Exploring Pain, Body Composition and Physical Activity in Childhood Cancer: a Case Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pressure hyperalgesia (child)
研究概览
简要总结
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.
详细描述
Participant recruitment
Cancer patients will be recruited by the oncology department of the children's hospital of the University Hospital Brussels and Ghent. All children with cancer between 8-18y and their parents will be informed about the study and receive a consent form. The recruitment procedure will start in July 2019 and pursue until the calculated sample size is reached. 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. Cancer patients with a portal catheter will also be included in a concurrent pilot randomized controlled trial, including the same baseline assessments. In this pilot randomized controlled trial, children will be distracted by a humanoid robot during painful medical procedures. Given the observation that children up to 12 years of age are more likely than children over 12 years to believe that a robot possesses human characteristics, only the children between the ages of 8 and 12 years also participate in this randomized controlled trial. The lower age limit is chosen because child self-report questionnaires have been validated from that age. Self-reports in children also require a variety of cognitive skills, which develop gradually and are only acquired at the age of 7 or 8 in most children. Children and their parents can only be included in the study if they meet the inclusion criteria and after written informed consent from the (co-participating) parent/guardian and child is obtained. All parents/guardians and children will receive verbal and written information on all aspects of the study prior to consent for participation.
Sample size calculation was performed with G*Power 3.1.9.2 (Franz Faul, Kiel, Germany). The a priori sample size calculation for this study was based on the sample size calculation of a previous study on pain hypersensitivity in juvenile idiopathic arthritis compared with healthy children. Targeting a study power of 80% with an α error probability of 0.05 and allocation ratio (N1/N2) defined as 1, the calculation revealed sample sizes of 26 participants for the cancer group and 26 participants for the healthy controls (total sample size n=52). Accounting for a 10% dropout and keeping in mind that every sample size calculation has its limitations, the investigators propose studying at least 30 participants per group. Hence, the total number of participants to be included will be equal to 60. Because of the low number of new cases of childhood cancer (<15 years of age) per year in Belgium, the monocentric nature of this trial and the limited time for data collection (1 year 9 months) the calculated sample size remains as a target.
Risk management: In case of slow patient recruitment or a dropout rate that exceeds 10%, the age range of the participants will be extended (1) and French speaking children and their parents will no longer be excluded (2).
Assessments
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants:
- •Willing to participate and comply with pre-determined interventions
- •8-18y (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
排除标准
- •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.)
研究组 & 干预措施
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.
结局指标
主要结局
Pressure hyperalgesia (child)
时间窗: 1 day
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.
次要结局
- Fat percentage (child)(1 day)
- Fat percentage (only healthy controls) (child)(1 day)
- Fat mass (child)(1 day)
- Fat free mass (child)(1 day)
- Muscle mass (child)(1 day)
- 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)
- Muscle mass percentage (only healthy controls) (child)(1 day)
- Total body water (child)(1 day)
- Total body water percentage (child)(1 day)
- Intracellular water (child)(1 day)
- Extracellular water (child)(1 day)
- Body mass index (child)(1 day)
- Body mass index (only healthy controls) (child)(1 day)
- Visceral fat rating (child)(1 day)
- Visceral fat rating (only healthy controls) (child)(1 day)
- Basal metabolic rate (child)(1 day)
- Basal metabolic rate (only healthy controls) (child)(1 day)
- Attention control child (child)(1 day)
- Attention bias (child)(1 day)
- Responses to child's pain experience (parent)(1 day)