Does the guided online cognitive behavioral therapy for insomnia “i-Sleep youth” improve sleep of adolescents and young adults with insomnia after childhood cancer? (MICADO-study): study protocol of a randomized controlled trial

S.H.M. Peersmann, A. van Straten, G.J.L. Kaspers, A. Thano, E. van den Bergh, M.A. Grootenhuis, R.R.L. van Litsenburg

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

© 2021, The Author(s).Background: 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. Discussion: 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. Trial registration: NL7220 (NTR7419; Netherlands Trial register). Registered on 2 August 2018
Original languageEnglish
Article number307
JournalTrials
Volume22
Issue number1
DOIs
Publication statusPublished - 1 Dec 2021

Funding

We would like to thank the participating adolescents, the patient-parent organization VOKK and adolescent sleep experts Ed de Bruin and Anne-Marie Meijer for their feedback during the adaptation process of i-Sleep youth. The institution of the principal investigator RvL is the sponsor of this investigator-initiated trial: Princess Maxima Center for pediatric oncology, Heidelberglaan 25, 3584 CS Utrecht, Netherlands. Contact person head of trial and data center: Prof. Michel Zwaan. [email protected]. The sponsor evaluated the study design through internal peer review evaluation and provides support in data management through the Trial Data Center. However, the sponsor plays no part in the collection, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. The trial is funded by the Dutch Cancer Society (DCS, call number 2016–2, grant number 10706). The role of the Dutch Cancer Society is limited to peer review of grant proposal. The Dutch Cancer Society is not involved in data collection, analyses, and interpretation of the data nor in writing the manuscripts.

FundersFunder number
Dutch Cancer Society2016–2, 10706
Princess Maxima Center

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