OncologyGASTNCT07372690
Goal Attainment Scale in Transplantation
A study testing GAS group in people with Oncology and Hematology, run by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Oncology, Hematology
- What is being tested?
- GAS group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jun 2022to 23 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Patients that are not able and willing to comply with study visits and procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
A.O.U. Città della Salute e della Scienza - OIRM
Torino, TO, 10126
Francesca Rossi, +39 0113131643, francesca.rossi@unito.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Oncology, Hematology
- Being tested
- GAS group, control group
- Keywords
- adolescents, children, hematopoietic stem cell transplantation, physical therapy, motor performance, fatigue, family centered care
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAS groupOther
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.
control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise programme (EP) and rehabilitation counselling indication (RCI) | Other | 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. Receives: Other: control group |
| Exercise programme (EP), rehabilitation counselling indication (RCI) and Goal Attaiment Scale (GAS) | Experimental | 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. Receives: Other: GAS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: - At the admission to the ward - At hospital discharge - At 60 days after HSCT
Secondary outcomes (11)
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).
Measured: - 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: - 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.
Measured: - 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.
Measured: - 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.
Measured: - 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;
Measured: - 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.
Measured: - 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 +).
Measured: - At 60 days after HSCT - At 90 days after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start23 Jun 2022
- Primary completion23 Jun 2027 (estimated)
- Study completion23 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Franca Fagioli, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
- Investigators
- Francesco Saglio, PhD Medical Doctor, Principal investigator, A.O.U. Città della Salute e della Scienza - OIRM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372690
- Sponsor's protocol ID
- GAST
- Other IDs
- 137/2022
- Acronym
- GAST
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07372690
- Acronym / sponsor ID
- GAST / GAST
- Conditions
- Oncology, Hematology
- Keywords
- adolescents, children, hematopoietic stem cell transplantation, physical therapy, motor performance, fatigue, family centered care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 23 Jun 2027 (estimated)
- Study completion
- 23 Dec 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise programme (EP) and rehabilitation counselling indication (RCI) | Other | Other: control groupExercise 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) | Experimental | Other: GAS groupExercise 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. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients that are not able and willing to comply with study visits and procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAS groupThis 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. | Other | Exercise programme (EP), rehabilitation counselling indication (RCI) and Goal Attaiment Scale (GAS) |
| control groupParticipants 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. | Other | Exercise programme (EP) and rehabilitation counselling indication (RCI) |
Primary outcome
Functional Abilities Assessment in Paediatric Oncology (FAAPO) Scale
Time frame: - At the admission to the ward - At hospital discharge - At 60 days after HSCT
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.
11 secondary outcomes
Global Rating of Change (GCR)
Time frame: - At hospital discharge - At 60 days after HSCT
Achievement of the functional objectives established with GAS (Goal Attainment Scaling)
Time frame: Each 7 days from the baseline to the discharge from the ward.
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.
Percentage of GAS application in the experimental group.
Time frame: Each 7 days from the baseline to the discharge from the ward.
Sit and Reach Test
Time frame: - At the admission to the ward - At hospital discharge - At 60 days after HSCT
Hand grip test
Time frame: - At the admission to the ward - At hospital discharge - At 60 days after HSCT
Time Up and Go Test
Time frame: - At the admission to the ward - At hospital discharge - At 60 days after HSCT
2-Minutes Walking Test
Time frame: - At the admission to the ward - At hospital discharge - At 60 days after HSCT
Pediatric Quality of Life Multidimensional Fatigue Scale
Time frame: - At the admission to the ward - At 60 days after HSCT
Pediatric Quality of Life Cancer Module
Time frame: - At the admission to the ward - At 60 days after HSCT
Changes in immunological variables
Time frame: - At 60 days after HSCT - At 90 days after HSCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesco Saglio, PhD Medical Doctor principal investigator
A.O.U. Città della Salute e della Scienza - OIRM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GAS group in people with Oncology and Hematology, run by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Saglio, PhD Medical Doctor (+39 0113135449, francesco.saglio@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Abilities Assessment in Paediatric Oncology (FAAPO) Scale (time frame: - At the admission to the ward - At hospital discharge - At 60 days after HSCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.