NCT06321016Not yet recruiting
POZIKIDS: Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer
Source: ClinicalTrials.gov · Last updated 20 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 6 Feb 2024
- Start date
- 15 Nov 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Nere Mendizabal
- Diseases
- Childhood cancers
- NCT number
- NCT06321016
What you commit to
- Study type: Interventional
- Planned participants: 45
- From 15 Nov 2024 to the primary completion date, 30 Jun 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with severe neurological pathology with a motor impairment that prevents or significantly hinders the performance of physical exercise
Age
- Patients \< 16 years with a functional status score according to Lanskyi scale \<60%
- Patients \> 16 years with Karnofsky scale \<60%.
Other
- Patients with cognitive deficits that prevent participation in and performance of physical exercise interventions.
- Patients and families or guardians with language comprehension difficulties that make it difficult or impossible to carry out the physical exercise intervention.
- Any other criteria that the physician deems inappropriate for participation in the study
Who the study is looking for
- 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.
Age in the registry: 4 years to 18 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.