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

Overview

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.

Interventions

• 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.
• Other 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

Primary outcome measures

• Quarterly recruitment rates assessed by comparing those who participate with those who do not. [Time frame: 2 years]
• Adherence rates assessed by the proportion of sessions completed and adherence to the prescribed exercise protocol [Time frame: 2 years]
• Body composition assessed by the Body Mass Index [Time frame: 2 years]
• Muscle mass [Time frame: 3 months]
• Bone mineral density [Time frame: 3 months]
• Physical condition assessed by the 6 min walking test and manual grip test with a dynamometer [Time frame: 3 months]
• Muscular strength assessed by manual grip test with a dynamometer [Time frame: 3 months]
• General Quality of life assessed by the PedsQL 4.0 questionnaire [Time frame: 3 months]
• Specific Quality of life assessed by the PedsQL cancer questionnaire [Time frame: 3 months]
• Fatigue assessed by the PedsQL Multidimensional Fatigue Scale Acute Version (PedsQL-MFS) [Time frame: 3 months]

Secondary outcome measures (3)

• Security assessment [Time frame: 2 years]
• Costs associated estimation [Time frame: 3 years]
• Implementation barriers and facilitators [Time frame: 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06321016 · 2023111039

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗