Pain and Sleep Disturbances in Children Living Beyond Cancer: A Case-Control Study

NCT07120646 | Not Yet Recruiting

• 1 other identifier: PEEPTrial_CaseControl
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Childhood Cancer Survivors

Keywords

children living beyond cancer; pain; sleep disturbances; case-control

Outcome Measures

Primary Outcomes (2)

• Activity limitations due to pain

  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)

  Baseline about the past 14 days + 14 days following baseline in daily sleep diary

• Sleep disturbances

  Assessed with the PROMIS Parent Proxy Item Bank v1.0 - Sleep Disturbance - Short Form 8a parent-report for the 6-7 year olds and PROMIS Pediatric Item Bank v1.0 - Sleep Disturbance - Short Form 8a for the 8-12 year-olds. Additionally, this outcome measure is assessed with the Children's Sleep Habits Questionnaire (CSHQ) (parent-report for all ages).

  Baseline

Secondary Outcomes (13)

• Pain severity

  Baseline

• Pain coping

  Baseline

• Pain reporting and assessment during follow-up care

  Baseline

• Health-related quality of life

  Baseline

• Fatigue

  Baseline

Other Outcomes (1)

• Information about prior night's sleep pattern and day

  From baseline to 14 days later

Study Arms (2)

children living beyond cancer (CBC)

Other: Questionnaire, actigraphy measurement and sleep diary

healthy controls

age- and sex-matched healthy controls

Other: Questionnaire, actigraphy measurement and sleep diary

Interventions

Questionnaire, actigraphy measurement and sleep diary OTHER

Baseline questionnaires (measuring socio-demographic and health-related information, as well as most outcome measures), followed by 2 weeks of actigraphy measurement and daily sleep diary.

children living beyond cancer (CBC); healthy controls

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children living beyond cancer (6-12 years old) and age- and sex-matched healthy controls, together with one of their parents.

You may qualify if:

• 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 speaker and reader (age-dependent)
• Parents: 1) fluent Dutch speaker and reader

You may not qualify if:

• 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

Vrije Universiteit Brussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Pain; Parasomnias

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Emma Rheel, PhD

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Rheel, PhD

CONTACT

+32496908353; emma.rheel@vub.be

Nijs Jo, PhD

CONTACT

+32496908353; jo.nijs@vub.be

Study Design

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

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: August 13, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within one year following the end of the study, for 10 years.
• Access Criteria: Closed access (only on reasonable request)

Locations

BE (1)