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

ConditionChildhood Cancer Survivors

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age6-12

SponsorVrije Universiteit Brussel

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Questionnaire, actigraphy measurement and sleep diary
Other intervention
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.

Treatment groups

76 Participants

are divided into 2 treatment groups

Group A: children living beyond cancer (CBC)1 intervention

Group B: healthy controls1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

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).

Time frame

Baseline

Secondary outcomes

Pain severity

Assessed with the Pain Frequency Severity Duration scale (PFSD) (parent-report for the 6-7 year-olds; self-report for the 8-12 year-olds)

Time frame

Baseline

Pain coping

Assessed with the Pain Coping Questionnaire short form (parent-report for the 6-7 year-olds; self-report for the 8-12 year-olds)

Time frame

Baseline

Pain reporting and assessment during follow-up care

Assessed using a selfmade set of items about pain reporting and assessment during medical follow-up consultations

Time frame

Baseline

Health-related quality of life

Assessed with the PedsQL Generic Score Scales 4.0 (5-7yo parent-report) for the 6-7 year-olds and the PedsQL Generic Score Scales 4.0 (8-12yo self-report) for the 8-12 year-olds.

Time frame

Baseline

Other outcomes

Information about prior night's sleep pattern and day

This data is collected via a daily sleep diary to interpret the Actigraphy data (bedtime, time of falling a sleep, number of wakings during the night, time of waking up in the morning, time of getting up in the morning, time and reasons for taking of the Fitbit, time of naps)

Time frame

From baseline to 14 days later

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vrije Universiteit Brussel

Lead sponsor

Research Foundation Flanders

Collaborator

Source ClinicalTrials.gov

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