Sleep Quality in Patients With Advanced Cancer

NCT02585609 | Completed

• 1 other identifier: Sleep study II
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorders; Neoplasms

Keywords

Sleep

Outcome Measures

Primary Outcomes (1)

• total sleep time

  1 night total sleep measured for comparison by ambulatory polysomnography (PSG), actigraphy and sleep questionnaires

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

Institutt for sirkulasjon og bildediagnostikk

Trondheim, Norway

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Pål Klepstad, md phd

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 23, 2015
• Study Start: October 1, 2015
• Primary Completion: March 10, 2017
• Study Completion: March 10, 2017
• Last Updated: April 21, 2017

Record last verified: 2017-04

Locations

NO (1)