Early Palliative Care for Patients With Advanced Pancreatic Cancer.

NCT ID: NCT04632303

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-23
• Study Completion Date: 2026-11-30

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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. Referral to exercise training and nutritional specialist.

Group Type: EXPERIMENTAL

Early Palliative Care

Intervention Type: 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

Standard Care Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Vejle Hospital

OTHER

Sponsor Role: collaborator

Zealand University Hospital

OTHER

Sponsor Role: collaborator

Hillerod Hospital, Denmark

OTHER

Sponsor Role: collaborator

Herning Hospital

OTHER

Sponsor Role: collaborator

Inna Chen, MD

OTHER

Sponsor Role: lead

Responsible Party

Inna Chen, MD

Senior physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mette Nissen, MD

Role: PRINCIPAL_INVESTIGATOR

Herlev & Gentofte Hospital

Locations

Herlev & Gentofte University Hospital, Denmark

Herlev, , Denmark

Countries

Denmark

Other Identifiers

GI 2031

Identifier Type: -

Identifier Source: org_study_id