Clinical trial NCT04632303: Early Palliative Care for Patients with Advanced Pancreatic Cancer.
Official title: Early Palliative Care for Patients with Advanced Pancreatic Cancer (EarlyCarePan).
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
Early palliative care
Specialized palliative care
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
name: Rigshospitalet, Denmark
name: Hvidovre University Hospital
name: Odense University Hospital
name: Aalborg University Hospital
name: Aarhus University Hospital
name: Vejle Hospital
name: Zealand University Hospital
name: Hillerod Hospital, Denmark
name: Herning Hospital
First posted: 2020-11-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adjusted mean change in global health status/QoL score at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: 1 year
measure: Adjusted mean change from baseline in global health status/QoL at 6 and 24 weeks.
timeFrame: 24 weeks
measure: Adjusted mean change from baseline in functional and symptom scales at 6, 12 and 24 weeks
timeFrame: 24 weeks
measure: Chemotherapy dose intensity.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev & Gentofte University Hospital, Denmark
Study officials:
affiliation: Herlev & Gentofte Hospital
name: Mette Nissen, MD
role: PRINCIPAL_INVESTIGATOR
References: