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

Exercise Clinical Trial

— PoziKids  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06321016
• Other study ID #: 2023111039
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: March 2024
• Source: Basque Health Service
• Contact: Nere Mendizabal
• Phone: +34946006637
• Email: nere.mendizabalgallastegui[@]osakidetza.eus
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Cancer
• Exercise

Intervention

Other:
• Physical exercise program
At least two sessions a week for a 6-month supervised and individualized physical exercise program that will have two phases: one that will be carried out in person in the hospital environment taking advantage of medical visits, and a second phase that will allow the patient to carry out the exercise sessions from home with live virtual supervision.
• Type of the physical exercise program
Two types of intervention are proposed depending on the age of the patients: Exercise intervention for adolescents (12 to 18 years): training will be based on strength training (2 - 3 sets of 8 - 12 repetitions) with elastic bands, weights, weights, medicine balls or body weight and aerobic work on a stationary bike, treadmill or other aerobic exercises. Sessions will last about 30-60 minutes (depending on the patient's situation). Exercise intervention for children (4 to 11 years old): The aim will be to work on basic motor skills through play, thus trying to avoid the delay in motor development, and to indirectly work on their physical condition to better cope with the effects of the treatments. Music, games that require movement and materials such as balls, hoops, etc., will be used to motivate the child to move while enjoying themselves. This will be done in sessions of 20 - 40 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nere Mendizabal

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quarterly recruitment rates assessed by comparing those who participate with those who do not.	To assess the feasibility of the exercise programme, quarterly recruitment rates will be calculated over the recruitment and follow-up period, and socio-demographic and morbidity variables associated with study participation will be identified, comparing those who participate with those who do not, using logistic regression analysis.	2 years
Primary	Adherence rates assessed by the proportion of sessions completed and adherence to the prescribed exercise protocol	Participants' adherence to the programme will be described in terms of the proportion of sessions completed and compliance with the exercise protocol prescribed for each patient, and variables associated with compliance will be identified.	2 years
Primary	Body composition assessed by the Body Mass Index	Body Mass Index (BMI): Diagnoses and classifies obesity. weight and height will be combined to report BMI in kg/m^2). Measured at baseline, and 3 months.	2 years
Primary	Muscle mass	Muscle mass will be measured in kgs by a bioimpedance scale. Measured at baseline, and 3 months.	3 months
Primary	Bone mineral density	Bone mineral density will be in g/cm2 measured by a bioimpedance scale. Measured at baseline, and 3 months.	3 months
Primary	Physical condition assessed by the 6 min walking test and manual grip test with a dynamometer	The 6 minutes walking Test applies to assess functional capacity, as well as a predictor of morbidity and mortality in people with different pathologies. Most of the daily activities that the patients with these pathologies are performed at submaximal exercise intensity, similar to this test is performed. It would be measured at 0 and 3 months.	3 months
Primary	Muscular strength assessed by manual grip test with a dynamometer	The manual grip test with a dynamometer applies to assess muscular strength. Most of the daily activities that the patients with these pathologies are performed at submaximal exercise intensity, similar to this test is performed. It would be measured at 0 and 3 months.	3 months
Primary	General Quality of life assessed by the PedsQL 4.0 questionnaire	The PedsQL Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL Measurement Model integrates seamlessly both generic core scales and disease-specific modules into one measurement system. The questionnaire is self-reported for children over 8 years old and self-reported by parents for children under 8 years old. This questionnaire has been validated in the Spanish population. It would be measured at 0 and 3 months.	3 months
Primary	Specific Quality of life assessed by the PedsQL cancer questionnaire	The Pediatric Quality of Life Inventory (PedsQL) Cancer Module is a standard tool designed to assess the HRQOL among pediatric oncology patients. Consists of an instruction section and 27 items, contained in 8 dimensions. This questionnaire has been validated in the Spanish population. It would be measured at 0 and 3 months.	3 months
Primary	Fatigue assessed by the PedsQL Multidimensional Fatigue Scale Acute Version (PedsQL-MFS)	The PedsQL™ Multidimensional Fatigue Scale was designed as a generic symptom-specific instrument to measure fatigue in patients with acute and chronic health conditions as well as healthy school and community populations. The appropriate questionnaire will be used depending on the age of the patients (Toddlers (2-4 years of age), Young Child (5-7 years of age), Child (8-12 years of age), Adolescent (13-18 years of age)). This questionnaire has been validated in the Spanish population. It would be measured at 0 and 3 months.	3 months
Primary	Physical activity level assessed by accelerometers	Objectively registered with Actigraph wGT3X-BT accelerometer. Measured at 0 and 3 months	3 months
Secondary	Security assessment	To assess the safety of this new exercise programme by describing the occurrence of injuries, incidence of complications.	2 years
Secondary	Costs associated estimation	Estimate the costs associated with the implementation of the programme.	3 years
Secondary	Implementation barriers and facilitators	Describe the most important difficulties encountered in its implementation, identify barriers and facilitating factors for its implementation and realisation with minimum quality criteria, using the Consolidated Framework for Implementation Research (CFIR) as a theoretical framework for implementation.	2 years