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NCT Number: NCT06300515

Exercise and Health Counseling in Pediatric Hematopoietic Stem Cell Transplantation

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.

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Key information

Conditions

Hematopoietic System--Cancer Behavior Motor Activity Neoplasms

Age range

4 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control Group (Active Comparator)

Behavioral

During the intervention phase (hospitalization for 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).

Other names: Health Counseling only

Intervention Group

Behavioral

Same as Control Group + exercise program as described below:

Same as Control Group + exercise program as described below:

Hospital ward (during HSCT); and Hospital Gym or online (patients' home) during the outpatient phase. Frequency: 3-5 days/week. Session duration: 15 to 65 minutes. Muscle strength training (30 minutes): large muscle group exercises (upper/lower limb + trunk exercises) performed as a circuit using body weight or against resistance (against gravity and with body weight, elastic bands, dumbbells, weighted vests, machines), with a wide range of joint mobility and at submaximal/maximum voluntary speed. Aerobic training (10-20 minutes): bicycling, crank-ergometry, circuit-style exercises, and games. Inspiratory muscle training will also be performed (5 min daily, using a specific device that creates resistance against inspiration).

Other names: Health Counseling + Exercise

Primary outcomes

  1. 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

  1. Change in unilateral knee-extension muscle strength (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

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

  2. Change in unilateral maximal voluntary isometric contraction of the elbow flexor muscles (at 90º angle) (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 maximal voluntary isometric contraction of the elbow flexor muscles (at 90º angle) will be assessed using a portable digital dynamometer tissue

  3. Change in unilateral maximal voluntary isometric contraction of the elbow flexor muscles (at 90º angle) (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Unilateral maximal voluntary isometric contraction of the elbow flexor muscles (at 90º angle) will be assessed using a portable digital dynamometer tissue

  4. Change in unilateral maximal voluntary isometric contraction of the knee extensor muscles (at 90º angle) (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 maximal voluntary isometric contraction of the knee extensor muscles (at 90º angle) will be assessed using a portable digital dynamometer tissue

  5. Change in unilateral maximal voluntary isometric contraction of the knee extensor muscles (at 90º angle) (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Unilateral maximal voluntary isometric contraction of the knee extensor muscles (at 90º angle) will be assessed using a portable digital dynamometer tissue

  6. Change in handgrip 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)

    Handgrip strength will be assessed using a handheld digital Smedley dynamometer (TKK 5401, Takei Scientific Instruments Co., Ltd., Niigata, Japan)

  7. Change in handgrip strength (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Handgrip strength will be assessed using a handheld digital Smedley dynamometer (TKK 5401, Takei Scientific Instruments Co., Ltd., Niigata, Japan)

  8. Change in maximum inspiratory 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)

    Maximum inspiratory muscle strength will be assessed using a mouth pressure meter (CareFusion MicroRPM Respiratory Pressure Meter; Kent, UK)

  9. Change in maximum inspiratory muscle strength (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Maximum inspiratory muscle strength will be assessed using a mouth pressure meter (CareFusion MicroRPM Respiratory Pressure Meter; Kent, UK)

  10. Change in VO2 (mL·kg-1·min-1) at peak (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)

    VO2 (mL·kg-1·min-1) at peak will be assessed using a ramp-like bicycle ergometer

  11. Change in VO2 (mL·kg-1·min-1) at peak (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    VO2 (mL·kg-1·min-1) at peak will be assessed using a ramp-like bicycle ergometer

  12. Change in VO2 (mL·kg-1·min-1) at the ventilatory threshold (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)

    VO2 (mL·kg-1·min-1) at the ventilatory threshold will be assessed using a ramp-like bicycle ergometer

  13. Change in VO2 (mL·kg-1·min-1) at the ventilatory threshold (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    VO2 (mL·kg-1·min-1) at the ventilatory threshold will be assessed using a ramp-like bicycle ergometer

  14. Change in power output (watts) at peak (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)

    Power output (watts) at peak will be assessed using a ramp-like bicycle ergometer

  15. Change in power output (watts) at peak (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Power output (watts) at peak will be assessed using a ramp-like bicycle ergometer

  16. Change in power output (watts) at the ventilatory threshold (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)

    Power output (watts) at the ventilatory threshold will be assessed using a ramp-like bicycle ergometer

  17. Change in power output (watts) at the ventilatory threshold (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Power output (watts) at the ventilatory threshold will be assessed using a ramp-like bicycle ergometer

  18. Change in walking distance covered (m) (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)

    Walking distance will be assessed using the 6-minute walking test

  19. Change in walking distance covered (m) (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Walking distance will be assessed using the 6-minute walking test

  20. Change in heart rate recovery (beats/min) (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)

    Heart rate recovery will be assessed using a heart rate monitor after completing the 3-minute step test

  21. Change in heart rate recovery (beats/min) (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Heart rate recovery will be assessed using a heart rate monitor after completing the 3-minute step test

  22. Change in range of motion of the ankle (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)

    Range of motion of the ankle will be assessed using a goniometer (Baseline Evaluation Instruments, Fabrication Enterprises Inc.; Elmsford, NY)

  23. Change in range of motion of the ankle (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Range of motion of the ankle will be assessed using a goniometer (Baseline Evaluation Instruments, Fabrication Enterprises Inc.; Elmsford, NY)

  24. Change in physical activity (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)

    Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire (GLTEQ)

  25. Change in physical activity (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire (GLTEQ)

  26. Change in body mass index (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)

    Body mass index will be calculated dividing body weight in kilograms by the square of the height in meters (kg/m2)

  27. Change in body mass index (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Body mass index will be calculated dividing body weight in kilograms by the square of the height in meters (kg/m2)

  28. Change in waist-to-hip ratio (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)

    Waist-to-hip ratio will be calculated dividing waist by hip circumference (Gulick II Tape Measure, Country Technology, Inc.; Gays Mills, WI) using the same units

  29. Change in waist-to-hip ratio (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Waist-to-hip ratio will be calculated dividing waist by hip circumference (Gulick II Tape Measure, Country Technology, Inc.; Gays Mills, WI) using the same units

  30. Change in arm circumference (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)

    Arm circumference will be assessed under relaxed and contracted conditions (Gulick II Tape Measure, Country Technology, Inc.; Gays Mills, WI)

  31. Change in arm circumference (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Arm circumference will be assessed under relaxed and contracted conditions (Gulick II Tape Measure, Country Technology, Inc.; Gays Mills, WI)

  32. Change in lean mass (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)

    Lean mass will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)

  33. Change in lean mass (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Lean mass will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)

  34. Change in fat mass (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)

    Fat mass will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)

  35. Change in fat mass (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Fat mass will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)

  36. Change in visceral fat (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)

    Visceral fat will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)

  37. Change in visceral fat (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Visceral fat will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)

  38. Change in fat percentage (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)

    Fat percentage will be assessed using triceps skinfold (Harpenden caliper, Crymych, United Kingdom)

  39. Change in fat percentage (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Fat percentage will be assessed using triceps skinfold (Harpenden caliper, Crymych, United Kingdom)

  40. Change in bone mineral density of the total body (less head) (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)

    Bone mineral density of the total body (less head) will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)

  41. Change in bone mineral density of the total body (less head) (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Bone mineral density of the total body (less head) will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)

  42. Change in bone mineral density of the femoral neck (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)

    Bone mineral density of the femoral neck will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)

  43. Change in bone mineral density of the femoral neck (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Bone mineral density of the femoral neck will be assessed using a dual-energy X-ray absorptiometry assessment (Hologic Serie Discovery QDR, Software Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)

  44. Change in phase angle (º) (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)

    Phase angle (º) will be assessed using multi-frequency bioelectrical impedance analysis (BodyComposition software, version 9.0.21212-29; Dietosystem, Italy), and it is calculated as the arctangent of reactance to resistance, following standardized measurement procedures.Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)

  45. Change in phase angle (º) (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Phase angle (º) will be assessed using multi-frequency bioelectrical impedance analysis (BodyComposition software, version 9.0.21212-29; Dietosystem, Italy), and it is calculated as the arctangent of reactance to resistance, following standardized measurement procedures.Physician's Viewer, APEX System Software version 3.1.2.; Bedford, MA)

  46. Change in adherence to Mediterranean diet (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)

    Adherence to Mediterranean diet will be assessed using the Mediterranean Diet Quality Index for children and adolescents (KIDMED) questionnaire

  47. Change in adherence to Mediterranean diet (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Adherence to Mediterranean diet will be assessed using the Mediterranean Diet Quality Index for children and adolescents (KIDMED) questionnaire

  48. Change in health-related quality of life (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)

    Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL) 3.0 (Patients and Tutor's version, Cancer Module)

  49. Change in health-related quality of life (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL) 3.0 (Patients and Tutor's version, Cancer Module)

  50. Change in cancer-related fatigue (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)

    Cancer-related fatigue will be assessed using the Pediatric Quality of Life Inventory (PedsQL) 3.0 (Patients and Tutor's version, Multidimensional Fatigue Scale)

  51. Change in cancer-related fatigue (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Cancer-related fatigue will be assessed using the Pediatric Quality of Life Inventory (PedsQL) 3.0 (Patients and Tutor's version, Multidimensional Fatigue Scale)

  52. Change in survival (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)

    Survival will be assessed from diagnosis to the end of the study or death using medical records

  53. Change in survival (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Survival will be assessed from diagnosis to the end of the study or death using medical records

  54. Change in treatment tolerability (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)

    Treatment tolerability will be assessed as the number of days of treatment interruption/delay and hospitalization length (additional/prolonged hospitalization during treatment) using medical records

  55. Change in toxicity grades (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)

    Toxicity grade will be assessed using the formula from Langlais et al (2022)

  56. Change in toxicity grades (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Toxicity grade will be assessed using the formula from Langlais et al (2022)

  57. Change in left-ventricular (LV) mass (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)

    LV mass will be assessed using 2-D guided M-mode imaging

  58. Change in left-ventricular (LV) mass (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    LV mass will be assessed using 2-D guided M-mode imaging

  59. Change in interventricular septum thickness (IVS) (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)

    IVS will be assessed using 2-D guided M-mode imaging

  60. Change in interventricular septum thickness (IVS) (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    IVS will be assessed using 2-D guided M-mode imaging

  61. Change in LV end-diastolic volume (LVEDV) (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)

    LVEDV will be assessed using 2-D guided M-mode imaging

  62. Change in LV end-diastolic volume (LVEDV) (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    LVEDV will be assessed using 2-D guided M-mode imaging

  63. Change in LV posterior wall thickness (LVPW) (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)

    LVPW will be assessed using 2-D guided M-mode imaging

  64. Change in LV posterior wall thickness (LVPW) (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    LVPW will be assessed using 2-D guided M-mode imaging

  65. Change in relative wall thickness (RWT) (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)

    RWT will be assessed using the following formula: RWT = (IVS + LVPW)/LVEDV

  66. Change in relative wall thickness (RWT) (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    RWT will be assessed using the following formula: RWT = (IVS + LVPW)/LVEDV

  67. Change in LV hypertrophy (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)

    LV hypertrophy will be assessed using the age-specific >95th percentile for LV mass indexed by height (in g·m-2.7)

  68. Change in LV hypertrophy (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    LV hypertrophy will be assessed using the age-specific >95th percentile for LV mass indexed by height (in g·m-2.7)

  69. Change in LV ejection fraction (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)

    LV ejection fraction will be assessed using color tissue Doppler echocardiography

  70. Change in LV ejection fraction (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    LV ejection fraction will be assessed using color tissue Doppler echocardiography

  71. Change in LV fractional shortening (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)

    LV fractional shortening will be assessed using color tissue Doppler echocardiography

  72. Change in LV fractional shortening (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    LV fractional shortening will be assessed using color tissue Doppler echocardiography

  73. Change in LV global longitudinal strain (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)

    LV global longitudinal strain will be assessed using 2D-speckle tracking echocardiography

  74. Change in LV global longitudinal strain (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    LV global longitudinal strain will be assessed using 2D-speckle tracking echocardiography

  75. Change in NT-proBNP (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)

    NT-proBNP will be determined with the relevant immunoassay kits on an automated biochemistry analyzer (Cobas C701, Roche Diagnostics; Madrid, Spain)

  76. Change in NT-proBNP (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    NT-proBNP will be determined with the relevant immunoassay kits on an automated biochemistry analyzer (Cobas C701, Roche Diagnostics; Madrid, Spain)

  77. Change in high-sensitivity cardiac troponin-I (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)

    High-sensitivity cardiac troponin-I will be determined with the relevant immunoassay kits on an automated biochemistry analyzer (Cobas C701, Roche Diagnostics; Madrid, Spain)

  78. Change in high-sensitivity cardiac troponin-I (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    High-sensitivity cardiac troponin-I will be determined with the relevant immunoassay kits on an automated biochemistry analyzer (Cobas C701, Roche Diagnostics; Madrid, Spain)

  79. Change in high-sensitivity C-reactive protein levels (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)

    High-sensitivity C-reactive protein levels will be assessed using a chemistry analyzer (Cobas C701, Roche Diagnostics; Madrid, Spain)

  80. Change in high-sensitivity C-reactive protein levels (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    High-sensitivity C-reactive protein levels will be assessed using a chemistry analyzer (Cobas C701, Roche Diagnostics; Madrid, Spain)

  81. Change in total cholesterol (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)

    Fasting blood samples will be used to assess total cholesterol

  82. Change in total cholesterol (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Fasting blood samples will be used to assess total cholesterol

  83. Change in high-density lipoprotein cholesterol (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)

    Fasting blood samples will be used to assess high-density lipoprotein cholesterol

  84. Change in high-density lipoprotein cholesterol (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Fasting blood samples will be used to assess high-density lipoprotein cholesterol

  85. Change in low-density lipoprotein cholesterol (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)

    Fasting blood samples will be used to assess low-density lipoprotein cholesterol

  86. Change in low-density lipoprotein cholesterol (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Fasting blood samples will be used to assess low-density lipoprotein cholesterol

  87. Change in triglycerides (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)

    Fasting blood samples will be used to assess triglycerides

  88. Change in triglycerides (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Fasting blood samples will be used to assess triglycerides

  89. Change in apolipoprotein B (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)

    Fasting blood samples will be used to assess apolipoprotein B

  90. Change in apolipoprotein B (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Fasting blood samples will be used to assess apolipoprotein B

  91. Change in fasting glycaemia (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)

    Fasting blood samples will be used to assess glycaemia

  92. Change in fasting glycaemia (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Fasting blood samples will be used to assess glycaemia

  93. Change in glycated hemoglobin (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)

    Fasting blood samples will be used to assess glycated hemoglobin

  94. Change in glycated hemoglobin (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Fasting blood samples will be used to assess glycated hemoglobin

  95. Change in insulin (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)

    Fasting blood samples will be used to assess insulin

  96. Change in insulin (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Fasting blood samples will be used to assess insulin

  97. Change in homeostasis model assessment-insulin resistance index (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)

    Fasting blood samples will be used to assess glucose and insulin, and homeostasis model assessment-insulin resistance index will be computed

  98. Change in homeostasis model assessment-insulin resistance index (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Fasting blood samples will be used to assess glucose and insulin, and homeostasis model assessment-insulin resistance index will be computed

  99. Change in total leukocyte and monocyte count (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)

    Total leukocyte and monocyte count will be assessed using a hematology analyzer (Advia 120 Hematology System, Bayer Corporation; Tarrytown, NY)

  100. Change in total leukocyte and monocyte count (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Total leukocyte and monocyte count will be assessed using a hematology analyzer (Advia 120 Hematology System, Bayer Corporation; Tarrytown, NY)

  101. Change in main lymphocyte subpopulations (%) (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)

    Main lymphocyte subpopulations will be assessed on fresh blood samples using a multiparametric flow cytometer (FACSCantoTM II, Becton Dickinson and Company BD Biosciences; San Jose, CA) together with BD FACSDivaTM software version 8 (Becton Dickinson and Company BD Biosciences)

  102. Change in main lymphocyte subpopulations (%) (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Main lymphocyte subpopulations will be assessed on fresh blood samples using a multiparametric flow cytometer (FACSCantoTM II, Becton Dickinson and Company BD Biosciences; San Jose, CA) together with BD FACSDivaTM software version 8 (Becton Dickinson and Company BD Biosciences)

  103. Change in gut microbiome diversity (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)

    DNA sequencing to determine gut microbiome diversity (i.e., alpha and beta)

  104. Change in gut microbiome diversity (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    DNA sequencing to determine gut microbiome diversity (i.e., alpha and beta)

  105. Change in specific bacteria abundance (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)

    DNA sequencing to determine specific bacteria abundance

  106. Change in specific bacteria abundance (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    DNA sequencing to determine specific bacteria abundance

  107. Change in functional mobility (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)

    Functional mobility will be assessed using the Timed Up and Go test

  108. Change in functional mobility (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Functional mobility will be assessed using the Timed Up and Go test

  109. Change in functional mobility (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)

    Functional mobility will be assessed using the Timed Up and Down Stairs test

  110. Change in functional mobility (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Functional mobility will be assessed using the Timed Up and Down Stairs test

  111. Change in functional mobility (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)

    Functional mobility will be assessed using the 30-second chair stand test

  112. Change in functional mobility (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Functional mobility will be assessed using the 30-second chair stand test

  113. Change in functional mobility (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)

    Functional mobility will be assessed using the 5-times Sit-To-Stand test

  114. Change in functional mobility (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Functional mobility will be assessed using the 5-times Sit-To-Stand test

  115. Change in functional mobility (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)

    Functional mobility will be assessed using the Quick test

  116. Change in functional mobility (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Functional mobility will be assessed using the Quick test

  117. Change in the number and duration of viral infections (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)

    Number and duration of viral infections will be retrieved from medical records

  118. Change in the number and duration of viral infections (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Number and duration of viral infections will be retrieved from medical records

  119. Change in the number and duration of bacterial infections (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)

    Number and duration of bacterial infections will be retrieved from medical records

  120. Change in the number and duration of bacterial infections (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Number and duration of bacterial infections will be retrieved from medical records

  121. Change in the number and duration of fungal infections (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)

    Number and duration of fungal infections will be retrieved from medical records

  122. Change in the number and duration of fungal infections (from baseline to follow-up)

    Time frame: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)

    Number and duration of fungal infections will be retrieved from medical records

  123. Reach: Exclusion rate (baseline)

    Time frame: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)

    Exclusion rate will be evaluated using the Reach questionnaire

  124. Reach: Non-participation rate (baseline)

    Time frame: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)

    Non-participation rate will be evaluated using the Reach questionnaire

  125. Reach: Recruitment rate (baseline)

    Time frame: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)

    Recruitment rate will be evaluated using the Reach questionnaire

  126. Reach: Test feasibility rate (from baseline to follow-up)

    Time frame: 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)

    Feasibility rate will be evaluated using the Reach questionnaire

  127. Reach: Intervention session feasibility rate (end of treatment)

    Time frame: Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment)

    Intervention session feasibility rate will be evaluated using the Reach questionnaire

  128. Reach: Dropout rate (from end of treatment to follow-up)

    Time frame: 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)

    Dropout rate will be evaluated using the Reach questionnaire (from end of treatment to follow-up)

  129. Reach: Intervention satisfaction level (end of treatment)

    Time frame: Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment)

    Intervention satisfaction level will be evaluated using the Reach questionnaire

  130. Reach: Reasons why the patient participates in the trial (baseline)

    Time frame: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)

    Reasons why the patient participates in the trial will be evaluated using the Reach questionnaire

  131. Reach: Reasons why the patient does not participate in the trial (baseline)

    Time frame: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)

    Reasons why the patient does not participate in the trial will be evaluated using the Reach questionnaire

  132. Reach: Reasons why the patient is excluded (baseline)

    Time frame: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)

    Reasons why the patient is excluded will be evaluated using the Reach questionnaire

  133. Reach: Reasons why the patient drops out (from end of treatment to follow-up)

    Time frame: 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)

    Reasons why the patient drops out will be evaluated using the Reach questionnaire (from end of treatment to follow-up)

  134. Reach: Medical conditions and sociocultural of the patient and caregivers (baseline)

    Time frame: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)

    Medical conditions and sociocultural of the patient and caregivers will be evaluated using the Reach questionnaire

  135. Reach: Sociocultural, economic and demographic characteristics of the patient and caregivers (baseline)

    Time frame: Assessed at one time point (implementation phase): (1) at baseline (diagnosis)

    Sociocultural, economic and demographic characteristics of the patient and caregivers will be evaluated using the Reach questionnaire

  136. Reach: Reasons why efficacy and effectiveness research evaluation tests are not carried out (from baseline to follow-up)

    Time frame: 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)

    Reasons why efficacy and effectiveness research evaluation tests are not carried out will be evaluated using the Reach questionnaire

  137. Reach: Reasons why the planned intervention sessions are not being carried out (end of treatment)

    Time frame: Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment)

    Reasons why the planned intervention sessions are not being carried out will be evaluated using the Reach questionnaire

  138. Effectiveness: RE-AIM Effectiveness component (end of treatment)

    Time frame: Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment)

    RE-AIM Effectiveness component will be evaluated using the Effectiveness questionnaire

  139. Effectiveness: Impact of the intervention on the results of the efficacy and effectiveness variables (end of treatment)

    Time frame: Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment)

    Impact of the intervention on the results of the efficacy and effectiveness variables will be evaluated using the Effectiveness questionnaire

  140. Effectiveness: Serious adverse effects of the intervention (from end of treatment to follow-up)

    Time frame: 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)

    Serious adverse effects of the intervention will be evaluated using the Effectiveness questionnaire

  141. Maintenance: RE-AIM maintenance component (wear rate) (from end of treatment to follow-up)

    Time frame: 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)

    RE-AIM maintenance component (wear rate) will be evaluated using the Maintenance questionnaire

  142. Maintenance: Reasons why the end-of-follow-up evaluation of the research focused on efficacy and effectiveness was not carried out (follow-up)

    Time frame: Assessed at one time point (implementation phase): (1) 3 months after the end of treatment (follow-up)

    Reasons why the end-of-follow-up evaluation of the research focused on efficacy and effectiveness was not carried out will be evaluated using the Maintenance questionnaire

  143. Adoption: RE-AIM adoption component related to the clinical team (participation) (from baseline to follow-up)

    Time frame: 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)

    RE-AIM adoption component related to the clinical team (participation) will be evaluated using the Adoption questionnaire

  144. Adoption: RE-AIM adoption component related to the clinical team (non-participation rate) (from baseline to follow-up)

    Time frame: 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)

    RE-AIM adoption component related to the clinical team (non-participation rate) will be evaluated using the Adoption questionnaire

  145. Adoption: RE-AIM adoption component related to the clinical team (dropout rate) (from end of treatment to follow-up)

    Time frame: 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)

    RE-AIM adoption component related to the clinical team (dropout rate) will be evaluated using the Adoption questionnaire

  146. Adoption: Reasons why the clinical team participates in the trial (preparatory phase)

    Time frame: Assessed at one time point (preparatory phase): (1) at the beginning of the trial over an average of two months

    Reasons why the clinical team participates in the trial will be evaluated using the Adoption questionnaire

  147. Adoption: Reasons why the clinical team does not participate in the trial (preparatory phase)

    Time frame: Assessed at one time point (preparatory phase): (1) at the beginning of the trial over an average of two months

    Reasons why the clinical team does not participate in the trial will be evaluated using the Adoption questionnaire

  148. Adoption: Reasons why the clinical team drops out (from end of treatment to follow-up)

    Time frame: 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)

    Reasons why the clinical team drops out will be evaluated using the Adoption questionnaire

  149. Adoption: Sociocultural, economic, demographic and motivational characteristics of the clinical team (preparatory phase)

    Time frame: Assessed at one time point (preparatory phase): (1) at the beginning of the trial over an average of two months

    Sociocultural, economic, demographic and motivational characteristics of the clinical team will be evaluated using the Adoption questionnaire

  150. Adoption: RE-AIM adoption component in relation to the environment (HSCT units) (from baseline to follow-up)

    Time frame: 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)

    RE-AIM adoption component in relation to the environment (HSCT units) will be evaluated using the Adoption questionnaire

  151. Adoption: Participation rate of HSCT units (preparatory phase)

    Time frame: Assessed at one time point (preparatory phase): (1) at the beginning of the trial over an average of two months

    Participation rate of HSCT units will be evaluated using the Adoption questionnaire

  152. Adoption: Facilitators/barriers to implementing the intervention (from baseline to follow-up)

    Time frame: 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)

    Facilitators/barriers to implementing the intervention will be evaluated using the Adoption questionnaire

  153. Adoption: Suitability of the implementation strategies applied (closing phase)

    Time frame: Assessed at one time point (closing phase): (1) at the end of the trial over an average of two months

    Suitability of the implementation strategies applied will be evaluated using the Adoption questionnaire

  154. Adoption: Differences between efficacy/effectiveness research and implementation research (closing phase)

    Time frame: Assessed at one time point (closing phase): (1) at the end of the trial over an average of two months

    Differences between efficacy/effectiveness research and implementation research will be evaluated using the Adoption questionnaire

  155. Adoption: Intervention costs (closing phase)

    Time frame: Assessed at one time point (closing phase): (1) at the end of the trial over an average of two months

    Intervention costs will be evaluated using the Adoption questionnaire

  156. Implementation: RE-AIM implementation component (feasibility rate) (from baseline to follow-up)

    Time frame: 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)

    RE-AIM implementation component (feasibility rate) will be evaluated using the Implementation questionnaire

  157. Implementation: Level of satisfaction related to communication between families, patients, research team and clinician (end of treatment)

    Time frame: Assessed at one time point (implementation phase): (1) 8-9 weeks post discharge (i.e., end of treatment)

    Level of satisfaction related to communication between families, patients, research team and clinician will be evaluated using the Implementation questionnaire

  158. Implementation: Degree of execution of the clinical team's implementation research functions within their usual practice (from baseline to follow-up)

    Time frame: 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)

    Degree of execution of the clinical team's implementation research functions within their usual practice will be evaluated using the Implementation questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Carmen Fiuza-Luces, PhD

CONTACT

[email protected]

+34658961509

Sponsors and collaborators

Lead sponsor

Alejandro Lucia

Other

Collaborators

  • Hospital General Universitario Gregorio Marañon
  • Hospital Infantil Universitario Niño Jesús, Madrid, Spain
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz

Registry information

Official study title

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

Acronym: Henkō

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 8, 2024
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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