Physical Exercise and Health Counseling in Patients With Pediatric Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation: From Research to Clinical Reality.

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 21
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital 12 de Octubre
RECRUITING
Madrid
Contact Information
Primary
Carmen Fiuza-Luces, PhD
cfiuza.imas12@h12o.es
+34658961509
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 48
Treatments
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).
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
Related Therapeutic Areas
Sponsors
Collaborators: Hospital General Universitario Gregorio Marañon, Hospital Universitario 12 de Octubre, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Hospital Universitario La Paz
Leads: Alejandro Lucia

This content was sourced from clinicaltrials.gov