Sleep Quality in Patients With Advanced Cancer

Sleep Quality in Patients With Advanced Cancer. A Comparison of Objective Assessments and Self-reports of Sleep Quality

The primary focus of this clinical study is the objective and subjective measurements of sleep quality in patients with advanced cancer using opioids. It also examines sleep disturbances and associations between sleep quality and symptoms in order to improve symptom management in patients with advanced cancer.

The overall aim of this study is to improve the clinical understanding of sleep quality in patients with advanced cancer using opioids and to improve the understanding of how sleep quality may best be measured in order to improve symptom management.

Inclusion Criteria:

• A verified diagnosis of a malignant disease
• Presence of metastatic/disseminated disease
• Regularly scheduled oral, subcutaneous, transdermal or intravenous opioid treatment corresponding to step III at the WHO pain ladder with a duration of treatment not less than 3 days
• Able to comply with all study procedures
• Signed informed consent according to ICH Good Clinical Practice and national/local regulations

Exclusion Criteria:

• Not consenting to participation
• Not mastering the language used at the study centre
• Severe cognitive impairment as judged by the principal investigator
• Any reason why, in the opinion of the investigator, the patient should not participate
• Impaired use of the dominant arm
• Local anatomical illness or abnormalities precluding the use of polysomnography (e.g. facial tumour)
• having received chemotherapy for more than 4 weeks, having received the previous dose less than 5 days ago and receiving the next dose within the study period.