- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06300515
Exercise and Health Counseling in Pediatric Hematopoietic Stem Cell Transplantation (HENKO)
Physical Exercise and Health Counseling in Patients With Pediatric Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation: From Research to Clinical Reality.
Study Overview
Status
Conditions
Intervention / Treatment
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]: cardiorespiratory fitness (primary outcome) and ventilatory threshold, muscle strength, left ventricle ejection fraction, fractional shortening and global longitudinal strain, total cardiac mass, functional mobility, adiposity (waist to hip ratio), body mass index, dual-energy X-ray absorptiometry (DXA)-determined body composition (lean and fat mass, bone mineral density), accelerometry-determined physical activity levels, ankle dorsiflexion range of motion, health-related quality of life, cancer-related fatigue, and immune subpopulations. We will also determine clinical outcomes during hospitalization (survival, treatment tolerability, toxicities) as well as molecular biomarkers in blood.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carmen Fiuza-Luces, PhD
- Phone Number: +34658961509
- Email: cfiuza.imas12@h12o.es
Study Locations
-
-
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Madrid, Spain, 28041
- Hospital 12 de Octubre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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).
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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:
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Experimental: 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
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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: 30 to 55-60 minutes Aerobic training (5-25 minutes): bicycling, crank-ergometry, circuit-style exercises, and games. Muscle strength training (10-20 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. Inspiratory muscle training will also be performed (5 min daily, using a specific device that creates resistance against inspiration).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in objectively-assessed cardiorespiratory fitness (CRF) from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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CRF assessed as peak oxygen uptake, as determined during a ramp bicycle ergometer test until volitional exhaustion (unit = mL of oxygen/kg body mass/minute),
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in estimated cardiorespiratory fitness (CRF) from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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CRF estimated with 6-minute walking distance (maximum distance achieved) (unit = meters)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in isometric leg muscle strength from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Dynamometer-determined maximal isometric strength of knee flexor muscles (unit = Newtons)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in dynamic lower-limb muscle strength from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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One-repetition maximum (1RM) during leg press exercise, as estimated from 5RM leg press (unit = kg)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in upper-limb muscle strength from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Maximal handgrip strength, mean of 3 attempts with both arms (unit = kg)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in respiratory muscle strength from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Maximal inspiratory pressure (unit = mm H20)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in the 'ventilatory threshold' (VT) from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Workload eliciting the ventilatory threshold, as determined during the ramp test (unit = watts)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in left ventricle (LV) ejection fraction from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Echocardiography-determined LV ejection fraction (unit = percent)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in left ventricle (LV) fractional shortening from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Echocardiography-determined LV fractional shortening (unit = percent)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in left ventricle (LV) global longitudinal strain (GLS) from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Echocardiography-determined GLS of the LV (unit = percent)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in total cardiac mass from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Echocardiography-determined total cardiac mass (unit = grams divided by body surface area (im meters squared)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in functional mobility (stairs test) from baseline to follow-uo
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Stairs test (time to walk up and down a 12-step stair) (unit = seconds)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in functional mobility (chair rising) from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Sit-stand test (time to stand from a chair 5 times) (unit = seconds)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in functional mobility (Quick Function test) from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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We will use the Quick Motor Function test, which takes approximately 10 to 15 minutes.
An evaluator observes the performance of a patient and scores the 16 items separately on a 5-point ordinal scale (ranging from 0 to 4).
If items can be performed on both left and right extremities, the right side is taken.
A total score is obtained by adding the scores of all items.
The total score ranges between 0 and 64 points (units = points, from 0 to 64)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in body mass index (BMI) from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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BMI is measured as weight (kg) divided by height squared (m2)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in adiposity index from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Waist-to-hip ratio (no units)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in dual-energy X-ray absorptiometry (DXA) measures of total lean mass from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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DXA-determined total lean mass (grams)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in dual-energy X-ray absorptiometry (DXA) measures of total fat mass from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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DXA-determined total fat mass (grams)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in dual-energy X-ray absorptiometry (DXA) measures of bone health from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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DXA-determined bone mineral density (unit = grams/m2)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in physical activity (PA) from baseline to end of treatment
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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PA levels (moderate/vigorous PA) determined using triaxial accelerometry (unit = minutes/week)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in ankle-dorsiflexion from baseline to end of treatment
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Goniometer-determined active and passive ankle range of motion in dorsiflexion (unit = degrees)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in psychological status (health-related quality of life) from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Health-related QoL (HRQoL) (Paediatric Quality of Life Inventory [abbreviated as PedsQL 4.0] Cancer Module [3.0], designed to measure paediatric/adolescent cancer specific HRQoL) (unit = 0 to 100 scale, with higher scores indicating better HRQoL)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in psychological status (fatigue) from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Cancer-related fatigue (Paediatric Quality of Life (PedsQL 3.0) Multidimensional Fatigue Scale) (0 to 100 score, higher scores meaning higher fatigue)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in lymphocyte subpopulations from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Flow-cytometry determined lymphocyte subpopulations (unit = %)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in immune phenotype from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Flow-cytometry determined natural killer (NK) cell subsets (unit = %)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in survival from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Survival (number of days from diagnosis to the end of the study or death)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in treatment tolerability from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Treatment interruption/delay (number of days)
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in treatment toxicities from baseline to follow-up
Time Frame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Common Toxicity Criteria for Adverse Events [CTCAE, global score, 1 (low toxicity) to 5 (highest])
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Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
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Change in the 'acute' molecular response to a single exercise session from baseline to 8 weeks after hospital discharge
Time Frame: Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge.
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Panel of cytokines/chemokines and peptides (oncostatin-M, osteonectin, FGF21, irisin, follistatin-1, musclin, VEGF-A, fractalkine, interleukin (IL)-8, IL-6 and IL-15 in serum using Luminex® (all assessed in the same units, micrograms/dL) before and after a single exercise training session
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Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge.
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Change in the 'chronic' (resting conditions) transcriptome from baseline to 8 weeks after hospital discharge
Time Frame: Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge.
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RNA sequencing (RNAseq) profile in peripheral blood mononuclear cells under resting conditions at baseline and 8 weeks after hospital discharge
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Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge.
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Change in the 'acute' transcriptome response to a single exercise session from baseline to 8 weeks after hospital discharge
Time Frame: Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge.
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RNA sequencing (RNAseq) profile in peripheral blood mononuclear cells before and after a single exercise training session
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Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge.
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Change in the 'acute' transcriptome response from baseline to 8 weeks after hospital discharge
Time Frame: Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge.
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RNA sequencing (RNAseq) profile in peripheral blood mononuclear cells before and after and exercise training session
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Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PI23/00396
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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