CancerPhase 3NCT01081899
The Effectiveness of the LCP in Improving End of Life Care for Dying Cancer Patients in Hospital.
A Phase 3 study testing The LCP-I Program in people with Cancer, run by Regional Palliative Care Network at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the effectiveness of the LCP-I Program in improving the quality of end-of-life care provided to cancer patients who die on hospital medical wards as compared to standard healthcare practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- The LCP-I Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2009to Oct 2012
- Phase
- Phase 3
- 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
- "Medical", "General Medical" or "Internal Medical" ward;
- at least 25 cancer deaths on the ward per year;
- consent from the Hospital and Ward Management to participate to the trial;
- consent from an expert and skills-trained PCU to implement the LCP-I Program
- all cancer patients deceased in the ward during the evaluation period;
Who cannot join
- in the hospital another Medical Ward has already been randomised.
- Individual level
- the deceased was a relative of a professional working in the hospital.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of the Liverpool Care Pathway in Improving End of Life Care for Dying Cancer Patients in Hospital. A Cluster Randomised Trial.
The purpose of this study is to evaluate the effectiveness of the LCP-I Program in improving the quality of end-of-life care provided to cancer patients who die on hospital medical wards as compared to standard healthcare practices.
Read the detailed description
The availability of an effective quality improvement program for the care of dying patients in hospitals is particularly relevant to the healthcare scenario. The LCP-I Program has provided enough evidence to justify a randomized trial to evaluate its effectiveness.
Although the core objective of the LCP-I is improving the quality of end of life care for dying patients, the Program targets the healthcare professionals working on the hospital ward. The only feasible method of assessing the effectiveness of this Program is by performing a cluster trial, where hospital wards are randomized to receive (or not to receive) the implementation of the LCP-I Program.
Pairs of eligible medical wards from different hospitals will be randomized to receive the experimental intervention (the LCP-I Program) or no intervention at all for the duration of the study.
The LCP-I Program will be implemented in the experimental ward by the PCU. The LCP-I Program has a duration of 6 months from the beginning of the intensive training. No intervention will be implemented in the control ward until the end of the evaluation.
Quality of end-of-life care will be evaluated for each pair of randomized wards for all eligible cancer deaths occurring in the six months after the conclusion of the LCP-I Program in the experimental ward.
- Conditions
- Cancer
- Being tested
- The LCP-I Program
- Keywords
- dying patients, cancer, hospital, Liverpool Care Pathways
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The LCP-I ProgramOther
Also called continuous quality Improvement Program
The LCP-I Program is a continuous quality Improvement Program of end-of-life care implemented by a Palliative Care Unit (PCU) in a hospital Medical Ward.
| Study group | Role | What they receive |
|---|---|---|
| The LCP-I Program. | Experimental | The Italian version of the Liverpool Care Pathways version 11 for hospital) Programme. Receives: Other: The LCP-I Program |
| standard healthcare practices | No intervention | No specific interventions are planned in the control wards. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of end-of-life care provided to dying cancer patients and their families.
Measured through the Global Scale of the Italian version of the Toolkit "After-death Bereaved Family Member Interview" (Teno J, et al 2001).
Measured: six months after the implementation of the LCP Program
Secondary outcomes (7)
quality of communication between the healthcare professionals, patients and families
Measured through the specific Scales of the Italian version of the Toolkit "After-death Bereaved Family Member Interview" (Teno J, et al 2001).
Measured: six months after the implementation of the LCP Program
quality of emotional support to family members before and after the patients' death
Measured through the specific Scales of the Italian version of the Toolkit "After-death Bereaved Family Member Interview" (Teno J, et al 2001).
Measured: six months after the implementation of the LCP Program
coordination of care
Measured through the specific Scales of the Italian version of the Toolkit "After-death Bereaved Family Member Interview" (Teno J, et al 2001).
Measured: six months after the implementation of the LCP Program
provision of care focusing on patient's individual needs
Measured through the specific Scales of the Italian version of the Toolkit "After-death Bereaved Family Member Interview" (Teno J, et al 2001).
Measured: six months after the implementation of the LCP Program
patient's physical well-being through a better control of physical symptoms
Symptom scales (pain, breathlessness and vomiting) from the Italian version of VOICES (Costantini M, 2005)
Measured: six months after the implementation of the LCP Program
quality of communication between hospital staff and GPs
interview with GPs
Measured: six months after the implementation of the LCP Program
appropriateness of therapeutic and diagnostic procedures
Tool for recording all diagnostic and therapeutic procedures effectively performed during the last 3 days of life
Measured: six months after the implementation of the LCP Program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Palliative Care Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimo Costantini, MD, Principal investigator, National Cancer Research Institute - Genoa (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081899
- Sponsor's protocol ID
- RFPS-2006-6-341619
- Status last verified
- Jan 2013
- First submitted
- 4 Mar 2010
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Costantini M, Romoli V, Leo SD, Beccaro M, Bono L, Pilastri P, Miccinesi G, Valenti D, Peruselli C, Bulli F, Franceschini C, Grubich S, Brunelli C, Martini C, Pellegrini F, Higginson IJ; Liverpool Care Pathway Italian Cluster Trial Study Group. Liverpool Care Pathway for patients with cancer in hospital: a cluster randomised trial. Lancet. 2014 Jan 18;383(9913):226-37. doi: 10.1016/S0140-6736(13)61725-0. Epub 2013 Oct 16.
PubMed 24139708Costantini M, Ottonelli S, Canavacci L, Pellegrini F, Beccaro M; LCP Randomised Italian Cluster Trial Study Group. The effectiveness of the Liverpool care pathway in improving end of life care for dying cancer patients in hospital. A cluster randomised trial. BMC Health Serv Res. 2011 Jan 24;11:13. doi: 10.1186/1472-6963-11-13.
PubMed 21261949
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Liverpool Care Pathway in Improving End of Life Care for Dying Cancer Patients in Hospital. A Cluster Randomised Trial.
- ClinicalTrials.gov ID
- NCT01081899
- Acronym / sponsor ID
- RFPS-2006-6-341619
- Conditions
- Cancer
- Keywords
- dying patients, cancer, hospital, Liverpool Care Pathways
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Regional Palliative Care NetworkUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Mar 2010 (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.
The purpose of this study is to evaluate the effectiveness of the LCP-I Program in improving the quality of end-of-life care provided to cancer patients who die on hospital medical wards as compared to standard healthcare practices.
Detailed description
The availability of an effective quality improvement program for the care of dying patients in hospitals is particularly relevant to the healthcare scenario. The LCP-I Program has provided enough evidence to justify a randomized trial to evaluate its effectiveness.
Although the core objective of the LCP-I is improving the quality of end of life care for dying patients, the Program targets the healthcare professionals working on the hospital ward. The only feasible method of assessing the effectiveness of this Program is by performing a cluster trial, where hospital wards are randomized to receive (or not to receive) the implementation of the LCP-I Program.
Pairs of eligible medical wards from different hospitals will be randomized to receive the experimental intervention (the LCP-I Program) or no intervention at all for the duration of the study.
The LCP-I Program will be implemented in the experimental ward by the PCU. The LCP-I Program has a duration of 6 months from the beginning of the intensive training. No intervention will be implemented in the control ward until the end of the evaluation.
Quality of end-of-life care will be evaluated for each pair of randomized wards for all eligible cancer deaths occurring in the six months after the conclusion of the LCP-I Program in the experimental ward.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The LCP-I Program. | Experimental | Other: The LCP-I ProgramThe Italian version of the Liverpool Care Pathways version 11 for hospital) Programme. |
| standard healthcare practices | No intervention | –No specific interventions are planned in the control wards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- "Medical", "General Medical" or "Internal Medical" ward;
- at least 25 cancer deaths on the ward per year;
- consent from the Hospital and Ward Management to participate to the trial;
- consent from an expert and skills-trained PCU to implement the LCP-I Program
- all cancer patients deceased in the ward during the evaluation period;
Key exclusion criteria (3 listed)
- in the hospital another Medical Ward has already been randomised.
- Individual level
- the deceased was a relative of a professional working in the hospital.
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 |
|---|---|---|
| The LCP-I ProgramAlso: continuous quality Improvement ProgramThe LCP-I Program is a continuous quality Improvement Program of end-of-life care implemented by a Palliative Care Unit (PCU) in a hospital Medical Ward. | Other | The LCP-I Program. |
Primary outcome
Quality of end-of-life care provided to dying cancer patients and their families.
Time frame: six months after the implementation of the LCP Program
Measured through the Global Scale of the Italian version of the Toolkit "After-death Bereaved Family Member Interview" (Teno J, et al 2001).
7 secondary outcomes
quality of communication between the healthcare professionals, patients and families
Time frame: six months after the implementation of the LCP Program
quality of emotional support to family members before and after the patients' death
Time frame: six months after the implementation of the LCP Program
coordination of care
Time frame: six months after the implementation of the LCP Program
provision of care focusing on patient's individual needs
Time frame: six months after the implementation of the LCP Program
patient's physical well-being through a better control of physical symptoms
Time frame: six months after the implementation of the LCP Program
quality of communication between hospital staff and GPs
Time frame: six months after the implementation of the LCP Program
appropriateness of therapeutic and diagnostic procedures
Time frame: six months after the implementation of the LCP Program
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 14 Jan 2013.
- Derived from this study: PubMed 24139708Costantini M, Romoli V, Leo SD, Beccaro M, Bono L, Pilastri P, Miccinesi G, Valenti D, Peruselli C, Bulli F, Franceschini C, Grubich S, Brunelli C, Martini C, Pellegrini F, Higginson IJ; Liverpool Care Pathway Italian Cluster Trial Study Group. Liverpool Care Pathway for patients with cancer in hospital: a cluster randomised trial. Lancet. 2014 Jan 18;383(9913):226-37. doi: 10.1016/S0140-6736(13)61725-0. Epub 2013 Oct 16.
- Derived from this study: PubMed 21261949Costantini M, Ottonelli S, Canavacci L, Pellegrini F, Beccaro M; LCP Randomised Italian Cluster Trial Study Group. The effectiveness of the Liverpool care pathway in improving end of life care for dying cancer patients in hospital. A cluster randomised trial. BMC Health Serv Res. 2011 Jan 24;11:13. doi: 10.1186/1472-6963-11-13.
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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.
Massimo Costantini, MD principal investigator
National Cancer Research Institute - Genoa (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing The LCP-I Program in people with Cancer, run by Regional Palliative Care Network at 1 site in Italy.
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 5 inclusion and 3 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 14 Jan 2013. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of end-of-life care provided to dying cancer patients and their families. (time frame: six months after the implementation of the LCP Program). 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 NCT01081899, which also lists 2 linked publications.
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 14 Jan 2013.