Clinical trial NCT04862130: Validation of the GMFM-88 Scale and of the FAAP-O Scale in Pediatric Patients Affected by Cancer
Official title: Rehabilitative Evaluation of Functional Abilities in Children/Adolescents Affected by Cancer: a Validation Study of the GMFM-88 Scale and of the Functional Abilities Assessment in Pediatric Oncology (FAAP-O) Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncology
Keywords: Physiotherapy
Rehabilitation
Functional abilities evaluation
motor function evaluation
Lead sponsor: Associazione Italiana Ematologia Oncologia Pediatrica
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 217
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents affected by cancer referred to the rehabilitation services of the participants centres.

Brief summary: The primary objective of this study is to validate the Gross Motor Function Measure Scale-88 (GMFM-88) on the Italian pediatric cancer population. The secondary objective is to implement the use of the GMFM-88 in clinical practice by validating a reduced panel of items that will be called the Functional Ability Assessment in Pediatric Oncology (FAAP-O) Scale.

Detailed description: In recent decades, improvements in the treatment of pediatric cancer patients have resulted in increased survival rates. Consequentially, clinicians now pay more attention to the quality of life of these patients, both during and after treatment. Functional abilities have an important role in the quality of life and these skills can be compromised by the tumor itself or by anti-neoplastic treatments. A recent Cochrane review regarding rehabilitation and motor activity in this population has documented the effectiveness of exercise in children with cancer. Furthermore, to improve the rehabilitation care of pediatric cancer patients it is important to broaden the research by structuring multi-center trials, which allow the collection of longitudinal data. Objective, repeatable, specific, and sensitive rehabilitation assessment tools are needed, to define the functional status of the patient and to measure the motor outcomes. The psychometric properties of a measurement are closely linked to the specific population in which the measurement is used. Currently, there are two validated assessment tools for children/adolescents with cancer used to evaluate functional abilities: The Gross Motor Function Scale-Acute Lymphoblastic Leukemia (GMFM-ALL) and the Motor Performance in Pediatric Oncology (MOON). The ladder has the merit of being structured to evaluate the motor skills of children/adolescents affected by various forms of cancer but it also presents some limits. This test does not investigate functional abilities in a rehabilitation optic and it requires the use of specific materials that can reduce its usability in multicenter trials. The GMFM-ALL scale is a modified version of the Gross Motor Function Measure 88 (GMFM-88) Scale. This scale is specific only for children/adolescents with Lymphoblastic Leukemia and it mainly evaluates motor skills that require a high functional level (i.e. jumps, running), possessed neither by younger children nor by those who show major physical impairments or during specific phases of cancer treatment, such as palliative care.

The GMFM-88 scale is a rehabilitation assessment tool that was originally created to investigate functional abilities in children affected by cerebral palsy (CP) and has subsequently been validated for other populations of pediatric patients. It was also used to evaluate functional abilities in some studies conducted on pediatric cancer patients. Some aspects make this tool easily applicable in multicenter studies: it does not require any material to be administered nor a specific certified training to use it and, lastly, it comprises all principal motor skills including the basic ones (i.e. lying and rolling on the ground).

Eligibility criteria: Inclusion Criteria:

* age between 6 months - 17 years and 11 months
* diagnosis of oncological disease
* being during antineoplastic treatment or up to 1 year off-therapy
* Written informed consent from patient or parents/legal representative, and age-appropriate assent.

Exclusion criteria:

• Patients that are not able and willing to comply with study visits and procedures.

Primary outcomes:
measure: Construct validity of the GMFM-88 in measuring functional abilities of children and adolescents affected by cancer.
timeFrame: up to 1 year
Secondary outcomes:
measure: Content validity of the GMFM-88 items in evaluating functional abilities of children and adolescents affected by cancer
timeFrame: up to 1 year
measure: Construct validity of the FAAP-O in assessing functional abilities of children and adolescents affected by cancer
timeFrame: up to 18 months
measure: Inter-observer reliability and intra-observer reliability of the FAAP-O
timeFrame: through study competition, an average of 2 years
measure: Test-retest reliability of the FAAP-O
timeFrame: through study competition, an average of 2 years
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E. Medea La Nostra Famiglia
state: Lecco
city: Conegliano
country: Italy
facility: IRCCS E. Medea La Nostra Famiglia
state: Treviso
city: Bergamo
country: Italy
facility: Ospedale Papa Giovanni XXIII, UOS Onco-ematologia Pediatrica
city: Bolzano
country: Italy
facility: Ospedale Azienda Sanitaria dell'Alto Adige - Comprensorio di Bolzano Servizio di Riabilitazione Fisica
city: Brindisi
country: Italy
facility: IRCCS E. Medea La Nostra Famiglia
city: Firenze
country: Italy
facility: AOU Meyer - UP Riabilitazione
city: Genova
country: Italy
facility: IRCCS Istituto Giannina Gaslini - U.O. Med Fisica e riabilitazione
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori - S.C. Cure palliative, Terapia del Dolore e Riabilitazione
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza - OIRM
city: Trieste
country: Italy
facility: IRCCS Materno Infantile Burlo Garofolo - S.C. Oncoematologia
Study officials:
affiliation: A.O.U. Città della Salute e della Scienza - OIRM, Turin, Italy
name: Francesca Rossi, dr
role: PRINCIPAL_INVESTIGATOR
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