CancerPOEM INCT03286127
Palliative Outcome Evaluation Muenster I
An observational study of Cancer and Chronic Heart Failure, run by University Hospital Muenster at 5 sites in Germany.
Trial summary
For patients with an advanced disease and their families an excellent and compassionate care is essential. However, in hospitals optimal end-of-life care is not yet fully realized and patient's needs are often not met. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chronic Heart Failure, COPD Exacerbation
- What is being tested?
- specialized palliative care
- How many people
- 347 participants
- Where
- 5 sitesGermany
- Study dates
- 11 Sep 2017to Dec 2019
- Phase
- Observational
- 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
Study population: The study population will consist of patients with an advanced life-limiting and progressive disease needing palliative care. The three groups are formed depending of the setting in which palliative care will be provided.
Who may be able to join
- Indication for palliative care due to any advanced life-limiting and progressive disease
- 18 years and older
Who cannot join
- Age under 18 years
- pregnant or breastfeeding women
- Inability to understand information for participation
- Refusal of participation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites, 5 recruiting
- Not yet recruiting
Hospital St. Raphael Muenster
Münster, North Rhine-Westphalia, 48143
Marc Theisen, Dr. med., +49 (0)251 5007 4118, m.theisen@alexianer.de
- Not yet recruiting
Hospital St. Franziskus Muenster
Münster, North Rhine-Westphalia, 48145
Anne Bremer, Dr. med., +49 (0)251 935 5564, onkologie@sfh-muenster.de
- Recruiting
University Hospital Muenster
Münster, North Rhine-Westphalia, 48149
Philipp Lenz, PD Dr. med., +49 (0)251 8353052, philipp.lenz@ukmuenster.de
- Recruiting
Palliativnetz Muenster
Münster, North Rhine-Westphalia, 48161
Ulrike Hofmeister, Dr. med., +49 (0)251 1625662, info@palliativnetz-muenster.de
- Not yet recruiting
Hospital St. Josef Warendorf
Warendorf, North Rhine-Westphalia, 48231
Dirk Domagk, Prof. Dr. med., +49 (0)2581 20 1752, palliativstation@jhwaf.de
About this study
Official title: Assessment of Palliative Care in Inpatient and Outpatient Settings Using the Integrated Palliative Care Outcome Scale: a Multi-centric Observational Study
For patients with an advanced disease and their families an excellent and compassionate care is essential. However, in hospitals optimal end-of-life care is not yet fully realized and patient's needs are often not met. Palliative care is able to increase patients' quality of life and to carefully meet their and their families' needs.
To improve the awareness of unmet needs patient-reported outcome measurement has been the pivot of latest palliative care research. Besides the improvement of care outcome measurement allows the evaluation of the quality of palliative care and comparisons on a national and international level.
Read more
The aim of the present study is to evaluate the quality of palliative care in different settings (palliative care unit, inpatient and outpatient consultation teams) using the Integrated Palliative Care Outcome Scale (IPOS). The IPOS has been lately developed as improved follow-up version of the Palliative Care Outcome Scale (POS) integrating most important questions and simultaneously being brief and comprehensive. The study is planned as a multi-centric observational study. Primary endpoint is the reduction of symptom burden of patients.
The clinical study hypothesis bases on the assumption that palliative care can change the symptom burden, measured by a change in the IPOS overall profile score, and that there might be a difference in the size of the effect depending on the caring setting.
Read the detailed description
After the enrolment and consent of participation the patient receive a questionnaire consisting of three independent assessments: To assess the symptom burden and specific palliative care needs the Integrated Palliative Outcome Scale (IPOS) is used. To measure the generic health-related quality of life the patient has to answer the EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L). To get an opinion of the general condition the patient is to complete the NCCN Distress Thermometer which includes a visual analogue scale (with values from 0 to 10).
Meanwhile, a professional palliative caregiver completes a questionnaire about the main demographic aspects of the patients and assess the palliative care needs and the symptom burden using the IPOS.
After one week both, patient and professional palliative caregiver, will receive the same questionnaires again to assess the change from baseline.
- Conditions
- Cancer, Chronic Heart Failure, COPD Exacerbation, Palliative Care
- Being tested
- specialized palliative care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specialized palliative careOther
specialized palliative care provided in different settings
| Study group | Role | What they receive |
|---|---|---|
| PCU (unit) | Those patients who received specialised palliative care on a palliative care unit.(palliative care unit) Receives: Other: specialized palliative care | |
| IPCC (hospital) | Those patients admitted to a regular hospital ward who received specialised palliative care from an inpatient palliative care consultation team.
(inpatient palliative care consultation team) Receives: Other: specialized palliative care | |
| OPCC (outpatient) | Those patients who received specialised palliative care at home from an outpatient palliative care consultation team. (outpatient palliative care consultation team) Receives: Other: specialized palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom burden (IPOS)
Change from baseline in palliative care needs and specific symptoms (at day 7) assessed with the Integrated Palliative Care Outcome Scale (IPOS). The IPOS includes 10 symptoms and 7 questions on patients and carers emotional situation, spiritual concerns, and provision of information and support. The overall profile score is the sum of the scores from each of the 17 questions.
Measured: From Baseline to End of Follow-Up (0, 1 week)
Secondary outcomes (1)
Generic health-related quality of life (EQ-5D-5L)
Change from baseline in patients' generic health-related quality of life measured with the EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale of the EQ-5D-5L questionnaire ranges from 0 to 100 (with 0 representing the worst health the patient can imagine and 100 representing the best health the patient can imagine).
Measured: From Baseline to End of Follow-Up (0, 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start11 Sep 2017
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 347 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- St. Franziskus Hospital, Raphaelsklinik Münster, Josephs Hospital Warendorf, Palliativnetz Muenster gGmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286127
- Sponsor's protocol ID
- UKM_POEM I
- Acronym
- POEM I
- Status last verified
- Oct 2018
- First submitted
- 14 Sep 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Palliative Care in Inpatient and Outpatient Settings Using the Integrated Palliative Care Outcome Scale: a Multi-centric Observational Study
- ClinicalTrials.gov ID
- NCT03286127
- Acronym / sponsor ID
- POEM I / UKM_POEM I
- Conditions
- Cancer, Chronic Heart Failure, COPD Exacerbation, Palliative Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 347 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- St. Franziskus Hospital, Raphaelsklinik Münster, Josephs Hospital Warendorf, Palliativnetz Muenster gGmbH
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Sep 2017 (actual)
- 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.
For patients with an advanced disease and their families an excellent and compassionate care is essential. However, in hospitals optimal end-of-life care is not yet fully realized and patient's needs are often not met. Palliative care is able to increase patients' quality of life and to carefully meet their and their families' needs.
To improve the awareness of unmet needs patient-reported outcome measurement has been the pivot of latest palliative care research. Besides the improvement of care outcome measurement allows the evaluation of the quality of palliative care and comparisons on a national and international level.
The aim of the present study is to evaluate the quality of palliative care in different settings (palliative care unit, inpatient and outpatient consultation teams) using the Integrated Palliative Care Outcome Scale (IPOS). The IPOS has been lately developed as improved follow-up version of the Palliative Care Outcome Scale (POS) integrating most important questions and simultaneously being brief and comprehensive. The study is planned as a multi-centric observational study. Primary endpoint is the reduction of symptom burden of patients.
The clinical study hypothesis bases on the assumption that palliative care can change the symptom burden, measured by a change in the IPOS overall profile score, and that there might be a difference in the size of the effect depending on the caring setting.
Detailed description
After the enrolment and consent of participation the patient receive a questionnaire consisting of three independent assessments: To assess the symptom burden and specific palliative care needs the Integrated Palliative Outcome Scale (IPOS) is used. To measure the generic health-related quality of life the patient has to answer the EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L). To get an opinion of the general condition the patient is to complete the NCCN Distress Thermometer which includes a visual analogue scale (with values from 0 to 10).
Meanwhile, a professional palliative caregiver completes a questionnaire about the main demographic aspects of the patients and assess the palliative care needs and the symptom burden using the IPOS.
After one week both, patient and professional palliative caregiver, will receive the same questionnaires again to assess the change from baseline.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCU (unit) | – | Other: specialized palliative careThose patients who received specialised palliative care on a palliative care unit.(palliative care unit) |
| IPCC (hospital) | – | Other: specialized palliative careThose patients admitted to a regular hospital ward who received specialised palliative care from an inpatient palliative care consultation team. (inpatient palliative care consultation team) |
| OPCC (outpatient) | – | Other: specialized palliative careThose patients who received specialised palliative care at home from an outpatient palliative care consultation team. (outpatient palliative care consultation team) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients with an advanced life-limiting and progressive disease needing palliative care. The three groups are formed depending of the setting in which palliative care will be provided.
Key inclusion criteria (2 listed)
- Indication for palliative care due to any advanced life-limiting and progressive disease
- 18 years and older
Key exclusion criteria (4 listed)
- Age under 18 years
- pregnant or breastfeeding women
- Inability to understand information for participation
- Refusal of participation
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 |
|---|---|---|
| specialized palliative carespecialized palliative care provided in different settings | Other | IPCC (hospital), OPCC (outpatient), PCU (unit) |
Primary outcome
symptom burden (IPOS)
Time frame: From Baseline to End of Follow-Up (0, 1 week)
Change from baseline in palliative care needs and specific symptoms (at day 7) assessed with the Integrated Palliative Care Outcome Scale (IPOS). The IPOS includes 10 symptoms and 7 questions on patients and carers emotional situation, spiritual concerns, and provision of information and support. The overall profile score is the sum of the scores from each of the 17 questions.
1 secondary outcome
Generic health-related quality of life (EQ-5D-5L)
Time frame: From Baseline to End of Follow-Up (0, 1 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Chronic Heart Failure, run by University Hospital Muenster at 5 sites in Germany.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philipp Lenz, PD Dr. med. (+49 (0)251 8353052, philipp.lenz@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptom burden (IPOS) (time frame: From Baseline to End of Follow-Up (0, 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2018.