Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
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.
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
Study:
NCT01795157
Study Brief:
Protocol Section:
NCT01795157