Clinical trial · Interventional
Sleep Disorders Prior to and During a Course of Radiotherapy for Breast Cancer
Sleep Disorders Prior to and During a Course of Radiotherapy for Breast Cancer and the Potential Impact of Smartphones
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main goal of the study is to evaluate sleep disorders in breast cancer patients prior to and during a course of radiotherapy in terms of severity of sleep disorders, distress for the patients and use of sleeping drugs, in order to evaluate the potential effect of habituation to radiotherapy during the course of treatment and generate hypotheses thereof. The patients will be asked to complete a questionnaire prior to radiotherapy, after 5 and 15 fractions of radiotherapy, and at the end of radiotherapy. The questionnaire includes questions regarding symptoms, distress, sleep disorders and sleeping drugs. In addition, a questionnaire regarding the use of smartphones / tablets will be completed prior to radiotherapy. Forty-eight patients with documented start of radiotherapy and with a documented completed questionnaire at baseline and at least one completed questionnaire after start of radiotherapy should be subjected to statistical analysis. Assuming that 5% of patients do not fulfil these requirements, a total of 51 patients should be enrolled to this study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| self-rating scale for distress caused by sleep disorders | Diagnostic Test | — | UNRESOLVED |
| self-rating scale for severity of sleep disorders | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients irradiated for breast cancer
- description
- Participants with breast cancer who receive adjuvant radiotherapy following breast-conserving surgery or mastectomy.
- interventionNames
- Diagnostic Test: self-rating scale for severity of sleep disorders
- Diagnostic Test: self-rating scale for distress caused by sleep disorders
Primary outcomes (1)
- measure
- Number of Participants With Decreased Sleep Disorders
- timeFrame
- 3 weeks
- description
- Sleep disorders during the course of radiotherapy (assessed after 15 fractions) will be compared to sleep disorders at baseline (prior to radiotherapy).
Secondary outcomes (1)
- measure
- Number of Participants With Decreased Sleep Disorders
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patient with histologically proven breast cancer 2. Indication for radiotherapy 3. Sleep disorders (i.e. at least 2 points on the sleep disorder self-rating scale) 4. Eastern Cooperative Oncology Group (ECOG) performance score 0-2 5. Age ≥18 years 6. Written informed consent 7. Capacity of the patient to contract Exclusion Criteria: 1. Pregnancy, Lactation 2. Expected non-compliance (patient unable to use the seizure diary)
References
Publications (1)
- DERIVEDRades D, Narvaez CA, Dziggel L, Janssen S, Olbrich D, Tvilsted S, Kjaer TW. A prospective interventional study investigating sleep disorders prior to and during adjuvant radiotherapy for breast cancer. BMC Cancer. 2021 Dec 20;21(1):1349. doi: 10.1186/s12885-021-09084-w. PMID 34930172