RecruitingNot ApplicableNCT07372690

Goal Attainment Scale in Transplantation

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.


Sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Enrollment

176 participants

Start Date

Jun 23, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 MonthsMax Age: 17 Years

Inclusion Criteria4

  • 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 Criteria1

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

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Interventions

OTHERGAS 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.

OTHERcontrol 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.


Locations(1)

A.O.U. Città della Salute e della Scienza - OIRM

Torino, TO, Italy

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NCT07372690


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