology (FAAP-O)

  The Functional Abilities Assessment in Pediatric Oncology (FAAP-O) scale assesses global motor abilities in children and adolescents with cancer through 36 items. Scores range from 0 to 3, where 0 indicates that the child does not initiate the task, 1 initiates the task (\<10%), 2 partially completes the task (10% to \<100%), and 3 completes the task as described in the criteria. Higher scores mean a better outcome. It is validated for children and adolescents aged 6 months to 18 years.

  One month

• Toronto Extremity Salvage Score (TESS)

  The Toronto ExtremitySalvage Score (TESS) isa self-administered questionnaire used to assess subjective functional abilities and residual disability in patients with musculoskeletal oncological diseases. Through30 items, patients are asked to rate perceived difficulty in performing specific activities. The tasks are rated from 0 (not possible) to 5 (without any problem). The raw score is converted to a score ranging from 0 to 100 points, with higher scores indicating a less functional limitation. It can be administered from the age of 12 years.

  Three months

• Pediatric Toronto Extremity Salvage Score (pTESS)

  The Pediatric Toronto ExtremitySalvage Score (pTESS) is self-administered questionnaire. Is the pediatric version of the TESS, adapted and validated for children and adolescents with bone tumors. The Ptess comprehends 30 items. Each item is an swered using a 5-point ordinal scale, and all item responses are aggregated into a single summary score. Five points are allotted for the first response option ("not at all hard"), 4 points for the second option, and so on, until 1 point is allotted for the fifth option("too hard. I can't"). Each item has a "not applicable" option, phrased as: "I do not do this." This not applicable (NA) option is notgiven a numeric score and for scoring is considered invalid. Summary scores indicate physical function ranging from 0 (lowest) to 100 (highest).It can be used from the age of 7 years.

  Three months

Secondary Outcomes (2)

• Pediatric Quality of Life Inventory™ (PedsQL)

  One month

• DUX for Bone Tumors in Children and Adolescents (Bt-DUX)

  Three months

Interventions

Rehabilitation intervention OTHER

This is an observational study, so it does not have a specific rehabilitation treatment protocol to be followed. The chort is followed with a periodic evaluation (monthly or every three month only for bone tumour diagnosis) during the period of the rehabilitation treatment

Eligibility Criteria

• Age: 0 Months - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children, adolescents and young adults aged between 0 and 24 years old with a diagnosis of cancer at any stage of treatment and off therapy. They must be 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

You may qualify if:

• 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.

You may not qualify if:

• Failure to sign the consent/assent form for participation in the study by the subject and/or by the person exercising parental authority.

Sponsors & Collaborators

• Associazione Italiana Ematologia Oncologia Pediatrica: lead

Study Sites (13)

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

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Francesca Rossi Rossi, Master's degree

  AOU Città della Salute e della Scienza di Torino - Ospedale Infantile Regina Margherita

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AIEOP Clinical trial office AIEOP Clinical trial office

CONTACT

+390512144667; studiclinici@aieop.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 26, 2026
• Study Start: July 19, 2024
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

IT (13)