A prospective interventional study investigating sleep disorders prior to and during adjuvant radiotherapy for breast cancer

BMC Cancer

Carlos A. Narvaez¹  Liesa Dziggel¹  Stefan Janssen¹  Dirk Rades²  Troels W. Kjaer³  Soeren Tvilsted⁴  Denise Olbrich⁵ 

[1] Department of Radiation Oncology, University of Lübeck, Lübeck, Germany;Department of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany;Neurological Department, Zealand University Hospital, Roskilde, Denmark;Research Projects and Clinical Optimization, Zealand University Hospital, Koege, Denmark;The Centre for Clinical Trials Lübeck, Lübeck, Germany;

关键词: Breast cancer;    Adjuvant radiotherapy;    Sleep disorders;    Smartphones;    Prospective study;   

DOI  :  10.1186/s12885-021-09084-w

来源: Springer

【 摘 要 】

BackgroundMost breast cancer patients with non-metastatic disease receive adjuvant local or loco-regional radiotherapy. To be scheduled for irradiation may cause distress and fears that can lead to sleep disorders. Few reports focused on sleep problems in patients assigned to radiotherapy. This study evaluates the course of sleep disorders during adjuvant radiotherapy for primary breast cancer and potential risk factors including the use of smartphones or tablets at bedtime.MethodsThe main goal is the evaluation of sleep disorders prior to radiotherapy and after 15 fractions of radiotherapy. A potential effect of habituation to the procedure of radiotherapy can be assumed that will likely lead to improvement (decrease) of sleep disorders. Improvement of sleep disorders (compared to baseline before radiotherapy) is defined as decrease of the severity of sleep disorders by ≥2 points on a patient self-rating scale (0 = no problems; 10 = maximum problems) or decrease of distress caused by sleep disorders by ≥2 points on a self-rating scale (0 = no distress; 10 = maximum distress) or reduction of the dose of sleeping drugs by ≥25%. Additional endpoints include sleep disorders after 5 fractions and at the end of radiotherapy. Moreover, potential risk factors including the use of smartphones or tablets at bedtime are evaluated. Fifty-one patients (48 plus potential drop-outs) are required. With this sample size, a one-sample binomial test with a one-sided significance level of 2.5% has a power of 80% to yield statistical significance, if the rate of patients with improvement of sleep disorders is 25% (rate under the alternative hypothesis) and assuming that a decrease of ≤10% has to be judged as a random, non-causal change in this uncontrolled study setting (null hypothesis).DiscussionIf a decrease of sleep disorders during the course of radiotherapy is shown, this aspect should be included in the pre-radiotherapy consent discussion with the patients. Moreover, identification of additional risk factors will likely lead to earlier psychological support. If the use of smartphones or tablets at bedtime is a risk factor, patients should be advised to change this behavior.Trial registrationclinicaltrials.gov (NCT04879264; URL: https://clinicaltrials.gov/show/NCT04879264); registered on 7th of May, 2021.

【 授权许可】

CC BY