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| Name | Class |
|---|---|
| Bispebjerg Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
| Hvidovre University Hospital | OTHER |
| Odense University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Palliative Care | Experimental | 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. |
|
| Standard Care Arm | No Intervention | Palliative care visit only upon request from attending oncologist(s) or patient/family. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Palliative Care | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted mean change in global health status/QoL score at 12 weeks | Adjusted mean change from baseline in global health status/QoL score from the EORTC QLQ-C30 questionnaire at 12 weeks. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival after randomization, defined as the time from randomization to death from any cause. | 1 year |
| Adjusted mean change from baseline in global health status/QoL at 6 and 24 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mette Nissen, MD | Herlev & Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev & Gentofte University Hospital, Denmark | Herlev | 2730 | Denmark |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| OTHER |
| Aalborg University Hospital | OTHER |
| Aarhus University Hospital | OTHER |
| Vejle Hospital | OTHER |
| Zealand University Hospital | OTHER |
| Hillerod Hospital, Denmark | OTHER |
| Herning Hospital | OTHER |
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Adjusted mean change from baseline in global health status/QoL score from the EORTC QLQ-C30 questionnaire at 6 and 24 weeks.
| 24 weeks |
| Adjusted mean change from baseline in functional and symptom scales at 6, 12 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. | 24 weeks |
| Chemotherapy dose intensity. | Chemotherapy dose intensity. | 24 weeks |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |