Sleep Disorders Prior to and During a Course of Radiotherapy for Breast Cancer

NCT04879264 | Completed

• 1 other identifier: RADIO-SLEEP
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer Female

Keywords

Breast Cancer; Radiotherapy; Sleep Disorders

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Decreased Sleep Disorders

  Sleep disorders during the course of radiotherapy (assessed after 15 fractions) will be compared to sleep disorders at baseline (prior to radiotherapy).

  3 weeks

Secondary Outcomes (1)

• Number of Participants With Decreased Sleep Disorders

  3 - 6.5 weeks

Study Arms (1)

Patients irradiated for breast cancer

EXPERIMENTAL

Participants with breast cancer who receive adjuvant radiotherapy following breast-conserving surgery or mastectomy.

Diagnostic Test: self-rating scale for severity of sleep disorders; Diagnostic Test: self-rating scale for distress caused by sleep disorders

Interventions

self-rating scale for severity of sleep disorders DIAGNOSTIC_TEST

Participants report the severity of their sleep disorders on a self-rating scale form 0-10 (0=no sleep disorders, 10= maximum sleep disorders).

Patients irradiated for breast cancer

self-rating scale for distress caused by sleep disorders DIAGNOSTIC_TEST

Participants report their distress caused by sleep disorders on a self-rating scale form 0-10 (0=no distress, 10= maximum distress).

Patients irradiated for breast cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient with histologically proven breast cancer
• Indication for radiotherapy
• Sleep disorders (i.e. at least 2 points on the sleep disorder self-rating scale)
• Eastern Cooperative Oncology Group (ECOG) performance score 0-2
• Age ≥18 years
• Written informed consent
• Capacity of the patient to contract

You may not qualify if:

• Pregnancy, Lactation
• Expected non-compliance (patient unable to use the seizure diary)

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• Zealand University Hospital: collaborator

Study Sites (1)

Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein

Lübeck, 23562, Germany

Location

Related Publications (1)

• Rades 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Dirk Rades, MD

  Department of Radiation Oncology, University of Lübeck

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 10, 2021
• Study Start: June 1, 2021
• Primary Completion: November 16, 2021
• Study Completion: December 5, 2022
• Last Updated: January 15, 2025

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)