Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321016
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-02-06
Brief Title:
POZIKIDS Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer
Sponsor:
Nere Mendizabal
Organization:
Basque Health Service
Study Overview
Official Title:
POZIKIDS Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PoziKids
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None