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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Sleep Disorders

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • Institutt for sirkulasjon og bildediagnostikk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced cancer using opioids (step III on the WHO pain ladder)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital
• Investigators: Study Director: Pål Klepstad, md phd, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): March 10, 2017
• Study Completion (Actual): March 10, 2017

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 20, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Sleep
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: Sleep study II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No