Princess Máxima Center for Pediatric Oncology, Heidelberglaan 25, Utrecht, 3584 CS, The Netherlands.
Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit, Pediatric Oncology, Cancer Center Amsterdam, Amsterdam, The Netherlands.
Trials. 2021 Apr 26;22(1):307. doi: 10.1186/s13063-021-05263-z.
Adolescents and young adults who had childhood cancer are at increased risk for insomnia, due to being critically ill during an important phase of their life for the development of good sleep habits. Insomnia is disabling and prevalent after childhood cancer (26-29%) and negatively impacts quality of life, fatigue, pain, and general functioning and is often associated with other (mental) health problems. Insomnia and a history of childhood cancer both increase the risk of adverse health outcomes, posing a double burden for adolescents who had childhood cancer. The first-line treatment for insomnia is cognitive behavioral therapy for insomnia (CBT-I). However, access to this type of care is often limited. The guided online CBT-I treatment "i-Sleep" has been developed to facilitate access via online care. i-Sleep is shown effective in adult (breast cancer) patients, but it is unknown if iCBT-I is effective in pediatric oncology.
METHODS/DESIGN: We developed a youth version of i-Sleep. Our aim is to evaluate its effectiveness in a national randomized-controlled clinical trial comparing iCBT-I to a waiting-list control condition at 3 and 6 months (n = 70). The intervention group will be also assessed at 12 months to see whether the post-test effects are maintained. Adolescents and young adults aged 12-30 years with insomnia, diagnosed with (childhood) cancer, currently at least 6 months since their last cancer treatment will be eligible. Outcomes include sleep efficiency (actigraphic), insomnia severity (self-report), sleep and circadian activity rhythm parameters, fatigue, health-related quality of life, perceived cognitive functioning, chronic distress, depressive and anxiety symptoms, and intervention acceptability.
Insomnia is prevalent in the pediatric oncology population posing a double health burden for adolescents and young adults who had childhood cancer. If guided iCBT-I is effective, guidelines for insomnia can be installed to treat insomnia and potentially improve quality of life and the health of adolescents and young adults who had childhood cancer.
NL7220 (NTR7419; Netherlands Trial register). Registered on 2 August 2018.
儿童癌症患者在青少年和年轻人时期容易出现失眠，因为他们在生命中养成良好睡眠习惯的重要阶段处于重病状态。失眠在儿童癌症后普遍存在且会致残（26-29%），对生活质量、疲劳、疼痛、一般功能以及常常与其他（精神）健康问题产生负面影响。失眠和儿童癌症史都会增加不良健康结果的风险，这对患有儿童癌症的青少年造成了双重负担。失眠的一线治疗方法是失眠认知行为疗法（CBT-I）。但是，这种治疗方法往往难以获得。“i-Sleep”是一种指导式在线 CBT-I 治疗方法，旨在通过在线护理促进治疗的普及。“i-Sleep”在成年（乳腺癌）患者中显示出有效，但尚不清楚 iCBT-I 是否对儿科肿瘤学有效。
方法/设计：我们开发了 i-Sleep 的青少年版本。我们的目的是通过一项全国性随机对照临床试验来评估其效果，该试验将 iCBT-I 与等待名单对照组在 3 个月和 6 个月（n=70）进行比较。干预组还将在 12 个月进行评估，以观察是否维持了后测效果。符合条件的参与者为年龄在 12-30 岁之间、患有失眠症、被诊断患有（儿童）癌症、且最近一次癌症治疗后至少 6 个月的青少年和年轻人。结果包括睡眠效率（活动记录仪）、失眠严重程度（自我报告）、睡眠和昼夜节律活动参数、疲劳、健康相关生活质量、认知功能感知、慢性困扰、抑郁和焦虑症状以及干预接受度。
失眠在儿科肿瘤患者中普遍存在，对患有儿童癌症的青少年和年轻人造成了双重健康负担。如果指导式 iCBT-I 有效，那么可以为失眠症制定治疗指南，从而有可能改善青少年和年轻人的生活质量和健康。
NL7220（NTR7419；荷兰试验注册）。于 2018 年 8 月 2 日注册。
