Early Palliative Care for Patients With Advanced Pancreatic Cancer.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Other: Early Palliative Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult males and females (aged 18 and over) Confirmed by cytology or histology incurable PDAC who are planned to receive medical care for cancer in the first-line setting at the enrolling institution within ≤ 2 weeks Written informed consent before any study procedures Performance status: ECOG 0-2 Ability to read and respond to questions or able to complete questions with minimal assistance required from an interpreter or family member Planning to receive all medical care for cancer at the enrolling institution. Exclusion Criteria: Patients who are already receiving care from the palliative care service are not eligible for participation in the study Exhibiting signs of overt psychopathology or cognitive dysfunction Any medical condition that the Investigator considers significant to compromise the safety of the patient or that impairs the interpretation of study assessments Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention. Participation in protocols related only to treatment will not preclude participation in the present study. Cases of doubt will be settled by the protocol responsible.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Palliative Care<br>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. | Other: Early Palliative Care<br>* 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<br>|
| No Intervention: Standard Care Arm<br>Palliative care visit only upon request from attending oncologist(s) or patient/family. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, Early palliative care, Specialized palliative care