An observational study in Childhood Cancer Survivors, sponsored by Vrije Universiteit Brussel. Recruiting at 2 sites in Belgium. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Vrije Universiteit Brussel · Observational
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.
Pain and sleep disturbances are common and impactful following childhood cancer treatment
Worldwide, about 400 000 children aged 0-19 years are diagnosed with cancer each year. Largely due to more intensive treatment regimens and the implementation of immunotherapy for high-risk patients, 5-year survival rates for children with cancer in high income countries have increased to >80%. This is great news, however as a result, children living beyond cancer (CBC) represent a unique and growing population of young people in need of long-term clinical support.
Across the cancer continuum, pain is a prevalent, recurrent, and impactful symptom. Although we know that pain in childhood cancer is underreported and undertreated, the prevalence of pain in children during active cancer treatment varies from 28-62% across studies, with >50% of children reporting moderate to severe pain intensity. For many children, pain resolves following completion of the cancer treatment, yet for some, pain persists well beyond treatment7 and into adulthood. Indeed, studies suggest that 11-44% of CBC experience chronic pain (i.e., pain in ≥ 1 anatomic region persisting or recurring for >3 months), with 20% reporting moderate to extreme pain interference. Chronic pain can deleteriously impact the lives of CBC and their family. Specifically, if not addressed early on, chronic pain can negatively impact children's school functioning, sleep quality, social and family functioning, mental health, physical activity, and overall health-related quality of life. Moreover, it increases the risk of chronic pain across the lifespan. Further, also the families of children with chronic pain can experience significant physical and psychosocial sequelae due to the child's pain, e.g., high levels of anxiety and depressive symptoms, and a high financial burden due to direct and indirect medical costs.
Often comorbid with pain, one of the most chronic and disturbing side effects reported by childhood cancer patients and CBC are sleep disturbances, and in particular, difficulties initiating and maintaining sleep, suggesting that this is a major quality of life concern. Indeed, >50% of CBC report some form of sleep disturbance even 9 to 15 years after the cancer diagnosis. Good-quality sleep in childhood is crucial for a healthy emotional, cognitive, physical, and behavioral development. Healthy sleep involves receiving a developmentally appropriate number of hours of sleep (declining from infancy to adolescence), few or preferably no wakings during the night, and a subjective perception of feeling rested. CBC may be at increased risk for sleep disturbances, being critically ill during a life phase that is important in the development of good sleep habits. Disrupted sleep can also affect inflammatory pathways and immune functioning, incl. natural killer cell activity, and can contribute to or exacerbate other morbidities common to survivorship (e.g., anxiety, depression). Sleep disruption is unlikely to remit without intervention and longitudinal research shows that sleep disruption often persists from childhood into adolescence.
Study Rationale and Purpose
Some attention has been paid to sleep and pain as independent constructs within pediatric oncology, although Belgian data is lacking and little is known about how these domains interact with one another and subsequent indications for prevention and intervention. Early studies propose a bi-directional relationship between pain and sleep, such that sleep deficiency and pain reciprocally maintain symptoms over time. Yet, the interrelationship between pain and sleep 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.
This cross-sectional case-control study aims to explore the differences in pain and sleep disturbances in CBC (6-12 years old) compared to healthy age- and sex-matched healthy controls, as well as the interrelationship between both outcomes.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 76 is below the median of 100 across 1,252 observational studies indexed under Pain.
Browse Pain studies →Vrije Universiteit Brussel is the lead sponsor of 158 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children living beyond cancer (6-12 years old) and age- and sex-matched healthy controls, together with one of their parents.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: Questionnaire, actigraphy measurement and sleep diary
age- and sex-matched healthy controls
Other: Questionnaire, actigraphy measurement and sleep diary
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.
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
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
Fatigue
Assessed with the PedsQL Multidimensional Fatigue Scale 3.0 (5-7yo parent-report) for the 6-7 year-olds and the PedsQL Multidimensional Fatigue Scale 3.0 (8-12yo self-report) for the 8-12 year-olds.
Time frame: Baseline
Anxiety
Assessed with the PROMIS Parent Proxy 3.0 - Anxiety - Short Form 8a for 6-7 year-olds and the PROMIS Pediatric 3.0 - Anxiety - Short Form 8a for the 8-12 year-olds.
Time frame: Baseline
Depressive symptoms
Assessed with the PROMIS Parent Proxy 3.0 - Depressive Symptoms - Short Form 6a for the 6-7 year-olds and the PROMIS Pediatric 3.0 - Depressive Symptoms - Short Form 6a for the 8-12 year-olds.
Time frame: Baseline
Total sleep time
The total amount of time scored as sleep in minutes from sleep onset to sleep offset. Assessed with Actigraphy (Fitbit Sense 2)
Time frame: 14 days following baseline
Wake minutes after sleep onset
The number of minutes scored as wake after nighttime sleep onset. Assessed with Actigraphy (Fitbit Sense 2)
Time frame: 14 days following baseline
Sleep efficiency
The ratio of total sleep time and total time spent in bed at night as a percentage, with values closer to 100 indicating more efficient sleep. Assessed with Actigraphy (Fitbit Sense 2)
Time frame: 14 days following baseline
Sleep regularity index
Similarity of the child's sleep-wake pattern from one day to the next based on binary sleep-wake time series. Assessed with Actigraphy (Fitbit Sense 2)
Time frame: 14 days following baseline
Pain symptoms during the day
This data is collected via a daily sleep diary and includes: presence of pain (yes/no), and if yes; mean and worst pain during the day (0 = no pain; 10 = worst pain possible)
Time frame: 14 days following baseline
Medication intake during the day
This data is collected via a daily sleep diary and includes whether the child took medication during the day (yes/no), and if yes; which medication.
Time frame: 14 days following baseline
Pain catastrophizing
Child pain catastrophizing and parental pain catastrophizing, measured with the Pain Catastrophizing Scale for Children (PCS-C) (for 8-12yo) and Pain Catastrophizing Scale for Parents (PCS-P) (for all parents), respectively. The PCS consists of 13 statements that assess thoughts and feelings about pain experiences. Each statement is scored on a 5-point Likert scale, with higher scores indicating a greater degree of catastrophizing. The total score ranges from 0 to 52, with higher scores indicating higher levels of catastrophizing.
Time frame: Baseline
Fear of Cancer Recurrence
Fear of Cancer Recurrence, measured with the Fear of Cancer Recurrence Inventory Short Form - Child Version (FCRI-C) (for 8-12yo) and Fear of Cancer Recurrence Inventory Short Form - Parent Version (FCRI-P) (for all parents), respectively. The scale consists of 9 items assessing the severity of participants' FRC. The maximum score is 36, with score of 13 and above indicating the presence of "significant" FCR; score of 16 and above indicating the presence of "clinically significant" FCR; and score of 22 and above indicating the presence of "pathological" severe FCR (needing specialized intervention for FCR). The FCRI-C was translated for this study using forward-backward translation, pilot-tested with the first 11 participants in the study, re-evaluated following pilot-testing, and afterwards validated with the remaining participants during the course of this study.
Time frame: Baseline
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
Plan to share: Yes — Data will be documented both at the project level and at the data level: Data level: In research papers; Information about variables using labels and variables derivations Project level Documentation about the authors, background, aims, objectives, and the hypotheses that shape the research Data collection protocol \& procedures Project meeting reports Descriptive metadata of data items will be registered in Pure Database with restricted acces (closed access, only on reasonable request). In addition, the raw dataset will include labels in the .xlsx file including variable information providing documentation at the data level. Datasets will be accompanied by a separate word.doc file providing study-level documentation including the field methods used for data collection.
Time frame: Within one year following the end of the study, for 10 years.
Access criteria: Closed access (only on reasonable request)
Data sharing details ↗ · dmponline.be
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Dec 2026, 14 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.