CancerEPAT©NCT00595777
Edinburgh Pain Assessment Tool (EPAT©) Study
A study testing EPAT© Educational Package in people with Cancer, run by University of Edinburgh at 19 sites in United Kingdom.
Trial summary
To determine if the institutionalisation of a regular systematic approach to the assessment of pain in inpatient cancer units using the Edinburgh Pain Assessment Tool (EPAT©) leads to better control of pain than that achieved by usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- EPAT© Educational Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,928 participants
- Where
- 19 sitesUnited Kingdom
- Study dates
- Dec 2007to Aug 2012
- 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
- Able and consent to complete a Brief Pain Inventory score
- Aged over 18 years
- Have a pain score equal to or greater than 4 out of 10 at first assessment point (within 24 hours of admission) and pain is cancer related
- Are expected to be available for pain assessment at 3 days after admission
Who cannot join
- Do not consent to take part in the study or who are too ill to take part, including those with severe mental health problems
- Do not have cancer-related pain
- Are under 18 years of age
- Have a pain score of less than 4
- Are not expected to be available for pain assessment at 3 days after admission
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United Kingdom19 sites
Belfast City Hospital
Belfast
Queen Elizabeth Hospital
Birmingham
Bristol Haematology and Oncology Centre
Bristol, Sommerset, BS2 8ED
Addenbrookes Hospital
Cambridge
Velindre Hospital
Cardiff
The Western General Hospital
Edinburgh
Beaston Oncology Centre
Glasgow
Hull Royal Infirmary
Hull
St. James's Hospital
Leeds
Clatterbridge Centre for Oncology
Liverpool
The Royal Marsden Hospital
London
The Christie
Manchester
Freeman Hospital
Newcastle
Mount Vernon Cancer Centre
Northwood, Middlesex
City Hospital
Nottingham
Churchill Hospital
Oxford
Derriford Hospital
Plymouth
Southampton University Hospital
Southampton
The Royal Marsden Hospital
Sutton
About this study
Official title: Does the Institutionalisation of Pain Assessment Using the EPAT© Package Reduce the Pain in Cancer In-patients More Than Usual Care; a Cluster Randomised Trial.
To determine if the institutionalisation of a regular systematic approach to the assessment of pain in inpatient cancer units using the Edinburgh Pain Assessment Tool (EPAT©) leads to better control of pain than that achieved by usual care.
Read the detailed description
Background and relevance to cancer - Pain associated with cancer has a severe negative impact on quality of life and can also limit a patient's ability to tolerate potentially life-saving tumoricidal treatment. Unfortunately in practice only half of cancer patients receive adequate pain control. A fundamental reason for this is inadequate assessment of pain. The institutionalisation of pain assessment as a 5th vital sign on the bedside chart combined with training and guidance in pain management (EPAT) is a potentially effective solution.
We have already evaluated the feasibility and efficacy of EPAT in a randomised trial of 150 oncology inpatients and found that by Day 4 after admission 90% reported adequate pain control compared to only 52% of those who received usual care.
Aims - We now want to evaluate the effectiveness and cost-effectiveness of EPAT in practice and ask: Does it reduce cancer pain more that usual care? Are there adverse effects? Is it cost effective?
Outline plan - A UK-wide cluster randomised controlled trial of 18 inpatient cancer centres of which half will use the EPAT package and half usual care. The trial outcomes are clinically significant improvement, adverse effects such as opiate toxicity and cost effectiveness.
- Conditions
- Cancer
- Being tested
- EPAT© Educational Package
- Keywords
- Institutional change, Improved pain management
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPAT© Educational PackageBehavioural
The EPAT package consists of an education programme, which deals with the known common barriers to effective pain control and the bedside pain tool. The pain tool is uniquely incorporated into the vital signs chart to enable a systematic approach to cancer pain assessment and review. EPAT consists of 2 steps: step 1 is a colour-coded pain assessment on the bedside vital signs chart. Patients with moderate or severe pain on step 1 will progress to to step 2, which helps to identify the aetiology of the pain, screening for opioid side effects and is linked via flags to simple management plans. The intervention will be delivered to the clusters randomised to the intervention, after collection of baseline data (pre-intervention data) on 50 patients.
| Study group | Role | What they receive |
|---|---|---|
| 1. Comparison | No intervention | The centres allocated to the comparison group will continue to provide usual care only. |
| 2. Experimental | Experimental | The EPAT package consists of an educational programme, which deals with the common barriers to effective cancer pain control and the bedside pain tool. Receives: Behavioral: EPAT© Educational Package |
What is being measured
The primary outcome is the main question the study is designed to answer.
The magnitude of change in pain scores at the 2 evaluation points measured by patient self-rating
Measured: Maximum study duration is 9 days per patient
Secondary outcomes (3)
Magnitude of change in BPI scores over the 2 evaluation points (includes impact on function)
Measured: Maximum study duration is 9 days per patient
Patient satisfaction with attention to pain
Measured: Maximum study duration is 9 days per patient
Global distress
Measured: Maximum study duration is 9 days per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionAug 2012
- Study completionAug 2012
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 CancerStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,928 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Sponsor
- Investigators
- Marie Fallon, Study director, University of EdinburghMichael Sharpe, Study director, University of EdinburghLesley Colvin, Study director, University of EdinburghGordon Murray, Study director, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595777
- Sponsor's protocol ID
- 06/MRE10/84
- Acronym
- EPAT©
- Status last verified
- Sep 2012
- First submitted
- 7 Jan 2008
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fallon M, Walker J, Colvin L, Rodriguez A, Murray G, Sharpe M; Edinburgh Pain Assessment and Management Tool Study Group. Pain Management in Cancer Center Inpatients: A Cluster Randomized Trial to Evaluate a Systematic Integrated Approach-The Edinburgh Pain Assessment and Management Tool. J Clin Oncol. 2018 May 1;36(13):1284-1290. doi: 10.1200/JCO.2017.76.1825. Epub 2018 Mar 15.
PubMed 29543567
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Institutionalisation of Pain Assessment Using the EPAT© Package Reduce the Pain in Cancer In-patients More Than Usual Care; a Cluster Randomised Trial.
- ClinicalTrials.gov ID
- NCT00595777
- Acronym / sponsor ID
- EPAT© / 06/MRE10/84
- Conditions
- Cancer
- Keywords
- Institutional change, Improved pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,928 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- Dec 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 16 Jan 2008 (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.
To determine if the institutionalisation of a regular systematic approach to the assessment of pain in inpatient cancer units using the Edinburgh Pain Assessment Tool (EPAT©) leads to better control of pain than that achieved by usual care.
Detailed description
Background and relevance to cancer - Pain associated with cancer has a severe negative impact on quality of life and can also limit a patient's ability to tolerate potentially life-saving tumoricidal treatment. Unfortunately in practice only half of cancer patients receive adequate pain control. A fundamental reason for this is inadequate assessment of pain. The institutionalisation of pain assessment as a 5th vital sign on the bedside chart combined with training and guidance in pain management (EPAT) is a potentially effective solution.
We have already evaluated the feasibility and efficacy of EPAT in a randomised trial of 150 oncology inpatients and found that by Day 4 after admission 90% reported adequate pain control compared to only 52% of those who received usual care.
Aims - We now want to evaluate the effectiveness and cost-effectiveness of EPAT in practice and ask: Does it reduce cancer pain more that usual care? Are there adverse effects? Is it cost effective?
Outline plan - A UK-wide cluster randomised controlled trial of 18 inpatient cancer centres of which half will use the EPAT package and half usual care. The trial outcomes are clinically significant improvement, adverse effects such as opiate toxicity and cost effectiveness.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Comparison | No intervention | –The centres allocated to the comparison group will continue to provide usual care only. |
| 2. Experimental | Experimental | Behavioral: EPAT© Educational PackageThe EPAT package consists of an educational programme, which deals with the common barriers to effective cancer pain control and the bedside pain tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able and consent to complete a Brief Pain Inventory score
- Aged over 18 years
- Have a pain score equal to or greater than 4 out of 10 at first assessment point (within 24 hours of admission) and pain is cancer related
- Are expected to be available for pain assessment at 3 days after admission
Key exclusion criteria (5 listed)
- Do not consent to take part in the study or who are too ill to take part, including those with severe mental health problems
- Do not have cancer-related pain
- Are under 18 years of age
- Have a pain score of less than 4
- Are not expected to be available for pain assessment at 3 days after admission
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 |
|---|---|---|
| EPAT© Educational PackageThe EPAT package consists of an education programme, which deals with the known common barriers to effective pain control and the bedside pain tool. The pain tool is uniquely incorporated into the vital signs chart to enable a systematic approach to cancer pain assessment and review. EPAT consists of 2 steps: step 1 is a colour-coded pain assessment on the bedside vital signs chart. Patients with moderate or severe pain on step 1 will progress to to step 2, which helps to identify the aetiology of the pain, screening for opioid side effects and is linked via flags to simple management plans. The intervention will be delivered to the clusters randomised to the intervention, after collection of baseline data (pre-intervention data) on 50 patients. | Behavioural | 2. Experimental |
Primary outcome
The magnitude of change in pain scores at the 2 evaluation points measured by patient self-rating
Time frame: Maximum study duration is 9 days per patient
3 secondary outcomes
Magnitude of change in BPI scores over the 2 evaluation points (includes impact on function)
Time frame: Maximum study duration is 9 days per patient
Patient satisfaction with attention to pain
Time frame: Maximum study duration is 9 days per patient
Global distress
Time frame: Maximum study duration is 9 days per patient
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 26 Sep 2012.
- Derived from this study: PubMed 29543567Fallon M, Walker J, Colvin L, Rodriguez A, Murray G, Sharpe M; Edinburgh Pain Assessment and Management Tool Study Group. Pain Management in Cancer Center Inpatients: A Cluster Randomized Trial to Evaluate a Systematic Integrated Approach-The Edinburgh Pain Assessment and Management Tool. J Clin Oncol. 2018 May 1;36(13):1284-1290. doi: 10.1200/JCO.2017.76.1825. Epub 2018 Mar 15.
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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.
Marie Fallon study director
University of Edinburgh
Michael Sharpe study director
University of Edinburgh
Lesley Colvin study director
University of Edinburgh
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPAT© Educational Package in people with Cancer, run by University of Edinburgh at 19 sites in United Kingdom.
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 4 inclusion and 5 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 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United Kingdom. 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?
The magnitude of change in pain scores at the 2 evaluation points measured by patient self-rating (time frame: Maximum study duration is 9 days per patient). 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 NCT00595777, 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 26 Sep 2012.