Clinical trial NCT01795157: Computer Based Assessment and Treatment
Official title: Computer Based Assessment and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Pain
Keywords: decision support systems, clinical
decision making, computer assisted
evidence based practice
practice guidelines as topic
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-02-20
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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:

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

Eligibility criteria: 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

Primary outcomes:
measure: average and worst pain during the last 24 hours
timeFrame: 1 week
measure: average and worst pain during the last 24 hours
timeFrame: 3 weeks
measure: average and worst pain during the last 24 hours
timeFrame: 1 week
measure: average and worst pain during the last 24 hours
timeFrame: 3 weeks
Secondary outcomes:
measure: symptoms
timeFrame: 1 week
measure: symptoms
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Oncology outpatient clinic, St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Stein Kaasa, MD prof
role: STUDY_DIRECTOR
References:
citation: 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.