TY - JOUR
T1 - 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)
T2 - study protocol of a randomized controlled trial
AU - Peersmann, Shosha H. M.
AU - van Straten, Annemieke
AU - Kaspers, Gertjan J. L.
AU - Thano, Adriana
AU - van den Bergh, Esther
AU - Grootenhuis, Martha A.
AU - van Litsenburg, Raphaële R. L.
N1 - Funding Information: 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. TDCSecretary@prinsesmaximacentrum.nl. 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. Funding Information: 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. Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/12/1
Y1 - 2021/12/1
N2 - 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
AB - 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
KW - Adolescent
KW - CBT
KW - Childhood cancer
KW - Insomnia
KW - Randomized controlled trial
KW - Young adult
KW - eHealth
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85104871143&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/33902701
UR - http://www.scopus.com/inward/record.url?scp=85104871143&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-021-05263-z
DO - https://doi.org/10.1186/s13063-021-05263-z
M3 - Article
C2 - 33902701
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 307
ER -
