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. | Rades et al. BMC Cancer 2021 21 1349 https s12885-021-09084-w STUDY PROTOCOL Open Access A prospective interventional study investigating sleep disorders prior to and during adjuvant radiotherapy for breast cancer Dirk Rades1 Carlos A. Narvaez2 Liesa Dziggel3 Stefan Janssen4 Denise Olbrich5 Soeren Tvilsted6 and Troels W. Kjaer7 Abstract 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 radio- therapy. 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 radio- therapy 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 end- points include sleep disorders after 5 fractions and at the end of radiotherapy. Moreover potential risk factors includ- ing 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 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 .
