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Pediatric CancerREWORINCT07368582

Real World Pediatric Oncology Rehabilitation in Italy ( ReWori )

An observational study of Pediatric Cancer and Pediatric Cancer Patients, run by Associazione Italiana Ematologia Oncologia Pediatrica at 13 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 months to 24 years
What is being tested?
Rehabilitation intervention
How many people
249 participants
Where
13 sitesItaly
Study dates
19 Jul 2024to 30 Sep 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 months to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

AIEOP Clinical trial office AIEOP Clinical trial office contact

+390512144667

studiclinici@aieop.org

13 sites in 1 country

Italy13 sites, 10 recruiting

  • Ospedale Papa Giovanni XXIII USS Oncoematologia Pediatrica

    Bergamo, Italia

    Dott.ssa Laura Cavalleri, MD, lauracavalleri@asst-pg23.it

    Laura Cavalleri, MD

    Recruiting

  • Istituto Ortopedico Rizzoli Bologna Servizio di Assistenza Infermieristica, Tecnica e della Riabilitazione (SAITER)"

    Bologna

    Riccardo Ruisi, MD, riccardo.ruisi@ior.it

    Riccardo Ruisi, MD

    Recruiting

  • AS dell'Alto Adige comprensorio di Bolzano Dipartimento di Pediatria

    Bolzano

    Dott.ssa Michela Peranzoni, michela.peranzoni@sabes.it

    Michela Peranzoni, MD

    Not yet recruiting

  • IRCCS Eugenio Medea Associazione "La Nostra Famiglia"

    Bosisio Parini

    Dott.ssa Morena Delle Fave, MD, morena.dellefave@bp.inf.it

    Morena Delle Fave, MD

    Recruiting

  • IRCCS Eugenio Medea Associazione "La Nostra Famiglia"

    Brindisi

    Withdrawn

  • A.O.U. Policlinico Vittorio Emanuele U.O.C. Ematologia ed Oncologia Pediatrica con TMO

    Catania

    Milena La Spina Milena La Spina, MD, MD, mlaspina@unict.it

    Milena La Spina, MD

    Recruiting

  • IRCCS Eugenio Medea Associazione "La Nostra Famiglia"

    Conegliano

    Dott.ssa Silvia Spolverato, MD, silvia.spolverato@lanostrafamiglia.it

    Silvia Spolverato, MD

    Recruiting

  • Azienda Ospedaliero-Universitaria "Anna Meyer" IRCCS - SOC Professioni tecnico sanitarie e della riabilitazione

    Florence

    Margherita Dott.ssa Margherita Cerboneschi, MD, m.cerboneschi@meyer.it

    Margherita Cerboneschi, MD

    Recruiting

  • Fondazione IRCCS Istituto Nazionale Tumori S.C. Pediatrica Oncologica Milano

    Milan

    Active, not recruiting

  • Azienda Ospedale Università di Modena Dipartimento Materno Infantile, Unità Operativa complessa di Pediatria ad indirizzo oncoematologico

    Modena

    Withdrawn

  • IRCCS Ospedale Pediatrico "Bambino Gesù" Dipartimento Ematologia Oncologia e medicina trasfusionale

    Roma

    Dott. Riccardo Carbonetti, MD, riccardo.carbonetti@opbg.net

    Riccardo Carbonetti, MD

    Not yet recruiting

  • AOU Città della Salute e della Scienza di Torino

    Torino

    Dott.ssa Francesca Rossi, MD, +390113131643, francesca.rossi@unito.it

    Dott.ssa Caterina De Benedittis, +390512144667, caterina.debenedittis@aieop.org

    Recruiting

  • IRCCS Materno Infantile "Burlo Garofolo" Dipartimento Pediatrico S.C. Onco-ematologia Pediatrica SS Trapianto di Midollo

    Trieste

    Dott. Roberto Casalaz, roberto.casalaz@burlo.trieste.it

    Roberto Casalaz, MD

    Recruiting

Other trials in Italy

About this study

Official title: 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 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:

Read more
  1. What are the longitudinal changes in functional abilities among these patients receiving physiotherapy or neuropsychomotor rehabilitation?

The secondary research questions are:

  1. What types of rehabilitation practices are implemented across AIEOP centres?
  2. What are the rehabilitation needs among patients undergoing physiotherapy or neuropsychomotor rehabilitation?
  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.
Read the detailed description

Each year in Italy, about 1,400 children, 800 adolescents are diagnosed with cancer, with survival rates approaching 80percent. Despite improved survival, cancer and its treatments often lead to functional impairments and delays in neuropsychomotor development, affecting the musculoskeletal, nervous, and cardiovascular systems. These limitations can occur throughout all phases of care, from diagnosis to post-treatment, making rehabilitation increasingly important to preserve and improve quality of life. Although rehabilitation is recognized as beneficial in paediatric oncology, current evidence on the effectiveness of physiotherapy and neuropsychomotor interventions remains limited. Research has largely focused on general physical activity rather than targeted rehabilitation aimed at restoring specific functions such as mobility, balance, or joint function. A 2021 Cochrane review highlighted the need for high-quality, multicentre studies with standardized protocols, homogeneous patient groups, clearly defined and measurable outcomes, and long-term follow-up.

Currently, there are no shared international guidelines or Core Outcome Sets (COS) for rehabilitation in paediatric oncology. To address this gap, the Italian Association of Paediatric Haematology and Oncology (AIEOP) developed consensus-based recommendations for rehabilitation assessment and treatment and promoted the validation of the Functional Abilities Assessment in Paediatric Oncology (FAAP-O) scale. However, there is still the lack of data on prognostic factors influencing functional outcomes, rehabilitation needs, and types of rehabilitation care provided to children, adolescents, and young adults with cancer.

The primary objective is to describe changes in functional abilities in patients undergoing physiotherapy or neuropsychomotor rehabilitation. Secondary objectives include describing rehabilitation practices across AIEOP centres, estimating rehabilitation needs, and assessing quality of life at different stages of rehabilitation. The main endpoint is represented by functional ability levels, which are measured using the FAAP-O scale for patients with all types of cancer except bone tumours, and the TESS-pTESS questionnaires for patients with bone tumours. Secondary endpoints include rehabilitation tools, rehabilitation goals, treatment intensity, types of exercises, incidence of rehabilitation referrals with related impairments, and quality of life measured using the PedsQL and Bt-DUX questionnaires. The study will be conducted in compliance with Good Clinical Practice guidelines and the Declaration of Helsinki. Ethical approval from local ethics committees is required before patient enrolment, and no external funding is provided for the study. Patient confidentiality will be ensured through anonymised data collection. Each participant will be assigned a centre specific alphanumeric code. Personal identifiers will be accessible only to the enrolling centre. The year of birth will be recorded to minimize data entry errors.

All participants, or their legal guardians, will receive detailed information about the study objectives, data handling, and confidentiality measures. Participation is voluntary and will not affect rehabilitation care. Written informed consent will be obtained prior to enrolment. Data analysis will include descriptive statistics for continuous and categorical variables. Changes in functional abilities over time will be evaluated using paired statistical tests, while mixed-effects regression models will be used to explore associations between predictors and outcomes in a multicentre, longitudinal framework. Statistical significance will be set at 5%. Based on the primary outcome measures (FAAP-O, pTESS, and TESS), a sample size of 199 participants is required to detect a small effect size (0.20) with 80% power. Accounting for an anticipated 20% dropout rate, the total enrolment target is 249 patients. A rehabilitation assessment will be carried out upon referral to the rehabilitation service and then on a monthly basis throughout the rehabilitation process. Data will be collected electronically using an online case report form (CRF) on the REDCap platform, accessible to all participating centres following the ethical committee approbation.

Being tested
Rehabilitation intervention
Keywords
pediatric oncology, rehabilitation, motor performance, physical therapy, children, adolescents, young adults, exercise
Medical subject headings
Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rehabilitation interventionOther

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: One month

  2. 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.

    Measured: Three months

  3. 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.

    Measured: Three months

Secondary outcomes (2)

  1. Pediatric Quality of Life Inventory™ (PedsQL)

    The PedsQL questionnaire measures health-related quality of life in children and young people. There are two versions: a parent proxy version and a children's version. These are divided in differentage ranges (subjects aged 2-4 years, 5-7 years, 8-12 years, 13-18 years and 18-25 years). PedsQL includes 23 items across four domains: physical, emotional, social, and school functioning. The scoring system is based on a 5-point Likert scale (0-4), where 0 means "Never a problem" and 4 means "Almost always a problem" that is reversed-scored and transformed to a 0-100 scale, where higher scores indicate better health-related quality of life (0=100, 1=75, 2=50, 3=25, 4=0). It calculates scores by averaging items within subscales (physical, emotional, social, school). It is validated from 2 to18 years old.

    Measured: One month

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

    The Bt-DUX questionnaire identifies health-related quality of life in patients who have undergone surgery for malignant bone tumors of the lower limb. It consists of 20 items addressing social, emotional, aesthetic, and physical aspects. Each item can be scored using a five-point Likert scale ranging from 1, which means "very happy", to 5, which means "sad". These single-item scores are then converted in to total and domain scores. These raw scores are then converted into total and domain scores ranging from 0 to 100, with higher scores indicating a better quality of life.

    Measured: Three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start19 Jul 2024
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
249 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07368582
Sponsor's protocol ID
REWORI
Other IDs
AIEOP
Acronym
REWORI
Status last verified
Mar 2026
First submitted
20 Jan 2026
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pediatric Cancer and Pediatric Cancer Patients, run by Associazione Italiana Ematologia Oncologia Pediatrica at 13 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AIEOP Clinical trial office AIEOP Clinical trial office (+390512144667, studiclinici@aieop.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Abilities Assessment in Pediatric Oncology (FAAP-O) (time frame: One month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07368582.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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