Early Palliative Care for Patients With Advanced Pancreatic Cancer.

Pancreatic Cancer Clinical Trial

— EarlyCarePan  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04632303
• Other study ID #: GI 2031
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2023
• Source: Herlev Hospital
• Contact: Mette Nissen, MD
• Phone: +45 38686167
• Email: mette.nissen.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Herlev & Gentofte University Hospital, Denmark	Herlev

Sponsors (11)

Lead Sponsor	Collaborator
Inna Chen, MD	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

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	Overall survival after randomization, defined as the time from randomization to death from any cause.	1 year
Secondary	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
Secondary	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
Secondary	Chemotherapy dose intensity.	Chemotherapy dose intensity.	24 weeks