Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345391
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-15
Brief Title:
Co-creation of Pain Science Education for Children Living Beyond Cancer
Sponsor:
Vrije Universiteit Brussel
Organization:
Vrije Universiteit Brussel
Study Overview
Official Title:
The Added Value of Pain Science Education for Children Living Beyond Cancer PANACEA Co-creation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
PANACEA
Brief Summary:
A pain science education PSE intervention for children 8-12y living beyond cancer CBC will be developed through a co-creational approach with CBC their parents and pediatric oncology clinicians The study will be guided by the Intervention Mapping Protocol
Detailed Description:
PARTICIPANT RECRUITMENT STRATEGY
Co-creation is a bottom-up approach directly involving the end-users in developing the intervention For the co-creation of the PSE intervention 3 groups will be formed children 8-12yo living beyond cancer CBC their parents and pediatric oncology clinicians For each group 6 to 8 participants will be recruited
Using purposeful sampling CBC and their parents will be recruited through various ways including through patient lists of the participating hospitals University Hospital Brussels and University Hospital Ghent by convenience sampling eg research teams networks social media calls and through snowball sampling ie participating child-parent dyads encourage other dyads Taking into account the cognitive and emotional development of children the age range of CBC is set at 8-12y to restrain wide variation in developmental stage
Pediatric oncology clinicians eg physicians physiotherapists nurses psychologists child life specialists occupational therapists will be recruited from the participating hospitals and through the research teams networks
CBC their parents and pediatric oncology clinicians can only be included in the study if they meet the inclusion criteria and after written informed consent is obtained All CBC parents and pediatric oncology clinicians will receive verbal and written information on all aspects of the study prior to consent for participation CBC wishing to participate without a parent will not be excluded but will still require parental consent
SAMPLE SIZE CALCULATION
A recent report of the Belgium Cancer Registry stated that annually 360 children between 0-18y are diagnosed with cancer of which about 90 children of 8-12y According to the Belgian Cancer Registry the 5-year survival rate for this age group is about 93 resulting in an estimated 83 CBC per year that can be recruited for the current study Hence the foreseen recruitment rate of 6 to 8 participants seems feasible
RISK MANAGEMENT
In case of slow recruitment of CBC and their parents additional recruitment sources will be contacted to participate and share the recruitment flyers In case of slow recruitment of oncology clinicians other Flemish University hospitals will be approached through the research teams networks
BASELINE ASSESSMENT
One week before the first session clinical and socio-demographic characteristics of participating CBC parents and pediatric oncology clinicians will be assessed through a battery of online questionnaires Questionnaires will be completed using REDCap a secure web platform for building and managing online databases and surveys study feasibility data protection The following socio-demographic and clinical information will be collected
CBC parent-reported age sex diagnosis date and description cancer treatments received treating hospitals other medical history current or previous pain treatments psychosocial physical andor pharmacological
Parents age gender identification family situation education level occupation and health status
Oncology clinicians age gender occupation hospital where they are working work experience in pediatric oncology experience with pain education health status
CO-CREATION SESSIONS AND CONCEPT MAPPING SESSIONS
For the development of the PSE intervention 6 co-creation sessions will be organized with CBC and their parents separately and 3 sessions using concept mapping will be organized with pediatric oncology clinicians
The co-creation and concept mapping sessions will be guided by the Intervention Mapping Protocol IMP The IMP is being used worldwide as the standard protocol for the development implementation and evaluation of health promoting interventions
The content of the co-creation sessions with CBC and their parents will be as follows
Session 1 explanation of the study aim assessment of the needs barriers and facilitators for behavioral change and the outcome expectations of the PSE intervention
Session 2-3 determination of performance objectives and change objectives of the PSE intervention
Session 4-5 selection of practical strategies content format delivery method timing materials
Session 6 demonstration of the co-created PSE intervention followed by a discussion and evaluation of the developed PSE intervention in terms of satisfaction understandability empowerment and ownership
The concept mapping sessions with pediatric oncology clinicians will be structured as follows
Session 1 participants will be asked to answer one key question covering the scope and intention of the study How would you approach a pain science education intervention for CBC Answers will be collected through a round circle principle
Session 2 a card sorting task will be given to the participants in which they are asked to sort the answers of the previous concept mapping session by theme into different piles After completing the card sorting task they will have to rate each theme in terms of relevance population-level effect modifiability and expected outcomes on a scale from 1 to 10 With this input we will proceed to the co-creation sessions with CBC living beyond cancer and their parents
Session 3 after the co-creation sessions with CBC and their parents when the PSE intervention becomes more concrete final feedback on the co-created PSE intervention will be requested from the pediatric oncology clinicians who are willing to be part of the advisory committee
Results of the co-creation sessions and concept mapping sessions will be cross-validated after each session to end up with one final PSE intervention Each session will be audio-taped after assentconsent from the participants to ensure that no valuable information regarding the intervention development process will be lost All audiotapes will be transcribed and will not be used for any other study purposes The audiotapes will be deleted after study completion
PAIN SCIENCE EDUCATION
Pain science education PSE is a non-pharmacological pain management approach that aims to facilitate ones understanding of pain mechanisms It provides a foundation for other pain management strategies by addressing conceptual gaps and misconceptions regarding pain and by decreasing the perceived threat value of pain
In terms of the content of the PSE intervention an interdisciplinary expert panel identified 7 target concepts to form the foundation of a PSE curriculum for children 1 pain is a protector 2 the pain system can become overprotective 3 pain is a brain output 4 pain is not an accurate marker of tissue stage 5 there are many potential contributors to ones pain 6 we are all bioplastic and 7 pain education is treatment These 7 success ingredients of PSE will be presented yet will be open for discussion and will be supplemented with cancer-specific target concepts Hence the concrete PSE intervention for CBC will be developed during the co-creation process so the PSE intervention will not yet be appliedimplemented
Co-creation is a bottom-up approach directly involving the end-users in developing the intervention For the co-creation of the PSE intervention 3 groups will be formed children 8-12yo living beyond cancer CBC their parents and pediatric oncology clinicians For each group 6 to 8 participants will be recruited
Using purposeful sampling CBC and their parents will be recruited through various ways including through patient lists of the participating hospitals University Hospital Brussels and University Hospital Ghent by convenience sampling eg research teams networks social media calls and through snowball sampling ie participating child-parent dyads encourage other dyads Taking into account the cognitive and emotional development of children the age range of CBC is set at 8-12y to restrain wide variation in developmental stage
Pediatric oncology clinicians eg physicians physiotherapists nurses psychologists child life specialists occupational therapists will be recruited from the participating hospitals and through the research teams networks
CBC their parents and pediatric oncology clinicians can only be included in the study if they meet the inclusion criteria and after written informed consent is obtained All CBC parents and pediatric oncology clinicians will receive verbal and written information on all aspects of the study prior to consent for participation CBC wishing to participate without a parent will not be excluded but will still require parental consent
SAMPLE SIZE CALCULATION
A recent report of the Belgium Cancer Registry stated that annually 360 children between 0-18y are diagnosed with cancer of which about 90 children of 8-12y According to the Belgian Cancer Registry the 5-year survival rate for this age group is about 93 resulting in an estimated 83 CBC per year that can be recruited for the current study Hence the foreseen recruitment rate of 6 to 8 participants seems feasible
RISK MANAGEMENT
In case of slow recruitment of CBC and their parents additional recruitment sources will be contacted to participate and share the recruitment flyers In case of slow recruitment of oncology clinicians other Flemish University hospitals will be approached through the research teams networks
BASELINE ASSESSMENT
One week before the first session clinical and socio-demographic characteristics of participating CBC parents and pediatric oncology clinicians will be assessed through a battery of online questionnaires Questionnaires will be completed using REDCap a secure web platform for building and managing online databases and surveys study feasibility data protection The following socio-demographic and clinical information will be collected
CBC parent-reported age sex diagnosis date and description cancer treatments received treating hospitals other medical history current or previous pain treatments psychosocial physical andor pharmacological
Parents age gender identification family situation education level occupation and health status
Oncology clinicians age gender occupation hospital where they are working work experience in pediatric oncology experience with pain education health status
CO-CREATION SESSIONS AND CONCEPT MAPPING SESSIONS
For the development of the PSE intervention 6 co-creation sessions will be organized with CBC and their parents separately and 3 sessions using concept mapping will be organized with pediatric oncology clinicians
The co-creation and concept mapping sessions will be guided by the Intervention Mapping Protocol IMP The IMP is being used worldwide as the standard protocol for the development implementation and evaluation of health promoting interventions
The content of the co-creation sessions with CBC and their parents will be as follows
Session 1 explanation of the study aim assessment of the needs barriers and facilitators for behavioral change and the outcome expectations of the PSE intervention
Session 2-3 determination of performance objectives and change objectives of the PSE intervention
Session 4-5 selection of practical strategies content format delivery method timing materials
Session 6 demonstration of the co-created PSE intervention followed by a discussion and evaluation of the developed PSE intervention in terms of satisfaction understandability empowerment and ownership
The concept mapping sessions with pediatric oncology clinicians will be structured as follows
Session 1 participants will be asked to answer one key question covering the scope and intention of the study How would you approach a pain science education intervention for CBC Answers will be collected through a round circle principle
Session 2 a card sorting task will be given to the participants in which they are asked to sort the answers of the previous concept mapping session by theme into different piles After completing the card sorting task they will have to rate each theme in terms of relevance population-level effect modifiability and expected outcomes on a scale from 1 to 10 With this input we will proceed to the co-creation sessions with CBC living beyond cancer and their parents
Session 3 after the co-creation sessions with CBC and their parents when the PSE intervention becomes more concrete final feedback on the co-created PSE intervention will be requested from the pediatric oncology clinicians who are willing to be part of the advisory committee
Results of the co-creation sessions and concept mapping sessions will be cross-validated after each session to end up with one final PSE intervention Each session will be audio-taped after assentconsent from the participants to ensure that no valuable information regarding the intervention development process will be lost All audiotapes will be transcribed and will not be used for any other study purposes The audiotapes will be deleted after study completion
PAIN SCIENCE EDUCATION
Pain science education PSE is a non-pharmacological pain management approach that aims to facilitate ones understanding of pain mechanisms It provides a foundation for other pain management strategies by addressing conceptual gaps and misconceptions regarding pain and by decreasing the perceived threat value of pain
In terms of the content of the PSE intervention an interdisciplinary expert panel identified 7 target concepts to form the foundation of a PSE curriculum for children 1 pain is a protector 2 the pain system can become overprotective 3 pain is a brain output 4 pain is not an accurate marker of tissue stage 5 there are many potential contributors to ones pain 6 we are all bioplastic and 7 pain education is treatment These 7 success ingredients of PSE will be presented yet will be open for discussion and will be supplemented with cancer-specific target concepts Hence the concrete PSE intervention for CBC will be developed during the co-creation process so the PSE intervention will not yet be appliedimplemented
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