Real World Pediatric Oncology Rehabilitation in Italy ( ReWori )

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-24
SponsorAssociazione Italiana Ematologia Oncologia Pediatrica

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Rehabilitation intervention

    Other 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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
Three months

Secondary outcomes

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.

Time frame
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.

Time frame
Three months

Other outcomes

Sponsors and contacts

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