Early Palliative Care For Patients With Advanced Pancreatic Cancer.

Study Overview

Early Palliative Care for Patients With Advanced Pancreatic Cancer.

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.

Pancreatic Cancer

OTHER: Early Palliative Care

GI 2031

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-11-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-09-08
First Submitted that Met QC Criteria 2020-11-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-09-12
First Posted (ESTIMATED) 2020-11-17	Results First Posted N/A	Last Verified 2025-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Early Palliative Care 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. Referra	OTHER: Early Palliative Care 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
NO_INTERVENTION: Standard Care Arm Palliative care visit only upon request from attending oncologist(s) or patient/family.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Early Palliative Care

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. Referra

OTHER: Early Palliative Care

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

NO_INTERVENTION: Standard Care Arm

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

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Bispebjerg Hospital
Rigshospitalet, Denmark
Hvidovre University Hospital
Odense University Hospital
Aalborg University Hospital
Aarhus University Hospital
Vejle Hospital
Zealand University Hospital
Hillerod Hospital, Denmark
Herning Hospital

Investigators

PRINCIPAL_INVESTIGATOR: Mette Nissen, MD, Herlev & Gentofte Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record