Sleep Quality in Patients With Advanced Cancer

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585609
• Other study ID #: Sleep study II
• Status: Completed
• Phase: N/A
• First received: October 13, 2015
• Last updated: April 20, 2017
• Start date: October 2015
• Est. completion date: March 10, 2017

Study information

• Verified date: April 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 10, 2017
• Est. primary completion date: March 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders

Locations

Country	Name	City	State
Norway	Institutt for sirkulasjon og bildediagnostikk	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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