MedTrace Logo

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

NCT04879264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-01-15

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

self-rating scale for severity of sleep disorders

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

DIAGNOSTIC_TEST

self-rating scale for distress caused by sleep disorders

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

Sponsors & Collaborators

  • Zealand University Hospital

    collaborator OTHER

  • University Hospital Schleswig-Holstein

    lead OTHER

Principal Investigators

  • Dirk Rades, MD · Department of Radiation Oncology, University of Lübeck

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-11-16
Completion
2022-12-05

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04879264 on ClinicalTrials.gov