Sleep Quality in Patients With Advanced Cancer

NCT ID: NCT02585609

Last Updated: 2017-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-03-10

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Disorders Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pål Klepstad, md phd

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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Institutt for sirkulasjon og bildediagnostikk

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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Sleep study II

Identifier Type: -

Identifier Source: org_study_id

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