NCT01795157

Computer Based Assessment and Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Neoplasms
• Pain

Interventions

Type	Name	Description
DEVICE	CCADSS	Questionnaire is transferred wireless to the physician's PC
DEVICE	pen-paper	Questionnaire completed and transferred to the physician using standard methods

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2013-02-20
• Last updated: 2017-09-25

Locations

1 site across 1 country: Norway