Clinical trial NCT06321016: POZIKIDS: Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer
Official title: POZIKIDS: Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Exercise
Childhood Cancer
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2024-03-20
Enrollment: 45
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Quarterly recruitment rates assessed by comparing those who participate with those who do not.
timeFrame: 2 years
measure: Adherence rates assessed by the proportion of sessions completed and adherence to the prescribed exercise protocol
timeFrame: 2 years
measure: Body composition assessed by the Body Mass Index
timeFrame: 2 years
measure: Muscle mass
timeFrame: 3 months
measure: Bone mineral density
timeFrame: 3 months
measure: Physical condition assessed by the 6 min walking test and manual grip test with a dynamometer
timeFrame: 3 months
measure: Muscular strength assessed by manual grip test with a dynamometer
timeFrame: 3 months
measure: General Quality of life assessed by the PedsQL 4.0 questionnaire
timeFrame: 3 months
measure: Specific Quality of life assessed by the PedsQL cancer questionnaire
timeFrame: 3 months
measure: Fatigue assessed by the PedsQL Multidimensional Fatigue Scale Acute Version (PedsQL-MFS)
timeFrame: 3 months
measure: Physical activity level assessed by accelerometers
timeFrame: 3 months
Secondary outcomes:
measure: Security assessment
timeFrame: 2 years
measure: Costs associated estimation
timeFrame: 3 years
measure: Implementation barriers and facilitators
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Basque Health Service
name: Marta Menchaca Torio
role: PRINCIPAL_INVESTIGATOR
References: