An interventional study of CCADSS and pen-paper in Neoplasms and Pain, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-25.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Diagnostic
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.
Secondary hypothesis is, that this system improves overall symptom control and symptom management in an unselected group of cancer patients in an outpatient setting.
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:
Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
questionnaire completed using i-Pad
Device: CCADSS
Questionnaire completed using pen and paper
Device: pen-paper
Questionnaire is transferred wireless to the physician's PC
Questionnaire completed and transferred to the physician using standard methods
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 weeks
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.
Time frame: 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.
Time frame: 3 weeks
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Norwegian University of Science and Technology