Heart and Blood Diseases

All Conditions

Rare Diseases

Heart Failure

Heart Diseases

Chronic Graft Versus Host Disease

Those patients who received specialised palliative care on a palliative care unit.(palliative care unit)

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)

Those patients who received specialised palliative care at home from an outpatient palliative care consultation team. (outpatient palliative care consultation team)

specialized palliative care provided in different settings

specialized palliative care

Philipp Lenz, PD Dr. med.

Marc Theisen, Dr. med.

Anne Bremer, Dr. med.

Ulrike Hofmeister, Dr. med.

Dirk Domagk, Prof. Dr. med.

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.

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.

Palliative Outcome Evaluation Muenster I

Assessment of Palliative Care in Inpatient and Outpatient Settings Using the Integrated Palliative Care Outcome Scale: a Multi-centric Observational Study

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.

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).

St. Franziskus Hospital

Raphaelsklinik Münster

Josephs Hospital Warendorf

Palliativnetz Muenster gGmbH

University Hospital Muenster

Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Baseline palliative care visit within 10 calendar days of registration/randomization and palliative care visits (either at clinic or at home) or phone calls (if a visit is not feasible) at least every four weeks throughout the patient's life. Referral to exercise training and nutritional specialist.

Palliative care visit only upon request from attending oncologist(s) or patient/family.

Baseline palliative care visit Palliative care visits/calls at least every 4 weeks throughout life and additionally upon request Referral to exercise training Referral to nutritional specialist

Early Palliative Care

Mette Nissen, MD

Inna M Chen, MD

Pancreatic adenocarcinoma is one of the deadliest cancers. Patients with pancreatic cancer experience marked physical suffering, psychological distress and resource-demanding care at the end-of-life. Therefore, an urgent need exists to evaluate the early specialized palliative care model in a comparative study and across multiple care settings to define quality of life and survival benefits in patients with pancreatic cancer.

Pancreatic adenocarcinoma is one of the deadliest cancers. Approximately half of the patients diagnosed with advanced pancreatic cancer die within 2 months from the diagnosis. Patients eligible for systemic treatment have a median survival of less than one year and often receive limited benefit from chemotherapy, usually with progression of disease after only a few months of treatment. Patients with pancreatic cancer experience marked physical suffering, psychological distress and resource-demanding care at the end-of-life. Complications such as pain, fatigue, malnutrition, cachexia, exocrine insufficiency and diagnosis itself lead to a poor quality of life and are associated with high rates of depression and anxiety.

These invalidating symptoms are best alleviated by attachment to specialized palliative care and by starting this support early in the course of the disease and not just in the terminal phase. Early implementation of specialized palliative care is not a standard of care in Denmark.

Thus, an urgent need exists to evaluate the early, integrated palliative care model in a comparative study and across multiple care settings to define quality of life and survival benefits for patients with pancreatic cancer in Denmark.

Early Palliative Care for Patients With Advanced Pancreatic Cancer.

Early Palliative Care for Patients With Advanced Pancreatic Cancer (EarlyCarePan).

Adjusted mean change from baseline in global health status/QoL score from the EORTC QLQ-C30 questionnaire at 12 weeks.

Overall survival after randomization, defined as the time from randomization to death from any cause.

Adjusted mean change from baseline in global health status/QoL score from the EORTC QLQ-C30 questionnaire at 6 and 24 weeks.

Adjusted mean change from baseline in functional and symptom scales from the EORTC QLQ-C30 questionnaire at 6, 12 and 24 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Palliative Outcome Evaluation Muenster I	NCT03286127	Cancer Chronic Heart F... COPD Exacerbati... Palliative Care	specialized pal...	18 Years -	University Hospital Muenster
Early Palliative Care for Patients With Advanced Pancreatic Cancer.	NCT04632303	Pancreatic Canc...	Early Palliativ...	18 Years -	Herlev Hospital
Early Palliative Care for Patients With Advanced Pancreatic Cancer.	NCT04632303	Pancreatic Canc...	Early Palliativ...	18 Years -	Herlev Hospital
Palliative Outcome Evaluation Muenster I	NCT03286127	Cancer Chronic Heart F... COPD Exacerbati... Palliative Care	specialized pal...	18 Years -	University Hospital Muenster

Spots Global Cancer Trial Database for specialized palliative care