Computer Based Assessment and Treatment (COMBAT)

Norwegian University of Science and Technology

Status: Completed

Conditions: Neoplasms; Pain

Treatments: Device: pen-paper; Device: CCADSS

Study type: Interventional

Funder types: Other

Identifiers

NCT01795157

2009/859

Details and patient eligibility

About

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.

Full 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

Enrollment: 255 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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255 participants in 2 patient groups

CCADSS

Experimental group

Description:

questionnaire completed using i-Pad

Treatment:

Device: CCADSS

pen-paper

Active Comparator group

Description:

Questionnaire completed using pen and paper

Treatment:

Device: pen-paper