Goal Attainment Scale in Transplantation
GAST
Using Goal Attainment Scale (GAS) to Increase Active Involvement of Patients and Their Family in the Identification of Functional Objectives During Hospitalization for Hematopoietic Stem Cell Transplantation (HSCT): a Randomized Controlled Trial.
2 other identifiers
interventional
176
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 23, 2022
CompletedFirst Submitted
Initial submission to the registry
December 16, 2025
CompletedFirst Posted
Study publicly available on registry
January 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 23, 2027
January 28, 2026
January 1, 2026
5 years
December 16, 2025
January 20, 2026
Conditions
Keywords
Outcome Measures
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.
- At the admission to the ward - At hospital discharge - At 60 days after HSCT
Secondary Outcomes (11)
Global Rating of Change (GCR)
- At hospital discharge - At 60 days after HSCT
Achievement of the functional objectives established with GAS (Goal Attainment Scaling)
Each 7 days from the baseline to the discharge from the ward.
Percentage of adherence to the exercise programme and rehabilitation counselling indications.
Each 7 days from the baseline to the discharge from the ward.
Percentage of GAS application in the experimental group.
Each 7 days from the baseline to the discharge from the ward.
Sit and Reach Test
- At the admission to the ward - At hospital discharge - At 60 days after HSCT
- +6 more secondary outcomes
Study Arms (2)
Exercise programme (EP) and rehabilitation counselling indication (RCI)
OTHERExercise 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.
Exercise programme (EP), rehabilitation counselling indication (RCI) and Goal Attaiment Scale (GAS)
EXPERIMENTALExercise 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. GAS During their hospitalisation, children and caregivers in the experimental group define a functional goal together each week with the help of the therapist. This is verified using Goal Attainment Scaling, which identifies specific and significant objectives for the patient and their family.
Interventions
This 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.
Participants 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients that are not able and willing to comply with study visits and procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
A.O.U. Città della Salute e della Scienza - OIRM
Torino, TO, 10126, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Saglio, PhD Medical Doctor
A.O.U. Città della Salute e della Scienza - OIRM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
December 16, 2025
First Posted
January 28, 2026
Study Start
June 23, 2022
Primary Completion (Estimated)
June 23, 2027
Study Completion (Estimated)
December 23, 2027
Last Updated
January 28, 2026
Record last verified: 2026-01