Real World Pediatric Oncology Rehabilitation in Italy ( ReWori )

Condition(s) studied

Investigational drug(s) / intervention(s)

Rehabilitation intervention: 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

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Functional Abilities Assessment in Pediatric Oncology (FAAP-O) — One month
  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.
• Toronto Extremity Salvage Score (TESS) — Three months
  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.
• Pediatric Toronto Extremity Salvage Score (pTESS) — Three months
  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.

Trial sites (13)

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