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

BACKGROUND: Most 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. METHODS: The 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). DISCUSSION: If 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 REGISTRATION: clinicaltrials.gov (NCT04879264; URL: https://clinicaltrials.gov/show/NCT04879264 ); registered on 7th of May, 2021.