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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Other: Early Palliative Care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mette Nissen, MD; Phone Number: +45 38686167; Email: mette.nissen.01@regionh.dk
• Study Contact Backup: Name: Inna M Chen, MD; Phone Number: +45 38682898; Email: Inna.Chen@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Recruiting
    • Herlev & Gentofte University Hospital, Denmark
    • Contact: Mette Nissen, MD; Phone Number: +45 38686167; Email: mette.nissen.01@regionh.dk
    • Contact: Inna M Chen, MD; Phone Number: +45 38682898; Email: Inna.Chen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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. Referral to exercise training and nutritional specialist.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Inna Chen, MD
• Collaborators: Odense University Hospital; Zealand University Hospital; Aarhus University Hospital; Rigshospitalet, Denmark; Hvidovre University Hospital; Bispebjerg Hospital; Herning Hospital; Vejle Hospital; Hillerod Hospital, Denmark; Aalborg University Hospital
• Investigators: Principal Investigator: Mette Nissen, MD, Herlev & Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Pancreatic cancer; Early palliative care; Specialized palliative care
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: GI 2031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No