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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02585609

Enrollment

Registered

2015-10-23

Start date

2015-10-31

Completion date

2017-03-10

Last updated

2017-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Sleep Disorders

Keywords

Sleep

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
total sleep time	24 hours	1 night total sleep measured for comparison by ambulatory polysomnography (PSG), actigraphy and sleep questionnaires

Countries

Norway

Outcome results