Exercise Intervention in Childhood and Adolescence Hematopoietic Stem Cell Transplantation: The Henkō Trial

Alejandro Lucia1 site in 1 country48 target enrollmentApril 1, 2024

ConditionsHematopoietic System--Cancer

InterventionsControl Group (Active Comparator)Intervention Group

Overview

Phase: Not Applicable
Intervention: Control Group (Active Comparator)
Conditions: Hematopoietic System--Cancer
Sponsor: Alejandro Lucia
Enrollment: 48
Locations: 1
Primary Endpoint: Change in unilateral knee-extension muscle strength (from baseline to end of treatment)
Status: Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Thanks to medical advances, survival rates >5 years in children/adolescents undergoing hematopoietic stem cell transplant (HSCT) exceed 70%. However, these patients are at high risk of suffering sequelae associated with the underlying disease and/or the HSCT itself, which negatively affects their physical capacity. These patients also tend to spend too much time inactive, which further accelerates functional decline in addition to producing fatigue and impairing quality of life. Therefore, new strategies are needed to minimize the morbidity associated with HSCT. In this effect, although physical exercise represents an interesting adjuvant treatment option for HSCT, scientific evidence in this area is still scarce. Implementation of physical exercise intervention in pediatric HSCT units is challenging due to the lack of research on the effectiveness, affordability and accessibility of this type of intervention. Therefore, establishing the effectiveness of physical exercise under controlled conditions is an important step. The investigators therefore aim to assess the impact of a physical exercise and health counseling program, compared to health counseling only (control group), in pediatric patients with cancer undergoing HSCT on muscle strength (primary outcome), and several fitness/function, clinical burden (i.e., cardiac damage, treatment toxicities, health-related quality of life, among others) and biological variables (omics, blood immune phenotype, microbiome) (secondary outcomes). The investigators will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the intervention implementability in a real clinical situation in 3 different pediatric HSCT units.

Detailed Description

Hematopoietic stem cell transplantation (HSCT), which is used to treat high-risk malignancies, as well as some other conditions or even autoimmune processes, consists of several phases: mobilization and subsequent collection of hematopoietic stem cells from the patient (autologous HSCT) or from a donor (allogeneic HSCT); pre-HSCT conditioning; infusion of patient/donor cells; establishment of a new immune and hematopoietic system in the recipient; and prophylaxis/treatment of possible adverse effects. Since the first successful allogeneic transplant was performed in 1968, thanks to the advances experienced in conditioning regimens, as well as in donor-recipient histocompatibility testing, in patient care and in the management of graft versus host disease (GvHD), together with the increase in the number of donors, the expectations of children and adolescents who receive HSCT have improved, achieving long-term survival rates (\>5 years) \>70%. Yet survivors are at high risk of suffering side effects and toxicities derived from the HSCT itself and/or the underlying disease, with subsequent functional decline. In addition, they show a higher risk of rehospitalization than pediatric cancer survivors who did not receive HSCT and tend to develop chronic pathologies (especially cardiometabolic conditions and frailty) at earlier stages of adulthood than the general population. The investigators therefore aim to assess the impact of a physical exercise and health counseling program, compared to health counseling only (control group), in pediatric patients with cancer undergoing HSCT on the following outcomes assessed at 3 time points \[start of hospitalization for HSCT (i.e., baseline), and 8 weeks and 3 months after hospital discharge, respectively\]: muscle strength (primary outcome), and several fitness/function, clinical burden (i.e., cardiac damage, treatment toxicities, health-related quality of life, among others) and biological variables (omics, blood immune phenotype, microbiome) (secondary outcomes). We will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the intervention implementability in a real clinical situation in 3 different pediatric HSCT units.

Registry

clinicaltrials.gov

Start Date

April 1, 2024

End Date

December 31, 2026

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alejandro Lucia

Responsible Party

Sponsor Investigator

Principal Investigator

Alejandro Lucia

Professor

Universidad Europea de Madrid

Eligibility Criteria

Inclusion Criteria

•Age between 4 and 21 years.
•Undergoing hematopoietic stem cell transplantation (HSCT) for cancer diagnosis in complete remission or without remission, in 3 recruiting Hospitals in Madrid
•Undergoing treatment and follow-up in the same hospital.
•Speaking Spanish.
•Providing signed informed consent.

Exclusion Criteria

•Not being able to participate in the trial according to protocol.
•Comorbidity or acute condition not associated with the diagnosis and that contraindicates the practice of physical exercise, such as severe deficiencies in the locomotor, neurological, cardiovascular and pulmonary systems.
•Serious or chronic medical or psychiatric condition that may increase the risk associated with participation in the trial or that may interfere with the interpretation of the results and, in the opinion of the investigator in discussion with the team, makes having such condition inappropriate for entry to this study; inability to understand the study requirements.
•Not being able to attend hospital visits to perform assessment tests, nor participate in the physical exercise and health counseling program as stipulated in the protocol.
•Inability to understand the requirements of the study.

Arms & Interventions

Control

During the intervention phase (hospitalization for hematopoietic stem cell transplantation (HSCT) and subsequent 8-week outpatient phase following discharge), the control group will participate in a Health Counseling Program (1 time/week) on aspects related to a healthy lifestyle such as reducing sedentary lifestyle, acquiring healthy nutritional habits, the importance sleep, screen use, and how to address barriers related to clinical status. We will adapt the program to the needs and timing of the patient's treatment, providing the content in one session/week orally (e.g. using presentations) and in writing (e.g. through brochures).

Intervention: Control Group (Active Comparator)

Exercise

During the intervention phase (hospitalization for hematopoietic stem cell transplantation (HSCT) and subsequent 8-week outpatient phase following discharge), the intervention group will participate in exactly the same Health Counseling Program as the Control group. Additionally, this group will perform an exercise program combining aerobic and muscle strength exercises

Intervention: Intervention Group

Outcomes

Primary Outcomes

Change in unilateral knee-extension muscle strength (from baseline to end of treatment)

Time Frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment)

Unilateral knee-extension muscle strength will be assessed using a 5-RM test

Secondary Outcomes

Change in unilateral knee-extension muscle strength (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in unilateral maximal voluntary isometric contraction of the elbow flexor muscles (at 90º angle) (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in unilateral maximal voluntary isometric contraction of the elbow flexor muscles (at 90º angle) (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in power output (watts) at peak (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in unilateral maximal voluntary isometric contraction of the knee extensor muscles (at 90º angle) (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in unilateral maximal voluntary isometric contraction of the knee extensor muscles (at 90º angle) (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in handgrip strength (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in handgrip strength (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in maximum inspiratory muscle strength (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in maximum inspiratory muscle strength (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in VO2 (mL·kg-1·min-1) at peak (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in VO2 (mL·kg-1·min-1) at peak (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in VO2 (mL·kg-1·min-1) at the ventilatory threshold (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in VO2 (mL·kg-1·min-1) at the ventilatory threshold (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in power output (watts) at peak (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in power output (watts) at the ventilatory threshold (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in power output (watts) at the ventilatory threshold (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in walking distance covered (m) (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in walking distance covered (m) (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in heart rate recovery (beats/min) (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in heart rate recovery (beats/min) (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in range of motion of the ankle (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in range of motion of the ankle (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in physical activity (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in physical activity (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in body mass index (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in body mass index (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in waist-to-hip ratio (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in waist-to-hip ratio (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in arm circumference (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in arm circumference (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in lean mass (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in lean mass (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in fat mass (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in fat mass (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in visceral fat (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in visceral fat (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in fat percentage (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in fat percentage (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in bone mineral density of the total body (less head) (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in bone mineral density of the total body (less head) (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in bone mineral density of the femoral neck (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in bone mineral density of the femoral neck (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in interventricular septum thickness (IVS) (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in phase angle (º) (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in phase angle (º) (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in adherence to Mediterranean diet (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in adherence to Mediterranean diet (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in survival (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in health-related quality of life (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in health-related quality of life (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in cancer-related fatigue (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in cancer-related fatigue (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in survival (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in treatment tolerability (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in toxicity grades (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in toxicity grades (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in left-ventricular (LV) mass (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in left-ventricular (LV) mass (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in interventricular septum thickness (IVS) (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in LV end-diastolic volume (LVEDV) (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in LV end-diastolic volume (LVEDV) (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in LV posterior wall thickness (LVPW) (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in LV posterior wall thickness (LVPW) (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in relative wall thickness (RWT) (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in relative wall thickness (RWT) (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in LV hypertrophy (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in LV hypertrophy (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in LV ejection fraction (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in LV ejection fraction (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in LV fractional shortening (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in LV fractional shortening (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in LV global longitudinal strain (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in total cholesterol (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in LV global longitudinal strain (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in NT-proBNP (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in NT-proBNP (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in high-sensitivity cardiac troponin-I (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in high-sensitivity cardiac troponin-I (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in cardiometabolic-related proteome (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in cardiometabolic-related proteome (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in high-sensitivity C-reactive protein levels (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in high-sensitivity C-reactive protein levels (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Reach: Non-participation rate (baseline)(Assessed at one time point (implementation phase): (1) at baseline (diagnosis))
Change in total cholesterol (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in high-density lipoprotein cholesterol (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in high-density lipoprotein cholesterol (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in low-density lipoprotein cholesterol (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in low-density lipoprotein cholesterol (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in triglycerides (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in triglycerides (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in apolipoprotein B (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in apolipoprotein B (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in fasting glycaemia (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in fasting glycaemia (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in glycated hemoglobin (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in glycated hemoglobin (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in insulin (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in insulin (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in homeostasis model assessment-insulin resistance index (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in homeostasis model assessment-insulin resistance index (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in total leukocyte and monocyte count (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in total leukocyte and monocyte count (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in main lymphocyte subpopulations (%) (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in main lymphocyte subpopulations (%) (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in gut microbiome diversity (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in gut microbiome diversity (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in specific bacteria abundance (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in specific bacteria abundance (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in functional mobility (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in functional mobility (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in the number and duration of viral infections (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in the number and duration of viral infections (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in the number and duration of bacterial infections (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in the number and duration of bacterial infections (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Change in the number and duration of fungal infections (from baseline to end of treatment)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 8-9 weeks post-discharge (i.e., end of treatment))
Change in the number and duration of fungal infections (from baseline to follow-up)(Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up))
Reach: Exclusion rate (baseline)(Assessed at one time point (implementation phase): (1) at baseline (diagnosis))
Reach: Recruitment rate (baseline)(Assessed at one time point (implementation phase): (1) at baseline (diagnosis))
Reach: Test feasibility rate (from baseline to follow-up)(Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up))
Reach: Intervention session feasibility rate (end of treatment)(Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment))
Reach: Dropout rate (from end of treatment to follow-up)(Assessed at two time points (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment); and (2) 3 months after the end of treatment (follow-up))
Reach: Intervention satisfaction level (end of treatment)(Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment))
Reach: Reasons why the patient participates in the trial (baseline)(Assessed at one time point (implementation phase): (1) at baseline (diagnosis))
Reach: Reasons why the patient does not participate in the trial (baseline)(Assessed at one time point (implementation phase): (1) at baseline (diagnosis))
Reach: Reasons why the patient is excluded (baseline)(Assessed at one time point (implementation phase): (1) at baseline (diagnosis))
Reach: Reasons why the patient drops out (from end of treatment to follow-up)(Assessed at two points (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment); and (2) 3 months after the end of treatment (follow-up))
Reach: Medical conditions and sociocultural of the patient and caregivers (baseline)(Assessed at one time point (implementation phase): (1) at baseline (diagnosis))
Reach: Sociocultural, economic and demographic characteristics of the patient and caregivers (baseline)(Assessed at one time point (implementation phase): (1) at baseline (diagnosis))
Reach: Reasons why efficacy and effectiveness research evaluation tests are not carried out (from baseline to follow-up)(Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up))
Reach: Reasons why the planned intervention sessions are not being carried out (end of treatment)(Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment))
Effectiveness: RE-AIM Effectiveness component (end of treatment)(Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment))
Effectiveness: Impact of the intervention on the results of the efficacy and effectiveness variables (end of treatment)(Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment))
Effectiveness: Serious adverse effects of the intervention (from end of treatment to follow-up)(Assessed at two points (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment); and (2) 3 months after the end of treatment (follow-up))
Maintenance: RE-AIM maintenance component (wear rate) (from end of treatment to follow-up)(Assessed at two time points (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment); and (2) 3 months after the end of treatment (follow-up))
Maintenance: Reasons why the end-of-follow-up evaluation of the research focused on efficacy and effectiveness was not carried out (follow-up)(Assessed at one time point (implementation phase): (1) 3 months after the end of treatment (follow-up))
Adoption: RE-AIM adoption component related to the clinical team (participation) (from baseline to follow-up)(Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up))
Adoption: RE-AIM adoption component related to the clinical team (non-participation rate) (from baseline to follow-up)(Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up))
Adoption: Intervention costs (closing phase)(Assessed at one time point (closing phase): (1) at the end of the trial over an average of two months)
Adoption: RE-AIM adoption component related to the clinical team (dropout rate) (from end of treatment to follow-up)(Assessed at two time points (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment); and (2) 3 months after the end of treatment (follow-up))
Adoption: Reasons why the clinical team participates in the trial (preparatory phase)(Assessed at one time point (preparatory phase): (1) at the beginning of the trial over an average of two months)
Adoption: Reasons why the clinical team does not participate in the trial (preparatory phase)(Assessed at one time point (preparatory phase): (1) at the beginning of the trial over an average of two months)
Adoption: Reasons why the clinical team drops out (from end of treatment to follow-up)(Assessed at two time points (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment); and (2) 3 months after the end of treatment (follow-up))
Adoption: Sociocultural, economic, demographic and motivational characteristics of the clinical team (preparatory phase)(Assessed at one time point (preparatory phase): (1) at the beginning of the trial over an average of two months)
Adoption: RE-AIM adoption component in relation to the environment (HSCT units) (from baseline to follow-up)(Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up))
Adoption: Participation rate of HSCT units (preparatory phase)(Assessed at one time point (preparatory phase): (1) at the beginning of the trial over an average of two months)
Adoption: Facilitators/barriers to implementing the intervention (from baseline to follow-up)(Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up))
Adoption: Suitability of the implementation strategies applied (closing phase)(Assessed at one time point (closing phase): (1) at the end of the trial over an average of two months)
Adoption: Differences between efficacy/effectiveness research and implementation research (closing phase)(Assessed at one time point (closing phase): (1) at the end of the trial over an average of two months)
Implementation: RE-AIM implementation component (feasibility rate) (from baseline to follow-up)(Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up))
Implementation: Level of satisfaction related to communication between families, patients, research team and clinician (end of treatment)(Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment))
Implementation: Degree of execution of the clinical team's implementation research functions within their usual practice (from baseline to follow-up)(Assessed at three time points (implementation phase): (1) at baseline (diagnosis); (2) 8-9 weeks post discharge (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up))