Children Living Beyond Cancer (i.e. Child Cancer Survivor)PANACEANCT06345391
Co-creation of Pain Science Education for Children Living Beyond Cancer
An observational study of Children Living Beyond Cancer (i.e. Child Cancer Survivor), run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Children Living Beyond Cancer (i.e. Child Cancer Survivor)
- What is being tested?
- Co-creation and Concept Mapping
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Apr 2024to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children living beyond cancer and their parents will be recruited through patients lists of the participating hospitals (i.e. University Hospital Brussels and University Hospital Ghent), by convenience sampling (e.g. through the research team's networks, calls on social media), and through snowball sampling (i.e. participating dyads search for and encourage other dyads to participate). Oncology clinicians will be recruited from the participating hospitals by email invitation and through the research team's networks. All eligible children, parents, and oncology clinicians will be informed about the study and receive a consent form.
Who may be able to join
- Children living beyond cancer:
- history of (any) cancer diagnosis
- age 8-12y at the time of inclusion
- <2y post-treatment completion (early survivorship phase)
- fluently Dutch speaking and reading
- having access to internet/computer (in order to complete online questionnaires)
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- signed informed consent form
- Parents of children living beyond cancer:
- fluently Dutch speaking and reading
- having access to internet/computer (in order to complete online questionnaires)
- signed informed consent form
- Pediatric oncology clinicians:
- currently employed as a physician, nurse, physical therapist, occupational therapist, psychologist, or child life specialist in pediatric oncology
- fluently Dutch speaking and reading
- having access to internet/computer (in order to complete online questionnaires)
Who cannot join
- Children living beyond cancer:
- presence of psychiatric disorders or severe intellectual disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Added Value of Pain Science Education for Children Living Beyond Cancer (PANACEA): Co-creation
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.
Read the 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 (e.g. research team's networks, social media calls), and through snowball sampling (i.e. 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 (e.g., physicians, physiotherapists, nurses, psychologists, child life specialists, occupational therapists) will be recruited from the participating hospitals and through the research team's 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 team's 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 treatment(s) received, treating hospitals, other medical history, current or previous pain treatments (psychosocial, physical, and/or 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 assent/consent 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 one's 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 one's 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 applied/implemented.
- Being tested
- Co-creation, Concept Mapping
- Keywords
- children living beyond cancer, pain science education, co-creation, chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-creationOther
Participatory approach maximally and directly involving important stakeholders (bottom-up) to co-create a pain science education intervention for children living beyond cancer.
Concept MappingOther
Concept mapping to create a pain science education intervention for children living beyond cancer.
| Study group | Role | What they receive |
|---|---|---|
| Children living beyond cancer | Children between 8-12 years with a history of any cancer diagnosis that are currently in the early survivorship phase (<2y post-treatment). Receives: Other: Co-creation | |
| Parents of children living beyond cancer | Parents of children (8-12 years) living beyond cancer. Receives: Other: Co-creation | |
| Pediatric oncology clinicians | Clinicians (e.g. physician, nurse, physical therapist, occupational therapist, psychologist, child life specialist) currently employed in pediatric oncology. Receives: Other: Concept Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with the co-created intervention
Information about satisfaction of stakeholders (i.e. children living beyond cancer, their parents, and pediatric oncology clinicians) with various aspects of the co-created PSE intervention (e.g., content, complexity, comfort, delivery, and credibility) will be assessed through a small self-developed questionnaire at the end of the last co-creation and concept mapping session. The items of the questionnaire will be based on the ultimately developed intervention and will also include an open-ended question assessing to what extent the developed PSE intervention is what they needed, with the opportunity to suggest alternative treatment content.
Measured: at the end of the last co-creation/concept mapping session, approximately 6 months
Secondary outcomes (3)
Understandability of the co-created intervention
Information about understandability of stakeholders (i.e. children living beyond cancer, their parents, and pediatric oncology clinicians) with regard to the developed PSE intervention through a small self-developed questionnaire.
Measured: at the end of the last co-creation/concept mapping session, approximately 6 months
Empowerment with regard to the co-created intervention
Information about empowerment (self-efficacy, self-esteem, perceived stress and social support) of stakeholders (i.e. children living beyond cancer, their parents, and pediatric oncology clinicians) with various aspects of the co-created PSE intervention will be assessed through a small self-developed questionnaire at the end of the last co-creation and concept mapping session.
Measured: at the end of the last co-creation/concept mapping session, approximately 6 months
Ownership of the intervention development
Information about ownership (i.e. retention rates throughout the sessions) of stakeholders (i.e. children living beyond cancer, their parents, and pediatric oncology clinicians) will be assessed through a logbook.
Measured: at the end of each co-creation/concept mapping session, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start16 Apr 2024
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Living Beyond Cancer (i.e. Child Cancer Survivor)Studies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel, University Ghent, University Hospital, Ghent, University of Calgary
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345391
- Sponsor's protocol ID
- PANACEA_CO-CREATION_2024
- Acronym
- PANACEA
- Status last verified
- Aug 2026
- First submitted
- 15 Mar 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added Value of Pain Science Education for Children Living Beyond Cancer (PANACEA): Co-creation
- ClinicalTrials.gov ID
- NCT06345391
- Acronym / sponsor ID
- PANACEA / PANACEA_CO-CREATION_2024
- Keywords
- children living beyond cancer, pain science education, co-creation, chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel, University Ghent, University Hospital, Ghent, University of Calgary
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (e.g. research team's networks, social media calls), and through snowball sampling (i.e. 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 (e.g., physicians, physiotherapists, nurses, psychologists, child life specialists, occupational therapists) will be recruited from the participating hospitals and through the research team's 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 team's 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 treatment(s) received, treating hospitals, other medical history, current or previous pain treatments (psychosocial, physical, and/or 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 assent/consent 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 one's 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 one's 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 applied/implemented.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children living beyond cancer | – | Other: Co-creationChildren between 8-12 years with a history of any cancer diagnosis that are currently in the early survivorship phase (<2y post-treatment). |
| Parents of children living beyond cancer | – | Other: Co-creationParents of children (8-12 years) living beyond cancer. |
| Pediatric oncology clinicians | – | Other: Concept MappingClinicians (e.g. physician, nurse, physical therapist, occupational therapist, psychologist, child life specialist) currently employed in pediatric oncology. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children living beyond cancer and their parents will be recruited through patients lists of the participating hospitals (i.e. University Hospital Brussels and University Hospital Ghent), by convenience sampling (e.g. through the research team's networks, calls on social media), and through snowball sampling (i.e. participating dyads search for and encourage other dyads to participate). Oncology clinicians will be recruited from the participating hospitals by email invitation and through the research team's networks. All eligible children, parents, and oncology clinicians will be informed about the study and receive a consent form.
Key inclusion criteria (15 listed)
- history of (any) cancer diagnosis
- age 8-12y at the time of inclusion
- <2y post-treatment completion (early survivorship phase)
- fluently Dutch speaking and reading
- having access to internet/computer (in order to complete online questionnaires)
Key exclusion criteria (2 listed)
- presence of psychiatric disorders or severe intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-creationParticipatory approach maximally and directly involving important stakeholders (bottom-up) to co-create a pain science education intervention for children living beyond cancer. | Other | Children living beyond cancer, Parents of children living beyond cancer |
| Concept MappingConcept mapping to create a pain science education intervention for children living beyond cancer. | Other | Pediatric oncology clinicians |
Primary outcome
Satisfaction with the co-created intervention
Time frame: at the end of the last co-creation/concept mapping session, approximately 6 months
Information about satisfaction of stakeholders (i.e. children living beyond cancer, their parents, and pediatric oncology clinicians) with various aspects of the co-created PSE intervention (e.g., content, complexity, comfort, delivery, and credibility) will be assessed through a small self-developed questionnaire at the end of the last co-creation and concept mapping session. The items of the questionnaire will be based on the ultimately developed intervention and will also include an open-ended question assessing to what extent the developed PSE intervention is what they needed, with the opportunity to suggest alternative treatment content.
3 secondary outcomes
Understandability of the co-created intervention
Time frame: at the end of the last co-creation/concept mapping session, approximately 6 months
Empowerment with regard to the co-created intervention
Time frame: at the end of the last co-creation/concept mapping session, approximately 6 months
Ownership of the intervention development
Time frame: at the end of each co-creation/concept mapping session, up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children Living Beyond Cancer (i.e. Child Cancer Survivor), run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with the co-created intervention (time frame: at the end of the last co-creation/concept mapping session, approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.