NeoplasmsCOMBATNCT01795157
Computer Based Assessment and Treatment
A study testing CCADSS and pen-paper in people with Neoplasms and Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- CCADSS and pen-paper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2009to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Oncology outpatient clinic, St Olavs Hospital
Trondheim
About this study
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.
Read more
- 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.
Read the 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:
- Data from self assessment of cancer related symptoms
- Data from relevant variables reported by the physician
- Revisited guidelines on treatment of cancer pain
- Being tested
- CCADSS, pen-paper
- Keywords
- decision support systems, clinical, decision making, computer assisted, evidence based practice, practice guidelines as topic
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCADSSDevice
Questionnaire is transferred wireless to the physician's PC
pen-paperDevice
Questionnaire completed and transferred to the physician using standard methods
| Study group | Role | What they receive |
|---|---|---|
| CCADSS | Experimental | questionnaire completed using i-Pad Receives: Device: CCADSS |
| pen-paper | Active comparator | Questionnaire completed using pen and paper Receives: Device: pen-paper |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 weeks
Secondary outcomes (2)
symptoms
- 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.
Measured: 1 week
symptoms
- 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startSep 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Stein Kaasa, MD prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795157
- Sponsor's protocol ID
- 2009/859
- Acronym
- COMBAT
- Status last verified
- Sep 2017
- First submitted
- 18 Feb 2013
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28850380
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Based Assessment and Treatment
- ClinicalTrials.gov ID
- NCT01795157
- Acronym / sponsor ID
- COMBAT / 2009/859
- Keywords
- decision support systems, clinical, decision making, computer assisted, evidence based practice, practice guidelines as topic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Sep 2009 (actual)
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Data from self assessment of cancer related symptoms
- Data from relevant variables reported by the physician
- Revisited guidelines on treatment of cancer pain
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCADSS | Experimental | Device: CCADSSquestionnaire completed using i-Pad |
| pen-paper | Active comparator | Device: pen-paperQuestionnaire completed using pen and paper |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCADSSQuestionnaire is transferred wireless to the physician's PC | Device | CCADSS |
| pen-paperQuestionnaire completed and transferred to the physician using standard methods | Device | pen-paper |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
symptoms
Time frame: 1 week
symptoms
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Results publication: PubMed 28850380Raj 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stein Kaasa, MD prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCADSS and pen-paper in people with Neoplasms and Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average and worst pain during the last 24 hours (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01795157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.