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.

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.

Study Overview

• Status: Recruiting
• Conditions: Oncology; Hematology
• Intervention / Treatment: Other: control group; Other: GAS group

Detailed Description

HSCT is a potentially curative option for many diseases, including haematological malignancies and refractory solid tumours in children and adolescents. Its use in this age group has increased over the last three decades, as have survival rates decades. However, HSCT can cause a significant number of clinical complications and side effects in both the short and long term. Short-term effects include mucositis, fever, nausea and vomiting, while long-term effects include organ toxicity and fatigue. Allogeneic HSCT recipients can indeed develop graft-versus-host disease, which can lead to extensive multiorgan failure, systemic toxicity and mortality. Previous treatments, the severity of the conditioning regimen, the length of isolation and hospitalisation can all severely impair physical, cognitive and psychosocial functions, resulting in a reduction in quality of life (QoL). Recent studies have shown that exercise and rehabilitation are promising tools for decreasing the side effects of HSCT and improving QoL in the paediatric population undergoing HSCT). A systematic meta-analysis review reported that physical exercise is safe, feasible, and effective in preventing the decline in quality of life and physical performance in paediatric patients undergoing HSCT.

It is widely recognized that rehabilitation treatment in developmental age should consider the multiplicity of altered motor, perceptive, cognitive, affective, communicative and relational functions, their mutual interactions, as well as variables such as age and the role of the family, while respecting the individuality of each child. Health care professionals should treat patients with dignity, sensitivity, kindness, and respect for their individual needs and preferences for medical, clinical and rehabilitative care. These principles characterize the Family Centered Care (FCC), an approach based on the active involvement of the patients and their families in the care process. Other studies showed that uptake of an FCC approach in paediatric settings can positively impact children's HRQL. The FCC approach has been recognized as a model of best practice in pediatric rehabilitation, where it can be integrated in the rehabilitation programme by identifying clinically relevant and functional goals for the patients and their caregivers. Moreover, the approach can increase patient's compliance. Goal Attainment Scaling (GAS) has revealed itself as being a powerful tool to establish personalized goals and to objectively quantify the benefits of rehabilitation treatment. The GAS value lies in the possibility of identifying specific concrete objectives for each patient. The tool, which is used in different fields, is widely applied in pediatric rehabilitation. To date, the effects of active involvement of children, adolescents and their families in the definition of functional goals during hospitalization for HSCT have not yet been studied. The use of GAS to identify and achieve personalized, concrete and functional short-term goals during hospitalization could help patients to maintain a more active lifestyle. Consequently, it will reduce sedentary behaviors which are very frequent in this population. The increase in activity levels could significantly contribute to the maintenance of functional abilities that are often reduced during the treatment phase.

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesco Saglio, PhD Medical Doctor; Phone Number: +39 0113135449; Email: francesco.saglio@unito.it
• Study Contact Backup: Name: Francesca Rossi; Phone Number: +39 0113131643; Email: francesca.rossi@unito.it

Study Locations

• Italy
  • TO
    • Torino, TO, Italy, 10126
      • Recruiting
      • A.O.U. Città della Salute e della Scienza - OIRM
      • Contact: Francesca Rossi; Phone Number: +39 0113131643; Email: francesca.rossi@unito.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Exercise programme (EP) and rehabilitation counselling indication (RCI); 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.	Other: control group; 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.
Experimental: Exercise programme (EP), rehabilitation counselling indication (RCI) and Goal Attaiment Scale (GAS); 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. 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.	Other: GAS group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	- At hospital discharge - At 60 days after HSCT
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.	Each 7 days from the baseline to the discharge from the ward.
Percentage of adherence to the exercise programme and rehabilitation counselling indications.	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.	Percentage of GAS application in the experimental group.	Each 7 days from the baseline to the discharge from the ward.
Sit and Reach Test	Muscle extensibility of the posterior kinetic chain is measured with Sit and Reach Test. It is performed by sitting with legs extended against a box, then reaching forward as far as possible over the measuring line, holding for 2 seconds. It's scored by measuring the distance fingertips reach past (positive) or short of (negative) the toes.	- At the admission to the ward - At hospital discharge - At 60 days after HSCT
Hand grip test	The Hand Grip Test measures maximum isometric hand and forearm strength using a dynamometer, assessing overall physical capacity and potential indicators of health, functional status, and malnutrition. The procedure consists in squeezing the device for a few seconds, recording the force (in lbs), and often repeating trials to find the best score.	- At the admission to the ward - At hospital discharge - At 60 days after HSCT
Time Up and Go Test	The Timed Up and Go (TUG) test is a functional mobility assessment test. It requires a chair, stopwatch, and tape to mark 3 meters. A person stands from the chair, walks to the line at a normal pace, turns, walks back, and sits down, with the time recorded from "go" until seated.	- At the admission to the ward - At hospital discharge - At 60 days after HSCT
2-Minutes Walking Test	The 2-Minute Walk Test (2MWT) assesses a person's walking endurance and aerobic capacity. It is measured with the maximum distance they can cover in two minutes, walking back and forth along a clear, standardized path (30 metres), at their fastest safe pace.	- At the admission to the ward - At hospital discharge - At 60 days after HSCT
Pediatric Quality of Life Multidimensional Fatigue Scale	The Pediatric Quality of Life Multidimensional Fatigue Scale (PedsQL - MFS) is an 18-item questionnaire from the Pediatric Quality of Life Inventory (PedsQL) used to measure fatigue in children and adolescents (ages 2-18), assessing three specific dimensions: General Fatigue, Sleep/Rest Fatigue, and Cognitive Fatigue, with higher scores indicating better quality of life and less fatigue, using a Likert-type scale from "never" to "almost always". e;	- At the admission to the ward - At 60 days after HSCT
Pediatric Quality of Life Cancer Module	The Pediatric Quality of Life Cancer Module (PedsQL Cancer Module) is a widely used, cancer-specific questionnaire measuring health-related quality of life (HRQoL) in children and adolescents with cancer, using both child self-report and parent proxy-report, assessing dimensions like pain, fatigue, treatment anxiety, and appearance.	- At the admission to the ward - At 60 days after HSCT
Changes in immunological variables	Immune recovery will be evaluated through the counting of the different populations of white blood cells (leukocytes, monocytes and lymphocytes), of the lymphocyte subpopulations (total T lymphocytes (CD45+ CD3+ CD56-), B lymphocytes (CD19+ CD20+), NK lymphocytes (CD45+ CD3- CD56+), CD4+ T lymphocytes (CD3+ CD4+ CD8-) and CD8+ T lymphocytes (CD3+ CD4- CD8 +).	- At 60 days after HSCT - At 90 days after HSCT

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
• Investigators: Principal Investigator: Francesco Saglio, PhD Medical Doctor, A.O.U. Città della Salute e della Scienza - OIRM

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Estimated): June 23, 2027
• Study Completion (Estimated): December 23, 2027

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: fatigue; children; adolescents; physical therapy; hematopoietic stem cell transplantation; motor performance; family centered care
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms; Fatigue; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: GAST; 137/2022 (Other Identifier: Comitato Etico Interaziendale AOU Città della Salute e della Scienza di Torino, AO Mauriziano e ASL Città di Torino)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No