Goal Attainment Scale in Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorAzienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
About this trial
The primary aim of this monocentric randomised controlled study is to evaluate the impact of using GAS to maintain the functional abilities of children and adolescents undergoing TCSE. The secondary aims include evaluating parents' and adolescents' perceived changes in the subject's functional abilities from the moment of stem cell transplantation unit (SCTU) admission to subsequent follow-ups. Another secondary aim is to evaluate the achievement of functional goals as defined by GAS in the experimental group (EG). Other aims include investigating the feasibility of the exercise program and the rehabilitation counselling indications in both groups, as well as the effectiveness of the two interventions and GAS use in the EG.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age between 6 months - 17 years and 11 months
diagnosis of oncological or hematological disease undergoing HSCT
No specific rehabilitation treatment ongoing at the moment of recruitment
Written informed consent from patient or parents/legal representative, and age-appropriate assent.
Disqualifiers
Patients that are not able and willing to comply with study visits and procedures.
Trial design
Design model
Parallel
Treatments tested in this trial
GAS group
Other interventionThis intervention includes an exercise programme (EP) and rehabilitation counselling indication (RCI) during hospitalisation for HSCT. Participants in the experimental group also set their own functional goals using GAS (Goal Attainment Scaling) with the help of the therapist during hospitalization. EP is carried out five days/week (30-minute per session) and it consists in muscle-strengthening, aerobic and stretching exercises. RCI have to be followed daily and they are some practical advice on how to adopt an active lifestyle during recovery. GAS is structured around the definition of a starting level (-1) and the goal to be achieved (level 0). Two higher levels (+1 and +2) are used to indicate better performance than expected, and level -2 is used to indicate regression in the initial functional objective. The "Goaled" app, which is available for free on smartphones and tablets, is used to define and verify the objectives. This should increase patient's motivation.
control group
Other interventionParticipants assigned in this group follow an Exercise Program and Rehabilitation counselling indications. Exercise Program EP is carried out five days a week (two days independently with parental support and three days under supervision). Each 30-minute session is supervised by one therapist for all patients. The EP programme includes three types of exercise: muscle-strengthening exercises for the upper and lower extremities, preceded by a 10-minute warm-up; 15 minutes of aerobic exercise; and 5 minutes of stretching. Rehabilitation counselling indications RCI have to be followed daily. RCI consist of some practical advice on how to adopt an active lifestyle during recovery. Some examples are getting up to go to the bathroom or the window to talk to visitors, sitting on a chair for school lessons.
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: Exercise programme (EP) and rehabilitation counselling indication (RCI)Other 1 intervention
Group B: Exercise programme (EP), rehabilitation counselling indication (RCI) and Goal Attaiment Scale (GAS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Functional Abilities Assessment in Paediatric Oncology (FAAPO) Scale
This tool is a short version of the Gross Motor Function Measure and has been validated for use with Italian paediatric oncology patients aged 6 months to 18 years. It comprises 36 items, each of which can be scored as 0, 1, 2, 3 or 'not tested'. The scoring key is as follows: 0 - does not initiate; 1 - initiates; 2 - partially completes; and 3 - completes. The final FAAP-O score provides a percentage of functional abilities.
Time frame
- At the admission to the ward - At hospital discharge - At 60 days after HSCTSecondary outcomes
1
Global Rating of Change (GCR)
Change in functional abilities perceived by parents and adolescents between T0 and T1, and between T1 and T2, is tested using Global Rating of Change (GCR).
Time frame
- At hospital discharge - At 60 days after HSCT2
Achievement of the functional objectives established with GAS (Goal Attainment Scaling)
Achievement of the functional objectives established with GAS in the experimental group, using GAS.
Time frame
Each 7 days from the baseline to the discharge from the ward.3
Percentage of adherence to the exercise programme and rehabilitation counselling indications.
Percentage of adherence to the exercise programme and rehabilitation counselling indications.
Time frame
Each 7 days from the baseline to the discharge from the ward.4
Percentage of GAS application in the experimental group.
Percentage of GAS application in the experimental group.
Time frame
Each 7 days from the baseline to the discharge from the ward.Sponsors and contacts
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Source ClinicalTrials.gov