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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04632303
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : July 28, 2021
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Inna Chen, MD, Herlev Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Other: Early Palliative Care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Early Palliative Care for Patients With Advanced Pancreatic Cancer (EarlyCarePan).
Actual Study Start Date : June 23, 2021
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04632303


Contacts
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Contact: Mette Nissen, MD +45 38686167 mette.nissen.01@regionh.dk
Contact: Inna M Chen, MD +45 38682898 Inna.Chen@regionh.dk

Locations
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Denmark
Herlev & Gentofte University Hospital, Denmark Recruiting
Herlev, Denmark, 2730
Contact: Mette Nissen, MD    +45 38686167    mette.nissen.01@regionh.dk   
Contact: Inna M Chen, MD    +45 38682898    Inna.Chen@regionh.dk   
Sponsors and Collaborators
Inna Chen, MD
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
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Principal Investigator: Mette Nissen, MD Herlev & Gentofte Hospital
More Information
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Responsible Party: Inna Chen, MD, Senior physician, Herlev Hospital
ClinicalTrials.gov Identifier: NCT04632303    
Other Study ID Numbers: GI 2031
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inna Chen, MD, Herlev Hospital:
Pancreatic cancer
Early palliative care
Specialized palliative care
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases