NCT01795157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2013

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

3.4 years

First QC Date

February 18, 2013

Last Update Submit

September 20, 2017

Conditions

NeoplasmsPain

Keywords

decision support systems, clinicaldecision making, computer assistedevidence based practicepractice guidelines as topic

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • symptoms

    1 week

  • symptoms

    3 weeks

Study Arms (2)

CCADSS

EXPERIMENTAL

questionnaire completed using i-Pad

Device: CCADSS

pen-paper

ACTIVE COMPARATOR

Questionnaire completed using pen and paper

Device: pen-paper

Interventions

CCADSSDEVICE

Questionnaire is transferred wireless to the physician's PC

CCADSS
pen-paperDEVICE

Questionnaire completed and transferred to the physician using standard methods

pen-paper

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology outpatient clinic, St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 28850380RESULT

MeSH Terms

Conditions

NeoplasmsPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stein Kaasa, MD prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2013

First Posted

February 20, 2013

Study Start

September 1, 2009

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations

NO(1)