POZIKIDS: Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer (PoziKids)

Nere Mendizabal

Status

Not yet enrolling

Conditions

Childhood Cancer

Exercise

Treatments

Other: Physical exercise program

Other: Type of the physical exercise program

Study type

Interventional

Funder types

Other

Identifiers

NCT06321016

2023111039

Details and patient eligibility

About

Objective: To assess the feasibility of a supervised, controlled and personalised physical exercise programme and its potential efficacy in improving functional capacity and quality of life in children and adolescents with cancer.

Design: Hybrid quasi-experimental pilot trial, clinical and phase I implementation.

Methods: The learning collaborative approach based on the Institute for Healthcare Improvement Breakthrough Series Collaborative Model will be followed through quarterly Plan-Do-Study-Act (P-D-S-A) cycles. Participants: For feasibility, at least, 45 patients will be included in 3 successive PDSA cycles of at least 15 patients each, aged 4-18 years diagnosed with any type of cancer. Variables: clinical and socio-demographic, body composition, physical condition and mobility, quality of life, physical activity and implementation. Intervention: Everyone will receive a physical exercise intervention combining strength and aerobic capacity work. Initially it will be carried out in the hospital setting, and later in streaming supervised by a professional. The intervention will be modelled through a formative evaluation process with the collaboration of all the agents involved, experimenting in each cycle with an increasingly adapted version of the exercise programme.

Statistical analysis: Recruitment rates will be calculated, characteristics associated with project participation and adherence to the exercise programme will be identified. Outcome variables will be compared before and after the intervention, identifying those with the greatest validity, reliability and sensitivity to change, which will then be used in phase II and III trials.

Enrollment

45 estimated patients

Sex

All

Ages

4 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients diagnosed with cancer and other neoplasms
Age between 4 and 18 years at the time of inclusion in the study
Patients diagnosed with cancer and other malignancies aged between 4 and 18 years who are experiencing relapse
Paediatric patients requiring chemotherapy, radiotherapy, or oncological surgery
Patients and parents or guardians who agree to participate in the study and sign the informed consent forms by current legislation depending on the patient's age.

Exclusion criteria

Patients with cognitive deficits that prevent participation in and performance of physical exercise interventions.
Patients with severe neurological pathology with a motor impairment that prevents or significantly hinders the performance of physical exercise
Patients and families or guardians with language comprehension difficulties that make it difficult or impossible to carry out the physical exercise intervention.
Patients < 16 years with a functional status score according to Lanskyi scale <60%
Patients > 16 years with Karnofsky scale <60%.
Any other criteria that the physician deems inappropriate for participation in the study