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Active, Not Recruiting

NCT Number: NCT04632303

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev & Gentofte University Hospital, Denmark

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Adjusted mean change in global health status/QoL score at 12 weeks

    Time frame: 12 weeks

    Adjusted mean change from baseline in global health status/QoL score from the EORTC QLQ-C30 questionnaire at 12 weeks.

Secondary outcomes

  1. Overall survival

    Time frame: 1 year

    Overall survival after randomization, defined as the time from randomization to death from any cause.

  2. Adjusted mean change from baseline in global health status/QoL at 6 and 24 weeks.

    Time frame: 24 weeks

    Adjusted mean change from baseline in global health status/QoL score from the EORTC QLQ-C30 questionnaire at 6 and 24 weeks.

  3. Adjusted mean change from baseline in functional and symptom scales at 6, 12 and 24 weeks

    Time frame: 24 weeks

    Adjusted mean change from baseline in functional and symptom scales from the EORTC QLQ-C30 questionnaire at 6, 12 and 24 weeks.

  4. Chemotherapy dose intensity.

    Time frame: 24 weeks

    Chemotherapy dose intensity.

Sponsors and collaborators

Lead sponsor

Inna Chen, MD

Other

Collaborators

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

Registry information

Official study title

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

Acronym: EarlyCarePan

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Nov 17, 2020
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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