Computer Based Assessment and Treatment

Study Overview
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Brief Summary
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This study aims to investigate computer based symptom assessment in an outpatient cancer population, and the use of a computer based decision support system to facilitate the diagnosis and treatment of cancer related pain. 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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The traditional way of symptom assessment is by the paper-and-pen method, which suffers from several limitations. The assessment items are not individually adjusted to each patient and his/her subjective symptoms, the collected data is rarely used in clinical practice, and decision-support for the physician is not possible. 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: Data from self assessment of cancer related symptoms Data from relevant variables reported by the physician Revisited guidelines on treatment of cancer pain

Official Title
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Computer Based Assessment and Treatment

Conditions
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Neoplasms, Pain

Intervention / Treatment
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* Device: CCADSS
* Device: pen-paper


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: attending the outpatient clinic at the Cancer Clinic, St. Olavs Hospital Trondheim 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CCADSS<br>questionnaire completed using i-Pad | Device: CCADSS<br>* Questionnaire is transferred wireless to the physician's PC<br>|
| Active Comparator: pen-paper<br>Questionnaire completed using pen and paper | Device: pen-paper<br>* Questionnaire completed and transferred to the physician using standard methods<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average and worst pain during the last 24 hours | - The Brief Pain Inventory (BPI, a self-reported pain assessment tool aiming to quantify two aspects of cancer pain: Pain intensity and the functional disability as a result of cancer pain. | 1 week | 
| average and worst pain during the last 24 hours | - The Brief Pain Inventory (BPI, a self-reported pain assessment tool aiming to quantify two aspects of cancer pain: Pain intensity and the functional disability as a result of cancer pain. | 3 weeks | 
| average and worst pain during the last 24 hours | - The Alberta Breakthrough Pain Assessment Tool for cancer patients (ABPAT), a questionnaire developed in order to measure several dimensions of cancer-related breakthrough pain. It contains 15 questions, and was translated into Norwegian by our research group according to EORTC's rules for translation. | 1 week | 
| average and worst pain during the last 24 hours | - The Alberta Breakthrough Pain Assessment Tool for cancer patients (ABPAT), a questionnaire developed in order to measure several dimensions of cancer-related breakthrough pain. It contains 15 questions, and was translated into Norwegian by our research group according to EORTC's rules for translation. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms | - The Edmonton Symptom Assessment System (ESAS), a validated standardized questionnaire consisting of 10 items, which evaluate physical and psychological symptoms as well as general wellbeing. | 1 week | 
| symptoms | - The Edmonton Symptom Assessment System (ESAS), a validated standardized questionnaire consisting of 10 items, which evaluate physical and psychological symptoms as well as general wellbeing. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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evidence based practice, decision support systems, clinical, decision making, computer assisted, practice guidelines as topic