Clinical trial · Observational
Pain and Sleep Disturbances in Children Living Beyond Cancer: A Case-Control Study
The Co-Morbidity of Pain and Sleep Disturbances in Children Living Beyond Cancer: A Case-Control Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
Children living beyond cancer (CBC) represent a unique and growing population of young people in need of long-term clinical support. Studies suggest that 11-44% of CBC experience chronic pain, negatively impacting a wide range of child biopsychosocial outcomes and creating high financial burden for their families and society. Often comorbid with pain, one of the most chronic and disturbing side effects reported by CBC are sleep disturbances, and in particular, difficulties initiating and maintaining sleep. Indeed, \>50% of CBC report some form of sleep disturbance even 9 to 15 years after the cancer diagnosis. Much attention has been paid to sleep and pain as independent constructs within pediatric oncology, yet Belgian data is lacking. Additionally, little is known about how these domains interact with one another and subsequent indications for prevention and intervention. Although evidence shows an interrelationship between pain and sleep in adult and pediatric populations, this interrelationship is understudied in childhood cancer patients and CBC. (Chronic) pain may serve as a modifiable target for interventions to improve sleep quality and vice versa, and understanding this relationship is crucial for providing comprehensive care to CBC. Therefore, this cross-sectional case-control study aims to explore the differences in pain and sleep disturbances in CBC compared to healthy age- and sex-matched healthy controls, as well as the interrelationship between both outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Cancer Survivors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire, actigraphy measurement and sleep diary | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- children living beyond cancer (CBC)
- interventionNames
- Other: Questionnaire, actigraphy measurement and sleep diary
- label
- healthy controls
- description
- age- and sex-matched healthy controls
- interventionNames
- Other: Questionnaire, actigraphy measurement and sleep diary
Primary outcomes (2)
- measure
- Activity limitations due to pain
- timeFrame
- Baseline about the past 14 days + 14 days following baseline in daily sleep diary
- description
- Measured with the Child Activity Limitations Interview (CALI) - 9 (parent-report version for the 6-7 year-olds; self-report version for the 8-12 year-olds)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * CBC: 1) current age 6-12yo; 2) history of any cancer diagnosis; 3) ≤ 5y post- treatment completion; 4) ≥ 3 months since last cancer treatment (since pain and insomnia during treatment can be directly related to therapy and recover spontaneously); 5) fluent Dutch speaker and reader (age-dependent) * Healthy controls (age- and sex-matched): 1) current age 6-12yo; 2) no history of cancer ; 3) fluent Dutch/French/English speaker and reader (age-dependent) * Parents: 1) fluent Dutch/French/English speaker and reader Exclusion Criteria: * CBC: 1) receiving palliative therapy; 2) psychiatric disorder; 3) severe intellectual disability * Healthy controls: 1) history of cancer; 2) psychiatric disorder; 3) severe intellectual disability
References
Publications (0)
Data not yet available