Abstract
BackgroundAdolescents 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/designWe 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.DiscussionInsomnia 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.Trial registrationNL7220 (NTR7419; Netherlands Trial register). Registered on 2 August 2018
Highlights
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 prevalent in the pediatric oncology population posing a double health burden for adolescents and young adults who had childhood cancer
Insomnia is common in adolescents and young adults who had childhood cancer and poses a high burden that can persist for a long time if left untreated
Summary
Insomnia is common in adolescents and young adults who had childhood cancer and poses a high burden that can persist for a long time if left untreated. This paper presents the design of the MICA DO-study, a randomized controlled trail, to investigate the efficacy of the iCBT-I intervention “i-Sleep youth” in adolescents and young adults who had childhood cancer. This trial has several strengths and limitations. The online cognitive behavior therapy “i-Sleep youth” for adolescents and young adults with insomnia after childhood cancer was adapted and will be studied in this trial.
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