Pain, Body Composition and Physical Activity in Childhood Cancer.

NCT04004455 | Completed

• 1 other identifier: CASECONTROL_RE_2019-2020
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing baseline assessments of children with cancer and their parents with baseline assessments of healthy children and their parents in a case-control study will allow the investigators to make the comparison in terms of pressure hyperalgesia, pain catastrophizing, energy-balance related behavior, attention control and attention bias between healthy children and cancer patients. This also enables the investigators to compare parents of healthy children with parents of cancer patients in the field of catastrophizing about the pain of their child and responses to child's pain experiences. Correlations can also be calculated between, for example, pain pressure thresholds and energy-balance related behavior.

Conditions

Childhood Cancer

Keywords

children; cancer; pressure pain threshold; energy-balance related behavior; pain catastrophizing; body composition

Outcome Measures

Primary Outcomes (1)

• Pressure hyperalgesia (child)

  Pain response to stimuli that are normally not painful, induced by the lowering of the nociceptor threshold level and assessed by evaluating pressure pain thresholds (PPTs) at the dominant tibialis anterior and trapezius muscle by means of a digital pressure algometer (FPX 50, Wagner Instruments, Greenwich, CT, USA). Per test site, 3 measurements are performed with 30 seconds between each measurement. The measurements take place alternately between the two test sites, the first test site being randomly determined by an independent blinded researcher. The pressure pain threshold in kgf per muscle (test site) is determined by the mean of the 2nd and 3rd measurement.

  1 day

Secondary Outcomes (24)

• Energy-balance related behavior (child)

  1 day

• Waist circumference (child)

  1 day

• Body length (child)

  1 day

• Body weight (child)

  1 day

• Body weight (only healthy controls) (child)

  1 day

Other Outcomes (2)

• Pain catastrophizing (child)

  1 day

• Pain catastrophizing (parent)

  1 day

Study Arms (2)

Childhood cancer

Children with an established cancer diagnosis (any type) between 8-18 years old that are currently being treated for cancer (not necessarily hospitalized) in the University Hospital Brussels or Ghent.

Healthy controls

Healthy children between 8-12 years old, selected based on age and sex.

Eligibility Criteria

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

Study Population

Cancer patients will be recruited by the oncology department of the children's hospital of the University Hospital Brussels and Ghent. All eligibel children between 8-18y and their parents will be informed about the study and receive a consent form. Healthy controls will be recruited from several schools in the neighborhood and from family and acquaintances of the hospital personnel and researchers. In order to be able to compare their outcomes with the intervention group, they will be selected based on age and sex.

You may qualify if:

• All participants:
• Willing to participate and comply with pre-determined interventions
• y (children)
• Child and parent(s)/guardian cohabited for the past 5 years or, in case of divided custody, for at least half of the child's lifetime
• Cancer patients
• Established cancer diagnosis (any type)
• First cancer diagnosis
• Currently being treated for cancer (not necessarily hospitalized) in the University Hospital Brussels or Ghent

You may not qualify if:

• Developmental disabilities (e.g.: autism spectrum disorder, Attention Deficit (Hyperactivity) Disorder)
• Psychiatric disorders (e.g.: anxiety disorder, personality disorder)
• Significant vision or hearing impairment
• Chronic pain diagnosis (e.g.: fibromyalgia, migraine, chronic abdominal pain, etc.)
• Not able to read and speak fluent Dutch (parent and child)
• Already having undergone any kind of self-regulation and/or behavioral therapy for pain (i.e. relaxation, hypnosis, biofeedback, pain neuroscience education, cognitive behavioral therapy, etc.)

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Universitair Ziekenhuis Brussel: collaborator
• University Ghent: collaborator

Study Sites (1)

University Hospital Brussels

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: July 2, 2019
• Study Start: August 14, 2019
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

BE (1)