Co-creation of Pain Science Education for Children Living Beyond Cancer

NCT06345391 | Not Yet Recruiting

• 1 other identifier: PANACEA_CO-CREATION_2024
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Children Living Beyond Cancer (i.e. Child Cancer Survivor)

Keywords

children living beyond cancer; pain science education; co-creation; chronic pain

Outcome Measures

Primary Outcomes (1)

• 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.

  at the end of the last co-creation/concept mapping session, approximately 6 months

Secondary Outcomes (3)

• Understandability of the co-created intervention

  at the end of the last co-creation/concept mapping session, approximately 6 months

• Empowerment with regard to the co-created intervention

  at the end of the last co-creation/concept mapping session, approximately 6 months

• Ownership of the intervention development

  at the end of each co-creation/concept mapping session, up to 6 months

Study Arms (3)

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).

Other: Co-creation

Parents of children living beyond cancer

Parents of children (8-12 years) living beyond cancer.

Other: Co-creation

Pediatric oncology clinicians

Clinicians (e.g. physician, nurse, physical therapist, occupational therapist, psychologist, child life specialist) currently employed in pediatric oncology.

Other: Concept Mapping

Interventions

Co-creation OTHER

Participatory approach maximally and directly involving important stakeholders (bottom-up) to co-create a pain science education intervention for children living beyond cancer.

Children living beyond cancer; Parents of children living beyond cancer

Concept Mapping OTHER

Concept mapping to create a pain science education intervention for children living beyond cancer.

Pediatric oncology clinicians

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Children living beyond cancer:
• history of (any) cancer diagnosis
• \<2y post-treatment completion (early survivorship phase)
• fluently Dutch speaking and reading
• having access to internet/computer (in order to complete online questionnaires)
• 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)

You may not qualify if:

• Children living beyond cancer:
• presence of psychiatric disorders or severe intellectual disability

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Universitair Ziekenhuis Brussel: collaborator
• University Ghent: collaborator
• University Hospital, Ghent: collaborator
• University of Calgary: collaborator

Study Sites (1)

Vrije Universiteit Brussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sophie Pleysier, MSc

CONTACT

+32498900927; sophie.pleysier@vub.be

Emma Rheel, PhD

CONTACT

+32496908353; emma.rheel@vub.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Principal Investigator

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 3, 2024
• Study Start: April 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-03

Locations

BE (1)