Study Results
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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COMPLETED
NA
255 participants
INTERVENTIONAL
2009-09-30
2013-02-28
Brief Summary
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Primary hypothesis is, that this approach improves pain control and pain management in an unselected group of cancer patients in an outpatient setting.
* Improvement of average pain last 24 hours by at least 1.5 points on a 0-11 scale
* Improvement of worst pain last 24 hours by at least 1.5 points on a 0-11 scale
* An alteration in the prescribing dose of opioids in equipotent opioid dosage
Secondary hypothesis is, that this system improves overall symptom control and symptom management in an unselected group of cancer patients in an outpatient setting.
Detailed Description
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Although the body of evidence is accumulating regarding the benefits of computerised symptom assessment in cancer patients, there is still insufficient knowledge of the impact of computerised assessment tools on the management of cancer pain and other cancer related symptoms.
The COMBAT study aims to investigate if a computer based assessment of cancer related symptoms, and a computerized decision support can improve treatment of pain and other symptoms in cancer patients.
This is an open, comparative study with a sequential design with two consecutive study periods, the non-intervention period and the intervention period.
The computer-based clinical decision support system will utilize the following data to generate one or several treatment options:
1. Data from self assessment of cancer related symptoms
2. Data from relevant variables reported by the physician
3. Revisited guidelines on treatment of cancer pain
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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CCADSS
questionnaire completed using i-Pad
CCADSS
Questionnaire is transferred wireless to the physician's PC
pen-paper
Questionnaire completed using pen and paper
pen-paper
Questionnaire completed and transferred to the physician using standard methods
Interventions
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CCADSS
Questionnaire is transferred wireless to the physician's PC
pen-paper
Questionnaire completed and transferred to the physician using standard methods
Eligibility Criteria
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Inclusion Criteria
* histologically verified malignancy
* able to follow study instructions
* able to read the information on the computer screen in the intervention period of the study
* able to use a touch screen in the intervention period of the study
* cancer related pain measured as average pain in last 24 hours of 4 or above on a numeric rating scale
* elective or emergency consultation with a physician
18 Years
ALL
No
Sponsors
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St. Olavs Hospital
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Stein Kaasa, MD prof
Role: STUDY_DIRECTOR
Norwegian University of Science and Technology
Locations
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Department of Oncology outpatient clinic, St Olavs Hospital
Trondheim, , Norway
Countries
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References
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Raj SX, Brunelli C, Klepstad P, Kaasa S. COMBAT study - Computer based assessment and treatment - A clinical trial evaluating impact of a computerized clinical decision support tool on pain in cancer patients. Scand J Pain. 2017 Oct;17:99-106. doi: 10.1016/j.sjpain.2017.07.016. Epub 2017 Aug 8.
Other Identifiers
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2009/859
Identifier Type: -
Identifier Source: org_study_id