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Completed

NCT Number: NCT01795157

Computer Based Assessment and Treatment

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.

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Key information

Conditions

Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oncology outpatient clinic, St Olavs Hospital

Trondheim, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CCADSS

Device

Questionnaire is transferred wireless to the physician's PC

pen-paper

Device

Questionnaire completed and transferred to the physician using standard methods

Primary outcomes

  1. average and worst pain during the last 24 hours

    Time frame: 1 week

    • 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.

  2. average and worst pain during the last 24 hours

    Time frame: 3 weeks

    • 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. average and worst pain during the last 24 hours

    Time frame: 1 week

    • 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.

  4. average and worst pain during the last 24 hours

    Time frame: 3 weeks

    • 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.

Secondary outcomes

  1. symptoms

    Time frame: 1 week

    • 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.

  2. symptoms

    Time frame: 3 weeks

    • 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.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Acronym: COMBAT

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 20, 2013
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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